A milestone for the EU medical devices revolution

Last week saw the first certificate registered on EUDAMED, the new centralised European Database on Medical Devices as established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. EUDAMED, which is an integral part of the implementation of the two new Medical Devices Regulations, is intended to streamline and facilitate information flow between various stakeholders and make information regarding medical devices more readily available.

EUDAMED, once fully functional, will be composed of six modules related to actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and market surveillance. Registration of certificates of conformity by notified bodies is currently on a voluntary, basis but will become mandatory once all six modules of EUDAMED have been declared fully functional.