LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC ...

TÜV NORD CERT GmbHLangemarckstraße 2045141 EssenGermany

0044 *MD 1300 - Monitoring devices

- *MD 1301 - Monitoring devices of non-vital

physiological parameters

- *MD 1302 - Monitoring devices of vital physiological

parameters

*MD 1400 - Devices for radiation therapy and thermo

therapy

- *MD 1401 - Devices utilising ionizing radiation

- *MD 1402 - Devices utilising non-ionizing radiation

Full quality assurance

system

EC type-examination

EC verification

Production quality

assurance

Product quality assurance

Annex II

Annex III

Annex IV

Annex V

Annex VI

*MD 0100 - General non-active, non-implantable

medical devices

- *MD 0102 - Non-active devices for injection, infusion,

transfusion and dialysis

- *MD 0101 - Non-active devices for anaesthesia,

emergency and intensive care

- *MD 0103 - Non-active orthopaedic and rehabilitation

devices

- *MD 0104 - Non-active medical devices with

measuring function

- *MD 0105 - Non-active ophthalmologic devices

- *MD 0106 - Non-active instruments

- *MD 0107 - Contraceptive medical devices

- *MD 0108 - Non-active medical devices for

disinfecting, cleaning, rinsing

- *MD 0109 - Non-active devices for in vitro fertilisation

(IVF) and assisted reproductive technologies (ART)

*MD 0200 - Non-active implants


system

Production quality

assurance


Annex II

Annex V

Annex VI

Creation Date : 18/01/2018

LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notifiedbodies

ID Responsible for the following products/Horizontal technical competence

Responsible for thefollowing procedures

or modules

Annexes orarticles of the

directives

Limitations (English only)

1 / 344

- *MD 0201 - Non-active cardiovascular implants

- *MD 0202 - Non-active orthopaedic implants

- *MD 0203 - Non-active functional implants

- *MD 0204 - Non-active soft tissue implants

*MD 0300 - Devices for wound care

- *MD 0301 - Bandages and wound dressings

- *MD 0302 - Suture material and clamps

- *MD 0303 - Other medical devices for wound care

*MD 0400 - Non-active dental devices and accessories

- *MD 0401 - Non-active dental equipment and

instruments

- *MD 0402 - Dental materials

- *MD 0403 - Dental implants

*MD 1100 - General active medical devices

- *MD 1101 - Devices for extra-corporal circulation,

infusion and haemopheresis

- *MD 1102 - Respiratory devices, devices including

hyperbaric chambers for oxygen therapy, inhalation

anaesthesia

- *MD 1103 - Devices for stimulation or inhibition

- *MD 1104 - Active surgical devices

- *MD 1105 - Active ophthalmologic devices

- *MD 1106 - Active dental devices

- *MD 1107 - Active devices for disinfection and

sterilisation

- *MD 1108 - Active rehabilitation devices and active


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


2 / 344

prostheses

- *MD 1109 - Active devices for patient positioning and

transport


- *MD 1111 - Software

EC type-examination

EC verification

EC declaration of

conformity (full quality

assurance system)

EC declaration of

conformity (production

quality assurance)

EC declaration of

conformity (product quality

assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI

*MD 1200 - Devices for imaging

- *MD 1201 - Imaging devices utilising ionizing

radiation

- *MD 1202 - Imaging devices utilising non-ionizing

radiation


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


medical devices

- *MD 0110 - Non-active medical devices for ingestion

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI






or modules


directives


3 / 344

EC declaration of


assurance)


- *MD 1112 - Medical gas supply systems and parts

thereof

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI

*MDS 7001 - Medical devices incorporating medicinal

substances, according to Directive 2001/83/EC

*MDS 7002 - Medical devices utilising tissues of animal

origin, including Regulation 722/2012 (Directive

2003/32/EC up to 28.08.2013)

without medical devices according

to Commission Regulation (EU) No

722/2012

*MDS 7004 - Medical devices referencing the Directive

2006/42/EC on machinery

*MDS 7006 - Medical devices in sterile condition Including ethylene oxide gas

sterilisation (EOG), moist heat

sterilisation, radiation sterilisation

(gamma, x-ray, electron beam),

low temperature steam and

formaldehyde sterilisation, thermic

sterilisation with dry heat






or modules


directives


4 / 344

*MDS 7008 - Medical devices utilising nanomaterials

*MDS 7009 - Medical devices utilising biological active

coatings and/or materials or being wholly or mainly

absorbed

*MDS 7010 - Medical devices incorporating software

/utilising software /controlled by softwareNational Standards Authority of Ireland (NSAI)1 Swift Square, Northwood, SantryDublin 9Ireland

0050 *MD 0100 - General non-active, non-implantable

medical devices






devices


measuring function












EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI






or modules


directives


5 / 344








instruments








anaesthesia





sterilisation


transport









or modules


directives


6 / 344

prostheses



radiation


radiation

*MD 1300 - Monitoring devices




parameters


therapy


- *MD 1403 - Devices for hyperthermia / hypothermia

- *MD 1404 - Devices for (extracorporal) shock-wave

therapy (lithotripsy)





2003/32/EC up to 28.08.2013)

*MDS 7003 - Medical devices incorporating derivates of

human blood, according to Directive 2000/70/EC,

amended by Directive 2001/104/EC








or modules


directives


7 / 344

*MDS 7006 - Medical devices in sterile condition

*MDS 7007 - Medical devices utilising micromechanics



absorbed


/utilising software /controlled by softwareIMQ ISTITUTO ITALIANO DEL MARCHIO DIQUALITÀ S.P.A.Via Quintiliano, 4320138 - MILANOItaly


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

exclusion medical devices class III


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


EC declaration of


assurance system)

Annex II

Annex V

Annex VI







or modules


directives


8 / 344

devices EC declaration of


quality assurance)

EC declaration of


assurance)


medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


9 / 344


quality assurance)

EC declaration of


assurance)


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


10 / 344

quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




instruments

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI







or modules


directives


11 / 344

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


12 / 344

quality assurance)

EC declaration of


assurance)




anaesthesia

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI

*MD 1100 - General active medical devices EC type-examination Annex III






or modules


directives


13 / 344

- *MD 1104 - Active surgical devices EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex IV

Annex II

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


14 / 344

quality assurance)

EC declaration of


assurance)



sterilisation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



prostheses

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI

*MD 1100 - General active medical devices EC type-examination Annex III






or modules


directives


15 / 344


transport

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex IV

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



radiation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


16 / 344


assurance)



radiation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



parameters

EC type-examination

EC verification

EC declaration of

Annex III

Annex IV

Annex II






or modules


directives


17 / 344


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI


therapy


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


therapy


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


18 / 344


assurance)


therapy


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


therapy



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



thereof

EC type-examination

EC verification

EC declaration of

Annex III

Annex IV

Annex II






or modules


directives


19 / 344


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI



*MDS 7006 - Medical devices in sterile condition Including aseptic processing,

ethylene oxide gas sterilisation

(EOG), low temperature steam

sterilisation, moist heat


(gamma, x-ray, electron beam)


/utilising software /controlled by softwareMit International Testing S.r.l.Via G.Leopardi, 1420123 - Milano (MI)Italy


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III Medical Devices

*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III Medical Devices






or modules


directives


20 / 344

medical devices




assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI


medical devices


measuring function

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex IV

Annex II

Annex V

Annex VI



medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III Medical Devices






or modules


directives


21 / 344

medical devices



assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


Annex II

Annex V







or modules


directives


22 / 344

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



instruments

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

Annex II

Annex V

Annex VI







or modules


directives


23 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





anaesthesia

EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI


and hyperbaric chambers



EC verification

EC declaration of


Annex IV

Annex II

Annex V







or modules


directives


24 / 344

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC type-examination

EC declaration of

Annex III

Annex II







or modules


directives


25 / 344

sterilisation conformity (full quality

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI



prostheses

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI







or modules


directives


26 / 344



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


*MD 1300 - Monitoring devices EC declaration of Annex II Excluding class III Medical Devices






or modules


directives


27 / 344


parameters


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI


therapy


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI







or modules


directives


28 / 344



thereof

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




/utilising software /controlled by softwareBSIKitemark Court Davy Avenue KnowlhillMilton Keynes MK5 8PPUnited Kingdom


medical devices






devices


measuring function







system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


29 / 344




medical devices


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI












instruments



system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


30 / 344







anaesthesia






sterilisation


prostheses


transport

- *MD 1110 - Active devices for in vitro fertilisation

(IVF) and assisted reproductive therapy (ART)




thereof

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


31 / 344

quality assurance)

