Manufacturers of Class IIa, class IIb and class III devices pursuant to MDR Article 86 must provide a copy of the PMS plan referred to in MDR Article 84, together with the rationale and explanation of each preventive and corrective action taken, for each device and, where relevant, for each device category or group. Manufacturer prepares a periodic safety update report (“PSUR”) that summarizes the results of the analysis of the PMS data collected as a result and the outputs based on these results.
Manufacturers of class IIb, Implantable, and class III devices update the PSUR at least annually. Manufacturers of Class IIa devices update the PSUR as necessary and at least every two years.
For Class III devices or implantable devices, manufacturers submit PSURs to the notified body involved in conformity assessment through the electronic system referred to in MDR article 92.
The notified body examines the report and adds its own assessment to this electronic system, along with the details of each activity carried out. Such PSURs and notified body assessments are made available to the competent authorities through this electronic system.