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