The unique device identification (UDI) is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous identification of specific devices on the market and facilitates their traceability. The UDI comprises the following components
- a device identifier (UDI-DI)
- a production identifier (UDI-PI)
These provide access to useful information about the device. The specificity of the UDI
- makes traceability of devices more efficient
- allows easier recall of devices
- combats counterfeiting
- improves patient safety
The UDI will be an addition to, not a substitute for, the existing labelling requirements for medical devices.
EU Commission’s initiative
The EU, as chair of the International Medical Device Regulators Forum (IMDRF) working group on UDI, strongly contributed to the preparation of the international guidance on a unique device identification system for medical devices, which was adopted in December 2013.
The Commission issued a recommendation in April 2013 on a common framework for a unique device identification system for medical devices in the EU. This was intended to provide the basis of the EU’s future identification and traceability infrastructure, in line with the latest developments at international level.
The new medical device regulations introduce the unique device identification (UDI) system based on a unique device identifier.
The UDI Helpdesk provides support to economic operators in the implementation of the obligations and requirements introduced by the new UDI system, which include UDI assignment, labelling and registration of devices and on the European Medical Devices Nomenclature (EMDN).
What will the new UDI enable?
The new UDI system will make the traceability of medical devices easier. In parallel, the post-market safety-related activities for devices will also be more robust and allow for a better monitoring by the competent authorities.
It will also help to reduce medical errors and fight against falsified devices.
The new UDI system should also improve the buying policies and the waste disposal policies, alongside the stock-management strategy, by health institutions and other economic operators.
The new system will be applied to all medical devices and in-vitro diagnostic medical devices placed on the EU market except custom-made devices.
The new rules are based on internationally recognised principles including definitions that are compatible with those used by major trade partners.
Article 27 of the 2017/745 and Article 24 of Regulation 746/2017 lay down that the UDI system shall consist
- of production of a UDI that comprises a UDI device identifier ('UDI-DI') specific to a manufacturer and a device, providing access to the information and a UDI production identifier ('UDI-PI') that identifies the unit of device production and if applicable the packaged devices
- placing of the UDI on the label of the device or on its packaging
- storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs 8 and 9 of this article respectively
- establishment of an electronic system for unique device identification ('UDI database')
The role of the manufacturer
In accordance with the new rules, any manufacturer shall assign to the device and to all higher levels of packaging a UDI before placing a device on the market. The UDI carrier shall be placed on the label of the device and on all higher levels of packaging.
Before a device is placed on the market the manufacturer shall ensure that the information related to the device in question - referred to in Part B of annex VI of the 2 regulations - is correctly submitted and transferred to the UDI database.
Within the EU, the manufacturer shall assign to his devices, together with a UDI, also a Basic UDI-DI.
The Basic UDI-DI is the main key in the database 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 future European medical device database.
UDI Issuing Entities
Following a call for application launched at the end of 2018 and the Commission Implementing Decision (EU) 2019/939 of 6 June 2019, 4 issuing entities were designated to provide manufacturers with a list of UDIs to assign on medical devices.
See the UDI HRI & AIDC formats and basic UDI-DI formats used by each issuing entity below. This content is based on input from the issuing entities and will be regularly updated.