2023: Will The Road Ahead Be Any Smoother For The EU’s Medtech Regulations?

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Originally intended to increase medical device safety, the implementation of the EU’s medtech regulation was so hampered in 2022 that it had started to look as if the new regulations were a bigger potential threat to patients than any of the scandals leading to its more stringent requirements. With the European Commission’s latest plans to ease challenges around implementation, will 2023 be a more positive year for the EU medtech sector?

Bumpy Road Ahead — • Source: Shutterstock

During 2022, there had been little that had been straightforward when it came to the implementation of the EU’s new Medical Device and IVD Regulations. Originally due to first apply in 2020 and 2022 respectively, the slow rate of preparedness of the system and of its players resulted in warnings about products having to be unnecessarily withdrawn from the EU market and continuous calls to extend deadlines throughout the year.

As 2022 was drawing to a close, the volume of noise from the industry, notified bodies and even national regulatory...

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