Medical Technologies in Belgium: overview & challengesContent of the new regulations: Karel Verlinde...

20/02/2018Karel Verlinde - beMedTech

Medical Technologies in Belgium: overview & challenges

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On 5 April 2017, 2 new Regulations on medical devices were adopted, and they entered into force on 25 May 2017. These replace the existing Directives

• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

• Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Karel Verlinde - beMedTech

_________________________________________________________________________http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_nl

http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_nl

Content of the new regulations:

3Karel Verlinde - beMedTech

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• Stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism

• The reinforcement of the criteria for designation and processes for oversight of Notified Bodies;

• The inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations;

• The introduction of a new risk classification system for in vitro diagnostic medical devices in line with international guidance;



Content of the new regulations:


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• Improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification;

• The introduction of an “implant card” containing information about implanted medical devices for a patient;

• The reinforcement of the rules on clinical evidence, the strengthening of post-market surveillance requirements for manufacturers;

• Improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.



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UDI database

(network)

1. UDI Code

(x)012345678901(y)GH12345(z)20101231linear bar code of andere

dynamic data• expiration date• lot/serial no.

static data

device ID production IDof Rfid

2. UDI Carrier = AIDC

Unique Device Identifier (UDI)


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UDI: deadlines


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• Class III: 2021

• Class IIa & IIb: 2023

• Class I: 2025

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Overview Medical Devices


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Definition Medical Device


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Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, — investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, — providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.


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• Minimal potential risk for the patient/user• Non-invasif

• No direct contact with the patient or only on intact skin

• Simple procedure to obtain the CE-marking

Class I Medical Device


• Medium risk for the patient

• No implants with the exception of dental

Class IIa medical device


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High risk for the patient

• Invasive products

• Implants

Class IIb medical device


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Devices that are regarded as critical from a risk perspective

• in direct contact with the heart or central nervous system

• upgrades (breast and joint implants)

Class III medical device


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Technical file

- Conformity with the essential requirements

- Clinical evaluation

Intervention of a third party "Notified Body"

- Specialized in medical devices

- Indicated and controlled by the Member States

- List published in the Official Journal of the EU

Notified Body

- Check the technical and clinical documentation

- Check the production process on a regular basis

- Inspections at unexpected times

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CE-marking for class IIa, IIb en III devices


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Definition In-vitro diagnostic


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Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body

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In-vitro diagnostic: 3 categories


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• Laboratory tests used in medical laboratories• ‘Point-of-care' tests used by care providers near

a patient's bed• Self-testing (used by consumers)

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In-vitro diagnostic


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* Wolcott,J. & Goodman,C. (2009). The Value of Laboratory Screening and Diagnostic Tests for Prevention and Healthcare Improvement. Health Technology Report. The Lewin Group.* *DOI:10.1371/journal.pone.0149856

Healthcare budget Medical decissions

5%

http://www.lewin.com/


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Classification of in vitro diagnostic medical devices

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Competent authorities


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Medicines

- Monopoly for the pharmacist

Medical devices

- No monopoly=> But there are exceptions!

Public Pharmacy:Medicines versus Medical devices


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1.1 het steriel medisch materiaal dat in contact komt met de patiënt ;1.2het steriel injectie-, perfusie-, transfusie-, of drainagemateriaal alsmede de sonden enkatheters, alsmede al het materiaal voor geneeskundige of obstetrische tussenkomst bestemd, datals steriel voorgesteld wordt, inbegrepen de oplossingen voor doorbloeding en de concentratenvoor hemodialyse ;1.3 de implanteerbare hulpmiddelen (al dan niet steriel) ;1.4 de hulpmiddelen bestemd voor de beheersing van de bevruchting en/of deze bestemd voor devoorkoming van seksueel overdraagbare ziekten ;1.5 de hulpmiddelen die een verwantschap hebben met de geneesmiddelen en/of deze dievoorheen het voorwerp waren van een registratie ;1.7 de systemen en behandelingspakketten samengesteld uit deze hulpmiddelen.

Bron: annex XIII van het KB van 18 maart 1999


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Selfcare Medical devices


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Rule 21 - MDR


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Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as:

— class III if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose;

— class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body;

— class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities; and

— class IIb in all other cases.

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- Healthcare professional

• The first use of these tools by the professionals for a specific patient• Within the limits of the exercise of their profession• Not sold or offered to patients for later use

- Diabetes zorgtraject - Trajet de soins diabète

Glucose Monitoring Systems, strips & lancets Pharmacy Thuiszorgwinkel - Magasin de soin à domicile Patient Association

http://www.zorgtraject.be/nl/professioneel/Huisarts/Diabetes/Gezondheid.asp#2

Exceptions


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http://www.zorgtraject.be/nl/professioneel/Huisarts/Diabetes/Gezondheid.asp#2

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Tabel: ministerieel besluit van 18 mei 2005


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_________________________________________________________________________Tabel: ministerieel besluit van 18 mei 2005

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National Institute for Health and Disability Insurance (NIHDI-INAMI-RIZIV)


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Sixth State Reform: impact

- Labor market policy (4.7 billion euro)- Healthcare (5 billion euro)- Family suport (6.8 billion euro)- Justice- …

Healthcare:• Care for the disabled => mobility aids € 62.2 million• Hospitals => € 531 m• Elderly care => € 3.3 million• Rehabilitation => € 170 million• Mental healthcare• Prevention• Organization of primary health care• Healthcare professions

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• Driver = innovation

• Acquisitions/fusions

• Shift towards Extra-Muros

• Digital Health

• Self-testing & self-monitoring

Expectations


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Toekomstpact minister De Block & beMedTech


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• New EU-regulations• Autocontrole-system• Home care• Reimbursement procedures of MD• Digital Health

https://www.fagg-afmps.be/nl/news/pact_medische_technologie_overheid_en_industrie_werken_samen_aan_meer_veiligheid_en_kwaliteit

https://www.fagg-afmps.be/nl/news/pact_medische_technologie_overheid_en_industrie_werken_samen_aan_meer_veiligheid_en_kwaliteit

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Services & Technologies Home Assistance (STHA)


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• Les entreprises qui pourront intervenir au domicile des patients pour l’installation, la maintenance ou le retrait de certains dispositifs médicaux (conformes à l’article 60 de la loi du 15/12/2013)

• Arrêté royal relatif à la notification d’un point de contact matériovigilance et à l’enregistrement des distributeurs et exportateurs de dispositifs médicaux (15/11/2017)

• Livre blanc « SERVICES & TECHNOLOGIES HOME ASSISTANCE (STHA) »

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Digital Health


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• Definition

• Ref pilot projects

Tele

Health

Tele

Consult

Tele

Care

Mobile

Health

Outside Care

System

WellnessQuantified

Self

Inside Care

System

Self Management

Apps Wearables

Supervised

PreventionTele

MonitoringApps Wearables

Mobile authentication

Mobile EHR

for professionals

Mobile PHR

for citizens

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Digital Health: position paper beMedTech - DH


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1. CE-Medical Device

2. Evidence

3. Financing

3 Hurdles => framework vs jungle

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Digital Health: new framework in Belgium


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Validation pyramid=> 3 Levels

- Minimum requirements for every application that will have access to BE-healthcare system. => CE mark, privacy - & data security regulations.

- Requirements of level 1 + interoperability

- Requirements of level 2 + positive health economics evaluation => tailor-made financing model will be developed

Thank you for your attention!

Any questions?


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Medical Technologies in Belgium: overview & challengesContent of the new regulations: Karel Verlinde...

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