On May 21, the MDCG has issued a guidance document, MDCG 2021-08 Clinical investigation application/notification documents, collating a series of clinical investigation application/notification documents to support relevant procedures under the MDR.
These documents include:
– Clinical investigation application/notification form under the MDR (with the same data fields to the Eudamed system in development);
– Addendum to the clinical investigation application/notification form for: additional investigational device(s) (section 3); additional comparator device(s) (section 4); and additional investigation site(s) (section 5);
– Clinical investigation supporting documents ̶ appendix of documents to attach; and
– Checklist of general safety and performance requirements, standards, common specifications and scientific advice.
The document can be downloaded in our library
Source: European Commission