Presentation at the Q1 MDR conference in Arlington on 12 July 2018 about the consequences of the EU Medical Devices Regulation for US companies in the medtech industry

1. EU MDR
CLARIFICATION &
PRACTICAL IMPACT
ON US DEVICE
MANUFACTURERS
Q1 EU MDR Implementation
12 July 2018
Erik Vollebregt
www.axonadvocaten.nl

2. Overview
• Overview: Most important regulatory changes
• Defining critical impacts on the corporation
• First steps into the gap assessment

3. Most important regulatory
changes

5. Some questions to
help you sleep better
• Who has a copy of the MDR?
• Who has read it completely?
• Who understands it (sort of / completely)?
• Whose company has done a gap assessment?
• Whose company has done an impact assessment based on the
gap assessment?
• Whose company made a transition / implementation plan?
• Whose company has decided for each of its devices if it will
remediate, retire or replace it for the EU market?
• Whose department was allocated sufficient resources to
implement the transition plan?
• Whose company thinks it will complete transition in time?

6. New steps to market

7. MedTech Europe MDR flowcharts

8. What is new?
• MDR requires systematic lifecycle approach to compliance by requiring
implementation of ‘systems’ (article 10)
• MDR = More Data Really, which needs to be fed back into device design,
risk management and clinical evaluation quicker
• Clinical evaluation at a higher standard
• EUDAMED database will contain all economic operators and device UDIs

9. What is new?
• Definitions
• Many definitions are changed and have been added
• Document requirements
• Prescribed format for technical documentation, declarations of
conformity, Post Market Clinical Follow Up Plan, Risk
Management Plan
• Claims and advertising regulation
• Classification rules
• New functions and changes to existing functions
• Person responsible for regulatory compliance
• Authorised representative heavily regulated and product liable

10. What is new?
• Regulation of MaaS (medical device as a service)
• New supply chain regime
• Labeling and UDI
• Clinical evaluation and clinical investigation (more about that
immediately after this)
• Product liability rules changed
• Insurance requirements
• Facilitation of claims by competent authority
• AR jointly and severally liable with manufacturer

11. What is new?
• PMS and vigilance requirements changed
• Must be fitted in life cycle concept and continuous update of
clinical evaluation
• QMS requirements changed
• elements of QMS system in MDR

12. What is new?
• New parts and components regime
• Obligation of validation for part manufacturer
• Performance changing parts are devices in themselves
• Changes to the systems and kits regime
• MDD systems/kits can now feature IVDs and other stuff
• EUDAMED database

13. Core article is article 10 MDR
1. When placing their devices on the market or putting them into service,
manufacturers shall ensure that they have been designed and
manufactured in accordance with the requirements of MDR
2. Manufacturers shall establish, document, implement and maintain a
system for risk management as described in Section 3 of Annex I.
3. Manufacturers shall conduct a clinical evaluation in accordance with the
requirements set out in Article 61 MDR and Annex XIV MDR, including
a PMCF.
4. MDR ONLY: Manufacturers of devices other than custom-made devices
shall draw up and keep up to date technical documentation for those
devices. The technical documentation shall include the elements set out
in Annexes II and III.
5. Draw up an EU declaration of conformity in accordance with Article 17,
and affix the CE marking of conformity in accordance with Article 18
6. Comply with the obligations related to the UDI system
7. Comply with registration obligations

14. Core article of MDR: article 10
(gen. obligations manufacturer) (2)
8. keep the technical documentation, the EU declaration of conformity
and, if applicable, a copy of the relevant certificate including any
amendments and supplements, available to the competent authorities
for at least ten years after the last device covered by the declaration of
conformity has been placed on the market (15 for implantable devices)
9. Have and maintain QMS that takes standards and CS into account,
addressing the minimum requirements in the MDR
10.implement and keep up to date the post-market surveillance system
11.ensure that the device is accompanied by the information to be supplied
in accordance with Annex I in an official Union language(s) determined
by the Member State where the device is made available to the user or
patient
12.In case of non-conformity take the necessary corrective action to bring
device into conformity, withdraw it or recall it
13.have a system for recording and reporting of incidents and field safety
corrective actions as set out in MDR

15. Core article of MDR: article 10
(gen. obligations manufacturer) (3)
15.Cooperate with authority in information requests for product liability
claims
16.Where manufacturers have their devices designed and manufactured
by another legal or natural person the information on the identity of that
person shall be part of the information to be submitted into Eudamed
17.have measures in place to provide sufficient financial coverage in
respect of their potential liability under Directive 85/374/EEC
proportionate to the risk class, type of device and the size of the
enterprise (without prejudice to more protective measures under
national law)

