In a recent webinar titled “Strategies for Successful PMCF under EU MDR: Unlocking the Mystery,” medical device industry experts Smridula Hariharan and Parvathi Nambiar engaged in an illuminating discussion. They explored cost-effective PMCF strategies, discussed how to adeptly address Notified Body comments, and presented real-world case studies to illustrate successful PMCF implementations.

Access the full webinar for detailed insights.

Post-Market Clinical Follow-Up (PMCF) is a continuous process outlined in the EU Medical Device Regulation (MDR), playing a pivotal role in a manufacturer’s Post-Market Surveillance (PMS) plan. The primary aim of a PMCF is to confirm a device’s safety, performance, and clinical benefits throughout its lifecycle, encompassing the identification of unknown side effects, monitoring of known side effects, and ensuring the continued acceptability of the benefit-risk ratio. A PMCF can consider any systematic investigations conducted after a medical device has entered the market, which aims to continuously evaluate the device’s safety, performance, and efficacy. PMCF studies are instrumental in identifying new risks, confirming assumptions about device lifetime, assessing off-label use, and evaluating the device’s risk-benefit ratio.

Several scenarios necessitate mandatory PMCF, including devices based on novel technologies, those with unclear long-term safety or performance, or devices interacting with other medical products. Understanding these criteria is fundamental to compliance with EU MDR requirements. However, a generic PMCF with proactive collection of data on the safety and performance of the device, based on data obtained from PMS activities and literature, etc. is required to be a part of the manufacturer’s PMS Plan and is a requirement as per Notified Bodies (NB). 

A comprehensive PMCF plan is essential, encompassing general methods, specific procedures, rationale for chosen methodologies, details from the clinical evaluation such as the device risk management, PMCF objectives, and timelines. Manufacturers must analyze findings from these activities and document them in a PMCF evaluation report, which forms a part of subsequent clinical evaluation report and device technical documentation.

Contrary to common belief, the optimal time to devise a PMCF strategy is post-clinical evaluation completion. This allows for a thorough examination of available clinical data to identify gaps and risks, enabling the formulation of a tailored strategy. Depending on the gaps in clinical data and the device risk classification, an appropriate methodology for PMCF must be devised.

The PMCF plan template, as per MDCG 2020-7, includes manufacturer details, device description, planned post-market activities, chosen methodologies, objectives, and timelines. The manufacturer should be aware of any possible limitations of the planned activities, such as incomplete follow-up or missing data, which is crucial for effective planning.

General PMCF strategies involve screening scientific literature, assessing clinical experience, and analyzing adverse event databases. Specific methods include registry studies, patient surveys, studies based on real world evidence (RWE), and PMCF studies. 

• Registries: These can be hospital-based or population-based, collecting data from patients within healthcare facilities or specific geographical regions. Examples include the Delta Network Study for cardiovascular devices and the Kaiser Permanente National TJRR for total joint replacements.
• Clinical Investigations: These are systematic investigations involving human subjects to evaluate the safety and performance of a device. PMCF studies fall under this category and are conducted after the device has been launched and CE-marked.
• Real-World Evidence: This involves analyzing clinical evidence derived from real-world data sources like electronic health records, registries, hospital claims or billing data, patient-generated data, and mobile health applications. Real-world evidence studies can employ various designs such as prospective/retrospective cohort studies, case-control studies, or pragmatic clinical trials.
• Surveys: Surveys are commonly used for PMCF strategies due to their direct data collection from healthcare professionals (HCPs) or patients. Surveys should be concise, focused on specific objectives, and designed considering factors like risk class, device usage duration, and user demographics.

Efficient PMCF strategies aim to achieve regulatory compliance without excessive time or resource expenditure. Strategies for cost-effective PMCF include focusing on clear endpoints, leveraging existing data sources, utilizing real-world evidence, conducting surveys, and collaborating with other device manufacturers for data sharing.

Non-conformities in PMCF strategies may arise from insufficient proactive PMS activities, lack of detail of planned activities in PMCF plans, or failure to address gaps identified in clinical data.

The webinar presented various case studies exemplifying the importance and implementation of Post-Market Clinical Follow-up (PMCF) studies for medical devices under the EU Medical Device Regulation (EU-MDR).

The first case discussed leveraging a clinical investigation for CE marking analysis, utilizing a subset of the sample initially, then expanding to a larger sample for post-market follow-up. This approach facilitated continuity in data collection without necessitating new endpoints or objectives.

The second case highlighted the necessity of PMCF even for lower-risk devices, citing an instance with a cryotherapy product. Despite the device’s reliance on well-established technology, PMCF was crucial to gather specific clinical data related to safety and efficacy endpoints.

In another case, a class IIb monitoring device lacked direct patient impact and had limited clinical data. Despite following Route 61 (10) for conformity, PMCF became essential to validate risk mitigation methods, emphasizing the importance of ongoing data collection, post-market. 

Key takeaways included understanding PMCF’s proactive nature in collecting post-market data, methodological considerations such as sample size and scientific rigor, and the misconception that PMCF is only necessary in the absence of clinical data. Collaboration and efficient technology solutions were also highlighted to optimize PMCF processes.

In summary, PMCF studies play a critical role in establishing long-term safety and performance of medical devices post-market, ensuring ongoing compliance with regulatory requirements such as EU-MDR. Successful PMCF under EU MDR requires a strategic approach, meticulous planning, and adherence to regulatory requirements. By understanding PMCF criteria, devising tailored strategies post-clinical evaluation, and implementing comprehensive PMCF plans, manufacturers can ensure compliance, optimize product performance, and mitigate risks effectively.

Access the full webinar for detailed insights.

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