While Post Market Surveillance (PMS) is not mentioned in current In Vitro Diagnostics Device Directive (IVDD). The Manufacturer’s obligation to maintain a “systematic procedure to review experience gained from devices in the post-production phase” (IVDD Annex III (5) and other references) is generally considered to be synonymous with a requirement to have a PMS system. This at least has been the interpretation of the Notified Bodies, and that this “systematic procedure” should be the same the post production monitoring requirement of ISO 14971 clause 9. See NB-MED/2.12/Rec1.
That lack of clarity is completely removed with the publication of the new European Union In Vitro Diagnostics Regulation (EU IVDR). Not only is PMS now defined in the new Article 2 (63), a PMS system is listed as among the basic obligations of all manufacturers (new Article 10 (9)). The PMS system is also one of the topics specifically called out for monitoring by the person responsible for regulatory compliance (new Article 15 (3)).
Precisely what is expected of the manufacturer’s PMS system is set out in the new Article 78. Among other things, the PMS system is to be used to update the benefit-risk determination, the performance evaluation, the instructions for use and the labelling etc. The new Article 84 requires that a PMS plan for the device. The content of the PMS plan being specified in Section 1 of the new Annex III. The PMS plan also has to be included in the Technical Documentation for the device.
Unsurprisingly, the conclusions that result from the review of the PMS data for the device have to be summarised in a report. For devices in Classes A and B (new Article 80), the PMS report must be be kept available for any Competent Authority who wishes to examine it. However, neither the content of the PMS report, nor the frequency with which has to be updated are prescribed. For devices in Classes C and D (new Article 81), the main outputs of the new Periodic Safety Update Report (PSUR) are prescribed. They including the conclusions of the benefit-risk determination and the main findings of the Post Market Performance Follow-up (PMPF) activities. The frequency with which the new PSUR must be updated is also defined. For both Class C and D devices the PSUR must be updated at least annually. Additionally in the case of Class D devices, the PSUR must also be submitted annually to the Notified Body, with the Notified Body’s evaluation report being made available to the Competent Authorities through the EUDAMED system.