On 10 August 2020, the European Commission has published a Q&A document explaining how the Unique Device Identification (UDI) system will work under the EU medical devices Regulations 2017/745 and 2017/746.
Some of the key questions answered in the document are:
UDI data submission in EUDAMED
This applies from 26 November 2022 for medical devices and 26 November 2023 for in vitro diagnostic medical devices (provided that EUDAMED is fully functional before the date of application of the respective Regulation; otherwise, this obligation applies 24 months after EUDAMED has become fully functional). Manufacturers will be in a position to voluntarily comply with registration obligations as from 26 May 2021 for medical devices and 26 May 2022 for In Vitro diagnostic medical devices.
UDIs and legacy devices
Legacy devices, which make use of the MDR and IVDR grace period are not subject to UDI obligations, but should still be registered in EUDAMED. The question still remains when this would be required.
UDI and economic operators
Manufacturers shall be responsible for the UDI assignment and placement of the UDI carrier, the initial submission and updates of the identifying information and other device data elements in EUDAMED. Distributors and importers shall verify that, where applicable, a UDI has been assigned by the manufacturer. All economic operators shall store and keep, preferably by electronic means, the UDI of the devices which they have supplied or with which they have been supplied.
UDI and software
The UDI shall be assigned at the system level of the software. Only software that is commercially available on its own and software that constitutes a device in itself shall be subject to that requirement.
What does this mean to you?
This document is an important read to ensure you fully understand how the UDI system will work under the Medical Device Regulation and the IVD Regulation.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.