The shift from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) has brought about major changes in how medical devices are regulated, particularly in the area of Post-Market Clinical Follow-Up (PMCF). This transition significantly impacts legacy devices—those initially certified under MDD—as manufacturers must now meet stricter requirements to maintain compliance. Understanding these changes and their implications is critical for ensuring smooth navigation through this regulatory evolution.

PMCF Practices Under MDD for Legacy Devices

Under MDD, PMCF was largely seen as a supporting activity, mainly aimed at verifying that devices were safe and performed as expected in real-world use. Manufacturers often included PMCF as part of broader post-market surveillance (PMS) efforts, relying on reactive approaches like monitoring complaints, incident reports, and customer feedback. In many cases, these activities were sufficient to demonstrate compliance, especially when historical data or comparisons to similar devices were available.

However, the lack of detailed guidance under MDD led to inconsistent PMCF practices. Manufacturers often focused on meeting basic regulatory requirements without fully addressing long-term performance or emerging risks. This left gaps in the available clinical evidence for many legacy devices, particularly as new safety concerns and technologies emerged.

What’s New: PMCF Requirements Under MDR

The MDR has significantly raised the bar for PMCF, making it a central part of device lifecycle management. Key articles like Article 61 and Annex XIV, along with guidance such as MDCG 2020-6, emphasize the need for PMCF to be proactive, systematic, and tightly integrated into clinical evaluation and risk management.

Unlike MDD, MDR requires PMCF to be more than a supplementary activity. Manufacturers must develop a detailed PMCF plan as part of their clinical evaluation. This plan must outline how they will proactively collect and analyze high-quality clinical data. Methods such as post-market clinical investigations, patient registries, and structured surveys are now essential components of PMCF, going beyond the reactive approaches of the past.

Another key change is the focus on addressing specific safety and performance aspects, such as residual risks identified during pre-market evaluations, long-term outcomes, and potential risks arising from shifts in clinical practice or patient demographics. MDR also mandates regular updates to the clinical evaluation report (CER) based on PMCF findings, ensuring continuous assessment of safety and performance.

Major Differences Between PMCF Under MDD and MDR

The transition to MDR has fundamentally reshaped PMCF. Some of the most significant differences include:

Stricter Clinical Evidence Standards: MDR requires robust, high-quality clinical evidence to demonstrate that devices consistently meet General Safety and Performance Requirements (GSPR). This is a notable departure from MDD, where reliance on historical data or equivalence was often sufficient.
Proactive Data Collection: MDR places a strong emphasis on proactive data collection through methods like clinical investigations and patient registries. This ensures comprehensive monitoring of device performance and safety in real-world conditions, compared to MDD’s reactive approaches.
Integration with Risk Management and Clinical Evaluation: PMCF is now a core part of risk management and clinical evaluation. Data gathered through PMCF must feed into these processes, creating a dynamic feedback loop to address risks and improve device design. Under MDD, such integration was less emphasized.
Greater Documentation and Oversight: MDR demands detailed documentation of PMCF activities. Manufacturers must submit comprehensive PMCF plans and reports as part of their technical documentation, which undergoes close scrutiny by notified bodies. This level of oversight far exceeds what was required under MDD.

How the Changes Impact Legacy Devices

The transition to MDR significantly impacts legacy devices, which were originally certified under the less stringent MDD framework. One of the most significant impacts is the increased need for robust clinical evidence. Many legacy devices relied on equivalence claims or historical data to demonstrate compliance, but these are no longer sufficient under MDR. Manufacturers must now fill gaps in clinical evidence, often requiring new PMCF studies or clinical investigations. This shift can be resource-intensive and demands careful planning.

Another major impact is the reassessment of risk profiles. MDR mandates a fresh evaluation of residual risks, long-term safety, and how devices perform under real-world conditions. For legacy devices, this may reveal previously unaddressed risks or necessitate updates to design and risk mitigation strategies to meet modern standards.

Increased oversight by notified bodies adds another layer of complexity. Legacy devices are now subject to rigorous scrutiny, with detailed evaluations of PMCF plans, reports, and technical documentation. Manufacturers must ensure their documentation is thorough, transparent, and adhere to MDR’s stringent requirements. This increased scrutiny can result in delays or additional compliance costs if gaps are identified.

The changes require manufacturers to adopt a more proactive and systematic approach to compliance. Legacy devices must now meet current requirements for safety and performance, necessitating significant effort to align with MDR requirements.

Steps to Achieve Compliance for Legacy Devices

The implementation of MDR for legacy devices requires a proactive, structured, and well-documented approach. Firstly, manufacturers need to develop detailed PMCF plans that clearly outline objectives, methodologies, and data collection strategies. These plans should focus on addressing specific safety and performance questions, residual risks, and long-term outcomes. Proactive methods, such as post-market clinical investigations and structured patient surveys, are essential for gathering high-quality data.

Integrating PMCF findings with risk management and clinical evaluation is another critical step. By systematically incorporating PMCF data into the risk management file and CER, manufacturers can ensure a continuous feedback loop for assessing and improving device safety and performance. Thorough documentation is equally important; all PMCF activities must be carefully recorded, and the CER and PMS documentation must be regularly updated based on PMCF findings.

Engaging closely with notified bodies is also vital to ensure alignment with MDR expectations. Manufacturers should address any feedback or non-conformities received during assessments. By encouraging clear communication and maintaining transparency, delays, and compliance challenges can be minimized. Ultimately, the transition to MDR requires manufacturers to embrace a more vigorous and systematic approach to regulatory compliance, ensuring that legacy devices meet the high standards demanded under the new MDR framework.

Conclusion

The transition from MDD to MDR has redefined PMCF, making it a foundation of device safety and performance assurance. For legacy devices, this means adapting to stricter requirements and adopting a proactive approach to clinical evidence generation, risk management, and documentation. By understanding the changes and taking strategic steps to align with MDR, manufacturers can navigate the challenges of this transition while maintaining compliance and market access.

About the author

Dr. Saryu Tyagi, BDS, MBA

Junior Consultant , I3CGlobal