EU MDR and IVDR Postmarket Surveillance (PMS)

What is post-market surveillance under the EU MDR and IVDR?

Post-market surveillance, or PMS, is the manufacturer’s proactive and systematic process for collecting, recording and analyzing experience from devices after they enter the market. It is broader than complaint handling or incident reporting. Under the EU MDR and EU IVDR, PMS is part of the quality management system and must operate throughout the device lifetime.

A PMS system should detect changes in benefit-risk, new or increasing risks, performance problems, use issues and opportunities for corrective action. Its findings must feed back into ISO 14971 risk management, clinical or performance evaluation, labeling, design controls and CAPA.

What belongs in an EU post-market surveillance plan?

The plan defines data sources, collection methods, responsibilities, analysis methods, indicators, thresholds and actions. Sources can include complaints, incidents, literature, registries, user feedback, distributor information, trend data, PMCF or PMPF and information about similar devices.

The plan is not a generic annual checklist. It should reflect the intended purpose, risk class, technology, population, use environment and known residual risks. The current MDCG 2025-10 guidance explains how manufacturers can make PMS continuous and connected to the rest of the quality system.

What reports does the PMS system produce?

Under the MDR, Class I devices generally require a PMS Report that is updated when necessary. Class IIa, IIb and III devices require a Periodic Safety Update Report. Class IIa PSURs are updated at least every two years; Class IIb and III PSURs at least annually.

IVDR reporting follows its own class-based requirements. Manufacturers should not merge MDR and IVDR report rules or confuse a PMS plan with a report that summarizes results and conclusions.

How are vigilance and FSCA connected to PMS?

Vigilance addresses reportable serious incidents, trends and safety actions within the wider PMS system. An urgent issue cannot wait for the next periodic report. The manufacturer must assess reportability and act within the applicable timelines.

A Field Safety Corrective Action can include recall, correction, software update or new safety advice. The action and related field safety notice should be coordinated across every affected jurisdiction.

How should PMS remain connected to technical documentation?

PMS outputs should update the risk management file, clinical evaluation or performance evaluation, benefit-risk conclusions, labeling, verification evidence and technical documentation where needed. PMCF or PMPF findings form one proactive input, not a substitute for the full PMS system.

Pure Global supports integrated EU MDR and IVDR PMS programs, including plan design, data strategy, report preparation and alignment with the wider regulatory dossier.