Udi Medical Device Regulation

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.

Udi medical device regulation.

To be specific the concept of udi did appear on the imdrf guidance issued in 2013 this defined the basis of this new technology. It is the di assigned at the level of the device unit of use. Udi will also underpin the eudamed database. This will be introduced progressively through a risk based approach highest risk devices first.

It is the main key for records in the udi database and is referenced in relevant certificates and eu declarations of conformity. Include a unique device identifier udi on device labels and packages. This element will be key for the traceability of devices in europe. In annex vi part c of medical devices regulation 2017 745 the basic udi di is defined as.

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 primary identifier of a device model. 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. The udi pi characteristics such as the lot or serial number shall be defined by the manufacturer.

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 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. 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.

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.