On May 12th, 2023, the European Commission released a guidance, in accordance with Article 77(6) of Regulation (EU) 2017/745 on medical devices (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.
2023/C 163/06 – Commission Guidance on the content and structure of the summary of the clinical investigation report – May 2023
According to Article 77 (5) of the MDR, the sponsor of a clinical investigation needs to submit a clinical investigation report within one year of the end of the clinical investigation or within three months of the early termination or temporary halt of the clinical investigation, and this report shall be accompanied by a summary. The minimum requirements of the clinical investigation report as well as the outlines of what needs to be covered by the summary can be found in Section 7, Chapter III of Annex XV of the MDR.
According to Article 77(5) of the MDR, the report and summary shall be submitted to Member States in which the clinical investigation was conducted by means of the electronic system referred to in Article 73 of the MDR, which is EUDAMED. According to Article 77(7) of the MDR, the report and the summary shall become publicly accessible through EUDAMED, at the latest when the device is registered in accordance with Article 29 of the MDR and before it is placed on the market. In cases of early termination or temporary halt, the summary and the report shall become publicly accessible immediately after submission. In accordance with Article 123 (d) these requirements relating to EUDAMED shall only apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34 (3) of the MDR. Currently the publication of the Commission notice in the Official Journal of the European Union has been estimated to occur Q2 2024, in which case the use of EUDAMED with regards to the obligations and requirements for clinical investigations would become mandatory as of Q4 2024.
What does this mean to you?
MDCG 2020-03 Rev. 1 provides useful guidance for medical device manufacturers to draft their summary of clinical investigation reports.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.