EU MDR Clinical Evidence: Mastering CERs, PMCF, and Equivalence Arguments

Medical Device Global Market Access · Jan 30, 2026 · 3m

This episode delves into the stringent clinical evidence requirements under the European Union's Medical Device Regulation (MDR 2017/745). We explore the top challenges manufacturers face, including the heightened standards for clinical evaluation plans and reports (CEPs/CERs), the complexities of justifying 'sufficient data,' the difficulties in making equivalence arguments, and the continuous nature of Post-Market Clinical Follow-up (PMCF). Key Questions - What does "sufficient clinical evidence" truly mean under the EU MDR? - Why are so many companies forced to rewrite their Clinical…