PMCF (Post-Market Clinical Follow-up) is defined by Annex XIV, Part B of the MDR as an ongoing part of the manufacturer’s clinical evaluation plan. Its purpose is to confirm the clinical data of the CER under real-world conditions of use, to identify unanticipated risks, and to feed updates to the CER.
On paper, it is clear. In practice, it is one of the most frequently inadequate documents in MDR certification files.
Why so many PMCF plans are inadequate
Reason 1: the PMCF is not linked to the gaps in the CER.
This is the main reason. A credible PMCF plan responds precisely to the gaps identified in the CER: insufficient data on a subpopulation, lack of long-term data on the durability of an implant, indirect equivalence data that requires post-market clinical confirmation. If the PMCF is a generic document not connected to these specific gaps, it does not fulfil its regulatory function.
The notified body systematically checks the correspondence between the gaps in the CER and the content of the PMCF. This is the first consistency check it performs.
Reason 2: the collection methods are not defined.
“We will collect data from users” is not a PMCF plan. A compliant plan must specify: which collection method (registry, prospective observational study, structured questionnaire, systematised feedback via the distribution network), which protocol (patient inclusion criteria, parameters collected, collection frequency), which sites or which users are involved, and which evaluation criteria will allow conclusions to be drawn on the identified gaps.
Reason 3: the plan does not cover the commercial lifetime of the device.
The PMCF is not a two-year programme. It covers the entire life of the device on the market. The activities may vary in intensity according to the data accumulated, but the process does not stop.
Reason 4: the justification for the absence of a clinical study is not convincing.
For certain devices, the manufacturer may justify the absence of a PMCF clinical study (registry, observational study) with solid arguments: low usage volume, very specific population, sufficient post-market surveillance data. But this justification must be documented and argued in the PMCF plan. A plan that simply states “no PMCF clinical study is necessary” without argumentation will be returned.
What a credible PMCF plan must contain
PMCF objectives, directly linked to the gaps in the CER. Data collection methods, with a description of the protocol or a reference to an annexed protocol. Frequency of collection and of updating the PMCF report (PMCFR). Evaluation criteria allowing conclusions to be drawn on each gap. Data management plan. Frequency of updating the PMCF itself.