New timeline for EUDAMED

The Medical Devices Regulation, 2017/745, (MDR) and the In Vitro Diagnostics Regulation (IVDR) have replaced the three former EU Directives on medical devices, which Setterwalls has previously reported on here and here. The new regulations have introduced EUDAMED, the European Database on Medical Devices, as a database comprising several electronic systems for medical devices. The systems will include information on actors, such as manufacturers, authorised representatives, importers and distributors, as well as device-identifier elements and certificates issued by notified bodies. EUDAMED will also include a system for vigilance, market surveillance and clinical investigations.

The database is yet not ready and is behind schedule, as the process of the system is complex, but the EU Commission has now published a new timeline for the finalisation of EUDAMED. According to the new timeline, the system would reach full functionality in Q2 2027. It would be mandatory six months later, that is in Q4 2027, as regards most of its functions, such as mandatory use of actor, vigilance and market surveillance. The new timeline also states that all products and certificates must be registered 24 months thereafter, that is in Q2 2029.

The new timeline is a best case scenario and we continue to monitor the finalisation of EUDAMED.