Post-Market Surveillance and Follow-Up Support

Why Post-Market Activites Matter

Post-market surveillance is a central pillar of the EU MDR and IVDR and reflects a shift toward lifecycle-based regulatory oversight. Manufacturers are required to proactively collect, analyse, and act on data relating to the safety and performance of their devices once they are placed on the market. This obligation applies throughout the device lifecycle and is not limited to reactive complaint handling.

Under the MDR and IVDR, manufacturers must establish and maintain a structured PMS system that is appropriate for the device type and risk class. This includes a documented PMS plan, defined data sources, procedures for trend analysis, and clear mechanisms for feeding post-market information back into risk management and clinical evaluation. Regulators expect PMS activities to be systematic, rather than ad hoc, and to demonstrate continuous oversight of device performance.

Post-market clinical follow-up for medical devices and post-market performance follow-up for IVDs play a key role in confirming that pre-market assumptions remain valid in real-world use. These activities are particularly important where clinical evidence at the time of conformity assessment is limited, or where residual risks require ongoing monitoring. PMCF and PMPF plans must be clearly justified and proportionate to the device’s risk profile and intended use.

A common regulatory issue is that PMS documentation is treated as separate from other regulatory files. In practice, PMS outputs must directly inform updates to the risk management file, clinical evaluation, and technical documentation. For example, trends in complaints or vigilance reports may require reassessment of known risks or revision of labelling. Where this feedback loop is weak or undocumented, regulators may question the effectiveness of the PMS system.

Post-market reporting obligations also increase with device risk class. Higher-risk devices are subject to Periodic Safety Update Report requirements, while IVDs may require performance reporting depending on classification. These reports must be based on documented data analysis and presented in a clear and structured manner.

Effective PMS systems not only support compliance but also provide manufacturers with early visibility of emerging issues, reducing the likelihood of serious incidents or regulatory enforcement actions. Poorly implemented PMS systems, by contrast, are a frequent source of non-conformities and can undermine confidence in the manufacturer’s quality and regulatory controls.