Udi Medical Device Regulation

This will be introduced progressively through a risk based approach highest risk devices first.

Udi medical device regulation.

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. This element will be key for the traceability of devices in europe. 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. In annex vi part c of medical devices regulation 2017 745 the basic udi di is defined as.

On 7 june 2019 gs1 was designated by the european commission as an issuing entity for unique device identifiers udis. The primary identifier of a device model. 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. 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.

Include a unique device identifier udi on device labels and packages. The unique device identification system final rule udi rule requires device labelers typically the manufacturer to. To be specific the concept of udi did appear on the imdrf guidance issued in 2013 this defined the basis of this new technology. Systems and procedure packs as referred to in article 22.

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. The udi pi characteristics such as the lot or serial number shall be defined by the manufacturer. It is the di assigned at the level of the device unit of use. 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.

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.