According to Article 77 of the Medical Devices Regulation (MDR), the sponsor of a clinical investigation has to submit a report of the clinical investigation. Specifically, the sponsor has to submit the report within one year after the clinical investigation ends or within three months of the early termination. A summary has to accompany this report. On 8 May 2023, the Official Journal of the European Union published the Commission Guidance on the content and structure of the summary of the clinical investigation report.
Overview and timelines
According to the MDR, the summary has to include the following:
- Title and purpose;
- Description of the investigation, investigational design, and methods used;
- Results and conclusions.
The report has to be submitted to the Member States of the clinical investigation. Moreover, the report and summary must be publicly accessible at the latest upon device registration and before being placed on the market. In case of early termination or temporary suspension, the summary and report must become publicly accessible immediately after the submission.
Summary of the clinical investigation report
The Commission Guidance presents a structure that the clinical investigation report should follow. This structure foresees:
- Cover page, including identification details
- Content and structure of the summary of the clinical investigation report, with – among others – dates and locations. In particular, this section must include:
- Purpose of the clinical investigation
- Description of the investigational device, clinical investigation, and methods used
- Results of the investigation
- Conclusion of the clinical investigation
- Revision clause
- Glossary and abbreviations
Check out our Library of Documents with all relevant MDR guidance documents.