EC declaration of


assurance)



radiation


radiation





parameters


therapy







system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI





2003/32/EC up to 28.08.2013)







or modules


directives


32 / 344










absorbed


/utilising software /controlled by softwareLLOYD'S REGISTER QUALITY ASSURANCELTD (0088)1 Trinity Park Bickenhill LaneBirmingham B37 7ESUnited Kingdom


medical devices






devices


measuring function







system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


33 / 344














instruments








anaesthesia










or modules


directives


34 / 344


sterilisation


prostheses


transport






radiation


radiation





parameters


therapy












or modules


directives


35 / 344




2003/32/EC up to 28.08.2013)






absorbedSGS United Kingdom LimitedUnit 202B, Worle Parkway,Weston-super-Mare, Somerset, BS22 6WAUnited Kingdom

0120 *MD 1100 - General active medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




anaesthesia


system

Production quality

assurance


Annex II

Annex V

Annex VI



EC declaration of


assurance system)

Annex II

Annex V

Annex VI






or modules


directives


36 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI



sterilisation


system

Production quality

assurance


Annex II

Annex V

Annex VI

*MD 1100 - General active medical devices Full quality assurance Annex II






or modules


directives


37 / 344


prostheses

system

Production quality

assurance


Annex V

Annex VI



transport


system

Production quality

assurance


Annex II

Annex V

Annex VI





system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI



radiation


system

Production quality

assurance


Annex II

Annex V

Annex VI



radiation


system

Production quality

Annex II

Annex V

Annex VI






or modules


directives


38 / 344

assurance





EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



parameters

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


therapy



system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy



system

Production quality

Annex II

Annex V






or modules


directives


39 / 344

assurance


Annex VI


therapy



system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


40 / 344


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


devices


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


measuring function


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


system

Annex II

Annex V






or modules


directives


41 / 344

- *MD 0106 - Non-active instruments Production quality

assurance


Annex VI


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI

Excluding Breast Implants






or modules


directives


42 / 344




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI



instruments


system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Annex II

Annex V






or modules


directives


43 / 344

Production quality

assurance


Annex VI


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



thereof

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





2003/32/EC up to 28.08.2013)








or modules


directives


44 / 344





absorbed


/utilising software /controlled by softwareTÜV SÜD Product Service GmbHZertifizierstellenRidlerstraße 6580339 MÜNCHENGermany

0123 *MD 0300 - Devices for wound care






instruments




system

Production quality

assurance


Annex II

Annex V

Annex VI






anaesthesia






system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


45 / 344


sterilisation


prostheses


transport





EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



radiation


radiation






system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


46 / 344

parameters


therapy







medical devices






medical devices


devices


measuring function







system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


system

Annex II

Annex III






or modules


directives


47 / 344





EC type-examination

EC verification

Production quality

assurance


Annex IV

Annex V

Annex VI






system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




thereof

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI





2003/32/EC up to 28.08.2013)







or modules


directives


48 / 344







(EOG), moist heat sterilisation,

radiation sterilisation (gamma,

x-ray, electron beam), low

temperature steam and

formaldehyde sterilisation,

sterilisation with hydrogen

peroxide, thermic sterilisation with

dry heat, sterilisation with liquid

sterilants





absorbed


/utilising software /controlled by softwareDEKRA Certification GmbHHandwerkstraße 1570565 STUTTGARTGermany

0124 *MD 0200 - Non-active implants






system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


49 / 344







instruments






EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




anaesthesia


system

Production quality

assurance


Annex II

Annex V

Annex VI





EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI






or modules


directives


50 / 344

- *MD 1106 - Active dental devices conformity (production

quality assurance)

EC declaration of


assurance)



sterilisation


prostheses


system

Production quality

assurance


Annex II

Annex V

Annex VI



transport




radiation


radiation





parameters

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


therapy



system

Production quality

Annex II

Annex V

Annex VI






or modules


directives


51 / 344

assurance



therapy





EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices






devices


measuring function




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI






or modules


directives


52 / 344


quality assurance)

EC declaration of


assurance)


medical devices






system

Production quality

assurance


Annex II

Annex V

Annex VI



thereof

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





2003/32/EC up to 28.08.2013)









or modules


directives


53 / 344









dry heat




absorbed


/utilising software /controlled by softwareTÜV Rheinland LGA Products GmbHTillystraße 290431 NürnbergGermany




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI





system

Production quality

assurance


Annex II

Annex V

Annex VI

*MD 0200 - Non-active implants Full quality assurance Annex II






or modules


directives


54 / 344

- *MD 0204 - Non-active soft tissue implants system

EC type-examination

EC verification

Production quality

assurance


Annex III

Annex IV

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI



instruments


system

EC type-examination

Annex II

Annex III

Annex IV






or modules


directives


55 / 344

EC verification

Production quality

assurance


Annex V

Annex VI





system

Production quality

assurance


Annex II

Annex V

Annex VI



transport





anaesthesia






sterilisation


prostheses




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


56 / 344



medical devices




devices


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


measuring function



system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI

*MD 0100 - General non-active, non-implantable Full quality assurance Annex II






or modules


directives


57 / 344

medical devices







system

Production quality

assurance


Annex V

Annex VI



radiation


radiation





parameters


therapy







system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


medical devices


EC declaration of


assurance system)

Annex II

Annex V

Annex VI






or modules


directives


58 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)



thereof

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI





2003/32/EC up to 28.08.2013)



for active medical devices only










or modules


directives


59 / 344

electron beam), low temperature

steam and formaldehyde

sterilisation, sterilisation with

hydrogen peroxide, thermic

sterilisation with dry heat,

sterilisation by liquid chemical

sterilants





absorbed


/utilising software /controlled by softwareDQS Medizinprodukte GmbHAugust-Schanz-Straße 2160433 FRANKFURT AM MAINGermany

0297 *MD 1200 - Devices for imaging


radiation


system

Production quality

assurance


Annex II

Annex V

Annex VI



radiation


system

Production quality

assurance


Annex II

Annex V

Annex VI





system

Production quality

Annex II

Annex V

Annex VI






or modules


directives


60 / 344

assurance




parameters


system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy



system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy



system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance

Annex II

Annex V







or modules


directives


61 / 344

medical devices



system

Production quality

assurance

Annex V


medical devices


devices


system

Production quality

assurance

Annex II

Annex V


medical devices


measuring function


system

Production quality

assurance

Annex II

Annex V


medical devices



system

Production quality

assurance

Annex II

Annex V


medical devices



system

Production quality

assurance

Annex II

Annex V


medical devices




system

Production quality

assurance

Annex II

Annex V




system

Production quality

assurance

Annex II

Annex V

vascular implants only






or modules


directives


62 / 344




system

Production quality

assurance

Annex II

Annex V




system

Production quality

assurance

Annex II

Annex V




system

Production quality

assurance

Annex II

Annex V




system

Production quality

assurance

Annex II

Annex V




system

Production quality

assurance

Annex II

Annex V




system

Production quality

assurance

Annex II

Annex V



instruments


system

Production quality

Annex II

Annex V






or modules


directives


63 / 344

assurance




system

Production quality

assurance

Annex II

Annex V




system

Production quality

assurance

Annex II

Annex V




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI



sterilisation


system

Production quality

Annex II

Annex V

Annex VI






or modules


directives


64 / 344

assurance




prostheses


system

Production quality

assurance


Annex II

Annex V

Annex VI



transport


system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI





system

Production quality

assurance


Annex II

Annex V

Annex VI




anaesthesia


system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


65 / 344




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



thereof

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V








or modules


directives


66 / 344



2003/32/EC up to 28.08.2013)












dry heat





absorbed


/utilising software /controlled by softwareAGENCIA ESPAÑOLA DE MEDICAMENTOSY PRODUCTOS SANITARIOSCampezo 1. Edificio 828022 MADRIDSpain



radiation


radiation


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


67 / 344




parameters


therapy







medical devices






devices


measuring function








quality assurance)

