Commission Guidance on the Content and Structure of the Summary of the Clinical Investigation Report

8 May 2023 – the Official Journal of the European Union published the summary document on the clinical investigation report for the medical device.

This document is intended to provide Commission guidance, in accordance with Article 77(6) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (hereafter: the MDR), for the content and structure of the summary of the clinical investigation report.

This guidance aims to ensure that the summary of the clinical investigation 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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