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EC Guidance Document Details Notification Process For Clinical Investigation Reports

 
• By Amanda Maxwell

The Medical Device Regulation requires sponsors of clinical investigations to file a summary of their report shortly after study completion. The commission explains the steps and the need for conciseness.

Summary

The European Commission has published a new guidance document on the content and structure of the summary of the clinical investigation report in the context of the Medical Device Regulation.

The guidance aims to ensure that the summary of the clinical investigation report presents information about the design, conduct,...

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