2. NEW MDR
Regulatory Context

3. NEW MDR
Regulatory Context
MODERNIZED

4. NEW MDR
Regulatory Context
MORE ROBUST

5. NEW MDR BETTER PROTECTION Regulatory Context
of public health and patient safety

6. 1 TWO NEW 2017/745 3 YEARS Regulations
Regulation (EU)
2017/745
of the European Parliament and the European Council of 5 April 2017 on MDs, amending Directive 2001/83/EC, Regulation (EC) No 178/2002, and Regulation (EC) No 1223/2009 and repealing European Council Directives 90/385/EEC and 93/42/EEC
3 YEARS
Applies only after transitional period of

7. 2 TWO NEW 2017/746 5 YEARS Regulations
Regulation (EU)
2017/746
of the European Parliament and the European Council of 5 April 2017 on in vitro diagnostic medical devices (IVMDs) repealing Directive 98/79/EC and Commission Decision 2010/227/EU
5 YEARS
Applies only after transitional period of

8. CONTEXT 1992 MDR Regulatory AIMD Directive (90/385/EEC) and
‘92
1992
Introduction of
AIMD Directive (90/385/EEC) and
MD Directive (93/42/EEC)

9. CONTEXT 2007 MDR Regulatory‘
2007
‘92
Directive 2007/47/EC modified the Medical Devices Directive (MDD) and the active implantable medical device (AIMD) in an attempt to address the weaknesses and concerns of previous directives

10. CONTEXT 2010 MDR Regulatory
‘92
‘07
2010
Scandal involving defective breast implants manufactured by Poly Implant Prothèse in France, which surfaced in 2010 and which demonstrated additional structural weaknesses in the system

11. CONTEXT 2012 MDR Regulatory
‘92
‘07
‘10
2012
September: European Commission published proposals for MDR 2017/745 and In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. Discussion between the European Commission, the European Parliament, and the European Council compromises text in June 2016 and translation into all European Union languages by September-October 2016

12. CONTEXT 2017 MDR Regulatory
‘92
‘07
‘10
‘12
2017
New medical device regulations (MDRs) (2017/745) were formally published in the Official Journal of the European Union in May 2017, heralding the official transitional period

13. CONTEXT 2020 MDR Regulatory Full implementation of
‘92
‘07
‘10
‘12
‘17
2020
Full implementation of
MDR 2017/745 in May 2020

14. CONTEXT High risk devices New MDR Regulatory
Stricter ex ante control of
High risk devices

15. CONTEXT Designation & processes New MDR Regulatory
Reinforcement of the criteria covering
Designation
& processes
for oversight by notified bodies

16. New MDR Regulatory
CONTEXT
Inclusion of certain
Aesthetic
devices

17. CONTEXT Classification SYSTEM New MDR Regulatory
Introduction of a new risk
Classification
SYSTEM

18. New MDR Regulatory
CONTEXT
Improved
transparency

19. New MDR Regulatory
CONTEXT
Introduction of an
Implant card

20. CONTEXT Clinical evidence New MDR Regulatory
Reinforcement of the rules on
Clinical evidence

21. CONTEXT Surveillance Requirements New MDR Regulatory
Strengthening of postmarketing
Surveillance
Requirements

22. New MDR Regulatory
CONTEXT
Improved
Coordination
mechanisms

23. New MDR Regulatory
CONTEXT
More
Information
available

24. Important modifications
Stricter premarket control
Inclusion of aesthetic products
Data on real-life use of devices
Oversight by notified bodies
Implant card
European Union database
Rules on clinical data 7
Important modifications

25. Face
more
liability
IMPACT
of new regulations on manufacturers

26. data of higher quality IMPACT Acquire more clinical
of new regulations on manufacturers

27. improve data management IMPACT
Have to
improve data management
IMPACT
of new regulations on manufacturers

28. IMPACT the full product life cycle
Monitor quality and safety throughout
the full product life cycle
IMPACT
of new regulations on manufacturers

29. Prepare supply chains for unannounced audits
COMPLIANCE
Addressing MDR

30. Distribution will have a role in vigilance and postmarketing surveillance
Addressing MDR
COMPLIANCE

31. Manufacturers should thoroughly assess entire device portfolios
Addressing MDR
COMPLIANCE

32. COMPLIANCE Addressing MDR
Supports portfolio assessment and CE dossier preparation to ensure compliance with the MDR.
Addressing MDR
COMPLIANCE

33. COMPLIANCE EUDAMED planned go-live in 2019. Addressing MDR
Obliged to report under the MDR should the EUDAMED not go live before the date of application in May 2020.
Addressing MDR
COMPLIANCE

34. COMPLIANCE STRATEGIES that plan for TRANSITION Addressing MDR
Strongly recommended:
Addressing MDR
COMPLIANCE

35. COMPLIANCE Addressing MDR
Expiration dates of their CE Marking certificates
Notified bodies’ policies
Availability of clinical data
Expiration dates of devices
Helps manufacturers BUILD STRATEGIES BASED ON:
Addressing MDR
COMPLIANCE

36. TIMELINE Complex MDR 05 May 2017 25 May 2017 25 Nov 2017 26 Nov 2017
Publication of new MDR-IVDR 25
May
2017
New MDR-IVDR comes into effect 25
Nov
2017
Early applicability of regulation concerning notified bodies: notified bodies may apply for MDR designation
26 Nov 2017 to
26 May 2020
Notified bodies may issue certificates under the MDD or the AIMDD, with a maximum validity of five years 25
May
2018
Cooperation of competent authorities and the commission

37. TIMELINE Complex MDR 25 May 2019 25 May 2020 27 May 2022 26 May 2024
Notified bodies for UDIs
Certificates issued in accordance with AIMDD (Annex 4) and MDD (Annex IV); EC-type verifications that have not yet expired will become void 25
May
2020
Full applicability of regulation; other regulations are nullified 27
May
2022
MDD certificates expire (Annex IV) 26
May
2024
Other certificates issued under current directives that have not yet expired will become void 26
May
2025
Devices CE Marked under the MDD or AIMDD may no longer be marketed or put into service in Europe

38. EUDAMED MDR timeline also dependent on functionality of 25 May 2020 25
Regulation related to EUDAMED and the UDI database 25
Nov
2020
Registration obligation in EUDAMED (registration of product, test certificates)
(18 months later)
25 May 2021 to
25 May 2025
UDI labelling obligation (timeline depending on risk class)
25 May 2023 to
25 May 2025
UDI direct marketing in reusable products

39. GREAT OPPORTUNITY AHEAD
New MDR requires more action from industry = additional burden for companies
= efficient regulatory & quality services
across the MD life cycle
GREAT OPPORTUNITY AHEAD

40. specialises in helping international life sciences organisations more effectively get their products and therapies to market by providing those clients with functional support across all of the regulated stages of the product life cycle—from development to launch, to postmarketing.