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

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 nonconformity” and how can it impact your device certification? - How can you design a PMS plan that generates truly usable signals about your device? - When is a Post-Market Clinical Follow-up (PMCF) study truly justified? - What are Notified Bodies looking for during a surveillance audit of your post-market activities? - How does the EU MDR change the expectations for PMS and PMCF execution? - Are your post-market surveillance activities prepared for the scrutiny of a renewal audit? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies. We streamline global market access by developing efficient regulatory strategies, including robust post-market surveillance and clinical follow-up plans. Our expert teams and advanced AI tools help you manage technical dossiers, monitor regulatory changes, and ensure ongoing compliance in over 30 markets. Avoid costly nonconformities and maintain your market presence with a proactive approach. To learn how we can accelerate your global expansion, visit us at https://pureglobal.com, contact [email protected], or explore our free AI tools and database at https://pureglobal.ai.