9/10/07 1
Carl Youngmann, PhDRegulatory Affairs Certified
Port Townsend, Washington
(360) 379 3660
Medical Devices for the EU
9/10/07 2
27 member states of theEuropean Union• Austria
• Belgium
• Bulgaria
• Cyprus
• Czech Republic
• Denmark
• Estonia
• Finland
• France
• Germany
• Greece
• Hungary
• Ireland
• Italy
• Latvia
• Lithuania
• Luxembourg
• Malta
• Netherlands
• PolandPortugal
• Romania• Slovakia• Slovenia• Spain• Sweden• United
Kingdom
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The European Free TradeAssociation (EFTA)
• 3 of the 4 states ofthe EFTA are part ofthe EEA internalmarket:– Iceland– Norway– Liechtenstein
• The fourth state,Switzerland, hasbilateral agreementswith the EEA.
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US versus EU Medical DeviceRegulation
• Directives to Member States– Implemented by Member State parliaments
in national legislation– Overseen by national Competent Authorities– Compliance checked by Notified Bodies– Enforcement under national jurisdiction
• Based on compliance not notice or approval• No EU centralized authority• Different approach to determining standard
of care: national health systems,
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The U.S. compared to the E.U.-1
Design Controls
Personnel /Training
Audits
Managementresponsibility
Quality PlanningQuality System& Policy
Quality Plan
Few definitionsMore definitions
ISO 1348521 CFR 820Quality System
EU specificSharedUS specific
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The U.S. compared to the E.U.-2
Corrective &Preventative Action
NonconformingProduct
Measurement &Test Equipment
Inspection
Process Control
ProductIdentification
PurchasingQuality System,continued
EU specificSharedUS specific
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The U.S. compared to the E.U.-3
Complaints
Quality Records
Installation
Handling,Storage &Delivery
TranslationPackagingLabelingDevice MasterRecordDevice HistoryRecord
Quality System,continued
EU specificSharedUS specific
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The U.S. compared to the E.U.-4
MDD EssentialRequirements
BiocompatibilityFDA GuidanceProductRequirements
Electrical Safety
ElectromagneticCompatibility
ISO 14971Risk Management
StatisticalTechniques
ServicingQuality System,continued
EU specificSharedUS specific
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The U.S. compared to the E.U.-5
SterilizationValidation
Post MarketSurveillance
Recalls &Removals
MDRPost Market
Technical FileCE-Marking
510(K), IDE &PMA
RegulatoryCompliance
AuthorizedEuropeanRepresentative
U. S. Agent forDevices
Representation
SterilePackaging
shelf-lifesterile barriershipping
ProductRequirements
continued
EU specificSharedUS specific
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The U.S. compared to the E.U.-6
ISO 14155-1, -2IDEClinical
Auditsinitialcontinuing
Inspectionsbiennial GMPpre-PMA
Assessments
EU specificSharedUS specific
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The CE Mark
• Possibly CommuniteeEuropéen, French forEuropean Community.
• Could be ConformitéEuropéen.
• Invented by somebureaucrat in Brussels.
• Officially, just a logoand has no linguisticmeaning.
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Medical Device Directives
• Medical Devices — Council Directive93/42/EEC of 14 June 1993 (OJ No L 169/1 of1993-07-12)
• Active Implantable Medical Devices —Council Directive 90/385/EEC of 20 June1990 (OJ No L 189/17 of 1990-07-20)
• In-vitro diagnostic medical devices —Directive 98/79/EC of 27 October 1998(1998-12-07 OJ No L 331/1)
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Recent Changes to the MDD
• Clarification of design documentation anddesign review requirements
• Clarification of the clinical evaluationrequirements
• Substances of animal origin or containinghuman blood
• Software validation• Alignment of the original MDD 93/42/EEC
with other directives
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Council Directive 93/42/EEC 14 June1993 concerning medical devices — 1
• 23 Articles– Definitions, scope– Placing on the market and
putting into service– Essential requirements– Free movement, devices
intended for special purposes– Reference to standards– Committee on Standards and
Technical Regulations– Safeguard clause– Information on incidents
occurring following placing ofdevices on the market
– Classification– Conformity assessment
procedures– Registration of persons
responsible for placing deviceson the market
– Clinical investigation– Notified bodies– CE marking and Wrongly
affixed CE marking– Confidentiality– Implementation, transitional
provisions
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Council Directive 93/42/EEC 14 June1993 concerning medical devices — 2
• 12 AnnexesI Essential RequirementsII EC Declaration of Conformity (Full Quality
Assurance – ISO 13485 + MDD )III EC Type - ExaminationIV EC Verification i.e. batch testingV EC Declaration of Conformity (Production
Quality Assurance – ISO 13485 MDD)VI EC Declaration of Conformity (Product
Quality Assurance – ISO 13485 + MDD)
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Council Directive 93/42/EEC 14 June1993 concerning medical devices — 3
• 12 AnnexesVII EC Declaration of Conformity, self-
certification for Class I productsVIII Statement concerning devices for special
purposesIX Classification criteria i.e. rules for the
classification of productsX Clinical evaluationXI Criteria for the designation of Notified
BodiesXII CE Marking of conformity
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CE-Marking Medical Devices
• Classify the device• Assess device conformity
– Essential Requirements– Risk Management– Certification Procedures
• Performance• Quality
– Labeling– Technical construction file or design dossier
• Authorize a European representative• CE mark the product
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MDD Device Classification
• Duration of use: transient, short-termor long-term
• Invasiveness: non-invasive, bodyorifice, surgically invasive, implantable
• Activity: therapeutical or diagnostic• Central circulatory contact• Central nervous system contact
MDD Annex IX
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4 ( Really 6 ) Device Classes — 1
• Class I – low risk–non-sterile dressings–bandages–hospital gowns– light sources
• Class I (Sterile)–disposable surgical instruments–urine drainage bags
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4 ( Really 6 ) Device Classes — 2
• Class I (Measuring)–scales–digital thermometers
• Class IIa – medium risk– IV catheters– tubings for anesthesia / ventilation–ultrasound devices
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4 ( Really 6 ) Device Classes — 3
• Class IIb – elevated risk– intra-ocular lenses
–breast implants
–endoprostheses
–ventilators
• Class III – high risk–heart valves
– reabsorbable implants
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Class I Conformity Assessment
• Manufacturer self-declares conformity
for performance
and
for quality system
• Aspects of sterile products and measuringdevices relating to sterility and/or metrologyare certified by a Notified Body.
