Post-market clinical follow-up (PMCF) is a central requirement under the EU Medical Device Regulation (MDR). Its purpose is to confirm the safety and performance of medical devices once they are on the market and used in real-world conditions. For medical device manufacturers, choosing the right PMCF strategy can be challenging, and potentially costly. Two of the most common approaches are full-scale PMCF clinical trials and PMCF surveys. Each carries its own strengths, limitations, and ideal use cases. This article explores both strategies, offering guidance on when to choose one over the other.
What are the Strategies for PMCF?
Manufacturers have several PMCF strategies available, and the choice depends on the device type, risk classification, and the amount of existing clinical evidence already supporting the device. The EU MDR emphasizes that PMCF is not optional but an integral part of the post-market surveillance (PMS) system. At minimum, manufacturers are required to plan and conduct reactive general PMCF activities such as complaint monitoring, review of public vigilance databases for adverse events and field safety notices, and periodically review the scientific literature. Where there are gaps or an absence of high quality evidence to demonstrate safety and performance for all intended uses for all indications and patient populations, if there are significant changes to the design or indications, or if initial certification was based on regulatory strategies such as equivalence, specific PMCF activities may be required.
The two most widely recognized proactive specific PMCF methods are:
- Full-Scale PMCF Clinical Trials: These are prospective, interventional or non-interventional studies designed to collect high-quality, real-world clinical data. Unlike pre-market clinical investigations, PMCF trials are conducted in routine clinical practice and may include larger, more diverse patient populations. They are particularly important for implantable devices, high-risk Class III devices, and novel technologies where long-term performance and safety outcomes must be confirmed.
- PMCF Surveys: Structured questionnaires distributed to healthcare professionals (HCPs) and/or patients. These can be retrospective chart reviews where clinical data is reported directly from patient records, or can solicit general experience feedback such as usability, satisfaction, or perceived performance. Data is collected through non-interventional efforts, collects real-world evidence, and typically does not have the same requirements as clinical trials – most notably not requiring adherence to ISO 14155 or ethics committee / institutional review board (IRB) approval. Surveys can also help detect emerging safety signals or usability issues across different regions, clinical settings, and user groups.
In addition to these core approaches, other specific PMCF activities may include:
- Device Registries: Longitudinal databases tracking outcomes for specific devices (commonly used in devices like joint replacements, cardiovascular stents).
- Analysis of Real-World Evidence (RWE) from other sources such as insurance claims databases.
While all these activities may be acceptable PMCF methods under MDR, PMCF clinical trials and surveys remain the most common pathways for closing gaps in evidence, ensuring continued device safety and performance, and demonstrating ongoing compliance when general methods alone are not sufficient.
When to Choose a Full-Scale PMCF Trial?
A full-scale PMCF clinical trial is often the preferred option when:
- Device Risk is High: Class III or implantable devices usually demand rigorous post-market data.
- Limited Pre-Market Evidence Exists: New technologies or novel mechanisms of action require additional validation beyond initial clinical investigations.
- Specific Safety Concerns Arise: If signals of risk appear during post-market surveillance, a trial can help confirm or rule out potential hazards.
- Endpoints Must Be Objectively Measured: Some quantitative performance data, complication rates, or device lifetime claims are better assessed through structured clinical trials.
- There are significant changes to design or indications: Use of devices outside approved use or with significant changes in patients likely requires adherence to standards for clinical investigations such as ISO 14155
While these trials provide the strongest level of evidence, they are resource-intensive. Manufacturers must weigh regulatory expectations against costs and time to complete them.
When to Choose a PMCF Survey?
A PMCF survey may be more appropriate in scenarios where:
- The Device Has a Well-Established Safety and Performance Profile: Mature technologies with a long history of real world usage, but there are gaps in reported evidence.
- Wider Clinical Experience Needs to Be Captured: Surveys can cover diverse user groups, geographies, and clinical settings efficiently.
- Quantitative Data is Needed: Retrospective chart review studies can quickly gather high-quality clinical data for approved devices used according to labeling.
- Qualitative Insights Are Valuable: Information about usability, ease of use, user satisfaction, and perceived safety and performance is often best gathered through direct feedback and can be gathered quickly from existing users.
- Resource Constraints Exist: Compared to full-scale trials, surveys are less expensive, quicker to implement, and easier to repeat periodically.
- Lifetime Claims have Gaps: Implants can be approved without long-term data, but PMCF data at mid- and long-term follow-up is expected to substantiate lifetime claims
That said, surveys must be carefully designed to avoid bias, ensure representative responses, and provide enough depth to satisfy regulators.
Key Considerations for Both Strategies
| Full-Scale PMCF Trial | PMCF Survey | |
| Level of evidence (per MDCG 2020-6 Appendix III) | High (Rank 1 or 2) | Moderate – low (Rank 4 or 8) |
| Best for | High-risk devices (Class III), novel technology, major clinical data gaps, long-term performance issues | Lower-risk or well-established devices, usability feedback, general user experience, supplementing other evidence |
| Pros | Highest data quality, maximum regulatory acceptance, systematic and controlled data collection | Cost-effective, time-efficient, adaptable, can reach a large user base |
| Cons | High cost, resource-intensive, long timelines, complex regulatory process | Lower evidence quality, potential for bias, depends on user access and response rates |
Partner with RQM+ for Your PMCF Strategy
Navigating the complexities of EU MDR compliance requires more than a checkbox approach. A well-structured PMCF strategy not only meets regulatory requirements but also safeguards patients and supports the long-term success of your device portfolio.
At RQM+, we bring together deep regulatory acumen, clinical expertise, and cross-functional execution to help you design and implement PMCF activities that stand up to notified body scrutiny. Whether your needs call for a full-scale clinical trial, targeted surveys, registry participation, or literature reviews, our specialists build strategies tailored to your device’s risk class, evidence gaps, and life cycle stage.
Why Work with RQM+?
- Strategic Alignment: We develop actionable PMCF plans and reports that align with MDR and IVDR requirements, ensuring your activities are defensible and future-proof.
- Integrated Support: Our regulatory, clinical, quality, and testing experts collaborate seamlessly with your team, scaling from advisory input to full outsourcing depending on your internal resources.
- Regulatory Insight: With constant updates to EU MDR expectations, we keep you ahead by interpreting notified body feedback and guiding multi-year PMCF planning.
- Operational Efficiency: By managing complex PMCF activities, we reduce the risk of regulatory delays and free your team to focus on innovation and commercialization.
Building Your PMCF Roadmap
Whether you are addressing legacy device compliance, preparing for new product launches, or optimizing existing PMCF studies, RQM+ can help you move forward with confidence. Our approach combines scientific rigor with practical execution, giving you the assurance that your devices continue to perform safely in the real world.
Connect with us today to discuss how RQM+ can strengthen your PMCF strategy and support your broader regulatory and clinical goals.
In case you missed it, here’s your chance to dig deeper into the nuances of PMCF survey success with our expert panel. Watch the on-demand discussion, PMCF Surveys That Survive Scrutiny, to gain practical insights on designing, executing, and defending surveys that meet MDR expectations.
