If you’re conducting a clinical investigation of a medical device in a European Union member state, you will be required to submit a clinical investigation report (CIR) along with a summary of the CIR to that member state.

The European Union Medical Device Regulation (EU MDR) lists this as one of the requirements of a sponsor in Chapter VI, Article 77 of the regulation. However, EU MDR doesn’t specify the format of the CIR summary. It only notes that, “The Commission shall issue guidelines regarding the content and structure of the summary of the clinical investigation report.”

Well, those guidelines are finally here.

The EU Medical Device Coordination Group released guidance (2023/C 163/06) “on the content and structure of the summary of the clinical investigation report” in May 2023.

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