22 May European Commission launches new information on Unique Identification System
On 3 May, the European Commission launched three consultation documents for medical device manufacturers, which include important information on the UDI (Unique Device Identifier) system for medical devices. Two of them include details on what information should be included for medical devices and in vitro medical devices, and the third is a centralised repository of the data to be included in EUDAMED, with a detailed description of these data.
The MDR Regulation considers it a requirement to include the name of the manufacturer and the value of the UDI-DI among others, in addition to indicating whether the device is implantable or a reusable surgical instrument.
The IVDR regulation states that information must be provided on whether the IVD is intended for self-testing, whether it is a companion diagnostic device, a reagent, whether it is intended to administer or dispose of a medicinal product, or whether it is designed for professional testing.
Finally, the data repository (designed in Excel spreadsheet format) is very useful, as it describes the data to be provided to EUDAMED, among other information.
Last April, two documents were published by the European Union’s Medical Device Coordination Group (MDCG). These documents explain how legacy devices can be registered in EUDAMED even if they do not have a UDI. In addition, it reports that companies will have until November 2021 to register their device data with Eudamed.