WATCH the recorded webinar here: http://www.emergogroup.com/resources/video-webinar-europe-mdr-changes The first major revision to device regulations since 2007 has been released and the changes are significant. Although the MDR won't take effect until early 2020, smart companies are planning ahead to beat the crush of companies that will inevitably wait until the last minute, overwhelming EU Notified Bodies. Ronald Boumans, Senior Global Regulatory Consultant for EMERGO (and former IGZ compliance inspector in The Netherlands) outlines the most important changes you need to know in this 35 minute recorded webinar from September 2016. Topics addressed include: How the MDR is organized Scope of the legislation Device classification rules New clinical evaluation requirements UDI and EUDAMED database Adverse event reporting And much more...

1. Ronald Boumans
Senior Global Regulatory Consultant
Telephone: +31 70 345 85 70
rboumans@emergogroup.com
Understanding Europe’s new
Medical Devices Regulation
(MDR)

2. The new Medical Devices Regulation!
Be aware of some major
changes
Prepare in advance
Make sure your team is
prepared
MDR = ‘Medical Devices
Regulation’

3. Today’s agenda
Relevance of the MDR proposal
Major concepts of the MDR
Critical items:
Clinical data
Post-Market Surveillance
Periodic Safety Update Report
EUDAMED
Timelines

4. Before we begin…
The Hague, The Netherlands
108 Embassies in The Hague!
Dutch
Parliament

5. Relevance of the MDR:
Leading a global trend

6. Once upon a time…
There was a Technical File of about
12 pages…
… for a Class III device…
Those days are long gone…

7. Medical Devices Directive (MDD)
in need of revision
Structural problems:
Oversight by the Notified Bodies insufficient
Post-market safety
Transparency and traceability of devices
Access to medical expertise
But also:
New types of products introduced
Lack of consensus among competent authorities
New market concepts
Further globalization
PIP scandal was a wake up call!

8. MDR indicator of a global trend
More liability for the manufacturer
More clinical data needed
Clinical data of higher quality
Monitoring of quality and safety during
product life cycle
Increased data management

9. It took a while to deliver…
First weaknesses identified in 2002 by MDEG
Modifications to MDD in 2007 (2007/47/EC)
European Commission public consultation in 2008
Deficiencies became clear (PIP, metal-on-metal etc.)
September 2012 first version by European Commission
April 2014 European Parliament 347 amendments
September 2015 European Council with its own version
June 2016 current compromise text
Final version expected in Q1 of 2017
40 – 80 delegating and implementing acts to follow

10. Significant influence by IMDRF
International Medical Device Regulators
Forum - IMDRF (Australia, Brazil, Canada,
China, Europe, Japan, Russia, USA)
Builds on Global Harmonization Task Force
(GHTF)
Influence can be seen in:
•Introduction of UDI
•Requirements for Technical File
•Post Market Surveillance
MDR will likely impact future legislation in
other markets

11. More control over industrial network
Manufacturer must control supply chain as well as distribution
chain:
Prepare supply chain for unannounced audits by NB
Critical supply must be part of the Technical File and the Quality
Management System
Control over distribution chain must be part of QMS
Characteristics of distribution chain may lead to design
requirements
Distribution chain will have role in vigilance and PMS
Be prepared to update your QMS

12. Stricter control over Notified Bodies
Less of an industry partner, more an extension of the authorities
Tighter requirements for Notified Bodies
Expect Notified Bodies to be more critical
Increased procedural requirements
•Joint Assessment Teams – several competent authorities, highly
trained
•Less room for outsourcing expertise
•More clinical expertise in-house
•Opinion provided by MDCG during conformity assessment of
high risk devices

13. Economic Operators
Manufacturers, Authorized
Representatives, Importers and Distributors
(MAID)
Each role well defined (articles 8-12)
Economic Operators to verify if upstream
supplier is in conformity
Able to identify to whom delivered
Reporting requirements re. Vigilance
Must act in case of Field Safety Corrective
Action
The manufacturer is responsible to
organize and train distribution chain.

14. Clinical evaluation:
A next step in
compliance assessment

15. Major changes
Old:
Clinical Evaluation Report
Much information from literature review
Often with data referring to devices that
were not equivalent
How well did your Notified Body look
into your updates to your CER?

16. Major changes
New:
Constantly updated set of data from subject
device
Benefit – risk evaluation
Permanent updating
Notified Body will look into data AND
methodology!
Notified Bodies will
look into data AND
methodology.

17. Increase data quality requirements
MEDDEV 2.7/1 Rev. 4 already lifts the bar
MDR goes further: only data from
equivalent devices is accepted, and
This data must adequately demonstrate
compliance with the relevant requirements
Collecting this data may take longer than
you think.

18. Equivalent devices
Equivalence is defined in detail in Annex XIII, section 4a
Equivalence = Technical (similar design), Biological (same
materials/substances) and Clinical (same condition or purpose) –
no significant differences in clinical performance and safety
Equivalent device of another manufacturer: full access to the
technical file
Many current “equivalent devices” will no longer be accepted

19. Clinical Evaluation and QMS
Collection and evaluation of clinical data must be part of the QMS
Each device should be part of a continuous cycle of improvement

20. Clinical investigations
Strict requirements for clinical investigations
Specific requirements for vulnerable or
incapacitated subjects
Timelines of reporting of Serious Adverse
Events
Clear rationales for sample sizes
Clinical investigations will take more time and
they will be more expensive
Clinical investigations
will take more
time and they will be
more expensive.

