For the lifetime of the device under evaluation, the PSURs for the EU should include:
- Rationale and description of any preventive and corrective actions taken e.g. FSCAs
- The main findings of the Post Market Clinical Follow-up
- Conclusions stemming from the benefit-risk determination
- Sales volume and an evaluation of the population that has used the device and other details like the frequency of use
The requirements depend on the classification of the device in question. For device classes IIb and III, the PSUR will be part of the technical documentation outlined in Annexes II and III, with an exception to custom-made devices. This should be done at least annually. For class IIa, manufacturers must produce an updated PSUR when necessary, but at least every two years. Annexes II and III also provide the requirements for the PSUR within the technical documents for these devices as well.
When creating the PSUR for custom-made devices, refer to Section 2 of Annex XIII. For class III devices or implantable devices, manufacturers shall submit PSURs utilizing the electronic system i.e. EUDAMED (details can be found in Article 92) to their notified body conducting the conformity assessment as outlined in Article 52. PSURs and the evaluation by the notified body shall be made available to competent authorities through the electronic system.