Application for clinical investigation of medical devices
Overview of guidelines and forms to be used in connection with clinical investigation of medical devices.
EU/MDCG guidance documents on clinical investigation:
Here you can find guidance documents published on the website of the European Commission. Especially two guidance documents are relevant for clinical investigations of medical devices:
- MDCG 2021-6: Regulation (EU) 2017/745 - Questions & Answers regarding clinical investigation
- MDCG 2020-10: Guidance on safety reporting in clinical investigations incl. Appendix: Clinical investigation summary safety report form
Application for modifications to the clinical investigation
In the case of clinical investigations authorised by the Danish Medicines Agency before 26 May 2021, the modification must be applied for to the Danish Medicines Agency and the Regional Research Ethics Committee formerly having assessed the research project. Application form for modifications to clinical investigations authorised before 26 May 2021.
In the case of clinical investigations authorised by the Danish Medicines Agency after 26 May 2021, the modification must be applied for simultaneously to the Danish Medicines Agency and the Medical Research Ethics Committees. Application form for modifications to clinical investigations authorised after 26 May 2021.
Applying for substantial modifications in general
If a sponsor wants to introduce modifications to a clinical investigation that might substantially impact the safety, health or rights of research participants or the robustness or reliability of the clinical data generated in connection with the investigation, the Danish Medicines Agency must authorise the modifications prior to their implementation.
The Danish Medicines Agency has 38 days to review the application for a modification, and the research ethics committee must have finished its review of the modification before the Danish Medicines Agency can make a decision. The sponsor must submit updated versions of the relevant documentation in which the modifications must be clearly identifiable.
Find more information about substantial modifications in the MDCG guidance MDCG 2021-6: Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation.