Start early to avoid surprises
Europe’s medical device directive (MDD) is changing as a result of MDR 2017/745 published on May 5, 2017. The new regulations will come into full force in Q2 2020, after a 3 year transition period. With over 300 pages, you probably have a lot of questions about preparing for MDR 2017/745: What is new, what has changed, where to start and how this will affect you and your company.
While I can’t cover every single change in detail, I would like to highlight some of the main themes in the new regulations.
- The MDR shifts from the current pre-approval stage process to a lifecycle approach similar to the US FDA, as illustrated by the requirements for clinical evaluation, vigilance and post-market clinical follow-up. Notified Bodies will be under stricter supervision with increased requirements for Notified Body staff qualifications.
- Demonstrating clinical safety or performance for lower risk devices by equivalence, and referencing studies performed with other devices, will be more rigorously reviewed and challenged.
- For implantable and Class III medical devices, clinical investigations will be expected, and demonstrating equivalence will be no longer acceptable (with some exceptions). Notified Bodies will expect more in depth and extensive clinical investigations and evidence.
This is a lot to cover. How can you prepare for all of these changes?
- Because all existing devices will need to be re-certified to the new MDR by Q2, 2020 to remain on the market, manufacturers will need to review and update their technical documentation, systems and processes. Product portfolios will need a review to ensure the data supporting safety and effectiveness are up to the new requirements for CE mark. The effect of the new regulations on supply-chains will need to be identified and changes planned. The essential requirements check list and technical files will need to be revisited. All labeling will need a review to include the new requirements for Single Registration Number (SRN), Unique Device Identification (UDI), etc. Post Market Surveillance (PMS) planning will also be required.
- Notified Bodies must begin planning how they will conduct conformity assessments and how they will assess technical documentation. Assessment of legacy devices will probably be the most challenging as Notified Bodies will have to identify and address any gaps against the new requirements. Hopefully, PMS activities can be used to address these gaps.
- Manufacturers and Notified Bodies will have to align their expectations with the new MDR realities. There will be more pre-market scrutiny, more clinical requirements and more performance expectations than before. Manufacturers will need more resources to achieve and maintain compliance with the regulations and that will lead to bigger budgets for internal resources and additional costs from the Notified Bodies.
- Big issues to address: Manufacturers will need to study in detail the new MDR and decide when and how to comply during the transition period. Here are some practical transition period questions to answer:
- Should you update your legacy device to the new MDR? Is the investment required to cover the new requirements justified?
- Are there any international implications affecting tenders, label changes and registrations in other areas?
- When will Notified Bodies be designated under the MDR? It is possible that some Notified Bodies will no longer participate because they cannot cover the new requirements. Is your Notified Body getting a designation under the MDR and do they have a transition plan?
- How are your other economic operators (EU representatives, distributors, partners, importers) in the EU affected by the new regulations?
- How much time will be needed to obtain MDR CE certificates? Think about Notified Body wait times, possible bottle necks/ delays, time to resolve any interpretation/conformity issues.
- How much data is enough? How will you achieve alignment between manufacturer and Notified Body expectations?
The MDR is published but there is still a lot of work to be done during the three year transition period. There are 80 implementing and delegating acts to be published, approximately 58 Notified Bodies to be re-designated, numerous guidances to be issued and close to 500,000 devices to be re-CE Marked.
Although a 3 year transition period sounds like a lot of time to deal with all these changes, there is less time than you think! Technical documentation needs to be updated, new conformity assessments need to be completed, and Notified Body and manufacturer expectations need to be aligned. Start early to avoid surprises when preparing for MDR 2017/745.
Virginia Anastassova, RAC, is the Regulatory Affairs Manager/ Senior QA Specialist at StarFish Medical. She brings extensive experience in quality management and regulatory affairs to our clients.