EU MDR PMS and Vigilance

For each device, the manufacturer must plan, establish, document, implement, maintain, and update a PMS system proportionate to risk class and device type. The system belongs inside the quality management system and must actively and systematically gather, record, and analyse quality, performance, and safety data throughout the device lifetime.

The PMS plan is the operating document for that system. Annex III expects it to cover serious incidents, PSUR information, FSCAs, non-serious incidents, undesirable side-effects, trend reporting, literature, registers or databases, user feedback, complaints, distributor and importer inputs, public information about similar devices, assessment methods, indicators, thresholds, complaint investigation tools, communication methods, corrective-action procedures, traceability tools, and a PMCF plan or a justified reason why PMCF is not applicable.

PMCF is a continuous process that updates the clinical evaluation. It must be addressed in the PMS plan and uses clinical data from real use of the CE-marked device within its intended purpose to confirm safety and performance, keep identified risks acceptable, and detect emerging risks.

The PMCF plan should be device-specific. It should name the general methods, such as clinical experience, user feedback, scientific literature, and other clinical data sources, plus any specific methods such as registries or PMCF studies. It should also connect to the clinical evaluation report and risk management file, explain why the chosen methods are appropriate, and define a justified schedule for PMCF activities and reporting.

The output changes by device class. Class I manufacturers prepare a PMS report that summarises PMS data analysis, conclusions, and the rationale and description for preventive or corrective actions. Class IIa, IIb, and III manufacturers prepare a PSUR for each device and, where relevant, each category or group of devices.

A PSUR should summarise PMS analysis, conclusions, preventive and corrective actions, benefit-risk conclusions, main PMCF findings, sales volume, estimated population using the device, population characteristics, and usage frequency where practicable. MDCG 2022-21 treats the PSUR as a stand-alone, organised, searchable document that summarises results and conclusions rather than duplicating every PMS record.

Vigilance starts with reportability triage. MDR Article 87 requires manufacturers to report serious incidents involving Union-market devices, except expected side-effects that are clearly documented, quantified in technical documentation, and handled through Article 88 trend reporting. Article 87 also requires reporting of FSCAs for Union-market devices, including third-country FSCAs for a device also legally available in the Union unless the reason is limited to the third-country device.

MDCG 2023-3 frames a reportable serious incident around three checks: an incident occurred, it led or might lead to a serious health or public-health outcome, and a causal relationship with the manufacturer's device is established, reasonably possible, or suspected. If the manufacturer is uncertain whether a potentially reportable incident is reportable, the MDR requires reporting within the applicable timeframe.

A defensible PMS and vigilance file should show the route from signal to decision. Keep the raw signal, triage, reportability assessment, trend calculation, risk analysis, benefit-risk conclusion, CAPA or FSCA decision, communications, authority submissions, notified-body interactions, and the updates made to clinical evaluation and technical documentation.

EUDAMED is part of the MDR reporting architecture, but practical submissions may depend on module availability and transitional guidance. Keep evidence of the route used: EUDAMED submission receipts where applicable, national or notified-body submission records where EUDAMED is not the operative route, and the rationale for the route selected.