New MDCG 2024-3 on ‘Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices’

In March 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-3 to provide guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices. It includes an Appendix A with a Clinical Investigation Plan Synopsis Template.

For more, see the Commission’s webpage on guidance.