EU: New MDCG Documents on Clinical investigation

The Medical Device Coordination Group (MDCG) has established a series of clinical investigation application/notification documents to support clinical investigation procedures with respect to MDR.

These documents include:

  • Clinical investigation – application/notification form under the MDR
  • Addendum to the clinical investigation application/notification form for: Additional investigational device(s) (section 3), Additional comparator device(s) (section 4), Additional investigation site(s) (section 5)
  • Clinical investigation supporting documents – Appendix of documents to attach
  • Checklist of general safety and performance requirements, Standards, common specifications and scientific advice

You can find them in the following document: Clinical investigation application/notification documents

Additionally, the MDCG has published a document with the questions and answers in respect to the clinical investigations under the MDR.

You find the document here:  MDCG 2021-6 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation.


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