EU Commission has published guidance on the content and structure of report summaries for clinical investigations with medical devices
The EU Medical Device Regulation (EU 2017/745, MDR) aims to improve patient safety with medical devices, increase the transparency of consumer information and improve the management of device-related information throughout device life cycle. To contribute to this objective, the European Commission has published guidance on the content and structure of the report summaries of clinical investigations in the Official Journal of the European Union on 8 May 2023.
Clinical investigations conducted with medical devices generate important evidence of their safety and performance. In the future, certain parts of the results of clinical trials will be public. The MDR requires for the sponsor of a clinical investigation to submit a summary of the results of a clinical investigation that is easily understandable for the intended user together with the clinical investigation report via the Common European Database for Medical Devices, EUDAMED.
The Regulation requires for the sponsor of an investigation to report the results of the clinical investigation within one year of the end of the investigation, regardless of its results. A report with detailed results has to be submitted to the Member States where the investigation was conducted and the report summary has to be made public to all in EUDAMED before a device is placed on the market.
According to the Commission’s guidance, the summary of the report must include information on the planning, process, analysis and results of the investigation with concepts and format that are easy to understand for the intended users of the medical device. A key part of the results is safety information, including potential adverse events.
The section for clinical trials in EUDAMED is not ready yet, so sponsors submit their reports and summaries to the authorities – to the Finnish Medicines Agency Fimea in Finland.
EU Commission guidance on the content and structure of the summary of the clinical investigation report in the Official Journal of the European Union (2023/C 163/06)
Medical Device Regulation (EU 2017/745, MDR) (EUR-Lex)
Medical Devices Act 719/2021 (Finlex.fi) (in Finnish)
Medical devices on the Fimea website
- Hanna-Maria Matinolli, Coordinator, tel. +358 29 522 3244
- Fimea e-mail addresses are in the format firstname.lastname@example.org