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...
Webinar: Europe's new Medical Device Regulations (MDR)
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
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.
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
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.
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
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!
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