The European Commission’s Medical Device Coordination Group (MDCG) recently published a new guidance (MDCG 2021-6) on clinical investigations under the MDR. The guidance is published in the form of a Q&A and may be updated with further questions and answers.
The 19-page document covers 28 questions of relevance to sponsors of clinical investigations conducted under the MDR.
The guidance covers general questions and answers, e.g., what is a clinical investigation or what is a pilot clinical investigation. For the first time, guidance is also provided into specific requirements relating to clinical investigations, such as:
- What are the general differences and improvements related to clinical investigations under the MDR as compared to the Medical Devices Directives?
- What are the safety reporting requirements for clinical investigations?
- What is the difference between the performance, clinical performance, and clinical benefit?
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