Post-Market Surveillance for Medical Devices in Europe


This lecture describes the key changes regarding post market surveillance and what companies should do to meet their new obligations. After the course you can take a final test to receive your certification. Enjoy!

  • Course Type: Video Lessons
  • Language: English
  • Level: Advanced
  • Session: year 2020
  • Time: 0 - 1 Hour

Course Breakdown

Section Time
Introduction 00:03:13
PMS Requirements in the MDR 00:02:25
PMS vs PMCF 00:05:33
Economic Operators and PRRC 00:06:22
Post-Market Surveillance 00:01:54
PMS Plan: Content Requirements 00:01:28
Periodic Safety Update Report (PSUR) 00:02:07
Surveillance Audits 00:01:26
Timelines for the application of MDR provisions for PMS 00:00:59

Exam and Certifications

  • Final Test – Post-Market Surveillance for Medical Devices in Europe
  • Certification


Why take this course

This Meditrial Recorded Video Lecture By Dr Monica Tocchi is designed to help gain detailed knowledge of implementing your PMS procedure, applying the requirements listed in Annex III / IV, and understanding whats new in the MDR for PMS and PMCF.

Skills I will gain

  • Understand PMCF and PMS and their relevance for medical device assessment
  • Integration with QMS and RMS
  • Understand the role of PRRC
  • Gain thorough knowledge of PMS, PM plan, and PM report
  • Know the requirements of PSUR and EUDAMED
  • Understand role of Notified Bodies in Surveillance Audits


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