Market surveillance

The activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection. Under the IVDR: the activities carried out and measures taken by public authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection.

Reference: MDR Article 2(61); IVDR Article 2(64)

PMCF evaluation report — Post-market clinical follow-up evaluation report

The manufacturer’s analysis of the findings of PMCF activities. It forms part of both the clinical evaluation report and the technical documentation, and its conclusions feed back into the clinical evaluation and the benefit-risk determination.

Reference: MDR Annex XIV Part B point 7

PMCF — Post-market clinical follow-up

The continuous process of proactively collecting and evaluating clinical data from a device already on the market, in order to confirm safety and performance across its expected lifetime, identify previously unknown side effects, and check that the benefit-risk position still holds. It is a planned activity, not a reaction to complaints.

Reference: MDR Annex XIV Part B

PMCF plan — Post-market clinical follow-up plan

The document specifying the methods, rationale and time schedule for PMCF activities, including the general and specific methods to be used, references to the relevant parts of the clinical evaluation report, and the objectives the activities are meant to address.

Reference: MDR Annex XIV Part B point 6

PMPF — Post-market performance follow-up

The IVDR counterpart to PMCF: a continuous process of updating the performance evaluation using data gathered from the device in routine use, addressed in a PMPF plan and reported in a PMPF evaluation report that forms part of the performance evaluation report.

Reference: IVDR Annex XIII Part B

PMS plan — Post-market surveillance plan

The plan describing how the manufacturer will collect and analyse experience from devices on the market, what indicators and thresholds will be used, and how complaints, trends and field data feed into corrective action. It forms part of the technical documentation.

Reference: MDR Article 84 and Annex III; IVDR Article 79 and Annex III

PMS report — Post-market surveillance report

The lighter-touch reporting route for lower-risk devices, summarising the results and conclusions of post-market surveillance together with any preventive and corrective actions taken. It is updated as necessary and made available to authorities on request rather than routinely submitted.

Reference: MDR Article 85; IVDR Article 80

Post-market surveillance

All activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.

Reference: MDR Article 2(60); IVDR Article 2(63)

PSUR — Periodic safety update report

The recurring post-market report required for higher-risk devices, summarising surveillance findings, the conclusions of the benefit-risk determination, the main findings of post-market follow-up, and sales volume with an estimate of the population using the device. Update frequency depends on risk class.

Reference: MDR Article 86; IVDR Article 81