EU In Vitro Diagnostic Medical Devices Regulation (IVDR) IVDR-Art.78: Post-market surveillance plan and system (Article 78)

Article 78 requires manufacturers to plan, establish, document, implement, maintain and update a post-market surveillance (PMS) system, proportionate to the risk class and appropriate for the type of device. The PMS system actively + systematically gathers, records and analyses data on the quality, performance and safety of the device throughout its entire lifetime; the PMS plan is part of the technical documentation (Annex III). PMS information feeds back into performance evaluation (Article 56), into vigilance (Articles 82-86), and into the SSP (Article 29).