EC declaration of


assurance)






or modules


directives


68 / 344













instruments








sterilisation


prostheses


transport







or modules


directives


69 / 344







anaesthesia






2003/32/EC up to 28.08.2013)




89/686/EEC on personal protective equipment (PPE)






absorbedDEKRA Certification B.V.Meander 1051 / P.O. Box 51856825 MJ ARNHEM / 6802 ED ARNHEMNetherlands


medical devices



EC type-examination

EC verification

EC declaration of


Annex III

Annex IV

Annex II

Annex V






or modules


directives


70 / 344




devices


measuring function



















instruments


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI






or modules


directives


71 / 344




radiation


radiation





parameters


therapy











anaesthesia









or modules


directives


72 / 344



sterilisation


prostheses


transport





thereof





2003/32/EC up to 28.08.2013)
















or modules


directives


73 / 344

absorbed


/utilising software /controlled by softwareISTITUTO SUPERIORE DI SANITA'Viale Regina Elena, 29900161 - ROMAItaly


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


medical devices


devices

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

*MD 0100 - General non-active, non-implantable EC type-examination Annex III Annex III limited to ophthalmic






or modules


directives


74 / 344

medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

solutions


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

*MD 0100 - General non-active, non-implantable EC declaration of Annex II






or modules


directives


75 / 344

medical devices



assurance system)

EC declaration of


quality assurance)

Annex V



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex III

Annex II

Annex V

Annex III limited to injectable

visco-elastic solutions for

intra-articular use



EC type-examination

EC declaration of


assurance system)

Annex III

Annex II

Annex V

Annex III limited intradermal fillers






or modules


directives


76 / 344

EC declaration of


quality assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



instruments

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II






or modules


directives


77 / 344

- *MD 0402 - Dental materials conformity (full quality

assurance system)

EC declaration of


quality assurance)

Annex V



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



EC declaration of


assurance system)

Annex II


therapy


EC type-examination

EC verification

Annex III

Annex IV

Limited to accelerator for hadron

therapy and related dose delivery

system





2003/32/EC up to 28.08.2013)



(EOG), low temperature steam,

moist heat sterilisation, radiation

sterelisation (gamma, electron

beam)






or modules


directives


78 / 344



absorbed


/utilising software /controlled by softwareRISE Research Institutes of Sweden ABBox 857501 15 BORASSweden



radiation


system

Production quality

assurance


Annex II

Annex V

Annex VI





system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


measuring function


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


system

Annex II

Annex V






or modules


directives


79 / 344


assurance


Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI

Bone-anchored implants for dental

and cranio-facial reconstruction



instruments


system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI

Bone-anchored implants for dental

and cranio-facial reconstruction




anaesthesia


system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance

Annex II

Annex V

Annex VI






or modules


directives


80 / 344




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices


devices

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI






or modules


directives


81 / 344


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

*MD 1100 - General active medical devices EC declaration of Annex II






or modules


directives


82 / 344

- *MD 1103 - Devices for stimulation or inhibition conformity (full quality

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


Annex II

Annex V






or modules


directives


83 / 344

prostheses assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

Annex II

Annex V

Annex VI






or modules


directives


84 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)





/utilising software /controlled by softwareTÜV AUSTRIA SERVICES GMBHDeutschstraße 101230 WIENAustria


medical devices



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


medical devices



EC type-examination

EC verification

EC declaration of


assurance system)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


85 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)


medical devices


devices

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


medical devices


measuring function

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


86 / 344


medical devices


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


medical devices


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


medical devices


EC type-examination

EC verification

EC declaration of


assurance system)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


87 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)


medical devices



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


medical devices



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


88 / 344



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI

neurological and neurosurgical

implants excluded



EC type-examination

EC verification

EC declaration of


assurance system)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


89 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


90 / 344



instruments

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


91 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




anaesthesia

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


92 / 344



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


93 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



sterilisation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


94 / 344



prostheses

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



transport

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


assurance system)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


95 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



radiation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


96 / 344



radiation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



parameters

EC type-examination

EC verification

EC declaration of


assurance system)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


97 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)


therapy


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


therapy


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


98 / 344


therapy


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


therapy



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI





2003/32/EC up to 28.08.2013)

tissues according directive

2003/32/EC excluded







or modules


directives


99 / 344










absorbed


/utilising software /controlled by softwareINTERTEK SEMKO ABTorshamnsgatan 43 Box 1103SE-164 22 KISTASweden


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices




devices


system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


100 / 344


measuring function
















instruments








anaesthesia

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI






or modules


directives


101 / 344






sterilisation


prostheses


transport




radiation


radiation





parameters


therapy




EC declaration of


assurance)






or modules


directives


102 / 344



*MDS 7006 - Medical devices in sterile conditionICIM S.P.A.Piazza Don Enrico Mapelli, 7520099 - Sesto San Giovanni (MI)Italy


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Exclusion of class III medical

devices


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices


medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI


devices






or modules


directives


103 / 344


assurance)


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI


devices






or modules


directives


104 / 344

assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



instruments

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices






or modules


directives


105 / 344



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices




anaesthesia

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices and hyperbaric chambers

*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical






or modules


directives


106 / 344

- *MD 1106 - Active dental devices conformity (full quality

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI

devices



sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



EC declaration of


Annex II

Annex V


devices






or modules


directives


107 / 344

physiological parameters assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



parameters

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



thereof

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



(EOG), low temperature steam and






or modules


directives


108 / 344

formaldehyde sterilisation, moist

heat sterilisation, radiation

sterilisation (gamma, x-ray,

electron beam), others (need to be

specified)


/utilising software /controlled by softwareITALCERT SRLViale Sarca, 33620126 - MILANOItaly

0426 *MD 1300 - Monitoring devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices


therapy


EC declaration of


assurance system)

Annex II

Annex V

Annex VI


devices






or modules


directives


109 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices, except surgically devices,

intended for transient use, in direct

contact with central nervous

system


medical devices


devices

EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI


devices






or modules


directives


110 / 344


quality assurance)

EC declaration of


assurance)


medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices


medical devices


EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI


devices






or modules


directives


111 / 344

quality assurance)

EC declaration of


assurance)


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI


devices






or modules


directives


112 / 344

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI


devices






or modules


directives


113 / 344


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



instruments

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI


devices






or modules


directives


114 / 344

assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices






or modules


directives


115 / 344




anaesthesia

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices

*MD 1100 - General active medical devices EC declaration of Annex II Exclusion of class III medical






or modules


directives


116 / 344

- *MD 1105 - Active ophthalmologic devices conformity (full quality

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI

devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



EC declaration of


Annex II

Annex V


devices






or modules


directives


117 / 344

prostheses assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



thereof

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



2003/32/EC up to 28.08.2013)

Exclusion of medical devices

utilising tissues of animal origin

under Commission Regulation






or modules


directives


118 / 344

(EU) n. 722/2012







absorbed


/utilising software /controlled by softwareLaboratoire national de métrologie et d'essais /G-MED1, rue Gaston Boissier75724 PARIS Cedex 15France


medical devices






devices


measuring function









system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


119 / 344


medical devices













instruments








anaesthesia




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


120 / 344



sterilisation


prostheses


transport





EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI



thereof



radiation


radiation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


121 / 344





parameters


therapy






EC declaration of


assurance)





