Guidance on content and structure of the clinical investigation report summary

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


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