Faq Unique Device Identification (UDI) System

Faq Unique Device Identification (UDI) System

EC, 11.08.2020

The existing regulatory framework on medical devices dates back to the 1990s and consists of three Directives. Two new Regulations (Regulation (EU) 745/2017 on medical devices and Regulation (EU) 746/2017 on In Vitro diagnostic medical devices) were adopted in April 2017 and entered into force on 25 May 2017. The general application dates of the two Regulations are 26 May 2021 for medical devices and 26 May 2022 for In Vitro diagnostic medical devices, though different timelines apply for certain specific provisions.

These Regulations introduce an EU identification system for medical devices based on a Unique Device Identifier (UDI).

The UDI system will facilitate easier traceability of medical devices, significantly enhance the effectiveness of the post-market safety-related activities for devices and allow for better monitoring by competent authorities. It will also help to reduce medical errors and to fight against falsified devices. The use of the UDI system finally should also improve purchasing and waste disposal policies and stock-management by health institutions and other economic operators.

The new system will be applied to all medical devices except custom-made and performance study/investigational devices and is substantially based on internationally recognised principles, notably by using definitions that are compatible with those used by major trade partners

Article 27 of Regulation (EU) 2017/745 (‘MDR’) and Article 24 of Regulation (EU) 2017/746 (‘IVDR’) lay down that the UDI system shall consist of:

In accordance with the new rules, any manufacturer shall thus assign a unique UDI to a device and to all higher levels of packaging before placing that device on the market except custom-made medical devices and performance study/investigational devices.

The UDI carrier shall be placed on the label of the device and on all higher levels of packaging and in case of reusable devices on the device itself (direct marking). The manufacturer shall also ensure that the information – related to the device in question - referred to in Part B and Part A, Section 2, of Annex VI of the relevant Regulation, is correctly submitted to the European Database on Medical Devices (Eudamed) as required by Article 27(3) of MDR and Article 24(3) of IVDR. The manufacturer shall also maintain unique UDIs for its devices.

NOTE: Timelines related to those obligations are indicated under question 6 of this document.

Within the EU, the manufacturer shall assign to their devices, together with a UDI, also a Basic UDI-DI, which is not yet required by other jurisdictions. The Basic UDI-DI is the main key in Eudamed and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) and will also be the access key for device-related information entered in the database.

UDI issuing entities designated by the European Commission operate a system for the assignment of UDI in the EU

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