Final report – according to MDR

The sponsor has to submit a clinical investigation report to the Swedish Medical Products Agency (Swedish MPA) at the latest:

• one year after the end of the clinical investigation, or
• three months after premature end or temporary halt of the clinical investigation.

The minimum requirements for the content of the clinical investigation report are listed in Chapter III section 7 in Annex XV to MDR.

Additional guidance is available in the commission’s document with questions and answers regarding clinical investigations.

The European Commission has produced guidelines on the content and structure of the summary of the clinical investigation report.

Both the report and the summary will be made publicly accessible. The publication of clinical investigation reports on medical devices is an important part of the transparency and adequate access to information on these devices that EU Regulation 2017/745 (MDR) is intended to achieve.

Pending the availability of Eudamed for the publication of medical device clinical investigation study reports, the Commission has developed an interim solution for providing study reports and their summaries.

A dedicated public CIRCABC directory called “MDR Clinical Investigation reports and their summaries” has been established. The directory will gradually be supplemented with an increasing number of reports. To facilitate searching for a specific report, a dedicated tracking file listing the CI reports and their respective summaries uploaded in the library is available via the link below.

Guidance document MDCG 2024-15 provides information on the practical handling of the reports: