Overview of the PMS and PMCF requirements under the Medical Device Regulation (MDR)

by | Sep 1, 2023 | Past Trainings

This training currently has no open sessions. If you would like to attend, please leave us a message, and we will inform you when a new date is planned.


Training Objectives:

  • Understand Post Market Surveillance (PMS) & Post Market Clinical Follow-up (PMCF) requirements under the MDR 
  • Understand the PMS process (including its subset of PMCF) in the medical device lifecycle 


Training Content:

  • Importance of PMS and PMCF under the MDR and their role in the global product lifecycle 
  • Overview of possible PMS and PMCF activities  
  • Understanding the difference between active and reactive PMS/PMCF 
  • Creating compliant PMS and PMCF plans for products or product families 
  • Creating compliant PMS/PSUR & PMCF reports 
  • Introduction to SSCP (Summary of safety and clinical performance) 
  • Use of PMS & PMCF data to support clinical evaluation 
  • Introduction to Guidelines related to PMS and PMCF activities 


Training Format:

  • Presentation with interactive discussions
  • Exercises during the training
  • End of training assessment (participants will receive a training certificate)


Who Should Attend:

  • Managers and employees working in Quality Assurance or Regulatory Affairs departments of medical device manufacturing companies 
  • Managers and employees working in Research and Development departments of medical device manufacturing companies 
  • Technical medical device consultants and associates 
  • Auditors of medical devices