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Rebooting EU Medtech: Appetite For Urgent Discussions To Address Failing Regulations Grows

22 Dec 2023

Lack of predictability uncertainty over fees and inefficient working practices inherent in the current implementation of EU rules are all demanding a rethink in the EU’s current and future medtech rules. Industry expects discussions to kick off early next year.

Fuzzy man walking on hanging bridge vanishing in fog. Focus on middle of bridge — Waiting For The Mists To Clear On Way Forward For EU's Medtech Regulation • Source: Shutterstock

Action is essential, both mid-term and more immediately, to improve the implementation of the EU’s medtech regulations and to find a better way forward as the “EU is not where it should be.”

That is the view of Petra Zoellner, director regulatory affairs (IVDR and MDR) at MedTech Europe while speaking with Medtech...