Europe – Eudamed update: Phased implementation planned for European medical device, IVD database

The implementation of the European Database for Medical Devices, Eudamed, has been delayed by two years and the implementation of the Medical Devices Regulation (MDR) has been delayed by one year. The European Commission has informed Emergo that parts of Eudamed will be made available to users before the official Eudamed date of application in May 2022.

In this way it becomes possible for economic operators to start using Eudamed before they are legally required to do so. This will help companies to prepare and will also help the authorities to smooth out unforeseen issues before the date of application…