The European Union Medical Device Regulation (EU MDR 2017/745) has significantly reshaped the regulatory landscape for medical devices, demanding more rigorous post-market surveillance (PMS) and post-market clinical follow-up (PMCF) processes. The goal is to continuously collect and analyse clinical data to confirm the safety, performance, and benefit-risk profile of the device throughout its lifecycle.
This regulatory requirement aligns with the broader goal of ensuring devices remain effective and safe in real-world settings. Notified body which is a conformity assessment body when auditing the quality system of the manufacturer will review the appropriateness of the manufacturer’s general PMS procedures and plans, including plans for PMCF, as relevant.
Key Strategies for preparing for Notified Body scrutiny
A PMCF plan is a mandatory component of the PMS plan (Annex III and Annex XIV of the MDR). It must clearly outline the objectives which include verifying long-term safety, the acceptability of identified risks, detecting emerging risks, and confirming device performance.
The methods involve data collection through PMCF studies, registry data, surveys, and real-world evidence from electronic health records (EHRs), analysed using statistical methods, user feedback and literature reviews. Also specifying the duration and intervals aligned with the device’s lifecycle and explaining how PMCF data will be integrated into the overall PMS system. MDCG 2020-7 provides a template for PMCF plans, offering a structured approach to meeting regulatory expectations.
Studies for PMCF on a device are conducted within the intended use or purpose as stipulated in the instructions for use. PMCF studies should, however, be performed according to the applicable laws and regulations, proper methodology, appropriate guidance, and standards. When planning a PMCF study, manufacturers should engage with Notified Bodies early to align expectations.
Clearly define endpoints that reflect the device’s safety and performance, ensure robust data collection methods to avoid bias and ensure reliability. For Class III and implantable devices, PMCF studies are often essential to generate sufficient clinical evidence.
Data collected from PMCF activities should be systematically analysed to identify trends, adverse events, or emerging risks. The results should be documented in a PMCF Evaluation Report, which is part of the Periodic Safety Update Report (PSUR) for Class IIa, IIb, and III devices (Article 86 of the MDR). Key elements of the PMCF Evaluation Report include summary of data collected, analysis of safety and performance outcomes, identification of residual risks and recommendations for corrective actions, if necessary.
Notified Bodies are responsible for evaluating PMCF compliance during conformity assessment audits. They will assess whether the PMCF plan is adequate, activities are properly executed, and findings are effectively integrated into the device’s risk management and clinical evaluation processes.
To satisfy Notified Body scrutiny, manufacturers should maintain transparency by providing complete and well-organized documentation, demonstrate traceability by showing clear links between PMCF data, clinical evaluation updates, and risk management.
Also respond to feedback by addressing Notified Body observations or non-conformities promptly and comprehensively and submit PMCF documentation within the timelines set by the Notified Body.
The Clinical Evaluation Report (CER) and the Risk Management File (RMF) should be updated with detailed post-market follow-up data to prepare for review by a notified body. The CER now integrates the vast PMS data analysis that would include complaint trends, adverse event reports, and vigilance data in relation to the updated literature review findings and clinical studies.
A revised benefit-risk analysis confirms the device continues to meet its intended purpose while maintaining a favourable safety profile. The RMF should be updated with new risk assessments based on PMS findings, including the identification of emerging risks and the evaluation of risk control measures’ effectiveness. Both documents should align with the latest regulatory requirements, ensuring consistency, traceability, and evidence-based conclusions to support the continued compliance and safety of the device in the market.
The MDCG guidance documents MDCG 2020-7 and MDCG 2020-8 contain very comprehensive frameworks on the evaluation of PMCF plans and reports and overall compliance with the requirements under MDR. It underlines the necessity for robust clinical evidence that should establish the safety, performance, and benefit-risk balance of a medical device during all phases of its life cycle.
Notified Bodies are tasked with rigorously evaluating PMCF documentation to ensure it aligns with Annex XIV, Part B of the MDR. These resources help manufacturers align their PMCF processes with regulatory expectations, reducing the risk of non-compliance during Notified Body assessments.
Conclusion
Preparing for Notified Body scrutiny of PMCF studies requires a strategic, proactive approach. By developing a robust PMCF plan, ensuring alignment with risk management, maintaining high-quality documentation, and leveraging real-world evidence, manufacturers can demonstrate compliance with MDR requirements.
Early engagement with stakeholders, anticipation of challenges, and continuous monitoring of regulatory trends further strengthen preparedness. By adopting these best practices, manufacturers can not only withstand Notified Body scrutiny but also enhance the safety, performance, and marketability of their medical devices.
Dr Shrinidhi Ballal, MDS
Jr. Consultant