Medical device CE marking

EC guidance on legacy devices in EUDAMED


The European Commission has published a document explaining how and when legacy devices will be identified in the new Eudamed medical device database. Legacy devices are products that have been CE marked in the context of the current medical device directives but not under the new Medical Device Regulation, nor the IVD Regulation.

The Management of Legacy Devices is a technical document, the majority of which consists of flowcharts and other tables, which explains how the different Unique Device Identifiers (UDIs) will be generated/assigned for legacy devices as part of registration.

The document can be downloaded in our library.

Source: European Commission