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Under the EU Medical Device Regulation 2017/745, post-market evidence is no longer treated as a regulatory afterthought. Activities such as Post-Market Surveillance (PMS), Periodic Safety Update Reports (PSURs), and Post-Market Clinical Follow-up (PMCF) are now central components of the clinical evidence lifecycle, closely scrutinised by Notified Bodies during conformity assessments and ongoing surveillance audits.
Experience under MDR shows that many regulatory findings do not stem from missing documents, but from poor traceability and misalignment between PMS, PSUR, PMCF, and the Clinical Evaluation Report (CER). Designing a cohesive post-market evidence system is therefore essential to demonstrate ongoing compliance, maintain certification, and support the continued sufficiency of clinical evidence over time.
From Post-Market Monitoring to Evidence Generation
The scope and purpose of post-market activities have expanded significantly under the MDR. PMS is no longer limited to complaint handling and vigilance reporting; it is a structured and proactive process for actively collecting, analysing and interpreting real-world data on device safety and performance.
This intent clearly emphasizes that PMS outputs must feed directly into risk management, clinical evaluation updates, and benefit–risk assessments. Post-market data is therefore not supplementary; indeed, it is an extension of the clinical evidence base established at the time of certification and must be maintained throughout the device lifecycle.
PMS as the Foundation of Post-Market Evidence
A robust PMS system provides the foundation for both PSUR and PMCF activities. Notified Bodies assess whether PMS plans clearly define data sources, analysis methods, and feedback mechanisms into the quality management system.
Effective PMS goes beyond data collection by integrating multiple data streams, including complaints, trend reporting, vigilance data, registries, literature monitoring, and real-world performance feedback. Importantly, Notified Bodies expect manufacturers to demonstrate how PMS data is evaluated, not merely collected.
This expectation directly supports the lifecycle approach to clinical and performance evaluation, where post-market insights are used to confirm or refine clinical assumptions made during pre-market evaluation.
PSUR: Consolidating Safety and Performance Insights
PSURs serve as a formal mechanism for periodically summarizing and evaluating post-market safety and performance data for higher-risk devices (Class IIa, IIb and III). Under MDR, PSURs are not stand-alone safety summaries; they are analytical documents that must demonstrate ongoing acceptability of the device’s benefit–risk profile.
Notified Bodies expect PSUR conclusions to align with:
- PMS trend analysis
- Vigilance reporting outcomes
- Risk management updates
- Clinical evaluation conclusions
Inconsistencies between PSURs and CERs are one of the most common findings during MDR audit. A PSUR that identifies emerging risks or performance trends must trigger corresponding updates to the clinical evaluation and, where necessary, PMCF activities. These expectations are reinforced in MDCG guidance on PSUR requirements.
PMCF as a Tool for Addressing Clinical Evidence Gaps
PMCF plays a distinct and targeted role within the post-market evidence framework. It is not intended to generate clinical data indiscriminately, but to address specific residual uncertainties identified during clinical evaluation.
Notified Bodies increasingly assess whether PMCF plans are clearly justified by:
- Limitations in pre-market clinical data
- Gaps identified during Article 61 sufficiency assessments
- Changes in state of the art
- Information derived from PMS and PSUR activities
These expectations are articulated in MDCG 2020-7, which emphasizes traceability between clinical evaluation conclusions and defined PMCF objectives.
Poorly justified or generic PMCF plans are frequently challenged during audits, particularly where clinical evaluation relies heavily on literature or equivalence.
Traceability: The Core Notified Body Expectation
Across PMS, PSUR, and PMCF, traceability is the single most critical expectation under the MDR. Notified Bodies assess whether clear and documented connections exist between post-market evidence, risk management activities, clinical evaluation updates, and regulatory decision-making.
A traceable system demonstrates:
- How PMS findings are evaluated and escalated
- How PSUR conclusions impact benefit–risk assessments
- How PMCF activities are initiated, adjusted, or closed
- How overall post-market outputs fed back into the CER
Embedding these linkages within broader medical device lifecycle management practices helps manufacturers maintain consistency across regulatory documentation and avoid fragmented evidence narratives.
Post-Market Evidence and Article 61 Sufficiency
Post-market evidence plays a critical role in substantiating clinical evidence sufficiency under Article 61. Notified Bodies routinely assess whether PMS, PSUR, and PMCF data confirm or contradict the assumptions made in the CER.
This is particularly important for legacy devices, where historical data may no longer reflect current clinical practice or state of the art. Further, ongoing post-market data is essential to maintaining evidence sufficiency over time.
Special Considerations for SaMD and AI-Based Devices
For Software as a Medical Device (SaMD) and AI-enabled technologies, post-market evidence systems must accommodate rapid iteration, software updates, and evolving use environments. PMS and PMCF activities may need to capture performance metrics, algorithm behavior, and real-world clinical outcomes more dynamically than for traditional devices.
These challenges are reflected in IMDRF guidance on Software as a Medical Device (SaMD) clinical evaluation and regulatory perspectives from the European Medicines Agency (EMA) on digital health and artificial intelligence. Manufacturers must clearly explain how post-market evidence supports ongoing clinical performance validation.
Conclusion: Building a Sustainable Post-Market Evidence System Under MDR
Under MDR, PMS, PSUR, and PMCF are no longer isolated compliance activities. Together, they form a continuous post-market evidence system that underpins clinical evaluation, benefit–risk assessment, and regulatory confidence.
Manufacturers that design post-market processes with traceability, justification, and lifecycle integration in mind are better positioned to meet Notified Body expectations and sustain long-term compliance. A cohesive post-market evidence system not only supports regulatory obligations but also strengthens the scientific credibility of clinical evaluation throughout the device lifecycle.
How Freyr Supports Post-Market Evidence Integration
Designing a cohesive post-market evidence system requires alignment across clinical, regulatory, quality, and risk management functions. Freyr supports manufacturers in developing PMS strategies, preparing PSURs, designing PMCF plans, and ensuring traceability between post-market outputs and Clinical Evaluation Reports.
Freyr’s experts help organizations respond to Notified Body findings, strengthen lifecycle evidence alignment, and operationalize MDR post-market requirements for both legacy and innovative devices. For support with PMS, PSUR, PMCF, or post-market clinical evidence strategy under EU MDR, speak to a Freyr expert to discuss your regulatory objectives.
