Why Vital EU Guidance For Clinical Investigation Plans Is So Challenging To Read

Errors or omissions are commonplace when sponsors write their clinical investigation plans. Good signposting is urgently needed. Industry expert Maria Donawa gave some useful tips in how to best read the latest EU clinical trials guidance.

The EU’s Medical Device Coordination Group has published guidance on the content of the clinical investigation plan for clinical investigations of medical devices, MDCG 2024-3.

This 21-page document is relevant to any sponsor creating a clinical investigation plan (CIP) in the context of the EU’s...

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