© 2016 YourEncore, Inc. All rights reserved.
EU Medical Device Regulation: Preparing for Disruptive (Yet Incomplete) Regulation
April 14, 2016
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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
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Company Introductions
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Introducing Our Speakers
Minnie Baylor-Henry, J.D.Medical Devices Practice [email protected]
Jon LangePrincipal, Life Sciences R&D Global [email protected]
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• 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
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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
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• 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
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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
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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
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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
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• 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
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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
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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]
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