Gearing towards summer, the last key conference on EU-MDR was held last week in Brussels: the MedTech week hosted together with Informa and MedTech Insight. A significant portion of the event was focusing on the impact of the new EU-MDR and on exchanging views on how to solve the many unclarities and impossibilities.
The atmosphere at the conference was remarkably different from last year. Before the days started and during the breaks, delegates were found in abundance at the booths of service providers, trying to understand how consultants could help with resources and practical solutions. The relaxed approach of ‘wait and see’ is rapidly nearing its end.
That is also the key message that was heard from speakers in the opening sessions on Monday: Susana, Graeme, Hans-Heiner and myself; industry, competent authority, notified body and consultant, all focusing on the key aspects of time that delegates should realize:
- There is no grandfathering, so in limited time all technical documentation will need to be reviewed (high risk) or sampled (low risk), and hence prepared in time to have sufficient time for the conformity assessment.
- There will not likely be a generic delay in timelines except for the delay in EUDAMED as defined in the law.
- The law expects the manufacturer to be ready with revising processes by 26 May 2020, also when using the grace period with old MDD certificates in case an MDR certificate is not yet at hand.
- The time for early renewal is closing rapidly, as notified bodies indicate to only have resources for this until end of 2018 or in some cases until they receive their MDR designation.
- The time to switch notified bodies for one or more products or product groups is also nearing its end. Waiting list in some notified bodies are running up to 12-14 months, whilst others are becoming more selective in the type of clients and scope of products they still will allow starting a conformity assessment or transfer process. Uncertainty on Brexit is not helping, as even spokespersons of notified bodies earlier in the year indicated that by summer 2018, manufacturers would need to make up their mind and place their bets: transfer or hope for a good solution from EU/UK negotiations.
- The time to obtain real-world clinical evidence to replace the historic clinical evaluation based on literature is rapidly passing, and many have not yet managed to get the budget, or when having reserved budget are reluctant to spend money on clinical trials as it is uncertain if the additional data generated will qualify as “sufficient”.
- The realization that this is not a one-time effort is kicking in. Life cycle management, continuous evolvement of state of the art, frequently asking if the available data is still current and sufficient, together with enhanced market surveillance and a potentially growing set of product-specific common specifications with minimum requirements for safety and performance will enhance the efforts and money spend to keep products on the market even when they first make it onto the MDR certificate.
- The many plans and reports (risk management, literature search, clinical investigation, clinical evaluation, PMCF, PMS) and follow up reports such as Summary of Safety and Clinical Performance (SSCP), incident trending and Periodic Safety Update Reports (PSUR) will not only significantly add to the burden of work, they will also need to form an integral part of the organization’s full documentation system, as that is the only way to guarantee consistency between all documents.
Clearly, the notion was heard every hour that time is running out, and time to implement has come even though not all details are ready and clear yet. Getting to working, realizing the goals and plans would need continuous updates as interpretation will shift, and additional legislation and guidance will be provided.
That notion was also very clear in the lounge area’s and around the booths. Whilst in previous year’s during the time lectures were given these areas were flooded by people that kept on talking, this year saw a rapid clearing of the halls a few minutes before sessions began again. All delegates were absorbing as much of the thoughts and views of speakers and peers during the sessions as possible.
The message is clear: it is TIME TO ACT, as there is NO TIME TO WASTE !! We’ve used all of that in the recent past….
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