1) The EU medical devices regulatory system has evolved from member states having their own legislation to a set of harmonizing European directives. The first directives were introduced in 1990-1993 and the system was recently revised in 2017. 2) The new approach harmonization method is used, which limits legislative harmonization to essential safety requirements and relies on voluntary European standards and conformity assessment by notified bodies to demonstrate compliance. 3) Under the new approach, manufacturers affix the CE marking after completing the appropriate conformity assessment modules and declaring conformity. Notified bodies and national authorities then conduct market surveillance to check compliance.

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

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

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
7
 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

8. New Regulations
8
 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
9
 But … the approach remains the same

10. 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

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

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

13. Links with third countries
13
 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. 16
 Main aspects of the new approach
1. Legislative harmonization is limited to the adoption of the
essential safety requirements
2. The task of drawing up the technical specifications is
entrusted to organizations competent in the standardization
area
3. These technical specifications are not mandatory and maintain
their status of voluntary standards;
4. 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, 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)
…

18. CONFORMITY
ASSESSMENT
AND NOTIFIED
BODIES
MARKET
SURVEILLANCE
CE MARKING
EUROPEAN
STANDARDS
ESSENTIAL
REQUIREMENTS
STEP 1 STEP 2 STEP 3 STEP 4 STEP 5
The New approach: different steps
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
ANSM (France)
BfArM
(Allemagne)
MHPRA (UK)
…
Annex XII
directive
93/42/CE

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
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 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. CONFORMITY
ASSESSMENT
AND NOTIFIED
BODIES
MARKET
SURVEILLANCE
CE MARKING
EUROPEAN
STANDARDS
STEP 2 STEP 3 STEP 4 STEP 5
The New approach: different steps
•EN ISO 14971
Risk
Management
•EN ISO 13485
Quality
management
system
Annexes II, IV, V,
VI et VII
Directive
93/42/CE
ANSM (France)
BfArM
(Allemagne)
MHPRA (UK)
…
Annex XII
directive
93/42/CE

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
24

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

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
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 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
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 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)

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33. Notified bodies
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 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
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 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
35
 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
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 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. MARKET
SURVEILLANCE
CE MARKING
SEP 1 STEP 2 STEP 3 STEP 4 STEP 5
The New approach: different steps
ANSM (France)
BfArM
(Allemagne)
MHPRA (UK)
…
Annex XII
directive
93/42/CE

38. CE Marking
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 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
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 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
40

41. CE marking
41

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

43. Market Surveillance
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 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
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 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
45
 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
46
 Quicker
 Cheaper
 Reactive
 No direct control from a State body
 Too quick or quick enough?
 …

47. Thank you for your attention
Rodolphe Munoz