PMCS= Post Market Clinical Follow Up
Post-Market Clinical Follow-up (PMCF) is part of PMS activities and should be understood as a continuous process of updating clinical evaluation. It is a process carried out after a device has been CE marked.
The manufacturer should collect clinical data from use after commercializing his product or putting it into service for the intended use referred to in the relevant conformity assessment procedure.
Post-Market Clinical Monitoring should be performed to verify the safety and performance of the device over the expected lifetime. It should ensure the continued acceptability of identified risks and the identification of emerging risks on the basis of factual evidence.
The manufacturer should analyze the PMCF findings and record the results in the clinical evaluation report and technical documentation. For Class III and implantable devices, the clinical evaluation report should be updated at least annually.
Purpose of Post-Market Clinical Follow-up
a) to collect information about:
- rare complications;
- clinical observations only seen in a larger user/patient population;
- clinical observations are only visible after prolonged use of the device.
b) validation of clinical risk-benefit analysis results.
PMCF Plan Requirements
(A) Post-Market Clinical Follow-up requirements in accordance with EU MDR 2017/745;
Pursuant to the MDR, it should be performed to proactively collect and evaluate clinical data according to the method outlined in the PMCF plan, which aims to:
- Confirming the safety and performance of the device throughout its expected lifetime,
- Identifying previously unknown side effects and monitoring pre-defined side effects and contraindications,
- Identifying and analyzing emerging risks based on real evidence,
- Ensuring the continuation of the acceptability of the benefit-risk ratio, and
- To identify possible methodical misuse or off-label use of the device in order to demonstrate that the intended purpose is correct.
If the need for preventive and/or corrective measures has been identified through the PMCF, the manufacturer should implement them.
(B) MEDDEV 2.12/2 Rev. 2 as per PMCF requirements
Clinical evaluation documents should be actively updated with data from PMS. Where Post-Market Clinical Surveillance is not deemed necessary to be part of Post-Market Surveillance, this should be duly justified and documented (Exemption).
PMCF Plan
Under the MDR, a PMCF plan must include at a minimum:
- Gathering clinical experience gained,
- Getting feedback from users,
- General methods and procedures to be applied, such as searching other clinical data sources and scientific literature;
- Specific methods and procedures of PMCF to be implemented, ie evaluation of appropriate registries or post-market clinical studies;
- The rationale for the appropriateness of the methods and procedures referred to in the above points;
- A reference to the relevant parts of the clinical assessment report and risk management;
- Specific objectives to be addressed by the PMCF;
- An assessment of clinical data on equivalent or similar devices;
- The relevant Common Specifications, harmonized standards and relevant guidelines when used by the manufacturer, and a comprehensive and adequately justified timeline for PMCF activities (eg data review and reporting) to be undertaken by the Manufacturer.
