Medical Devices Regulation Implementation: Crisis Averted?

Chris Whitehouse, an expert on medical technology policy at Whitehouse Communications updates readers on changes to the timelines for implementation of the EU’s Medical Devices Regulation and highlights the need for the sector to engage with European institutions to avoid regulatory crises.

A crisis was fomenting in terms of European regulation of medical devices, but it seems last minute action can yet see it averted and manufacturers can breathe a sigh of relief.

The EU has never been renowned for quick decision-making, and the long-awaited implementation of its new Medical Devices Regulation, first enacted back in 2017 but not yet fully implemented, is no exception. The question is whether its provisions are still fit for purpose when assessed against the background of a global pandemic the like of which the EU has never previously seen, and which wasn’t anticipated back when the details of the regulation were agreed.

But, regulators, lawmakers and manufacturers all broadly accept that the new regulation is indeed fit for purpose not only to guarantee safety but also to facilitate innovation. The EU Medical Devices Regulation (MDR) is intended to meet that test. The problem that has come crashing to the fore post-pandemic, however, is that regulators and the third-party organisations that handle medical device assessment under the provisions of the regulation lack the capacity to meet the demand. Delay in implementation has, therefore, come as something of a relief across the sector.

A three-year transitional period was originally planned for the implementation of the key provisions of the MDR, but, last month, the Commission listened to manufacturer concerns and proposed an extension. Understanding the current state of play and future timeline for change are key for medtech developers’ and manufacturers’ future planning. 

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