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Since the implementation of the EU MDR 2017/745, the critical role of post-market surveillance (PMS) activities, particularly post-market clinical follow-up (PMCF), has been well recognized. Before outlining a strategy for PMCF studies, let's quickly recap the objective of a PMCF study.
Objective of PMCF Studies for Medical Devices
A PMCF study is conducted after a medical device receives marketing authorization. It aims to address specific questions regarding the safety, clinical performance, and/or effectiveness of the device as per its labeling. PMCF should be considered as a continuous process to confirm the device's safety and performance throughout its life in the market.
Strategy to follow for PMCF of Medical Devices
Applicability of PMCF
There are several factors that determine the applicability of PMCF to the devices:
- Well-established Device: If a device has well-documented safety and performance with no identified or unforeseeable risks, complications, or failures, PMCF can be waived. For example, a low-risk device like saline solution, which has no emerging risks or complications and well-established safety and performance data, may not require PMCF. However, a justification must be provided as per Annex III of the MDR.
- New Device: For new devices where established safety and performance data is not available, PMCF is applicable.
- High-risk Category Devices: For devices in the high-risk category, where unforeseeable risks, complications, or device failures are possible despite well-established safety and performance data, a PMCF study is required.
Identification of the Approaches wrt PMCF study designs and protocols
- Literature Monitoring: Screening scientific literature and other clinical data sources, including data from similar or equivalent devices.
- Direct Data Gathering: Collecting data through questionnaires, feedback forms, etc., from users and patients.
- Registry Studies: Collecting data via registry organizations.
- Clinical Trials: Conducting interventional or non-interventional clinical investigation studies with a limited number of patients or users.
Developing the PMCF Plan (Annex XIV Part B of the MDR)
- The PMCF plan aims to confirm the device's safety and performance, identify previously unknown side effects or contraindications, and determine any emerging risks, complications, or device failures based on factual evidence.
- A thorough and harmonized assessment process helps identify data availability, determine the approach, and often avoid over-commitment in the plan.
Drawing up the PMCF report
- The PMCF report should resonate with the PMCF plan submitted. Meaning to begin, refer to the PMCF plan number and version that corresponds to the evaluation report you are preparing. The objectives should be stated clearly as outlined in the PMCF plan.
- Provide a rationale for the appropriateness of the methods and procedures used in PMCF, including the collection and analysis of clinical data.
- Include a detailed and adequately justified time schedule for PMCF activities such as data analysis and reporting.
- Analyze the findings from the PMCF activities and document the results. This analysis should include any information and reports from previous PMCF activities.
- The content of the PMCF evaluation report should align with guidance such as Medical Device Coordination Group (MDCG) 2020-8.
- The conclusions of the PMCF evaluation report should be taken into account to update the clinical evaluation, risk management documentation, post-market surveillance plan, and the summary of safety and clinical performance (SSCP, if applicable).
A well-structured PMCF strategy is essential for compliance, ensuring safety and performance of the device throughout the lifecycle. To learn more about developing a robust PMCF strategy tailored to your devices, contact our expert team today and ensure your device's continued success in the market.
