Under the European Medical Device Regulation (EU MDR 2017/745), manufacturers are required to conduct post-market clinical follow-up (PMCF) as part of their post-market surveillance activities. PMCF is a systematic and proactive method for gathering clinical data on medical device performance and safety, focusing on the collection of ongoing clinical evidence once a device has been placed on the market.
PMCF is a key requirement under the EU MDR and is expected for most medical devices, although the extent of PMCF activities should be justified based on the device’s risk profile and available clinical data. The purpose of PMCF is to confirm the long-term safety and performance of a medical device in real-world clinical use and ensure that the clinical evaluation remains up to date throughout the device lifecycle.
Previously, the Medical Device Directive (MDD) governed post-market surveillance activities, including PMCF, but with the transition to MDR, there are increased PMCF requirements and a greater emphasis on compliance and real-world evidence generation.
Under MDR and MDCG 2020-7 guidance, PMCF is considered a continuous process that supports the identification of previously unknown risks, emerging safety signals, and changes in the device’s benefit-risk profile. Developing a comprehensive PMCF plan as part of the overall PMS strategy early in the medical device lifecycle is key for effective post-market surveillance. A PMCF plan must be developed as part of the overall PMS strategy to ensure systematic data collection and regulatory compliance.
PMCF Plan Requirements Under MDR
Under Annex XIV Part B of the MDR, manufacturers must establish a structured PMCF plan as part of their overall post-market surveillance strategy.
The PMCF plan outlines a systematic and proactive strategy for collecting clinical evidence, identifying residual risks, and confirming continued device safety and performance.
PMCF Plan Contents
The PMCF plan is designed to:
- Confirm the safety and performance of the medical device throughout its lifetime, including the clinical benefit, if applicable.
- Identify previously unknown side effects and contraindications.
- Identify and analyze any emergent risks of medical devices based on factual evidence.
- Ensure the continued acceptability of the benefit–risk profile by using PMCF activities to identify changes in the benefit–risk ratio and confirm its ongoing acceptability.
- Identify the medical device’s potential systematic misuse or off-label use and support updates to device documentation, including the Instructions for Use (IFU), where appropriate.
- Address the device’s risk class and risk classification, as the risk level determines the necessity, frequency, and scope of PMCF activities, with higher risk devices requiring more rigorous follow-up in line with regulatory expectations.
The PMCF plan must be drafted during the pre-market phase based on risk analysis and identified data gaps.
It is a part of the medical device post-market surveillance plan, as PMCF falls under post-market surveillance activities.
Key Considerations When Developing a PMCF Plan
Medical device manufacturers should consider the following questions when developing a PMCF plan and determining an appropriate strategy for PMCF activities and clinical data collection:
- Can you claim equivalence with another one of your products?
- Do you have adequate justifications in place for your choices of general and specific PMCF data collection?
- Are your clinical data collection tools validated?
- Do you rely on key opinion leaders?
- Did your last clinical evaluation report identify any gaps in your clinical data?
- How do you plan to communicate with the notified body to avoid issues pertaining to PMCF activities?
- Will your planned PMCF activities collect sufficient data to support regulatory compliance and device improvement?
PMCF activities should begin early in the post-market phase once sufficient clinical use data becomes available.
The findings of PMCF are analyzed and documented in a PMCF evaluation report, which is part of the clinical evaluation report and the technical documentation for your medical device.
The PMCF report includes the same sections as the PMCF plan and documents the plan results.
Methods for Collecting PMCF Data
Post-market clinical follow-up can include a variety of methods for gathering clinical evidence. The primary purpose of PMCF is to bridge the gap between controlled pre-market clinical trials and the device’s performance in diverse, real-world settings, generating real-world clinical evidence, often referred to as real-world evidence (RWE).
Manufacturers should select PMCF activities that are appropriate for the device’s risk profile, available data sources, and clinical context. PMCF activities provide valuable real-world data on device performance, outcomes, and long-term safety. These activities use proactive data collection methods, including clinical investigations, registry analysis, and structured clinician feedback, to identify adverse events and monitor long-term device safety. Continuous data collection helps ensure that the device’s clinical benefits continue to outweigh its risks as real-world use expands. PMCF helps identify rare side effects and long-term performance issues that may not have been visible during initial testing. PMCF findings may also inform improvements in device design, labeling, or clinical use instructions. Additionally, PMCF supports informed decision-making by providing healthcare professionals with robust clinical evidence.
The chosen PMCF activities should always be clearly justified within the PMCF plan.
Two types of PMCF activities are mentioned in the MDR: General and specific.
General Post-Market Clinical Follow-up Activities include
- Clinical experience from clinicians
- Feedback from healthcare professionals and patients
- Information from scientific literature and published research
- Other sources of clinical data, such as similar/equivalent device data
General PMCF activities are part of broader PMS activities and contribute to the overall quality of medical devices by supporting ongoing safety and performance monitoring. These activities include feedback from end users, information from scientific literature, and other sources of clinical data. General methods in PMCF include systematically gathering user feedback, regular reviews of published peer-reviewed reports, and evaluating information from patient or disease registries.
Some data collected through general PMCF activities is also subjective, such as user feedback, which makes the data unreliable to a degree.
Specific PMCF Activities Include
- PMCF studies and PMCF clinical investigations
- Post-market interventional clinical investigations
- Evaluation of third-party registry data
- Investigator-initiated studies
- Case series and cohort studies
- Other clinical data collection activities that are subject-specific
Specific methods in PMCF include formal observational or non-interventional studies designed to address specific safety or performance questions. Specific PMCF activities also include randomized clinical trials or registry studies that offer control over the raw data and a more rigorous level of evidence.
While specific PMCF activities provide direct access to raw data, they may be out of reach for many medical device manufacturers.
MDR encourages manufacturers to use a combination of general and specific PMCF methods when appropriate.
Selecting appropriate PMCF activities requires careful consideration of the device’s risk profile, available clinical data, intended use and risk classification. The device’s risk classification directly influences the selection and rigor of PMCF activities, with higher-risk devices typically requiring more comprehensive and frequent follow-up. The goal is to ensure that sufficient clinical evaluation evidence is generated to confirm the device’s ongoing safety and performance.
Each PMCF activity has pros and cons, and its usefulness depends on various factors.
Key Classification Documents:
MDCG 2021-24: Guidance on
classification of medical devices MDCG 2022-5: Guidance on borderline
products MDCG 2019-11: Guidance on
qualification and classification of software
Classification and Post-Market Surveillance Requirements
Availability in Markets and Sales Volume
Low sales can make collecting enough clinical data from observational activities challenging.
Available Clinical Evaluation Data
The clinical evaluation report essentially serves as a gap analysis for PMCF data – how many gaps you need to bridge will impact your choice of PMCF activities. Reviewing your last clinical evaluation report with PMCF in mind can significantly help you understand which PMCF activities you should be doing.
Performance Measures
How you measure your medical device‘s performance, as well as what data is required and from where can force you to exclude PMCF activities.
Access to Customers, End-users, and Patients
The use and Application of the Device in Practice
If your medical device always requires control from clinical experts or is interventional, you may be able to collect data from clinicians and other healthcare professionals.
Data Consent
Notified bodies and PMCF
Conclusion
When properly planned and implemented, PMCF activities provide critical clinical evidence that supports regulatory compliance and helps ensure that medical devices remain safe and effective throughout their lifecycle. As regulatory expectations continue to evolve under the EU MDR, robust PMCF strategies are becoming an essential component of lifecycle clinical evidence generation for medical devices.
