EU Medical Devices Regulatory System WHO Forum India December 2018 Rodolphe Munoz Sciences Po Paris Lecturer

Content of the presentation 1. Introduction 2. The legislative framework 3. The New Approach 4. Conclusion

Introduction General presentation / Some slides might be too detailed From member States legislation to a set of European Directives Revision / another presentation

Step by step evolution From 1957 to 1 January 1993 No EU legislation Application of national law Framed by treaty rules Consequences Difficulty to have an internal market for medical devices Necessity to harmonise the market (28+3 EFTA States+Turkey)

The first set of Directives Directive 90/385/EC Active implantable Medical Devices Directive 93/42/EC Medical Devices Directive 98/79/EC In Vitro Diagnostic Medical Devices

Current revision The revision: 2009: preliminary work started 2012: two proposals were published by the European Commission 2017: entry into force of the two Regulations 2020 to 2022: for the implementation

New Regulations Regulation (EU) 2017/745 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 OJ L 117, 5.5.2017, p. 1–175 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 OJ L 117, 5.5.2017

New Regulations New elements Stricter ex-ante control for high-risk devices Reinforcement of the criteria for designation and oversight of Notified Bodies Inclusion of certain aesthetic devices Introduction of a new risk classification system for in vitro diagnostic Improved transparency through the establishment of a comprehensive EU database Increased device traceability system based on Unique Device Identification Introduction of an “implant card” containing information about implanted medical devices for a patient Reinforcement of the rules on clinical evidence Strengthening of post-market surveillance requirements for manufacturers Improved coordination mechanisms between EU countries in the fields of vigilance …

New Regulations But … the approach remains the same

Outside to Directives The existence of “other documents” MDCG Documents Guidance MEDDEVs Commission statements Informative documents http://ec.europa.eu/growth/sectors/medical-devices/guidance_en

The Main actors The European Commission The national authorities The international fora

MEDICAL DEVICES WORKING GROUPS CONSTELLATION Vigilance EUDAMED NB-MED Electronic labelling MEDICAL DEVICES EXPERT GROUP MDEG MEDICAL DEVICES COORDINATION GROUP MDCG Clinical investigation and evaluation New Emerging Technologies Classification and borderlines IVD Technical group Compliance and enforcement group Notified Bodies Operation Group

Links with third countries The MRAs Switzerland Australia New Zealand The Role of the international forum From GHTF to IMDRF AHWP

Outside the Directives Other EU Acts Cosmetics Machinery Protective Reach …

The choice of harmonisation The European Union has mainly two types of harmonisation process Full harmonization New Approach harmonisation The choice of the new approach consequences Respect member States differences Diversity of the Medical devices Ensure more flexibility for manufacturers Free movement

Main aspects of the new approach Legislative harmonization is limited to the adoption of the essential safety requirements The task of drawing up the technical specifications is entrusted to organizations competent in the standardization area These technical specifications are not mandatory and maintain their status of voluntary standards; National authorities are obliged to recognize that products manufactured in conformity with Harmonized Standards are presumed to conform to the Essential Requirements established by the legislation.

The new approach history From 1985 Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards OJ C 136, 4.6.1985, p. 1–9 Other products concerned — The restriction of the use of certain hazardous substances in electrical and electronic equipment (Directive 2011/65/EU) — Appliances burning gaseous fuels (Directive 2009/142/EC) — Ecodesign requirements for energy-related products (Directive 2009/125/EC) — Simple pressure vessels (Directive 2009/105/EC and Directive 2014/29/EU) — Toys' safety (Directive 2009/48/EC) — Electrical equipment designed for use within certain voltage limits (Directive 2006/95/EC and Directive 2014/35/EU) — Machinery (Directive 2006/42/EC) — Electromagnetic compatibility (Directive 2004/108/EC and Directive 2014/30/EU) — Measuring instruments (Directive 2004/22/EC and Directive 2014/32/EU) — Non-automatic weighing instruments (Directive 2009/23/EC and Directive 2014/31/EU) …

The New approach: different steps ESSENTIAL REQUIREMENTS EUROPEAN STANDARDS CONFORMITY ASSESSMENT AND NOTIFIED BODIES CE MARKING MARKET SURVEILLANCE Annex I Directive 93/42/CE •EN ISO 14971 Risk Management •EN ISO 13485 Quality management system Annexes II, IV, V, VI et VII Directive 93/42/CE Annex XII directive 93/42/CE ANSM (France) BfArM (Allemagne) MHPRA (UK) …

The main steps of the new approach FIVE MAIN ELEMENTS 1. Essential requirements 2. Standards 3. Conformity Assessment 4. CE Marking 5. Market Surveillance

Essential requirements Definition A large part of Union harmonisation legislation limits legislative harmonisation to a number of essential requirements that are of public interest. Essential requirements define: the results to be attained, or the hazards to be dealt with, but do not specify the technical solutions for doing so. The list of essential requirements Annex I of Directives Role of the Medical Device Working Groups

Example 7. Chemical, physical and biological properties 7.1. The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in Section I on the ‘General requirements’. Particular attention must be paid to: — the choice of materials used, particularly as regards toxicity and, where appropriate, flammability, — the compatibility between the materials used and biological tissues, cells and body fluids, taking account of the intended purpose of the device, — where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.

