Unlock the strategic value of PMS and PMCF under EU MDR

Achieving CE marking is just the beginning. This webinar will clarify how Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) requirements shift once your medical device is on the market.

You'll get practical guidance on staying compliant under EU MDR—especially for legacy devices already in use.

Agenda:

00:00 – Introduction

03:50 – PMS after EU market approval

18:30 – PMS versus PMCF

21:44 – Data sources

29:17 – PMCF challenges & solutions

36:22 – Q&A

51:04 – Key takeaways and closing remarks

This session dives into the practical side of PMCF. Our team shares how we approach PMCF activities such as clinical investigations, literature reviews, usability studies, and surveys.

A notified body expert will provide real audit insights and share what they expect to see in your technical documentation.

Agenda:

00:00 – Introduction

04:55 – Literature Research

15:20 – PMCF Studies

27:25 – PMCF Surveys

37:50 – PMCF in Practice – A Notified Body Perspective

45:55 – Q&A

56:25 – Key takeaways and closing remarks