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

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

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

4. 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)

5. 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

6. 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

7. 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, , 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,

8. 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 …

9. New Regulations
But … the approach remains the same

10. Outside to Directives The existence of “other documents”
MDCG Documents
Guidance MEDDEVs
Commission statements
Informative documents

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

12. 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

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

14. Outside the Directives
Other EU Acts
Cosmetics
Machinery
Protective
Reach …

15. 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

16. 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.

17. The new approach history
From 1985
Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards OJ C 136, , 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) …

18. 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 Risk Management
•EN ISO 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) …

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

20. 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

21. 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.

22. The New approach: different steps
EUROPEAN STANDARDS
CONFORMITY ASSESSMENT AND NOTIFIED BODIES
CE MARKING
MARKET SURVEILLANCE
•EN ISO Risk Management
•EN ISO 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) …

23. 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)

24. Role of harmonised standards

25. 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

26. 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.

27. 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.

28. 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) …

29. 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

30. 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

31. 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)

33. 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.

34. 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.

35. 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.

36. 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)

37. 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) …

38. 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.

39. 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,

40. CE Marking

41. CE marking

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

43. 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

44. 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

45. 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

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

47. Thank you for your attention
Rodolphe Munoz