From different sources we have heard that the introduction of EUDAMED will be delayed – probably for two years. In the meantime, this has been confirmed on the European Commission’s EUDAMED website.
Originally, the European Commission planned the go-live for March 2020. Modules that wouldn’t be ready by then, were to be introduced at a later stage. This plan is off the table and the initial go-live of the database will now be in 2022.
Please note that this will not mean that the MDR or IVDR application will be delayed. However, if this scenario becomes officially confirmed, further guidance is expected how issues regarding registration, vigilance etc. will be handled. We will keep you informed about any progress in this direction.
Sources: EUDAMED website