The module on UDI/devices registration (second module) and the module on Notified Bodies and Certificates (third module) are available since October 2021 except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities. Afterwards, the remaining modules as well as the mechanism for scrutiny and the CECP will be released when EUDAMED is fully functional.
The Medical Devices Regulation (MDR, Regulation (EU) 2017/745) is fully applicable since 26 May 2021, following the transition period. Please keep the revised deadline firmly in mind. The corresponding date of application of the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746) remains in May 2022. If you manufacture, distribute or procure medical devices, or have other responsibilities under the new Regulations, please take advantage of […]