2003/32/EC up to 28.08.2013)



*MDS 7006 - Medical devices in sterile condition Chemical sterilization/Dry heat

sterilization/Hydrogen peroxid with

or without plasma process

sterilization/Ultra High

Temperature Infusion sterilization

process








or modules


directives


122 / 344



absorbed


/utilising software /controlled by softwareAMTAC CERTIFICATION SERVICES LTDDavy Avenue, KnowlhillMilton Keynes MK5 8NLUnited Kingdom




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI

Excluding breast implants




system

Annex II

Annex V






or modules


directives


123 / 344

instruments Production quality

assurance


Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI

Excluding Class III




system

Production quality

assurance


Annex II

Annex V

Annex VI

Excluding Class III


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI






or modules


directives


124 / 344

EC declaration of


assurance)


medical devices


devices

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI






or modules


directives


125 / 344


assurance)


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding Class III


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI






or modules


directives


126 / 344

assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





2003/32/EC up to 28.08.2013)

*MDS 7006 - Medical devices in sterile conditionKIWA CERMET ITALIA S.P.A.Via Cadriano, 2340057 - Cadriano di Granarolo (BO)Italy



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III medical devices,

except hip, knee and shoulder joint

replacements.



EC declaration of


assurance system)

Annex II

Annex V

Annex VI

Excluding class III medical devices






or modules


directives


127 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


128 / 344


quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


129 / 344

quality assurance)

EC declaration of


assurance)



instruments

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI


except surgically devices, intended

for transient use, in direct contact

with central nervous system






or modules


directives


130 / 344

EC declaration of


assurance)


medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


131 / 344


assurance)


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


132 / 344

assurance)




anaesthesia

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


and hyperbaric chambers for

oxygen therapy



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI







or modules


directives


133 / 344



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices






or modules


directives


134 / 344


prostheses


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI



transport

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


Annex II

Annex V


and devices for magnetic






or modules


directives


135 / 344

radiation assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI resonance




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




parameters

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



therapy


EC declaration of


assurance system)

Annex II

Annex V

Annex VI







or modules


directives


136 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)


therapy



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





*MDS 7006 - Medical devices in sterile condition Excluding class III medical devices,

except surgically devices, intended

for transient use, in direct contact

with central nervous system; hip,

knee and shoulder joint

replacementsEurofins Product Testing Italy S.r.l.Via Courgnè, 2110156 - TORINO (TO)Italy


medical devices



EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


137 / 344

quality assurance)

EC declaration of


assurance)


medical devices



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



medical devices


devices

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


measuring function

EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


138 / 344


quality assurance)

EC declaration of


assurance)


medical devices


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



medical devices


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


*MD 0100 - General non-active, non-implantable EC type-examination Annex III Excluding class III medical devices






or modules


directives


139 / 344

medical devices


EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex IV

Annex II

Annex V

Annex VI


medical devices



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


140 / 344


assurance)



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of

Annex III

Annex IV

Annex II







or modules


directives


141 / 344


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




instruments

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex III

Annex IV

Annex II

Annex V

Annex VI







or modules


directives


142 / 344


assurance)



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI





EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


143 / 344


quality assurance)

EC declaration of


assurance)




anaesthesia

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Only class IIa medical devices



EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


144 / 344

quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI







or modules


directives


145 / 344

EC declaration of


assurance)



prostheses

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




transport

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


146 / 344


assurance)



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


and devices for magnetic

resonance




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


147 / 344

assurance)


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



therapy



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI







or modules


directives


148 / 344





89/686/EEC on personal protective equipment (PPE)


*MDS 7006 - Medical devices in sterile condition Excluding class III medical devicesecm-Zertifizierungsgesellschaft fürMedizinprodukte in Europa mbHBismarckstraße 10652066 AachenGermany




system

EC type-examination

Production quality

assurance


Annex II

Annex III

Annex V

Annex VI

Only stents, implantable catheters,

vascular grafts, occlusion systems




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI

Only introcular lenses




system

Production quality

assurance


Annex II

Annex V

Annex VI







or modules


directives


149 / 344

medical devices



system

Production quality

assurance


Annex V

Annex VI


medical devices




system

EC type-examination

Production quality

assurance


Annex II

Annex III

Annex V

Annex VI

Annex III: Only infusion sets,

transfusion sets, catheters, tubing

systems for extra-corporal

circulation


medical devices


devices


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


measuring function


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


system

Annex II

Annex V






or modules


directives


150 / 344


assurance


Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance

Annex II

Annex V

Annex VI






or modules


directives


151 / 344





system

Production quality

assurance


Annex II

Annex V

Annex VI



instruments


system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI






or modules


directives


152 / 344

EC declaration of


assurance)




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

only products, which are based on

spring tension (pre-loaded) or gas

release for pressure build-up, e.g.

drug dosers



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

only wound drainage systems and

accessories for HF surgery (e.g.

scissors, pliers)


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI

Only medical devices in small

pressure vessels (e.g. coolant

sprays) for localized application

and medical devices, where heat

or cold is generated by chemical or

physical processes (e.g. hot/cold

packs) for localized application






or modules


directives


153 / 344


assurance)





2003/32/EC up to 28.08.2013)

Only devices with existing TSE

Certificate of Suitability for the

starting materials issued by the

European Directorate for the

Qualits of Medicines (EDQM)










dry heat



absorbedMEDCERT ZERTIFIZIERUNGS- UNDPRÜFUNGSGESELLSCHAFT FÜR DIEMEDIZIN GMBHPilatuspool 220355 HAMBURGGermany


medical devices





EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex III

Annex II

Annex V

Annex VI






or modules


directives


154 / 344

EC declaration of


assurance)


medical devices


devices


measuring function



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices


EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI


medical devices





EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI






or modules


directives


155 / 344

EC declaration of


assurance)



EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC type-examination

EC declaration of


assurance system)

EC declaration of


Annex III

Annex II

Annex V

Annex VI






or modules


directives


156 / 344

quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI





EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI






or modules


directives


157 / 344


instruments


quality assurance)

EC declaration of


assurance)



EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI






anaesthesia






sterilisation


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI






or modules


directives


158 / 344

prostheses


transport




radiation


radiation





parameters


therapy







medical devices




thereof






or modules


directives


159 / 344





2003/32/EC up to 28.08.2013)



for active medical devices only










dry heat




absorbed


/utilising software /controlled by softwareMDC MEDICAL DEVICE CERTIFICATIONGMBHKriegerstrasse 670191 STUTTGARTGermany




system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


160 / 344



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

Annex II

Annex V

Annex VI






or modules


directives


161 / 344

assurance





system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy



system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


162 / 344


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


devices


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


measuring function


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


system

Annex II

Annex V






or modules


directives


163 / 344

- *MD 0105 - Non-active ophthalmologic devices Production quality

assurance


Annex VI


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI



radiation


system

Production quality

assurance


Annex II

Annex V

Annex VI



radiation


system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


164 / 344





system

Production quality

assurance


Annex II

Annex V

Annex VI



parameters


system

Production quality

assurance


Annex II

Annex V

Annex VI



instruments


system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Annex II

Annex V






or modules


directives


165 / 344

sterilisation Production quality

assurance


Annex VI



prostheses


system

Production quality

assurance


Annex II

Annex V

Annex VI



transport


system

Production quality

assurance


Annex II

Annex V

Annex VI



thereof

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI






or modules


directives


166 / 344

EC declaration of


assurance)




system

Production quality

assurance


Annex II

Annex V

Annex VI




anaesthesia


system

Production quality

assurance


Annex II

Annex V

Annex VI

except hyperbaric chambers




system

Production quality

assurance


Annex II

Annex V

Annex VI

except external pacemakers and

heart defibrillators




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance

Annex II

Annex V

Annex VI






or modules


directives


167 / 344





system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





2003/32/EC up to 28.08.2013)














or modules


directives


168 / 344




dry heat





absorbed


/utilising software /controlled by softwareSLG PRÜF UND ZERTIFIZIERUNGS GMBHBurgstädter Strasse 2009232 HartmannsdorfGermany




