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Upcoming Medtech Guidance: 35 New Or Revised Documents Due In 2025

 
• By Amanda Maxwell

The latest list includes a new EU document in the wings that addresses the designation of medtech notified bodies under the AI Act.

The FDA has set out its 2025 list of planned guidance (Shutterstock)

The European Commission’s Medical Device Coordination Group has started work on a document clarifying the designation process of notified bodies according to the AI Act (Regulation (EU) 2024/1689).

The text, which is being worked on by the MDCG’s Notified Bodies Oversight subgroup, is due to be endorsed by...

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