Real-World PMCF Under the MDR: Cost Effective PMCF Strategies and Plans

MDR Paradigm Shift in Clinical Evidence Generation

The MDR introduces more stringent requirements for medical device manufacturers, emphasizing patient safety and a clinical evidence-based approach to the confirmation of the benefit-risk determination for each device.

Evolution from MDD to MDR: Expanded PMCF Requirements  MDR Paradigm Shift in Clinical Evidence Generation

Under the MDD the term PMCF was associated with formal post-market studies and only considered necessary for a few high-risk or novel devices. Under the MDR, PMCF is an integral part of the post-market surveillance (PMS) process applicable for all devices. Another important change with the MDR is that PMCF is defined as a continuous process which updates the clinical evaluation. To place a product on the market in Europe under the MDR is therefore a commitment to continue to gather information, including clinical data, for the lifetime of the device. Further insights are available in the white paper on device lifetime co-authored by NAMSA and BSI[1].

The good news is that under the MDR the concept of PMCF includes a wider range of methods for collecting clinical data–such as registries, literature, and surveys. This gives manufacturers more freedom to determine the best approach to meeting the PMCF requirements.

Integration of PMCF within MDR QMS Requirements and Clinical Evaluation Process Flow

Compliance with the PMCF requirements starts with the quality management system and understanding how the PMCF process interacts with other key processes. Article 9 of the MDR outlines the key quality system processes–including the post-market surveillance system of which the PMCF process is a part of and clinical evaluation (which includes PMCF). The PMS process outlined in articles 83-85 and Annex III require a PMCF plan and evaluation report to be generated, but the clinical evaluation process also requires this information be fed back into the clinical evaluation. The aims of PMCF, outlined in Annex XIV, include confirming safety and performance, assessing the benefit-risk ratio, and identifying any misuse or off-label use as well as emerging risks. These goals necessitate feedback into the risk management process and several other areas such as CAPAs, design, manufacturing, and labeling.

Compliant Documentation: Essential Elements of PMCF Plans and Reports

When developing a PMCF procedure, a manufacturer must ensure that the plan and report are generated. However, it’s also important to consider interrelationship(s) with other processes and consider how the data will be communicated and used within that organization.

Guidance has been issued for the PMCF Plan MDCG 2020-7 and the PMCF evaluation report MDCG 2020-8. These guidelines provide a template which sets the expectation for structure in these key documents.

It is worth noting that the PMCF plan is not a study protocol. It is a summary of the various PMCF activities which will be carried out for a particular medical device, together with a justification for the selection of those activities and timelines for completion. Full details of each individual PMCF activity should be documented separately in individual protocols and reports.

The PMCF plan forms part of the technical documentation. It also represents the manufacturer’s PMCF commitment for the medical device which will be subject to review by the Notified Body–or a competent authority in the case of Class I devices where a Notified Body is not involved.

Risk-Based PMCF Strategy Development: Balancing Regulatory Requirements with Commercial Feasibility

Before drafting the PMCF plan it is critical to identify the needs for the individual device and develop a strategy to address them adequately and efficiently. If the PMCF plan is too light, it could result in rejection by the Notified Body and delays in approval, or in the case of legacy devices transitioning to the MDR, even removal from the market. It’s also important not to over commit in the PMCF plan. Apart from the cost implications of carrying out activities beyond those which are strictly necessary to meet the requirements, proposing a PMCF activity which is not feasible in practice will lead to compliance issues further down the line. For example, including a study design in the PMCF plan where recruitment will be too slow to meet the proposed timeline.

Ultimately, there are multiple factors to be considered from both regulatory and commercial perspectives. The strategy must take account of the available clinical data–are there any gaps or weaknesses in the data? For new devices, the MDR requires a clinical development plan and therefore PMCF activities may already have been designed at the same time as the pivotal study. Adjustments to planned PMCF activities may still be needed in the light of any questions raised by the clinical data generated from the pivotal study–for example, the device results may not have been uniform in all patient populations or device sizes. For legacy devices, i.e. those already approved under the MDD, the situation may be more complicated since the clinical data used to obtain approval for the device may not be sufficient to meet the requirements of the MDR. The guidance for legacy devices, MDCG 2020-6, acknowledges this problem and allows  PMCF activities to be used to close any gaps prior to CE-marking of the device under the MDR. With the extension of the deadlines for transitioning devices to the MDR, manufacturers have additional time to generate the necessary PMCF. However, having the right strategy is essential to ensure that the data generated will be acceptable to the Notified Body.

Device-Specific PMCF Challenges and Solutions

Some devices present particular challenges for PMCF–for example, general use devices that can be used in many indications and populations. Searches of the published literature are unlikely to identify clinical data and formal clinical studies would be expensive and unnecessary. In these situations, a well-designed survey may be the optimal and most cost-effective approach.

At the opposite end of the scale, it can also be difficult to conduct PMCF for devices which are highly specialized in terms of indication or population. These orphan devices may be intended for use in rare conditions or diseases, or they may be used infrequently in a specific patient cohort of the general population, such as pregnant women. The guidance just published on orphan devices, MDCG 2024 -10, acknowledges the challenges in gathering clinical data and states that it may be acceptable for some limitations in clinical data to be addressed through specific PMCF activities. New and legacy devices can be considered as orphan devices if they meet the criteria. For further analysis please see our blog MDCG 2024-10 Clinical Evaluation of Orphan Medical Devices. Manufacturers opting for orphan device states for their devices will need to consider carefully how this impacts their PMCF strategy and what additional PMCF activities may be required.

Whatever your device, PMCF is a key requirement of the MDR. A good PMCF strategy will enable you to meet the regulatory requirements in the most cost-effective way.

Key MDCG Guidance References

NAMSA has extensive regulatory and clinical expertise–including post-market studies and market research. We can support manufacturers at every step of the process, ensuring that all aspects of PMCF are thoroughly addressed.

By leveraging our experience and knowledge, you can develop and implement effective PMCF Plans that ensure ongoing compliance with MDR requirements, enhance patient safety, and support continuous improvement. Our comprehensive services provide guidance and practical solutions, helping manufacturers navigate the complexities of PMCF and achieve successful outcomes.

[1] https://www.bsigroup.com/siteassets/pdf/en/insights-and-media/insights/white-papers/bsi-wp-medical-devices-lifetime-uk-en.pdf