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European Commission publishes guidance on medical device clinical investigation reports

New guidance from the European Commission outlines the expected “content and structure” of clinical investigation report summaries, a document that was originally expected in 2022.

MDR and guidance on clinical investigation report summaries

The European Medical Device Regulations (MDR) have had a challenging implementation and transitional period. Though published and in force since May 2017, the Commission hadn’t completed setting up the infrastructure necessary for complete compliance with the medical device (MDR; Regulation (EU) 2017/745) and in vitro diagnostic (IVDR; Regulation (EU) 2017/746) regulations.

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