According to Article 86 of the MDR, manufacturers of Class IIa, Class IIb, and Class III devices must prepare a Periodic Safety Update Report (PSUR) summarizing the analysis results of PMS data collected as a result of the PMS plan referred to in Article 84 of the MDR, including the justification and explanation for every preventive and corrective action taken for each device and, where applicable, each device category or group.

Manufacturers of Class IIb, implantable, and Class III devices must update the PSUR at least annually.

Manufacturers of Class IIa devices must update the PSUR as necessary and at least every two years.

For Class III or implantable devices, manufacturers must submit the PSURs to the notified body involved in the conformity assessment via the electronic system referred to in Article 92 of the MDR.

The notified body reviews the report and adds its own evaluation, including the details of the actions taken, to the electronic system. These PSURs and the notified body assessments are made accessible to the competent authorities via the electronic system.