Post-market Clinical Follow-up (PMCF) is one of the most important components of the post-market surveillance activities required under the EU Medical Device Regulation (MDR). Its purpose is to continuously collect, actively or passively, clinical data on device performance, safety, and clinical benefit throughout the product lifecycle.
The key to an effective PMCF program is early planning and ensuring that PMCF activities can generate the required data. So today, let's discuss the key points and challenges of the PMCF Plan.
1. What is the purpose of the PMCF Plan?
To confirm the device's safety and performance, including its clinical benefit, and to continue doing so throughout the device's service life;
To identify previously unknown side effects and monitor known side effects and contraindications;
To identify and analyze emerging risks and ensure that the benefit-risk profile remains acceptably maintained;
To identify any possible systematic misuse or off-label use of the device.
2. What should a PMCF Plan include?
The specific content of a PMCF Plan is described in detail in MDCG 2020-7, the EU guidance document on PMCF Plans. In general, your PMCF Plan will include seven sections:
The manufacturer's contact information;
A description and specification of the medical device under investigation;
PMCF-related activities (including both general methods and specific operational steps and procedures);
References to specific sections of any relevant technical documentation;
An evaluation of clinical data for equivalent or similar devices;
References to any applicable Common Specifications, harmonized standards, or guidance documents;
The anticipated completion date of the PMCF Evaluation Report.
The results of the activities documented in the PMCF Plan will be incorporated into the PMCF Report, whose structure is aligned with that of the PMCF Plan.
When selecting the relevant activities for the PMCF Plan, the most critical step is determining whichactivities will be used to obtain the data required for the device. If planning is inadequate at this stage, important data on the device's safety and/or performance may be missed. PMCF activities fall into two categories:general activities and specific activities.
General PMCF activities use a broad data collection approach and typically involve accessing existing data sources. In practice, this type of information gathering should already have been carried out during the process of placing the device on the market.
3. General PMCF activities include:
User feedback (e.g., feedback from patients)
Screening of scientific literature
Accumulated clinical experience (e.g., experience from physicians)
Other sources of clinical data, such as published data and study reports on similar devices,
General activities help collect clinical data, but they are usually insufficient to meet the standard required to demonstrate device performance and safety. Data obtained from these activities are often subjective, and their quality can vary considerably. For example, relying solely on subjective physician surveys makes it difficult to demonstrate clinical performance.
Fordevices with some complexity,general PPMCF activities will likely need to be combined with specific PMCF activities,
4. Specific PMCF activities include the following methods:
PMCF studies (or observational or non-interventional clinical investigations)
Post-market interventional clinical studies
Evaluation of data from appropriate registries
Investigator-initiated studies
Case discussions
Other discipline-specific clinical data collection activities proactively use specific methods, which are usually controlled and managed by the manufacturer, with the objective of obtaining data on device performance.
Tips for developing a robust, sufficient, and actionable PMCF plan. Given the wide variety of medical devices and their differing benefit-risk profiles, it is not possible to provide a one-size-fits-all set of recommendations. However, the following suggestions may help guide your thinking when developing a PMCF plan.
5. Clinical studies are not your only option
In the EU MDR and related guidance documents, PMCF (Post-market Clinical Follow-up) studies are frequently mentioned. This can sometimes leadcompaniesto believe that their post-market clinical follow-up must include a clinical study on their device. But this is not necessarily the case.
Depending on factors such as the device’s risk class, service life, and the available clinical data, you may be able to use other forms of PMCF activities, such as:
Surveys of healthcare professionals
Healthcare panel questionnaires or survey reports
Data collected directly from the device itself
Collection of feedback from lay users
Scientific literatureetc.
Some devices may require a clinical investigation, but be sure that your decision on whether to conduct a PMCF study is based on careful consideration of the device itself and any gaps in the existing clinical data.
6. How do you develop a plan for collecting and managing clinical data?
If you need to follow applicable requirements when conducting a clinical investigation (as part of your PMCF), then you should do so in accordance with ISO 14155:2020 (Clinical investigation of medical devices for human subjects — Good clinical practice), and apply the data management principles set out therein. These principles include, but are not limited to:
Any electronic data capture (EDC) system must meet the following requirement: “validation shall be performed to evaluate the authenticity, accuracy, reliability, and consistent intended performance of the data system.”
Ensure data traceability, integrity, reliability, consistency, and logical coherence.
Be sure that all data changes are documented and that audit trail information is retained.
Establish a secure system to prevent unauthorized internal and external use of data.
The depth and breadth of data collection depend largely on the device’s risk class. If the device’s mid- or long-term safety and clinical performance have been sufficiently demonstrated through real-world evidence, a post-market clinical investigation may not be necessary. However, if a PMCF study is required, be sure to plan and manage the study program in advance, including the study protocol, study management, patient/user recruitment, statistical design, etc.
In closing,PMCF should be a “well-designed, risk-based, device-specific” process—success depends on planning ahead.
That said,next time, we will continue with the key points of the PMCF report,and common challenges~