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI

excluding class III devices (valid for

the complete scope)




anaesthesia


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


the complete scope)




system

Annex II

Annex III


the complete scope)






or modules


directives


169 / 344

EC type-examination

EC verification

Production quality

assurance


Annex IV

Annex V

Annex VI




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


the complete scope)




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


the complete scope)



thereof

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


the complete scope)






or modules


directives


170 / 344

EC declaration of


assurance)



prostheses


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


the complete scope)



transport


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


the complete scope)




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


the complete scope)



radiation


system

EC type-examination

Annex II

Annex III


the complete scope)






or modules


directives


171 / 344

EC verification

Production quality

assurance


Annex IV

Annex V

Annex VI



radiation


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


the complete scope)





system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


the complete scope)



parameters


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


the complete scope)

*MD 1400 - Devices for radiation therapy and thermo Full quality assurance Annex II excluding class III devices (valid for






or modules


directives


172 / 344

therapy


system

EC type-examination

EC verification

Production quality

assurance


Annex III

Annex IV

Annex V

Annex VI

the complete scope)


therapy



system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


the complete scope)


therapy



system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


the complete scope)




/utilising software /controlled by softwareVTT Expert Services OyPO Box 345FI-33101 TampereFinland


medical devices

EC declaration of


assurance system)

Annex II

Annex V

Excluding class III






or modules


directives


173 / 344



EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



instruments

EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI

Excluding class III






or modules


directives


174 / 344


quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III




EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI

Excluding class III






or modules


directives


175 / 344

quality assurance)

EC declaration of


assurance)


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III


medical devices


devices

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI

Excluding class III






or modules


directives


176 / 344

EC declaration of


assurance)


medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI

Excluding class III






or modules


directives


177 / 344


assurance)


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI

Excluding class III






or modules


directives


178 / 344

assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III






or modules


directives


179 / 344



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



prostheses

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III

*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III






or modules


directives


180 / 344

- *MD 1111 - Software conformity (full quality

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



parameters

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III


therapy

EC declaration of


Annex II

Annex V

Excluding class III






or modules


directives


181 / 344

- *MD 1403 - Devices for hyperthermia / hypothermia assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



Excluding class III





heat sterilisation (gamma, x-ray,


specified)Presafe Denmark A/STuborg Parkvej 8DK-2900 HellerupDenmark


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices


EC declaration of


assurance system)

Annex II

Annex V

Annex VI






or modules


directives


182 / 344

transfusion and dialysis EC declaration of


quality assurance)

EC declaration of


assurance)


medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices


EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI






or modules


directives


183 / 344


quality assurance)

EC declaration of


assurance)


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI

Excluding orthopaedic implants ref.

2005/50/EEC and bone cement






or modules


directives


184 / 344

quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI






or modules


directives


185 / 344

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI






or modules


directives


186 / 344


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI






or modules


directives


187 / 344

assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




anaesthesia

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI






or modules


directives


188 / 344



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

*MD 1300 - Monitoring devices EC declaration of Annex II






or modules


directives


189 / 344




assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI



parameters

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI








or modules


directives


190 / 344



2003/32/EC up to 28.08.2013)

Only products not included in

Directive 2003/32/EC









absorbed


/utilising software /controlled by softwareCERTIQUALITY S.R.L. - ISTITUTO DICERTIFICAZIONE DELLA QUALITA'Via G. Giardino, 420123 - MILANOItaly


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices, except those classified in

class III only as incorporating

medicinal substances, according to

Directive 2001/83/EC and/or

utilising biological active coatings

and/or materials or being wholly or

mainly absorbed


medical devices



EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI











or modules


directives


191 / 344

quality assurance)

EC declaration of


assurance)



mainly absorbed


medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI








mainly absorbed


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI


devices






or modules


directives


192 / 344

EC declaration of


assurance)


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI








mainly absorbed



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI








mainly absorbed






or modules


directives


193 / 344


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI








mainly absorbed



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI








mainly absorbed



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI








mainly absorbed






or modules


directives


194 / 344

assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI








mainly absorbed



instruments

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI








mainly absorbed






or modules


directives


195 / 344



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI








mainly absorbed




anaesthesia

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding hyperbaric chambers

and all devices depending on a

source of electrical energy.



Class III only as incorporating





EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices

*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Excluding medical devices






or modules


directives


196 / 344

therapy



assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI

depending on a source of electrical

energy. Exclusion of class III

medical devices, except those

classified in Class III only as

incorporating medicinal

substances, according to Directive

2001/83/EC


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



Class III only as incorporating





thereof

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices








or modules


directives


197 / 344




absorbed


/utilising software /controlled by softwareSGS FIMKO OYP.O. Box 30 (Särkiniementie 3)00211 HELSINKIFinland


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

II: Up to class IIb only


medical devices


devices

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


measuring function

EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


198 / 344


quality assurance)

EC declaration of


assurance)


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


199 / 344

quality assurance)

EC declaration of


assurance)



instruments

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI







or modules


directives


200 / 344

EC declaration of


assurance)




anaesthesia

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI

II: Up to class IIb only; III, IV:

Hyperbaric chambers only



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI

II: Up to class IIb only; III, IV: Nerve

and muscle stimulator only



EC declaration of


assurance system)

Annex II

Annex V







or modules


directives


201 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


Dental units and dental patient

chairs only



sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC type-examination

EC verification

Annex III

Annex IV


Neurological and muscular






or modules


directives


202 / 344

prostheses EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

rehabilitation devices only



transport

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


203 / 344

assurance)



radiation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI

II: Up to class IIb only; III, IV: X-ray

devices only



radiation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


Magnetic resonance imaging (MRI)

devices only




EC type-examination

EC verification

EC declaration of


Annex III

Annex IV

Annex II

Annex V







or modules


directives


204 / 344

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



parameters

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


*MD 1400 - Devices for radiation therapy and thermo EC type-examination Annex III II: Up to class IIb only; III, IV:






or modules


directives


205 / 344

therapy


EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex IV

Annex II

Annex V

Annex VI

Surgical ultrasoud devices only


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





*MDS 7006 - Medical devices in sterile condition II: Up to class IIb onlyBerlin Cert Prüf- und Zertifizierstelle fürMedizinprodukte GmbHDovestraße 610587 BerlinGermany



prostheses


transport


EC verification

EC declaration of


assurance system)

EC declaration of


Annex IV

Annex II

Annex V

Annex VI






or modules


directives


206 / 344





anaesthesia






sterilisation


thereof


medical devices


devices




radiation



parameters



quality assurance)

EC declaration of


assurance)







or modules


directives


207 / 344


*MDS 7006 - Medical devices in sterile condition Including ethylene oxide gas

sterilisation (EOG), moist heat


(gamma)


/utilising software /controlled by softwarePRÜFSTELLE FÜR MEDIZINPRODUKTEGRAZKopernikusgasse 24/18010 GRAZAustria






anaesthesia






sterilisation


prostheses


transport




radiation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


208 / 344


radiation





parameters


therapy







medical devices




devices


measuring function











or modules


directives


209 / 344

*MDS 7007 - Medical devices utilising micromechanicsNATIONAL EVALUATION CENTER OFQUALITY AND TECHNOLOGY IN HEALTHS.A.- EKAPTYSmyrnis 15165 62 GLYFADAGreece


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices


devices

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI






or modules


directives


210 / 344


medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

*MD 0100 - General non-active, non-implantable EC declaration of Annex II






or modules


directives


211 / 344

medical devices



assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


Annex II

Annex V






or modules


directives


212 / 344

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



instruments

EC declaration of


assurance system)

