EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices.
The system will be multipurpose, and it will be structured around 6 interconnected modules and a public website.
The full implementation of EUDAMED is expected from 26th May 2022. However, the European Commission has planned a progressive module by module implementation of EUDAMED (https://ec.europa.eu/health/sites/health/files/md_sector/docs/2020-15-position-paper-actor-registration-module_en.pdf). The first module that will be activated is the Actor Registration Module, that is going to be made available from 1st December 2020. This module allows the registration of Manufacturers, Authorised Representatives and Importers in the system and the obtainment of the Single Registration Number (SRN). A specific webpage dedicated to the Actor Registration Module has recently been made available by European Commission (https://ec.europa.eu/health/md_eudamed/actors_registration_en).
The Actor registration is currently not mandatory, however, it is highly recommended by the European Commission.
RPN is ready to support companies in all the regulatory steps for the MDR requirements implementation, including the registration in EUDAMED since the date of the Actor Registration Module activation. Do not hesitate to contact us!