Eudamed identification requirements for legacy devices
While legacy devices will ultimately fall under MDR and IVDR registration requirements, they may not necessarily have to comply with the Regulations’ identification requirements to be assigned Basic UDI-DI and UDI-DI codes.
Under the MDR, the Basic UDI-DI is defined as the primary identifier of a device model, and the main identifier for records in Eudamed; the UDI-DI code is specific to a model of device, and used as an access key to data stored in Eudamed. In some instances, legacy devices have already been assigned UD-DI codes, which may be used for Eudamed registration and identification purposes.
However, some legacy devices will need identification elements known as Eudamed DI codes, which will function as equivalents to Basic UDI-DI codes for purposes of maintaining identification elements across all devices (legacy or otherwise) registered in the Eudamed database. In cases where a legacy device has had no UDI-DI assigned to it, a Eudamed ID will be generated and assigned for that device based on its Eudamed DI.
(Annex 1 of the new European Commission document provides in-depth format requirements for Eudamed DI codes.)
European Commissioners are conducting a phased implementation of the Eudamed database, with a target final date of application set for May 2022. Eudamed’s UDI and device registration module is anticipated to launch in May 2021.
Additional European MDR, IVDR and Eudamed compliance resources from Emergo by UL:
- European MDR preparation and compliance resource center
- European IVDR preparation and compliance resource center
- Webinar: Eudamed requirements under the MDR and IVDR
Related services for Europe:
- CE Mark Certification for Medical Devices
- Clinical Evaluation Reports (CER) for Medical Devices in Europe
- EU IVDR Gap Assessment and CE Transition for IVD Companies
- EU MDR compliance consulting for cosmetic and aesthetic products
- EU Medical Device Vigilance Reporting in Europe
- EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
- European Authorized Representative for Clinical Trials
- European Authorized Representative for Medical Device Companies
- European MDR 2017/745 Gap Assessment and CE Transition Strategy
- European Union Medical Device Classification
- In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
- IVD Certification and Registration to Obtain CE Marking in Europe
- Medical Device and IVD Emergency Use Routes in Europe
- Medical Device Technical File and Design Dossier for EU CE Marking
- Switzerland Representative for Medical Device Companies
- UKRP and Brexit consulting for medical device companies