Udi Medical Device Regulation

The global unique device identification database gudid is a database administered by the fda that will serve as a reference catalog for every device with a unique device identifier udi.

Udi medical device regulation.

The udi pi characteristics such as the lot or serial number shall be defined by the manufacturer. In annex vi part c of medical devices regulation 2017 745 the basic udi di is defined as. The eu s new medical device regulations will require virtually all devices to carry a unique identifier with effect from date of application which is likely to be mid 2020. This element will be key for the traceability of devices in europe.

The udi of such devices shall be placed on the device and be readable after each procedure to make the device ready for the next use. Systems and procedure packs as referred to in article 22. The unique device identification system final rule udi rule requires device labelers typically the manufacturer to. Udi will also underpin the eudamed database.

Include a unique device identifier udi issued under an fda accredited issuing agency s udi system on device labels device packages and in some instances directly on the device. To be specific the concept of udi did appear on the imdrf guidance issued in 2013 this defined the basis of this new technology. The eu medical device regulation mdr and in vitro diagnostic regulation ivdr were adopted on 5 april 2017 and define the requirements for the eu udi system. Massimop z annex 6 vi part c the udi system part 2 and the udi system annex annex vi annex vi information to be submitted upon the registration of devices and economic operators in accordance with articles 29 4 and 31 core data elements to be provided to the udi database together with the udi di in accordance with articles 28 and 29 mdr part 2 udi udi system.

It is the main key for records in the udi database and is referenced in relevant certificates and eu declarations of conformity. On 7 june 2019 gs1 was designated by the european commission as an issuing entity for unique device identifiers udis. The udi or unique identification number europe as there is also one in the usa is one of the new things that come with the new eu mdr 2017 745 and ivdr 2017 746. Include a unique device identifier udi on device labels and packages.

A class ii device that is required to be labeled with a udi must bear a udi as a permanent marking on the device itself if the device is a device.