PMCF

Post Market Clinical Follow Up – PMCF is a continuous process that updates the clinical Evaluation, which is the assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer.
PMCF plan should be included within the manufacturer’s PMS plan.
The PMS and PMCF plan serve as an organized, scheduled system of planned yearly activities based on which PMS and PMCF company procedures are performed.
BioReg will be happy to assess your PMS & PMCF plans for compliance with MDR or write them from the scratch in accordance and in harmony with the existing Company operating procedures. See our blog on how to design PMCF (and PMS) Plan here efficiently.
Designing a PMCF plan and report is a time-consuming and challenging task requiring considerable expertise.

Our experts can write for you:

• MDR-compliant PMCF plan & report
• PMCF Survey (questionnaire)
• Review the PMCF plan or survey written by your Company

According to EU MDR, PMS and PMCF plans are product specific and so you will need a separate plan for each product (or product family) in your portfolio. Medical devices of all classes need such a plan, the scope of which will differ based on product complexity and risks involved.

When conducting PMCF, the manufacturer should proactively collect and evaluate clinical data from the use in or on humans of a device that bears the CE Marking and is placed on the market to confirm the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.

The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data with the aim of:

• 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 analyzing emergent risks based on factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and
• Identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.

The PMCF plan shall include at least:

• The general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data;
• The specific methods and procedures of PMCF to be applied, such as Evaluation of suitable registers or PMCF studies;
• A rationale for the appropriateness of the methods and procedures used;
• A reference to the relevant parts of the clinical evaluation report and to the risk management;
• The specific objectives to be addressed by the PMCF;
• An evaluation of the clinical data relating to equivalent or similar devices;
• A reference to any relevant harmonized standards used by the manufacturer, and relevant guidance on PMCF; and
• A detailed and adequately justified time schedule for PMCF activities to be undertaken by the manufacturer.

The manufacturer shall analyze the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the clinical evaluation report CER and the technical documentation.

The conclusions of the PMCF evaluation report shall be considered for the clinical Evaluation and in the risk management. If, through the PMCF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them.

For more information, please contact the BioReg team.