Post-market surveillance (PMS) has taken on a far more prominent and structured role under the EU Medical Device Regulation 2017/745 (MDR). Manufacturers are now required to proactively and systematically collect, analyse, and act on data relating to device performance and safety throughout the entire product lifecycle. PMS is no longer a passive, complaint-driven activity – it is a continuous regulatory obligation and a key pillar of MDR compliance.
For many manufacturers, particularly those transitioning from the MDD, MDR PMS requirements represent a significant step change. Increased expectations around planning, documentation, clinical follow-up, and reporting mean that PMS activities are closely scrutinised by Notified Bodies. MD Compliance supports medical device companies in designing and implementing MDR-compliant PMS systems that are robust, proportionate, and fully integrated with clinical evaluation, risk management, and quality management systems.
A compliant PMS system begins with a clear, well-structured PMS plan that defines how post-market data will be collected, reviewed, and used. The MDR requires PMS activities to be device-specific, risk-based, and aligned with the intended purpose and claims of the device.
MD Compliance supports clients in developing and implementing MDR-compliant PMS systems and planning, tailored to device classification, technology, and market experience. We help define appropriate data sources, including complaints, vigilance data, trend reporting, user feedback, registries, literature, and sales or usage data. Our approach ensures that PMS plans are not only compliant, but practical, focusing on meaningful data that can genuinely inform safety and performance conclusions.
We also support the integration of PMS into existing quality management systems, ensuring clear interfaces with CAPA, risk management, clinical evaluation, internal auditing and management review. This helps manufacturers demonstrate a closed-loop approach to post-market activities during Notified Body assessment.
Post-Market Clinical Follow-Up is a central component of MDR PMS, particularly for higher-risk devices and those relying on limited pre-market clinical data. PMCF is intended to proactively confirm the ongoing safety and performance of a device, identify previously unknown risks, and ensure that the manufacturer’s benefit–risk conclusions remain valid in real-world use.
MD Compliance provides comprehensive support across all aspects of PMCF. This includes the development of PMCF strategies and PMCF plans that are proportionate, justified, and aligned with device risk and clinical claims. We help manufacturers determine when PMCF is required, what type of activities are appropriate, and how PMCF integrates with the broader PMS and clinical evaluation framework.
Our team also supports the practical execution and documentation of PMCF activities, including the design and implementation of PMCF surveys, questionnaires, registries, and data collection tools. We assist with data analysis and reporting, ensuring PMCF outputs are clearly documented and suitable for inclusion in Clinical Evaluation Reports and PMS documentation. For legacy devices, we also support remediation where PMCF expectations have increased under the MDR.
The MDR introduces new, formalised reporting obligations through Periodic Safety Update Reports (PSURs) and, for certain high-risk devices, the Summary of Safety and Clinical Performance (SSCP). These documents are key regulatory deliverables and are frequently reviewed in detail by Notified Bodies.
MD Compliance supports clients in preparing MDR-compliant PSURs, ensuring that safety and performance data from PMS, PMCF, vigilance, and risk management activities are analysed holistically and presented clearly. We help define PSUR scope and frequency based on device classification and ensure consistency between PSUR conclusions and other elements of the technical documentation.
For implantable and Class III devices, we also support the development of SSCPs intended for both professional and patient audiences. Our approach focuses on clarity, accuracy, and alignment with clinical evidence and device claims, helping manufacturers meet transparency requirements while avoiding unnecessary regulatory risk.
