Periodic safety update report (PSUR)

Manufacturers of class IIa, IIb and III devices prepare a PSUR for each device or, where relevant, each device group. It sets out the conclusions of the benefit-risk determination, the main PMCF findings, the sales volume and the size of the population using the device, and the preventive and corrective actions taken. Class IIb and III devices update it at least once a year, and class IIa devices when necessary and at least every two years.

1. Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned, that PSUR shall set out: (a) the conclusions of the benefit-risk determination; (b) the main findings of the PMCF; and (c) the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device. Manufacturers of class IIb and class III devices shall update the PSUR at least annually. That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III. Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years. That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III. For custom-made devices, the PSUR shall be part of the documentation referred to in Section 2 of Annex XIII.

EU MDR, Article 86(1)

The main objective of a PSUR is to present a summary of the results and conclusions of the analyses of post-market surveillance data relating to a device or a device group, thus allowing the reporting of any possible changes to the benefit-risk profile of the medical device(s), considering new or emerging information in the context of cumulative information on benefits and risks.

MDCG 2022-21, Section 2.1.1, Identification and evaluation of changes of the benefit-risk profile

The FDA has no PSUR for devices. The closest US obligations are the periodic reports required from PMA holders (21 CFR 814.84) and postmarket surveillance that FDA can order under section 522 of the FD&C Act (21 CFR 822), so a PSUR written for the EU does not answer a US requirement as it stands.