The European Commission guidance on the content and structure of the summary of the clinical investigation report

On May 8, 2023, the European Commission has published its guidance on the content and structure of the summary of the clinical investigation report, in accordance with Article 77(6) of Regulation (EU) 2017/745 (MDR).

This publication aims to ensure that the summary of this report presents information about the design, conduct, analysis and results of the clinical investigation in terms and in a format that are easily understandable to the intended user of the medical device.

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