The “market surveillance” (performed by the Competent Authority) is the set of activities carried out and the measures taken to verify and guarantee that the devices are compliant with MDR (Art. 93) and IVDR (Art. 88). The ultimate goal is to ensure that devices placed on the market do not endanger health and safety.

“Post-market surveillance” (PMS, performed by the Manufacturer) is a proactive and systematic process, designed to monitor the performance of a medical device by collecting and analyzing information relating to its use in the field (Ref. Art. 83 of MDR and Art. 78 of IVDR). An integral part of the Quality Management System (QMS) process, the PMS is based on a PMS plan and is carried out in collaboration with other economic operators.

Finally, “vigilance” (performed by the Manufacturer, the Authorised Representative EU REP and the competent Authority) is a reactive process and consists in reporting serious incidents and field safety corrective actions (FSCA) to the Competent Authorities involved. Both MDR (Art. 87), and IVDR (Art. 82) describe the requirements for this process, as well as the established deadlines for reporting based on the seriousness of the serious incident. Manufacturers must also report side effects trends, as well as trends of expected unwanted accidents that are not classified as serious.

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