The Medical Device Coordination Group (MDCG) has published the MDCG 2022-21 guidance on the Periodic Safety Update Report (PSUR).
In accordance with Regulation (EU) 2017/745 Article 86, manufacturers of Class IIa, IIb, and III devices are required to draft a PSUR to enable a more consistent, standardized, and systematic review of all Post-Market Surveillance (PMS) data.
The purpose of this guidance is to support manufacturers implementing the requirements for establishing and maintaining the report, providing information on:
- The minimum expectations for the content and structure of the PSUR,
- The strategy for grouping devices by PSUR,
- The cycle for establishing PSURs based on the risk class of devices,
- PSUR submission procedures, even in the absence of Eudamed.