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.1
According to Article 77 (5) of the MDR, the sponsor of a clinical investigation shall submit a report of the clinical investigation within one year of the end of the clinical investigation or within three months of the early termination and this report shall be accompanied by a summary. The minimum requirements of the clinical investigation report are outlined in Section 7, Chapter III of Annex XV of the MDR. Section 7, Chapter III of Annex XV of the MDR also outlines what will be covered by the summary, namely…