The New approach: different steps EUROPEAN STANDARDS CONFORMITY ASSESSMENT AND NOTIFIED BODIES CE MARKING MARKET SURVEILLANCE •EN ISO 14971 Risk Management •EN ISO 13485 Quality management system Annexes II, IV, V, VI et VII Directive 93/42/CE Annex XII directive 93/42/CE ANSM (France) BfArM (Allemagne) MHPRA (UK) …

European Standards Definition of harmonized standards ‘European standards’ adopted, upon a request made by the European Commission for the application of Union harmonisation legislation by a Recognised standardisation body. Harmonised standards maintain their status of voluntary application. The Statndardisation bodies CEN /CENELEC /ETSI International Standard ISO The Medical Devices Standards Annexes Z (ZA and ZZ)

Role of harmonised standards

European Standards Publication of references of a harmonized standard Verification of the conditions for the publication in the OJEU Publication of references in the OJEU Review and withdrawal

Presumption of conformity Harmonised standards provide a presumption of conformity with the essential requirements they aim to cover, if their references have been published in the Official Journal of the European Union. European standards, including harmonised standards, are often based fully or partially on international ISO or IEC standards. Sometimes, however, the presumption of conformity is possible only when applying the European version because of modifications introduced in it.

European Standards Revision of the standardization policy Regulation (EU) 1025/2012 on European standardisation strengthens the institutional framework for standardisation and its use by the Commission.

The New approach: different steps SEP 1 STEP 2 STEP 3 STEP 4 STEP 5 CONFORMITY ASSESSMENT AND NOTIFIED BODIES CE MARKING MARKET SURVEILLANCE Annexes II, IV, V, VI et VII Directive 93/42/CE Annex XII directive 93/42/CE ANSM (France) BfArM (Allemagne) MHPRA (UK) …

Conformity assessments Definition of Conformity assessment : A specific process Carried out by the manufacturer For demonstrating that a product conforms to legislative requirements Before it is placed on the market

Medical devices in the EU Different types of modules linked to the type of risk Class I Non sterile / Non measuring The others Class IIa Class IIb Class III/AIMD

Conformity assessment Two aspects of the product Design / Production Two categories Controlled by the company itself (Class I without any measurement or sterile obligation) Controlled by an independent body – Notified bodies (All the other classes)

Notified bodies Definition of notified bodies Conformity assessment bodies Which have been officially designated by their national authority To carry out the procedures for conformity assessment within the meaning of applicable Union harmonisation legislation When a third party is required.

Notified bodies Notified bodies Notified bodies are free to offer their conformity assessment services, within their scope of notification, to any economic operator established either inside or outside the Union. Notified bodies must provide relevant information to their notifying authority, the market surveillance authorities and other notified bodies. Notified bodies must operate in a competent, non-discriminatory, transparent, neutral, independent and impartial manner.

Notified bodies Notified bodies Obligations Notified bodies must have at their disposal the necessary personnel, who have sufficient and relevant knowledge and experience. Notified bodies must make adequate arrangements to ensure confidentiality of the information obtained in the course of conformity assessment. Notified bodies must be adequately insured to cover their professional activities.

Notified bodies Publication The European Commission publishes the list of notified bodies in the NANDO Website Control of the notified bodies Commission Implementing Regulation (EU) No 920/2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (OJ L253 of 25 September 2013) Commission Recommendation on the audits and assessments performed by notified bodies in the field of medical devices (OJ L 253 of 25 September 2013)

The New approach: different steps Annex XII directive 93/42/CE SEP 1 STEP 2 STEP 3 STEP 4 STEP 5 CE MARKING MARKET SURVEILLANCE Annex XII directive 93/42/CE ANSM (France) BfArM (Allemagne) MHPRA (UK) …

CE Marking Definition of CE Marking: It indicates the conformity of the product With the Union legislation applying to the product and request for CE marking.

CE Marking Who shall affix the CE Marking? The CE marking is affixed by the manufacturer (established inside or outside the Union), or by his authorised representative established within the Union. By affixing the CE Marking the manufacturer declares on his sole responsibility that the product conforms to all applicable Union legislative requirements,

CE Marking

CE marking

The New approach: different steps SEP 1 STEP 2 STEP 3 STEP 4 STEP 5 MARKET SURVEILLANCE ANSM (France) BfArM (Allemagne) MHPRA (UK) …

Market Surveillance National authorithies from every member States The controls are based on the documents produced by the manufacturer: Technical file EC Declaration of conformity Quality management certificate

EC Declaration of conformity Name and address of manufacturer or his authorised representative established in the EEA Description of the product Provision to which the product conforms Particular conditions applicable to the use of the product The certificate number Conditions and period of validity Name and position of signatory Signature of signatory Date of signature

Conclusions concerning the EU System Access to the market without direct intervention of european or national authorithies Control is performed by the notified bodies Neceesity to coordonate market surveillance

For and against Quicker Cheaper Reactive No direct control from a State body Too quick or quick enough? …

Thank you for your attention Rodolphe Munoz