The December 2025 reform proposals feel like the EU finally admitting the MDR needed practical fixes. To be fair, the original intent — stronger clinical evidence, better post-market surveillance, and a harmonised single market — was correct. In practice the implementation created bottlenecks: notified-body capacity, inconsistent equivalence interpretations, and an avalanche of PMCF/PSUR demands that small teams cannot realistically resource.
I read the proposals as a set of pragmatic trade-offs: faster access for well‑characterised innovation, tighter post‑market requirements where risk is uncertain, and more centralised support for clinical data reuse. Below I translate the headline ideas into what they mean for a Regulatory Affairs team three quarters away from your next audit.
What the proposals aim to fix (practical view)
Reduce time-to-market for high‑need or genuinely novel devices while keeping patient safety central.
Clarify equivalence and clinical evidence expectations so notified bodies stop inventing different versions of the same test.
