MDCG Offers Guidance on Complying With EU MDR Periodic Safety Update Report

The EU’s Medical Device Coordination Group (MDCG) has released new guidance and templates to help devicemakers in filing the newly-required Periodic Safety Update Reports (PSURs) based on postmarket surveillance.

PSURs summarize postmarket surveillance data to comply with Article 86 of the EU’s Medical Device Regulation (MDR), taking into consideration new data on safety and performance measures, and reporting possible changes to a device’s benefit-risk profile.

The guidance includes templates for presenting data in the PSUR as well as a summary table that lays out reporting requirements and frequency of reporting (either annually or biannually) by device class.

The PSUR requirement is applicable to Class IIa (low to medium risk), Class IIb (medium to high risk) and Class III (highest risk) devices medical devices.