This document discusses preparing for the upcoming EU Medical Device Regulation (MDR), which aims to improve patient safety but remains incomplete. It outlines an agenda including introductions, a discussion of MDR's likely impact on clinical evidence, transparency, and traceability, and common CEO questions. The discussion covers basic compliance questions companies should consider, mapping a compliance plan over the transition period, and notes that companies should start preparing now rather than waiting for full clarity.

1. © 2016 YourEncore, Inc. All rights reserved.
EU Medical Device Regulation:
Preparing for Disruptive (Yet Incomplete)
Regulation
April 14, 2016

2. 2 Confidential
Agenda
Introductions: 12:00 – 12:05 PM ET
Discussion: 12:05 – 12:30
1
2
Q&A: 12:30 – 12:40
Wrap-Up: 12:40 – 12:45
3
4

3. 3 Confidential
Company Introductions

4. 4 Confidential
Introducing Our Speakers
Minnie Baylor-Henry, J.D.
Medical Devices Practice Lead
YourEncore
Minnie.BaylorHenry@yourencore.com
Jon Lange
Principal, Life Sciences R&D Global Lead
EY
Jon.Lange@ey.com

5. 5 Confidential
• Has been discussed
since 2008
• Regulations still not
finalized
• 3 years to comply
• Many competing
priorities
Avoiding MDR “Fatigue”
BUT
It’s Easy to be
MDR Weary
Remember US UDI

6. 6 Confidential
Why the Change?
Patient Safety Concerns
Lack of Data
Transparency
• Existing rules from 1990s
• No access to clinical data
on safety/efficacy
• Difficult to track devices
back to suppliers
• Divergences in the
application of the rules
“The industry was facing a trust issue. Questions were being asked of the regulatory
system, and if the system cannot answer those questions, then that reflects badly - not
only on the system, but on the reputation of the industry.”
- John Brennan, Director Regulations and Industrial Policy, Eucamed
• PIP breast implants
• Vaginal mesh recall
• Dalkon Shield IUD
• FDA whistleblowers
• Metal on metal hip
implants

7. 7 Confidential
• A requirement for clinical trial data to be provided before a CE mark is
granted for implantable and high-risk devices
• Pre- and post-market approval processes for high-risk, implantable
devices
• Data transparency — including publication of clinical trial data and
safety summaries
• Defined content and structure for technical files to support registration
• Tightening of vigilance reporting timelines from 30 days to 15 days
• A unique device identification system, possibly similar to the US’
• The establishment of the Eudamed medical device database, through
which regulators, providers, and the public can access technical data,
clinical trial results and adverse event reports
• Expanded “directions for use” content associated with products
• A possible ban on the use of some restricted substances and a
requirement to track certain chemicals through the supply chain
• More power to notified bodies, including the establishment of “super”
notified bodies responsible for high-risk, implantable devices
• Economic operators in the supply chain (e.g. manufacturers) will need
to comply with new reprocessing, up-classification, post-market
surveillance and reporting rules
What is the (Likely) Impact?
Clinical
Evidence
Transpar
ency
Traceabi
lityTrace-
ability
Transparency

8. 8 Confidential
Common CEO / CFO Questions
How are Companies Reacting?
• What percent of our
revenue is at risk?
• What is the total cost of
compliance?
• Will we have to
rationalize our product
lines?
• How prepared are our
existing or future
partners?
• How can this enhance
our brand?
• How will this shape our
portfolio?
• Will this present M&A
opportunities?
• How can this increase
our competitive
positioning?
Compliance Strategy

9. 9 Confidential
Basic Questions – What’s Your Risk?
► How does UDI under MDR/IVDR differ from the US UDI solution?
► How does language specific labelling impact packaging design ?
► Will the current ‘artwork’ process be capable of handling the MDR/IVDR labelling
complexity?
► Can current processes handle the anticipated volume of complaints and questions
from the authorities?
► What level of change do we have in our technical files?
► How many of our products have up to date PMS plans?
► What proportion of our portfolio’s are implicated by the restrictive substance changes?
► Will we have extensive Clinical Investigations to be conducted for our high risk
devices?
► How will our re-certification plans be impacted in the transition period?
► Do we need to align with our NB’s on how the new MDR/IVDR will be assessed?
► Is our QMS up-to-date and able to deal with all the changes?
► Which companies will revise their business model?
► What new market strategies will be developed by competitors?
► Which companies will withdraw products from the market?
► To what extent is incremental innovation still adding business value when compliance
costs increase? Is a more radical approach more profitable?
R&D
Supply
Chain
Reg.
Affairs
Quality
Assurance
Commercial

10. 10 Confidential
Mapping Your Plan
Pre-Final Text Final Text (Day 0) Transition (3 – 5 years)
Leadership
C-suite understands
transformational impact
and prioritizes as strategic
objective
Business response defined
and leadership supports
transition
• Strategic issue
escalation
• Business continuity
Business
• EU MDR is on all
• business units’ agenda
• Gap assessment
completed (MDD vs EU
MDR)
Enabler projects to
support journey to
compliance
• Implementation
execution
• Cross-functional
complexity
management
Financial
• Revenue impact and
costs identified
• Year 1 transition budget
finalized
• Allocation of year 1
budget
• Resource allocation to
support transition
• Budget management
• Financial reporting
Governance
• Enterprise-wide
steering committee
• Regulatory leads and
has planning remit
• Communications
strategy agreed
Remit for validated
implementation plan
Implementation
management

11. 11 Confidential
• Don’t wait for 100% clarity
• Start acting now to:
o Understand your risk and gaps
o Budget accordingly
o Shape go-forward strategy – how can MDR
readiness improve your competitive position?
• While RA can drive this initiative, many
functions will need to get involved
• If you need help in the process, EY and
YourEncore have tools and SMEs to
assist you
Parting Thoughts

12. 12 Confidential
White Paper “New MDR Business
Implementation
Workshop”
Personal
Workshop
More detailed
overview of EU MDR
3 Ways to Learn More
Schedule 1 – 2 Day
Workshop
May 18th, 2016
Limerick, Ireland

13. 13 Confidential
Attend Upcoming Webinars
Staying Connected
No Surprises: Improving Medtech Due Diligence
Thursday, April 28th: 12:00 – 12:45 PM ET
• Donna Godward – Former Chief Quality Officer, J&J MD&D
• Janet Vargo, Ph.D. – Former Board Member and Head of Clinical and Regulatory
Affairs for Mentor, LLC, a Johnson & Johnson Company
483 Responses: Best Practices
Tuesday, May 10th: 12:00 – 12:45 PM ET
• Victor Chance – Former VP, External Operations and Supply Chain Chief Procurement
Officer for J&J MD&D
• Judith Meritz, J.D. – Former Assoc. General Counsel at Covidien/Medtronic

14. THANKS FOR ATTENDING
MINNIE BAYLOR-HENRY
Medical Devices Practice Lead
Minnie.BaylorHenry@YourEncore.com
JON LANGE
Principal, EY
Jon.Lange@ey.com
YOURENCORE INSIGHTS
TWITTER
LINKEDIN
http://info.yourencore.com/yourencore-insights
@YourEncoreInc
https://www.linkedin.com/company/yourencore/