The Post-Market Clinical Follow-up (PMCF) is a post market activity which should form part of a manufacturer’s PMS plan. It consists of proactively collecting and evaluating clinical data related to the use of a CE marked device already on the market. The aim of the PMCF is to confirm the safety and performance of the device throughout its lifetime and will be used to update the Clinical Evaluation Report conducted. Specifically, the PMCF shall evaluate the acceptability of identified risks and evaluate any emerging risk.
The PMCF aims laid out in Part B, Annex XIV MDR 2017/745 are for:
- confirming the safety and performance of the device throughout its expected lifetime,
- identifying previously unknown side-effects and monitoring the identified side-effects and contraindications,
- identifying and analysing emergent risks on the basis of factual evidence,
- ensuring the continued acceptability of the benefit-risk ratio referred to in Sections 1 and 9 of Annex I, and
- identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.
As can be seen from this list, the aim of the PMCF is centred around the continued assessment of safety and performance as intended by the manufacturer. Testing conducted to gather results which will not lead to the assessment of the product’s safety and performance might not be classified as a PMCF.
The PMCF shall therefore be conducted in accordance to a PMCF plan, whose requirements are also laid out in the MDR. The results are then presented within a PMCF report which shall form part of the Clinical Evaluation Report and the complete technical documentation. Its findings may then have effects on the Risk Management and Clinical Evaluation documentation and therefore all the necessary updates will need to be made.
We have the expertise available to establish both the PMCF Plan and develop the PMCF report which could then be used to update your other documentation. If you require any further assistance, or wish to learn more about PMCF or our services, please contact us at firstname.lastname@example.org.