16. Clinical Data Requirements
Conceptually Evaluated
Rev. 3
What the
MDD and
AIMDD
require
Rev. 4
What the
MDD and
AIMDD
require
restated in
a lot more
detail
MDR
What the
MDR
requires
Evolving thinking around same legal standard
New legal standard,
using existing
concepts

17. No grandfathering and no moving
of implementation deadlines
• All devices on the market are phased
into the new system by the end of
transitional period
• This means that you have to do a
new conformity assessment under
the new rules for all devices
currently on the market or remove
the product from the market
• If you don’t have a new CE under
MDR, you cannot place new product
on the market after transition period
• Do not count on the EU “having to
move deadlines because it will be
chaos”, as this would be
unprecedented

18. Defining critical impacts on the
corporation

19. The new MDR: main challenges for
US companies
• No grandfathering
• Every technical file for every product must be revisited
• Additional clinical data may be necessary
• Gap / impact assessment
• A lot of new things in the MDR means that your current regulatory
assumptions will not be valid anymore (e.g. reclassification), the
underlying documentation and data is no longer valid (e.g. new
technical file / DoC format) and your certificates will need to be
timely renewed under the MDR (notified body accreditation and
Brexit)
• Transition plan + execute plan
• Management will under-resource and underfund by default

20. The new MDR: main challenges for
US companies
• Using transitional regime wisely or obtaining a timely CE certification
under MDR
• Renew MDD/AIMDD certificate one last time or go for MDR
certificate?
• Monitor notified body
• Has it applied for MDR accreditation?
• Has it applied for the right scope?
• How did its joint audit go / what NCs?
• Will it even be in the Union (Brexit)?
• Monitor implementation
• CAMD Roadmap and FAQ
• Medtech Europe / COCIR

21. Notified body designation process
timelines
• Make sure that you know where your notified body is in the process

22. Transitional regime
Slide: Gert Bos at DIA Euromeeting 2017

23. Transitional regime
Slide: Gert Bos at DIA Euromeeting 2017

24. Timeline for certificate validity
• Make sure you understand how your certificates work and plan your
transition to MDR

25. Bottlenecks
‘soft transition’
• Be careful with ‘soft transition’
• Article 120 (3) restrictions
• No significant changes in design and intended purpose
• MDR level controls and obligations
• Notified body cannot be changed anymore
• Notified bodies will not accept last minute applications

26. Timelines and notified bodies
• Planning certificate remediation tail by notified body at the end of each
transition period is a bad idea
• Notified bodies have started to manage expectations, e.g.: “BSI
believes that many of our clients face the possibility of not
completing the transition in time and therefore are placing
themselves at real risk of not holding valid Directive or Regulation
certificates by the May 2020 deadline, for all products on the
market.”
• Do not count on NB capacity to complete anticipated additional
MDD/AIMDD work within the last 6-9 months of the MDR
transition period, so apply far in advance
Early 2019
MDR
remediation
for new and
existing
devices

30. First steps into gap assessment

31. Operationalising the transition
plan: business readiness

32. Operationalising the transition
plan: program readiness

34. Gap assessment

35. An overall plan could look like this

36. Four step approach
1. MDR interpretation exercise
2. Formation of cross-functional teams
3. Rectification plan and notified body approach
4. Portfolio rationalization and budget plan

37. Credits: Joachim Wilke, Medtronic

38. NEW AND LEGACY PRODUCTS
ARE AFFECTED
Credits: Joachim Wilke, Medtronic

39. Cross-functional organisation of
team
Credits: Joachim Wilke, Medtronic

40. What to focus on?
Credits: Joachim Wilke, Medtronic

41. Portfolio rationalization
Sales &
Marketing
Priorities
Availability of
Clinical Data
Management
Discretion
Technical
Documentation
Integrity
Criteria to be considered

42. GDPR dependencies

43. Concurrent privacy by design
requirements under GDPR
• General Data Protection Regulation has already entered into force,
transitional period ending 25 May 2018
• Will apply to any device that processes personal data, both on hardware
and software level – possible overlaps with MDR
• Relevant for everything clinical
• Requires privacy by
• Design
• Default
• Requires cybersecurity measures

45. www.axonlawyers.com
THANKS FOR YOUR ATTENTION
Erik Vollebregt
Axon Lawyers
Piet Heinkade 183
1019 HC Amsterdam
T +31 88 650 6500
M +31 6 47 180 683
E erik.vollebregt@axonlawyers.com
@meddevlegal
B http://medicaldeviceslegal.com
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