Post-market clinical follow-up study is a follow-up study that aims to answer specific questions (uncertainties) regarding the clinical safety and performance and/or efficacy of a device when used in accordance with its labeling.

Pusuant to MDR Annex XIV Part B, In order to confirm the safety and performance of the device during its expected lifetime, ensure continued acceptability of identified risks, and identify emerging risks based on real-world evidence, manufacturers proactively collect and evaluate clinical data obtained from the use of a device bearing the CE mark and placed on the market or put into service for its intended use, on or inside the human body, as specified in the relevant conformity assessment procedure.

PMCF studies should have a plan that explains the appropriate design and methodologies towards the stated objectives.

The MDCG 2020-7 Guide should be taken as a basis when preparing the PMCF Plan.

PMCF Report content should be based on the MDCG 2020-8 Guide.

Data and results from PMCF studies are part of the post-market surveillance program and are used as input into the clinical assessment and risk management process.

At the same time, PMCF may require a reassessment of whether a medical device continues to comply with essential requirements. Such an assessment may result in some corrective or preventive action such as;

  • Changes in labeling/instructions for use,
  • Changes in production processes,
  • Changes in design of device,
  • Public health notices or Product recall from the market,

 

The following issues should also be reviewed during the PMCF Study;

  • Update or Change in the Current Clinical Evaluation Report,
  • Reviewing the Existing Medical Device Risk Management File in terms of Impact/Probability Values Change, Validity of Existing Risks, Existence of New Risks and Evaluation of the Adequacy of Risk Reduction Methods,
  • Need for Update or Change in Safety and Clinical Performance Summary Report (SSCP),
  • Need for Changes in the Periodic Safety Update Report (PSUR), and
  • Need for Change in PMS Report.

 

The table below for the Critical Reporting processes of Medical Device manufacturers that come with the MDR will help to ensure easier understanding of the process.