|While Post Market Surveillance (PMS) is mentioned in Annex X of the existing Medical Device Directive (MDD) it was not defined in the MDD. Traditionally the requirement for Post Market Surveillance has been considered to be synonymous with another of the Manufacturer’s obligations; to maintain a “systematic procedure to review experience gained from devices in the post-production phase” (MDD Annex III and other references). This lack of definition was not addressed by the Competent Authorities, but by the Notified Bodies in their recommendation document NB-MED/2.12/Rec1. The consensus being that the MDD’s “post market surveillance” requirement is the same as the post production monitoring requirement of ISO 14971 clause 9.
That lack of clarity is completely removed with the publication of the new EU MDR. Not only is PMS defined in Article 2 (60), it is listed as one of the general obligations of all manufacturers (new Article 10), it is also one of the topics specifically called out for monitoring by the person responsible for regulatory compliance (new Article 15). Precisely what is expected of the manufacturer’s PMS system is set out in the new Article 83. Among other things, the PMS system is to be used to update the clinical evaluation, update the benefit-risk determination, update the instructions for use and the labelling etc.
The new Article 84 requires that a PMS plan be developed for each device. The content of the PMS plan being specified in Section 1.1 of the new Annex III. The PMS plan also has to be included in the Technical Documentation for the device.
Unsurprisingly, the conclusions which result from the review of the PMS data for the device have to be summarised in a report.
In the case of Class I devices (new Article 85), the 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 defined.
In contrast for Class IIa, Class IIb and Class III devices (new Article 86), the main outputs of the new Periodic Safety Update Report (PSUR) are prescribed. They including the current benefit-risk determination and the current findings of the Post Market Clinical Follow-up (PMCF) activities. The frequency with which the PSUR must be updated is also defined; for Class IIa devices the PSUR must be updated at least every two years. For Class IIb and Class III devices the PSUR must be updated at least annually. Additionally, in the case of Class III devices and implantable devices, the PSUR must be submitted annually to the Notified Body, and the Notified Body’s evaluation report has to be made available to the Competent Authorities through the EUDAMED system.