The European Commission recently published Management of Legacy Devices (version 1.1, issued on 08.02.2021.), a document that further clarifies the registration of Legacy devices on EUDAMED. Previously, in 2019, DG Growth published Management of Legacy Devices document.
To recall, legacy devices are defined as Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostic Medical Devices that are covered by a valid certificate issued in accordance with Directive 93/42/EEC, Directive 90/385/EEC or Directive 98/79/EC and that continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR).
The registration deadline for legacy devices is referred to in Article 123(3)(e) of the MDR – 18 months after the date of application (provided that EUDAMED is fully functional on time) or 24 months from the publication notice that EUDAMED is fully operational. However, in case a serious incident occurs, or there is a field safety corrective action to be applied, which requires immediate registration and at least before a follow up or final vigilance report is submitted.
The EC document clarifies the exceptional assignment of so-called EUDAMED DI and EUDAMED ID for legacy devices that are exempted from UDI obligations as per the MDCG Guidance 2019-5. All devices registered in EUDAMED will follow the same structure and identification elements, so legacy devices will have:
- as an equivalent of BASIC UDI-DI – EUDAMED DI. Basic UDI-DI will never be applicable and never be assigned to a Legacy Device, only EUDAMED DI.
- as an equivalent of UDI-DI – EUDAMED ID. A UDI-DI can be used to identify a legacy device in EUDAMED.
- Only one device identifier will be assigned to a legacy device, either a UDI-DI (where the EUDAMED DI is automatically generated) or a EUDAMED DI (where the EUDAMED ID is automatically generated).
Once a legacy device becomes a compliant Regulation device, i. e. obtains the MDR or IVDR certificate, the device must be registered in EUDAMED in accordance with the MDR/IVDR requirements. For this purpose, EUDAMED will allow linking of the Regulation Device with the legacy device and perform this linking automatically where the same UDI-DI has been assigned to both the legacy device and the Regulation device. The link will be made at the level of the UDI-DI.
The document also clarifies format structure of the EUDAMED DI identification number (when it is not generated from UDI-DI). Key characteristics of the format structure of the EUDAMED DI and the Basic UDI-DI structures used by Issuing Entities:
- 25 characters is the maximum length of the identifier (including the prefix and check digits);
- allows the use of characters inside the code -permits the use of a subset of characters already implemented in other formatting structures by other entities;
- two key check-digit;
- Prefix (B-) implemented in order to create easily recognisable format for EUDAMED DI
The EC document provides also useful visual presentations and graphs on how the system will look like. For all EUDAMED related documents, have a look at our dedicated category of MDlaw Library of Documents at the following link!
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