MDCG 2022-21: Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 (MDR)

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.

DOWNLOAD THE GUIDANCE MDCG 2022-21