21. Where does your current clinical data
come from?
Data somewhere on file…
Data from previous generations of
the device – still equivalent?
Data from previous companies
Data incomplete, because part is
stored in a format that can no longer
be accessed (e.g. floppy disks)
Verify that your clinical data is still
available, applicable, and valid

22. Post-Market Surveillance:
A giant leap forward

23. Post-market surveillance plan
Necessary for each device
Part of updated CER
Collect information on specific subjects (incidents, trending,
complaints, feedback etc.)
Procedures of how to collect that information
Define how to systematically evaluate information, including
indicators, thresholds, etc.
And many more…

24. Post-market clinical follow-up (PMCF)
Continuous process to
update clinical evaluation
Collect data and evaluate
PMCF is part of PMS

25. PMCF plan
Required for each device (family)
Process to update CER
Confirming safety and performance, side-
effects, risks, etc.
Methods and procedures used
Rationale for the appropriateness of these
methods and procedures
Objectives, time schedule, etc.
Start developing your
PMS plans now, they
may generate valuable
information for your
transition to the MDR.

26. Vigilance and market surveillance
Reporting of incidents will have to done through Eudamed
Accessible to European Commission, Competent Authorities,
Notified Bodies and public (limited)
Keep evaluating your device against the general safety and
performance characteristics
Competent authorities will monitor compliance of devices
involved in incidents and/or corrective actions
For fast and consistent reporting you need a smart data
management system

27. Benefit of risk determination
The clinical benefits must
outweigh the risks of the
device
The result of this analysis may
change over time
All this needs to be recorded
in the PMS report

28. Is this REALLY such a big leap forward?
The clinical benefits must outweigh the risks
of the device
The result of this analysis may change over
time
All this needs to be recorded in the PMS
report
For fast and consistent
reporting, you need a
smart data
management system.

29. Periodic Safety Update Report
A new concept

30. Class I: periodic updated PMS report
PMS report to be updated as new
clinical data is evaluated
Part of Technical File
To be assessed by the Competent
Authorities upon request
First indicator of Competent
Authorities if a manufacturer has an
active PMS system

31. Periodic Safety Update Report
For Class lla, Class llb and Class lll:
Conclusions of benefit risk
determination
Main findings of PMCF report
Volumes of sales/exposure in report
Would you be able to
draw up such a report
based on your current
procedures/data?

32. Publication of Periodic Safety Update
Reports
For Class lll and llb implants:
Must be uploaded to Eudamed
Evaluated by Notified Body
Possible conflict: freedom of information acts
versus sensitive commercial data
Your annual sales data may be published

33. EUDAMED:
A brave new world of
medical devices data

34. EUDAMED helps map Economic
Operators
Manufacturer, Authorized Representative, Importer, and
Distributor must all be listed in EUDAMED
Essential in demonstration of compliance
Competent authorities will map industry based on EUDAMED
Parts will be accessible to the public
At least you may know your parallel importer.

35. Single Registration Number (SRN)
Every Economic Operator needs an SRN for accessing EUDAMED
Multiple roles will require multiple SRNs (e.g. Authorized
Representative AND importer: two SRNs)
Competent authority will verify company information before
handing out SRN
No access to EUDAMED without SRN
SRN must be on certificates
Be aware: no Eudamed access, no market access.

36. Entering data
Economic operators can enter data in
EUDAMED:
•Devices
•Clinical investigations
•Incidents
•Etc.
Upload Periodic Safety Update Report
Upload Summary of Safety and Clinical
Performance Report
Confirm annually
Old data remain available in Eudamed
Take care data quality
in Eudamed is high!

37. Timelines:
Planning in the dark

38. The timeline…
MDR will be adopted in Q1 2017
After six months notified bodies may
apply for designation
At least six months before application
EUDAMED becomes operational
MDR will be applicable three years
after adoption
No ‘old’ certificates will be valid four
years after application
But…

39. The reality…
It is not clear in what order NBs will be designated and the
designating team has limited capacity
At the moment an NB is designated for the MDR it can no
longer issue MDD certificates
EUDAMED is crucial for producing the SRNs, but may not be
ready at the moment the first NB is designated: no certificates
can be issued until EUDAMED is operational

40. Grandfather devices
Currently compliant, safe device,
but insufficient clinical data:
grandfather device
Under MDR clinical data via clinical
investigations, but…
Under MDD clinical data via PMCF
study possible
Identify possible grandfather devices
now!

41. Continuity of supply
The transition to the MDR is a complex
process
Not all certificates may switch smoothly from
the MDD to the MDR
No certificate, no access to the market
Emergo expects authorities will have a
pragmatic approach…
…but this may only be achieved after some
high exposure cases
Emergo will keep you
informed of
developments. Please
let us know if you run
into this issue.

42. What can you do?
Get detailed knowledge of the MDR
Find out the plans of your notified
body
Assess the level of your clinical data
Start implementing PMS measures as
soon as possible
No worries - your competitors are
facing the same problems…

43. Thank you for your attention!
Device
Registration and
Compliance in
24 Countries
Worldwide
My contact information:
Ronald Boumans
EMERGO | Senior Regulatory Consultant
rboumans@emergogroup.com
Telephone: +31 70 345 85 70