Free template (MS Word)
Post-Market Clinical Follow-up (PMCF) Plan
Plan proactive PMCF activities that support ongoing medical-device safety and efficacy.
Manufacturers of medical devices selling products in the EU must perform post-market clinical follow-up (PMCF) activities as part of the post-market surveillance (PMS) system to ensure the safety and efficacy of their medical devices. The PMCF Plan helps manufacturers specify procedures and methods for proactively collecting and evaluating post-market clinical data and identifying potential device issues.
This template helps you:
- Plan proactive collection and evaluation of post-market clinical data
- Identify unknown side effects and monitor known side effects and contraindications
- Pinpoint and analyze emergent risks using factual evidence
- Confirm the ongoing acceptability of the benefit-risk ratio
- Identify systematic misuse or off-label use of the device
Prepared by Advisera experts to help you get started with EU MDR post-market clinical follow-up.
Get the free template
You may unsubscribe at any time. For more information on what personal data we collect, why we need it, what we do with it, how long we keep it, and what are your rights, see this Privacy Notice.