Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices introduce an EU device identification system based on a unique device identifier (UDI) allowing easier traceability of medical devices. This requires that manufacturers submit in EUDAMED the UDI/Device information of all devices they place on the EU market. Manufacturers can already enter UDI/Device information in the system on a voluntary basis.
The European Commission is not in a position to require the use of the UDI/Devices registration module until EUDAMED is fully functional according to the Medical Device Regulation. Therefore, additional national requirements on registrations cannot be excluded.
Registration of Legacy Devices
Currently, legacy devices should be understood as devices, which, in accordance with Article 120(3) of the Regulation (EU) 2017/745 (MDR), are placed on the market after the MDR’s date of application -26 May 2021- and until 26 May 2024 if:
- they are class I devices under Directive 93/42/EEC, for which an EC declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body
- they are devices covered by a valid EC certificate issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC prior to 26 May 2021.
The registration of legacy devices in EUDAMED will be only required when the system will be fully functional and only in two particular cases:
- By the end of the transitional period (24 months after publication in the Official Journal of the European Union of the notice referred to in Regulation (EU) 2017/745 Article 34(3)) if an equivalent device is not made compliant and registered as a MDR device by that date.
- In case of serious incident or field safety corrective action concerning a legacy device, such device must be registered in EUDAMED at the moment of the serious incident/field safety corrective action reporting in the Vigilance module. The Vigilance module will be available when EUDAMED is fully functional.
EUDAMED Medical Consultancy is always ready to help you manage EUDAMED UDI/DEvices Registration processes on behalf of your company.