EU IVDRCompliance
Post-Market Performance Follow-up (PMPF) Under IVDR: A Practical Guide
The IVDR transition is in full swing. Here is a deep dive into creating a robust PMPF plan that satisfies your Notified Body and ensures continuous compliance.
Navigating PMPF under IVDR
Under the In Vitro Diagnostic Regulation (IVDR 2017/746), the responsibility of a manufacturer doesn't end once the product hits the market. In fact, that's just the beginning.
Post-Market Performance Follow-up (PMPF) is a continuous process that updates the clinical evaluation and strictly aligns with Annex XIII Part B.
Why Notified Bodies are Rejecting Plans
Common reasons for PMPF plan non-conformities include:
- Lack of Specificity: Generic plans that don't address the specific device grouping.
- Passive Data Collection: Relying solely on complaints rather than proactive surveys or studies.
- Disconnected Risk Management: Failure to link PMPF findings back to the Risk Management File.
Structuring Your PMPF Plan
A robust plan should answer specific questions:
- What? (The specific device or device group)
- When? (Frequency of activities, e.g., annual literature reviews)
- How? (Methods: Clinical performance studies, user feedback surveys, registry data)
Key Takeaway: PMPF is not a "box-checking" exercise. It is the engine that keeps your technical documentation alive. Treat it as a loop, not a line.