Annex II

Annex V

Annex VI






or modules


directives


213 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of

Annex II

Annex VI






or modules


directives


214 / 344


assurance)




anaesthesia

EC declaration of


assurance system)

EC declaration of


assurance)

Annex II

Annex VI

Respiratory devices only



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Only for physiotherapy



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI






or modules


directives


215 / 344

quality assurance)

EC declaration of


assurance)



sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



prostheses

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Only for physiotherapy



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI






or modules


directives


216 / 344

EC declaration of


assurance)



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI






or modules


directives


217 / 344


assurance)



parameters

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI






or modules


directives


218 / 344

assurance)


therapy



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI






or modules


directives


219 / 344



thereof

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



Only for MD Codes referred above






(EOG), moist heat sterilisation, dry



electron beam) - Only for MD

Codes referred above


/utilising software /controlled by software


Eurofins Product Service GmbHStorkower Straße 38c15526 REICHENWALDEGermany


medical devices


devices

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of

Annex III

Annex IV

Annex II

Annex V

Annex VI


the complete scope)






or modules


directives


220 / 344


quality assurance)

EC declaration of


assurance)



prostheses

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


the complete scope)



transport

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


the complete scope)







or modules


directives


221 / 344



/utilising software /controlled by softwareTHERAPEUTIC GOODS ADMINISTRATION136 Narrabundah LaneSymonston ACTAustralia


medical devices






devices


measuring function













instruments


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI






or modules


directives


222 / 344







anaesthesia






sterilisation


prostheses


transport






radiation


radiation








or modules


directives


223 / 344



parameters


therapy










*MDS 7008 - Medical devices utilising nanomaterialsUL INTERNATIONAL (UK) LTDWonersh House Building C The Guildway OldPortsmouth RoadGuildford GU3 1LRUnited Kingdom


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Limited to sterile single use

devices, class IIb and below


medical devices


EC declaration of


assurance system)

Annex II

Annex V

Annex VI


devices and surgical instruments,

class IIb and below






or modules


directives


224 / 344

transfusion and dialysis EC declaration of


quality assurance)

EC declaration of


assurance)


medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Class IIb and below


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Class IIb and below


medical devices



EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI

Class IIb and below






or modules


directives


225 / 344


quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Class IIb and below



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


devices, class IIb and below



EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI

Class IIb and below






or modules


directives


226 / 344

quality assurance)

EC declaration of


assurance)



instruments

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Class IIb and below



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Class IIb and below



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Class IIb and below



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI

No class III or implants






or modules


directives


227 / 344

EC declaration of


assurance)



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




parameters

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


228 / 344


assurance)


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


229 / 344

assurance)


therapy



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

Annex II Limited to Cardiac catheters




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





anaesthesia

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI







or modules


directives


230 / 344

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


231 / 344


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




prostheses

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


232 / 344

assurance)



transport

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI
















or modules


directives


233 / 344

specified)Országos Gógyszerészeti ésÉlelmezés-egészségügyi IntézetEszközmin#sít# és KórháztechnikaiIgazgatóság (National Institute of Pharmacyand Nutrition)Zrínyi u. 3H-1051 BudapestHungary



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



radiation

EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI




EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI

*MD 1300 - Monitoring devices EC type-examination Annex III






or modules


directives


234 / 344


parameters

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


therapy


EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI


therapy


EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex III

Annex II

Annex V

Annex VI






or modules


directives


235 / 344

assurance)


medical devices



EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI


medical devices



EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI


medical devices


devices

EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex III

Annex II

Annex V

Annex VI






or modules


directives


236 / 344

EC declaration of


assurance)


medical devices


measuring function

EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI


medical devices


EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI


medical devices


EC type-examination

EC declaration of


assurance system)

EC declaration of

Annex III

Annex II

Annex V

Annex VI






or modules


directives


237 / 344


quality assurance)

EC declaration of


assurance)


medical devices



EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI

Annex III. designation excluding

materials of desinfecting, cleaning

and rinsing . For Annex II., V., VI.

there are no limitations.


medical devices



EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI



instruments

EC type-examination

EC declaration of


Annex III

Annex II

Annex V






or modules


directives


238 / 344

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI



EC type-examination

EC declaration of

Annex III

Annex II






or modules


directives


239 / 344

infusion and haemopheresis conformity (full quality

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI




anaesthesia

EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI



EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI






or modules


directives


240 / 344



EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI




EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI



EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex III

Annex II

Annex V

Annex VI






or modules


directives


241 / 344


assurance)



thereof

EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI



EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI



sterilisation

EC type-examination

EC declaration of


assurance system)

EC declaration of


Annex III

Annex II

Annex V

Annex VI






or modules


directives


242 / 344

quality assurance)

EC declaration of


assurance)



prostheses

EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI



transport

EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI



EC type-examination

EC declaration of


assurance system)

Annex III

Annex II

Annex V






or modules


directives


243 / 344

EC declaration of


quality assurance)



EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex III

Annex II

Annex V



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Excluding breast and body shaping

implants



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC type-examination

EC declaration of


Annex III

Annex II

Annex V






or modules


directives


244 / 344

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



EC type-examination

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex II

Annex V

Annex VI





2003/32/EC up to 28.08.2013)

Designation excludes products

related 2003/32/EC BSE/TSE field.

Designation includes Annex 2 and

5.











or modules


directives


245 / 344


heat sterilisation



absorbed


/utilising software /controlled by softwareELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV,s.p.Pod Lisem 129171 02 PRAHA 71 - TrojaCzech Republic


medical devices






devices


measuring function












system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


246 / 344







instruments








anaesthesia






sterilisation


prostheses


transport



system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


247 / 344



radiation


radiation





parameters


therapy








thereof

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


248 / 344

assurance)












specified)



absorbed


/utilising software /controlled by softwareINSTITUT PRO TESTOVÁNI A CERTIFIKACI,a. s.T. Bati 299Louky, 76302 ZLINCzech Republic


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Limited to devices of Classes Im,

Is, IIa, IIb plus epidural sets

*MD 0100 - General non-active, non-implantable EC declaration of Annex II Limited to devices of Classes Im,






or modules


directives


249 / 344

medical devices




assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI

Is, IIa, IIb plus balloon catheters

plus stent delivery systems


medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


Is, IIa, IIb


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


Is, IIa, IIb


medical devices

EC declaration of


Annex II

Annex V


Is, IIa, IIb






or modules


directives


250 / 344

- *MD 0106 - Non-active instruments assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


Is, IIa, IIb



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Limited to cardiovascular stents

including stent inserting tools plus

cardiac valves not containing

animal tissues



EC declaration of


assurance system)

Annex II

Annex V

Annex VI

Limited to devices of the Class IIb






or modules


directives


251 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


oesophageal, ureteral and biliary

stents



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


plus injection implants based on

hyaluronic acid and hyaluronic acid

derivates



EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI

Limited to devices of Classes Is,

IIa, IIb plus wound dressing being

wholly or mainly absorbed and/or

incorporating medicinal substances






or modules


directives


252 / 344


quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


IIa, IIb plus devices being wholly or

mainly absorbed plus sutures for

the central circulatory system



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


IIa, IIb plus wound care devices

being wholly or mainly absorbed

and/or incorporating medicinal

substances



instruments

EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI


Is, IIa, IIb






or modules


directives


253 / 344

quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


IIa, IIb



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Limited to devices of Classes IIa,

