EU – New MDCG guidance document on content of the clinical investigation plan for medical devices

The MDCG published a new guidance document (MDCG 2024-3) that details the requirements for the content of the clinical investigation plan that must be included in the application for clinical investigations for medical devices. Aside from a description of required contents, the document gives a template for the clinical investigation study plan synopsis in Annex A that is available as Word document.

Go back