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© 2016 YourEncore, Inc. All rights reserved.
EU Medical Device Regulation: Preparing for Disruptive (Yet Incomplete) Regulation
April 14, 2016
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 Confidential
Company Introductions
4 Confidential
Introducing Our Speakers
Minnie Baylor-Henry, J.D.Medical Devices Practice [email protected]
Jon LangePrincipal, Life Sciences R&D Global [email protected]
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 Confidential
Why the Change?
Patient Safety ConcernsLack 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 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
Transparency
TraceabilityTrace-
ability
Transparency
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 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 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 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 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, 2016Limerick, Ireland
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
THANKS FOR ATTENDING
MINNIE BAYLOR-HENRYMedical Devices Practice [email protected]
JON LANGEPrincipal, [email protected]
YOURENCORE INSIGHTS
http://info.yourencore.com/yourencore-insights
@YourEncoreInc
https://www.linkedin.com/company/yourencore/
