Post-Market Clinical Follow-up (PMCF)
The post-market clinical follow-up study aims to answer specific questions (uncertainties) regarding the clinical safety, performance, and/or effectiveness of a device when used in accordance with its label, conducted after market authorization.
Manufacturers, in accordance with MDR Annex XIV, Part B, proactively collect and evaluate clinical data obtained from the use of a CE-marked device within its intended purpose, on or inside the human body, throughout the device’s expected lifetime, to confirm its safety and performance, ensure the continuous acceptability of identified risks, and detect emerging risks based on real-world evidence.
PMCF studies should have a plan that outlines the appropriate design and methodology to meet the specified objectives.
The PMCF Plan should be based on the MDCG 2020-7 Guideline.
The content of the PMCF Report should be based on the MDCG 2020-8 Guideline.
The data and results obtained from PMCF studies are part of the post-market surveillance program and are used as input into the clinical evaluation and risk management processes.
Additionally, PMCF may lead to the need to reassess whether the medical device continues to meet the essential requirements. This reassessment may result in corrective or preventive actions such as:
- Changes to labeling/instructions for use
- Changes in manufacturing processes
- Changes in device design
- Public health notifications or withdrawal of the product from the market
In line with the PMCF study, the following topics should also be reviewed:
- Updates or changes to the existing Clinical Evaluation Report
- Review of the existing Medical Device Risk Management File, including changes in impact/probability values, validity of current risks, presence of new risks, and assessment of risk reduction methods
- Need for updates or changes to the Safety and Clinical Performance Summary Report (SSCP)
- Need for changes in the Periodic Safety Update Report (PSUR)
- Need for changes in the PMS report
The table below, which we have created for the critical reporting processes for medical device manufacturers introduced by MDR, will help to make the process more understandable.