Beyond the Plan: Mastering PMS and PMCF Execution Under EU MDR

Medical Device Global Market Access · Jan 31, 2026 · 3m

This episode explores the critical shift in regulatory focus from Post-Market Surveillance (PMS) planning to execution. We discuss why Notified Bodies and regulators, particularly under the EU MDR, are no longer accepting PMS and Post-Market Clinical Follow-up (PMCF) as a paperwork exercise. Learn about the concept of a “silent nonconformity” and how a weak, poorly executed surveillance strategy can lead to major issues during surveillance audits and certificate renewals, jeopardizing your market access. - Why are regulators no longer accepting PMS plans as mere paperwork? - What is a “silent…