| Theme | EUDAMED – Legacy Devices |
| Target Audience | Manufacturers |
| Products Concerned | Legacy Devices (MD, AIMD and IVD) |
| Regulatory reference | MDR (EU) 2017/745
Article 120(3) IVDR (EU) 2017/746 Article 110(3) |
| Documents mentioned |
This guide deals with the case of the registration of legacy devices (devices covered by a certificate of conformity to the Directives MD, AIMD or IVD that continue to be placed on the market after May 26, 2021) in Eudamed.
The obligation to assign an UDI and to affix the UDI medium is not applicable to these devices.
On the other hand, the registration of devices and economic operators (Annex VI part A) is required. The design of EUDAMED will be adapted to the registration of these devices in the absence of a basic IUDI-DI.