20.07.2021
To the attention of Romanian manufacturers of medical devices/authorised representatives
Registration of “Legacy devices” into the EUDAMED
“Legacy devices” are defined as medical devices, active implantable medical devices and in vitro diagnostic medical devices covered by a valid EC certificate of compliance issued in accordance with Directive 93/42/EEC, Directive 90/385/EEC or Directive 98/79/EC and which continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR).
“Legacy devices” are subject to MDR or IVDR registration requirements, with some exceptions, such as the assignment of a base UDI-DI and a UDI-DI.
Manufacturers will have the possibility to register any of the “legacy devices” in EUDAMED. Indications regarding the registration of “Legacy devices” in EUDAMED are provided in the document “MDCG 2019-5 Registration of legacy devices in EUDAMED April 2019” (https://ec.europa.eu/docsroom/documents/34922).
Although the assignment of a basic UDI-DI and UDI-DI is not necessary for a “legacy device”, in order to keep the same standard structure and identifiers for all devices registered into the EUDAMED, an EUDAMED DI identifier (the equivalent of the UDI- Basic DI) will be required and a EUDAMED ID (if no UDI-DI has been assigned) will be generated from the EUDAMED DI.
The basic UDI-DI will never be applicable and assigned to a “legacy device”, only the EUDAMED DI will.
The UDI-DI can be used to identify a legacy device into the EUDAMED, however, only one device identifier will be assigned to a “legacy device”, as follows:
• either a UDI-DI (where EUDAMED DI is automatically generated),
• either a EUDAMED DI (where the EUDAMED ID is automatically generated).
For more information, please read the document “Management of Legacy Devices – MDR EUDAMED”: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/legacy_dvc_management_en.pdf