IIb




EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI


Is, IIa, IIb






or modules


directives


254 / 344

EC declaration of


assurance)




anaesthesia

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


Is, IIa, IIb



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


Is, IIa, IIb



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI


Is, IIa, IIb






or modules


directives


255 / 344


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


Is, IIa, IIb



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


Is, IIa, IIb



sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI


Is, IIa, IIb






or modules


directives


256 / 344

assurance)



prostheses

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


Is, IIa, IIb



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


IIa, IIb



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


Is, IIa, IIb






or modules


directives


257 / 344



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


Is, IIa, IIb



parameters

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


Is, IIa, IIb


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


Is, IIa, IIb

*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II Limited to devices of Classes Im,






or modules


directives


258 / 344

therapy



assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI

Is, IIa, IIb



*MDS 7006 - Medical devices in sterile condition Limited to devices sterilised by one

of the following: Aseptic filling,

Ethylene oxide sterilisation,

Radiation sterilisation, Moist heat

sterilisation



absorbed

Limited to devices being wholly or

mainly absorbed




Is, IIa, IIbSchweizerische Vereinigung für Qualitäts- undManagementsystemeBernstrasse 1033052 ZollikofenSwitzerland


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

Annex II

Annex V

Annex VI






or modules


directives


259 / 344

devices assurance



medical devices


measuring function


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


260 / 344




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Annex II

Annex V






or modules


directives


261 / 344

Production quality

assurance


Annex VI



instruments


system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI





system

Production quality

assurance


Annex II

Annex V

Annex VI

excluding heart-lung machine




anaesthesia


system

Production quality

assurance

Annex II

Annex V

Annex VI

only respiratory devices






or modules


directives


262 / 344





system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI



sterilisation


system

Production quality

assurance


Annex II

Annex V

Annex VI







or modules


directives


263 / 344


prostheses

system

Production quality

assurance


Annex V

Annex VI



radiation


system

Production quality

assurance


Annex II

Annex V

Annex VI



radiation


system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy




system

Production quality

assurance


Annex II

Annex V

Annex VI



*MDS 7006 - Medical devices in sterile conditionQS Zürich AGPostfach 6335CH-8050 ZürichSwitzerland


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI

Single-use medical devices






or modules


directives


264 / 344


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI



medical devices


devices


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


measuring function


system

Production quality

assurance


Annex II

Annex V

Annex VI

Reusable instruments


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI



medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


system

Annex II

Annex V







or modules


directives


265 / 344

- *MD 0107 - Contraceptive medical devices Production quality

assurance


Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI





system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance

Annex II

Annex V

Annex VI






or modules


directives


266 / 344





system

Production quality

assurance


Annex II

Annex V

Annex VI



instruments


system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI







or modules


directives


267 / 344


transport

system

Production quality

assurance


Annex V

Annex VI



radiation


system

Production quality

assurance


Annex II

Annex V

Annex VI





system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI










or modules


directives


268 / 344







electron beam)



absorbedENTE CERTIFICAZIONE MACCHINE SRLVia Ca’ Bella, 243/A - loc. Castello di Serravalle40053 Valsamoggia (BO)Italy


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III devices


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI







or modules


directives


269 / 344


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III devices






or modules


directives


270 / 344




assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


Annex II

Annex V







or modules


directives


271 / 344

sterilisation assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



prostheses

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




transport

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

Annex II

Annex V

Annex VI







or modules


directives


272 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




parameters

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



therapy


EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


273 / 344


quality assurance)

EC declaration of


assurance)





/utilising software /controlled by softwareSLOVENIAN INSTITUTE OF QUALITY ANDMETROLOGY - SIQTrzaska cesta 21000 LJUBLJANASlovenia



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI

Annex III and IV lasers only





system

Production quality

assurance


Annex II

Annex V

Annex VI

Only infant incubators included

*MD 1100 - General active medical devices EC declaration of Annex II Included only devices for






or modules


directives


274 / 344



anaesthesia


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI

respiratory devices



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of

Annex III

Annex IV

Annex II

Annex III and IV lasers only






or modules


directives


275 / 344


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI



sterilisation


system

Production quality

assurance


Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



transport

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI






or modules


directives


276 / 344

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI






or modules


directives


277 / 344


assurance)




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



parameters

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



instruments

EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI






or modules


directives


278 / 344


quality assurance)

EC declaration of


assurance)



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



radiation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


medical devices


EC declaration of


assurance system)

Annex II

Annex V

Annex VI






or modules


directives


279 / 344

devices EC declaration of


quality assurance)

EC declaration of


assurance)


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI

Included only devices for injection,

infusion and transfusion






or modules


directives


280 / 344


medical devices


measuring function


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI






or modules


directives


281 / 344

EC declaration of


assurance)


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V





*MDS 7006 - Medical devices in sterile condition Excluding formaldehyde

sterilisation


/utilising software /controlled by softwareBUREAU VERITAS ITALIA S.P.A.Via Miramare, 1520126 - MILANOItaly


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices

EC declaration of


Annex II

Annex V







or modules


directives


282 / 344



assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI


medical devices


devices

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


EC declaration of


assurance system)

Annex II

Annex V

Annex VI







or modules


directives


283 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


284 / 344


quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




instruments

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


285 / 344

quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





anaesthesia

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


hyperbaric chambers for oxygen

therapy and medical gas pipeline

systems



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI







or modules


directives


286 / 344

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


287 / 344


assurance)



prostheses

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


288 / 344

assurance)




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




parameters

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI







or modules


directives


289 / 344




*MDS 7006 - Medical devices in sterile condition Excluding class III medical devicesPOLSKIE CENTRUM BADAN ICERTYFIKACJI S.A.ul. Klobucka 23A02-699 WarszawaPoland


medical devices




measuring function







devices











EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


290 / 344





instruments








anaesthesia






sterilisation


prostheses


transport



thereof







or modules


directives


291 / 344


radiation


radiation





parameters


therapy








2003/32/EC up to 28.08.2013)














or modules


directives


292 / 344



absorbed


/utilising software /controlled by softwareSGS Belgium NVNoorderlaan 87BE-2030 AntwerpenBelgium


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

No class III medical devices.


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



medical devices


devices

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


Annex II

Annex V







or modules


directives


293 / 344

quality assurance)


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


Limited to accessories (e.g.

lubricants etc) and male/female

condoms. No diaphragm's or IUD's


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


Limited to devices such as

receptacles, petri dishes, pipettes

or syringes. No media, substances

or mixture of substances.



EC declaration of


assurance system)

Annex II

Annex V

No class III medical devices. No

joints (partial or complete).






or modules


directives


294 / 344

EC declaration of


quality assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


Limited to implantable holders

used in radiotherapy

(brachytherapy) and class IIb

spinal Implants, spinal stents and

cervical cage.



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V




EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


Limited to clamps and staples.



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II No class III medical devices.






or modules


directives


295 / 344


instruments


assurance system)

EC declaration of


quality assurance)

Annex V



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V




EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


Limited to crowns, prostheses and

bridges.



thereof

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

No class III medical devices. Only

parts (e.g. connectors, flow meters,

Venturi, plastic tubing,…). No

complete gas supply systems. No

medical glasses.



EC declaration of


assurance system)

EC declaration of


Annex II

Annex V







or modules


directives


296 / 344

quality assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V




sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V




prostheses

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V




transport

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V




EC declaration of


assurance system)

Annex II

Annex V







or modules


directives


297 / 344

EC declaration of


quality assurance)



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V




radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V





EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V




parameters

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

No class III medical devices. No

devices intended for the monitoring

of vital physiological parameters,

where the nature of variations is

such that it could result in

immediate danger to the patient.

*MD 1400 - Devices for radiation therapy and thermo EC declaration of Annex II No class III medical devices.






or modules


directives


298 / 344

therapy



assurance system)

EC declaration of


quality assurance)

Annex V


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V





*MDS 7006 - Medical devices in sterile condition No class III medical devices. For

ETO, irradiation, moist heat,

aseptic process and clean rooms

technologies




TURKISH STANDARDS INSTITUTION (TSE)Necatibey Cad. No. 112, 06100 BakanliklarAnkaraTurkey


medical devices






devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V






or modules


directives


299 / 344

measuring function


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices
















EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V






or modules


directives


300 / 344



instruments








anaesthesia






sterilisation


prostheses


transport






radiation






or modules


directives


301 / 344


radiation





parameters


therapy


















absorbed






or modules


directives


302 / 344


/utilising software /controlled by softwareDARE!! CertificationsVijzelmolenlaan 7NL-3447 GX WoerdenNetherlands




EC type-examination

EC verification

Annex III

Annex IV

Limited to devices for infusion.

