European commission details management of Legacy Devices in EUDAMED

The European Commission (EC) has released a document explaining how Legacy Devices will be managed in its EUDAMED database.

A Legacy Device is a medical device, active implantable medical device or in vitro diagnostic medical device that has a valid certificate issued in accordance with existing device regulations and will continue to be placed on the market following the implementation of the European Union Medical Device Regulation (EU MDR) or EU In Vitro Diagnostic Regulation (IVDR).

The EUDAMED database has primarily been created to improve transparency and coordination of information regarding medical devices available on the EU market. Registration of Legacy Devices in EUDAMED is mandatory and will help coordinate vigilance activities such as serious incident reporting and field safety corrective actions. Note that class I non-sterile devices or those with a measuring function are not considered as Legacy Devices because they do not require Notified Body certification.

The document also describes the identification details for Legacy Devices. The assignment of a Basic Universal Device Identification-Device Identifier (UDI-DI) and a UDI-DI are not required for a Legacy Device. Where these identifiers are absent for a Legacy Device, for the purpose of EUDAMED registration device identification will take the form of a EUDAMED DI instead of the Basic UDI-DI and a EUDAMED ID instead of the UDI-DI.

When a Legacy Device becomes a compliant Regulation Device (upon fulfilment of all MDR/IVDR requirements), a new Regulation Device shall be registered in EUDAMED. The devices will be automatically linked in instances where the same UDI-DI has been assigned to both devices, otherwise the link can be created manually using the Legacy Device’s identifier.

The full guidance document can be found here.