Articles 85 and 86 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 85: For all lower risk (Class I) 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 83.
  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 1.2.) or the equivalent for custom made devices (Annex XIII, Section 2). The PMS report can be updated whenever the manufacturer considers it necessary and simply needs to be available if requested by an authority. But that means it must be produced/updated from time to time. At least once every three years is recommended.

Article 86: For all higher risk (Class IIa, IIb and III) 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 83.
  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 PMCF (Post Market Clinical Follow-up) activities during the period covered by the report. See also the dedicated page on Clinical 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 1.2.) or the equivalent for custom made devices (Annex XIII, Section 2). For Class IIa devices, the PSUR must be produced/updated at least annually. For Class IIb and Class III devices, the PSUR must be produced/updated at least annually. Additionally for Class III 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.