Limited to non sterile class Im, IIa

and IIb devices




anaesthesia

EC type-examination

EC verification

Annex III

Annex IV


and IIb devices



EC type-examination

EC verification

Annex III

Annex IV


and IIb devices



EC type-examination

EC verification

Annex III

Annex IV


and IIb devices



prostheses

EC type-examination

EC verification

Annex III

Annex IV


and IIb devices



transport

EC type-examination

EC verification

Annex III

Annex IV


and IIb devices



radiation

EC type-examination

EC verification

Annex III

Annex IV


and IIb devices




EC type-examination

EC verification

Annex III

Annex IV


and IIb devices

*MD 1300 - Monitoring devices EC type-examination Annex III Limited to non sterile class Im, IIa






or modules


directives


303 / 344


parameters

EC verification Annex IV and IIb devices


therapy


EC type-examination

EC verification

Annex III

Annex IV


and IIb devices




and IIb devices




and IIb devicesTUV Rheinland Italia SRLVia Mattei, 320010 - Pogliano Milanese (MI)Italy


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III medical devices






or modules


directives


304 / 344

medical devices


devices


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI


medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices

EC declaration of


Annex II

Annex V






or modules


directives


305 / 344

- *MD 0106 - Non-active instruments assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

Annex II

Annex V

Annex VI






or modules


directives


306 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




instruments

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


307 / 344


quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




prostheses

EC type-examination

EC verification

EC declaration of

Annex III

Annex IV

Annex II







or modules


directives


308 / 344


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI



transport

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI







or modules


directives


309 / 344




anaesthesia

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


and hyperbaric chambers for

oxygen therapy



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


310 / 344

EC declaration of


quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC declaration of


Annex II

Annex V







or modules


directives


311 / 344


EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


*MD 1300 - Monitoring devices EC type-examination Annex III






or modules


directives


312 / 344


parameters

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex IV

Annex II

Annex V

Annex VI


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



therapy


EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex IV

Annex II

Annex V

Annex VI







or modules


directives


313 / 344

assurance)


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI






or modules


directives


314 / 344



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




thereof

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI






(EOG), low temperature steam

sterilisation, moist heat


(gamma, x-ray, electron beam)








or modules


directives


315 / 344

absorbed


/utilising software /controlled by softwareKiwa Belgelendirme Hizmetleri A.#.Tepeören Mevkii Ankara Asfalt# Maret Arkas#ITOSB 9. Cadde No: 15 TuzlaIstanbulTurkey



radiation


radiation





parameters


therapy







medical devices






EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V






or modules


directives


316 / 344






devices


measuring function














instruments










or modules


directives


317 / 344



anaesthesia






sterilisation


transport






prostheses


medical devices




thereof










or modules


directives


318 / 344









absorbed


/utilising software /controlled by softwareSzutest Uygunluk De#erlendirme A.#.Yukar# Dudullu Mahallesi Nato Yolu CaddesiÇam Sokak No: 7 Ümraniye#STANBULTurkey


medical devices






devices


measuring function






system

Production quality

assurance

Annex II

Annex V


medical devices

EC declaration of


Annex II

Annex V






or modules


directives


319 / 344

- *MD 0107 - Contraceptive medical devices assurance system)

EC declaration of


quality assurance)











instruments








anaesthesia





system

Production quality

assurance

Annex II

Annex V






or modules


directives


320 / 344



sterilisation




radiation


radiation





parameters


therapy





prostheses


thereof

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V









or modules


directives


321 / 344





absorbed


/utilising software /controlled by software3EC International a.s.3EC International a.s. Hranicna 18 Bratislava82105 SLOVAKIABratislava 82105Slovakia


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices






devices


measuring function



system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


322 / 344


















instruments








anaesthesia






or modules


directives


323 / 344






sterilisation


prostheses


transport






radiation


radiation





parameters


therapy








or modules


directives


324 / 344








2003/32/EC up to 28.08.2013)

excluding Regulation 722/2012








absorbed


/utilising software /controlled by softwareTUV NORD Polska Sp. z o.oul. Mickiewicza 2940-085 KatowicePoland





system

Production quality

assurance


Annex II

Annex V

Annex VI

.




system

Production quality

assurance

Annex II

Annex V

Annex VI






or modules


directives


325 / 344





system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI



transport


system

Production quality

assurance


Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


Annex II

Annex V






or modules


directives


326 / 344


EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI




anaesthesia

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



prostheses

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

without acitive prostheses



radiation


system

Production quality

Annex II

Annex V

Annex VI






or modules


directives


327 / 344

assurance




radiation


system

Production quality

assurance


Annex II

Annex V

Annex VI





system

Production quality

assurance


Annex II

Annex V

Annex VI



parameters


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


devices


system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


328 / 344


medical devices


measuring function


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


therapy



system

Production quality

Annex II

Annex V

Annex VI






or modules


directives


329 / 344

assurance



therapy



system

Production quality

assurance


Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

Annex II






or modules


directives


330 / 344



thereof

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

Annex II



EC declaration of


assurance system)

Annex II





/utilising software /controlled by softwareDQS Polska Sp. z o.oul. Post#pu 17A02-676 WarszawaPoland




EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



EC declaration of


Annex II

Annex V






or modules


directives


331 / 344


EC declaration of


quality assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


medical devices


devices

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

excluding dialysers






or modules


directives


332 / 344


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



EC declaration of


assurance system)

EC declaration of

Annex II

Annex V






or modules


directives


333 / 344


quality assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



instruments

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



EC declaration of


Annex II

Annex V






or modules


directives


334 / 344

assurance system)

EC declaration of


quality assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V





2003/32/EC up to 28.08.2013)









/utilising software /controlled by softwareUDEM Uluslararasi Belgelendirme DenetimEgitim Merkezi San. ve Tic. A.#.Mutlukent Mahallesi 2073 Sokak No:10Umitkoy-CANKAYAAnkara

2292 *MD 0300 - Devices for wound care



EC declaration of


assurance system)

Annex II

Annex V






or modules


directives


335 / 344

Turkey - *MD 0303 - Other medical devices for wound care


medical devices






devices


measuring function
















instruments

EC declaration of


quality assurance)






or modules


directives


336 / 344








anaesthesia





sterilisation


prostheses


transport





thereof





therapy






or modules


directives


337 / 344















specified)



absorbed


/utilising software /controlled by softwareCE Certiso Orvos- és KórháztechnikaiEllen#rz# és Tanúsító Kft.Gyár u. 2.BudaörsHungary



radiation





parameters

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI






or modules


directives


338 / 344


therapy



medical devices






devices


measuring function















assurance)






or modules


directives


339 / 344






instruments





sterilisation


prostheses






anaesthesia







regarding Annex II, V, VI

*MDS 7004 - Medical devices referencing the Directive regarding Annex II, V, VI






or modules


directives


340 / 344


*MDS 7006 - Medical devices in sterile condition regarding Annex II, V, VI Including

aseptic processing, ethylene oxide

gas sterilisation (EOG), radiation

sterilization (gamma,x-ray, electron

beam), moist heat sterilization



absorbed





DNV GL Nemko Presafe ASVeritasveien 31363 HøvikNorway


medical devices






devices


measuring function







EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V






or modules


directives


341 / 344













instruments


EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex IV

Annex II

Annex V








anaesthesia


EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V






or modules


directives


342 / 344





sterilisation


prostheses


transport





thereof



radiation


radiation





parameters


therapy







or modules


directives


343 / 344









2003/32/EC up to 28.08.2013)












electron beam), others.



absorbed








or modules


directives


344 / 344

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