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Class IIa Conformity Assessment• Manufacturer self-declares conformity
for performanceandfor design control
• Notified Body must– certify full quality assurance system– certify production quality assurance system– certify final inspection and testing; or– exam and test sample products.
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Class IIb Conformity Assessment
• Notified Body will either
certify full quality assurance system
or
test and certify product performanceandcertify production quality assurance system
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Class III Conformity Assessment• Notified Body will
certify full quality assurance system
and
certify the technical dossier
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Technical Construction File (Class I & II)or Design Dossier (Class III)
• Essential Requirements Analysis– Product design specifications– Hazard and risk analysis– Verification and validation reports
• Engineering test reports• Laboratory reports• Clinical validation
– Product labeling• A combination of elements from the Design
History File and the Device Master Record
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Declaration of Conformity• Document created by the person placing the
device on the market that clearly identifies:– The manufacturer or their AER– Manufacture’s or AER’s European Address– The device (models, serial numbers, lots,
etc.)– The applicable directives– The major standards complied with– Signed by a responsible authority
• Included in the device labeling, usually in theinstructions for use and shipping documents
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Lumps in the Level Playing Field
• Each Member State was permitted toimpose requirements particular to theirnational cultures, i.e., use of languagesindigenous to their countries
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EU National Language Requirements -1
EstonianEstonia
DanishDenmark
CzechCzech Republic
Non-professional use devices in Greek. ProfessionalUse devices in Greek or English
Cyprus
CroatianCroatia (PendingEU state)
English, Bulgarian for self-test devices only.Bulgaria
Dutch + German + French (All three must be used forpatient instructions)
Belgium
GermanAustria
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EU National Language Requirements - 2
ItalianItaly
EnglishIreland
IcelandicIceland (EFTA)
HungarianHungary
GreekGreece
GermanGermany
FrenchFrance
Finnish + SwedishFinland
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EU National Language Requirements - 3
NorwegianNorway (EFTA)
DutchNetherlands
Maltese or EnglishMalta
Macedonia(Pending EUState)
FrenchLuxembourg
LithuanianLithuania
GermanLiechtenstein(EFTA)
Latvian for professional use; English or German isaccepted
Latvia
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EU National Language Requirements - 4
SwedishSweden
SpanishSpain
SlovenianSlovenia
SlovakSlovakia
SerbianSerbia
RomanianRomania
PortuguesePortugal
PolishPoland
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EU National Language Requirements - 5
EnglishUnited Kingdom
TurkishTurkey (PendingEU State)
French, German, ItalianSwitzerland(EFTA)
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How to label a device formarketing in Europe - 1
• Highly simplified instructions– Fourth grade vocabulary– Simple declarative sentences– No or minimal medical terminology– Maximum use of graphics
• Graphics!
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How to label a device formarketing in Europe - 2• Limit marketing to a few of the largest countries, e.g., UK (61M),
France (64M), Germany (84M), Italy (54M) & Spain (45M) toreach 62% of the 494M EU residents
– Label only for those markets
• Sell products F.O.B. in market countries, others in the EU canpurchase across borders
• Require training for professionals and service personnel wheremore complete materials can be provided in English
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Post-Market Surveillance
• Manufacturer must establish systems to–Record and analyze customer
responses–Process customer complaints–Collect, report and analyze any
adverse events–Actively monitor use and abuse of the
product
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Authorized European Representative(AER)• A point of contact within the EU where the Competent
Authorities can serve notices
• Generally not a sales office or a business facility
• Required to be shown on all labeling
• Only one required for the entire EU– Establishes the country of legal jurisdiction for criminal
and civil actions, including insurance
• Should be knowledgeable in the mechanics of the MDD
• May be required to respond within 2-3 days with technicalfile
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Questions?
• Ask the EU Commission:ec.europa.eu/enterprise/medical_devices/index_en.htm