The EU MDR is scheduled to go into full effect by May 26, 2021. Following MDR full implementation, PMCF activities will be mandated as part of medical device surveillance programs. As a result, manufacturers will be tasked to plan and execute PMCF activities to gather the clinical data needed to confirm the safety and effectiveness of certain high-risk devices.

To address the PMCF challenges arising from EU MDR implementation, Castor developed a 5-step approach to PMCF. This guide illustrates how Castor can help your organization meet PMCF requirements through a cost-effective, MDR-compliant solution.

The 5 steps are as follows:

  1. Decide on your approach.
  2. Define enrollment strategy.
  3. Validate model.
  4. Track progress.
  5. Extract PMCF data.
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