Understanding PMCF Requirements

New requirements under MDR Annex 14 Sections 5 and 6 require more in-depth post-market clinical follow-up (PMCF). Two of the main requirements are that PMCF activities are both proactive and ongoing.

The proactive nature of the regulation requires manufacturers to go out and get data on devices rather than relying solely on receiving incoming complaints.

The ongoing nature of PMCF planning requires maintaining a continuous review of the clinical evidence and post-market surveillance (PMS) data, in which the output of PMCF cycles into other PMS reports (PMS report/PSUR, CER, PMCF report).

To stay on the market under EU MDR, your company needs a PMCF plan for all relevant products. Meeting the PMCF requirements calls for advanced planning and ongoing execution by a cohesive team. 

At RQM+, we rely on the unrivaled collective knowledge of our team to develop and execute the proper elements to be included in a PMCF plan.

Use this checklist to:

  • Help you learn how to build a cohesive team to plan and execute PMCF requirements
  • Align operating procedures and quality management systems to meet submission timelines
  • Understand how to go about PMFC planning in a methodical, thorough manner

To access the “MDR PMCF Planning Checklist,” please fill out the form on the page.

Fill out the form to receive your MDR PMCF Planning Checklist.

“I am amazed at how much work and the number of decisions that have been made to-date on this project! I really appreciate the effort and patience of your entire team! Lots of work to go in 2021, but I am grateful that your team is helping us manage through this process.”

Director, Regulatory Affairs

"IVDR Implementation Project"
Global Medical Device and Diagnostics Manufacturer