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PMCF and PMPF

Overview​

Post-Market Clinical Follow-Up (PMCF) and Post-Market Performance Follow-Up (PMPF) are proactive, structured processes for collecting and evaluating clinical data from post-market use of a device to confirm its safety and performance throughout its expected lifetime. PMCF applies to medical devices under MedDO; PMPF is the IVDO equivalent.

PMCF Plan and Report​

The PMCF plan (required for Class IIa, IIb, and III devices) must specify:

  • The specific objectives of the PMCF activity
  • Methods: clinical studies, registries, surveys of clinical users, analysis of published literature
  • Rationale for the methods chosen
  • Reference to relevant harmonised standards (MDCG 2020-7)

The PMCF report summarises the findings and is updated following each PMCF activity. It must explicitly state whether the PMCF findings confirm or require updates to the clinical evaluation.

When PMCF Can Be Omitted​

PMCF can only be omitted for Class IIa and IIb devices where the manufacturer provides appropriate justification in the PMCF plan that PMCF is not necessary — for example, where the device is well-established, the clinical data is robust, and the risk profile is well characterised. This justification will be assessed by the NB.

PMPF (IVDs)​

The PMPF is the IVDO equivalent of PMCF. It applies to IVDs in List A, List B, and self-test categories. The PMPF plan and report must be integrated with the performance evaluation and updated based on post-market performance data.

Official Sources​

Disclaimer

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