PMS/PMCF Readiness Assessment Checklist for EU MDR

This brief checklist allows you to quickly score your company’s readiness for post-market surveillance (PMS) and post-market clinical follow-up (PMCF) under the EU Medical Devices Regulation (MDR) requirements.

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Are you prepared to meet the more stringent PMS/PMCF requirements operative under MDR?

Medical device manufacturers are required under the European Medical Devices Directive (MDD 93/42/EEC) to create PMS and PMCF plans in order to be eligible for CE Marking, but they will be governed by stricter rules under the Medical Devices Regulation (MDR 2017/745).

In addition to constituting a necessity for regulatory compliance, PMS and PMCF plans are vital to medical device manufacturers that want to maintain healthy operations. Having well-formulated plans in place helps companies to understand their products and gather constant feedback that can be used to design necessary improvements.

Our PMS/PMCF Readiness Checklist is designed to help you gauge your company’s progress to date and determine how far you are from MDR compliance and what help you may need to get there in time. This document covers such topics as:

  • Understanding the differences between MDD and MDR requirements;
  • Identifying relevant data types and setting up processes to systematically collect them;
  • Setting up templates and report population processes; and
  • Leveraging and ramping up current practices designed for MDD compliance.

Use this checklist to ascertain your level of readiness to meet PMS and PMCF requirements for CE Marking under MDR and strategize how to meet your goals in a timely fashion.