1. Articles 80 and 81 describe the Post Market Surveillance reporting requirements. These reports do not need to be part of the feedback systems of the eight or nine processes. These reports are primarily for the Authorities. They are the evidence that the manufacturer is complying with the Post Market Surveillance obligation, but they are a retrospective summary of a defined time period.

Article 80: For all lower risk (Class A and Class B) devices, Manufacturers must produce a Post Market Surveillance Report. At minimum, the PSM report must contain the following information:

  1. a summary of the results and the conclusions of the analyses/assessment of the post-market surveillance data defined in the PMS plan. To be consistent, in the opinion of the author, that requires a summary status update, for the period covered by the report, on the feedback received for each of the eight or nine processes listed in Article 78.
  2. a rationale and description of any preventive or corrective actions taken during the period covered by the report.

The PMS report is part of the Technical Documentation on Post Market Surveillance (Annex III, 2.). The PMS report can be updated whenever the manufacturer considers it necessary and simply needs to be available if requested by an Authority, or the Notified  Body in the case of Class B devices. But that means it must be produced/updated from time to time. At least once every three years is recommended.

Article 81: For all higher risk (Class C and D) devices, Manufacturers must produce a Periodic Safety Update Report (PSUR). At minimum, the PSUR must contain the following information:

  1. a summary of the results and the conclusions of the analyses/assessment of the post-market surveillance data defined in the PMS plan. To be consistent, in the opinion of the author, that requires a summary status update, for the period covered by the report, on the feedback received for each of the eight or nine processes listed in Article 78.
  2. a rationale and description of any preventive or corrective actions taken during the period covered by the report,
  3. the main findings of the PMPF (Post Market Performance Follow-up) activities during the period covered by the report. See also the commentary on Performance Evaluation,
  4. the conclusions of the reassessment of the benefit-risk determination during the period covered by the report,
  5. data on sales volumes and estimates of user population and frequency of use.

The PSUR is part of the Technical Documentation on Post Market Surveillance (Annex III, 2.). For both Class C and Class D devices, the PSUR must be produced/updated at least annually. Additionally for Class D devices the updated PSUR must be submitted to the Notified Body for review via the EUDAMED database.

Note: At the time of writing this commentary, no guidance had been published by the European authorities on Post Market Surveillance. As guidance becomes available, this commentary will be update.