The EU’s medical device regulations 2017/745 and 2017/746 require that each device placed on the market must be accompanied by a unique device identification (UDI) which shall be used for identification and traceability purposes. Note, this requirement applies to all devices apart from custom-made and investigational devices.
The above is the proposed symbol to be used for medical device labelling.
The product specific UDI is comprised of two parts: the UDI device identifier (UDI-DI) and the UDI production identifier (UDI-PI).
UDI-DI: This portion of the UDI is both specific to the manufacturer and device-group. This is considered to be the “access-key” to the UDI database information.
UDI-PI: This shall identify the unit of device production and may include the serial number, the lot number, software identification and manufacturing / expiry date. This tracks the specific production series.
Both the UDI-DI and UDI-PI may be made available in a numeric or alphanumeric code. Together, they are known as the device’s UDI which shall be displayed on the “UDI carrier”. We will discuss this later on in this article.
The Basic UDI-DI represents a device-type described as device with the same intended use, risk classification and design and manufacturing characteristics. It will be the key to device-specific information on the Eudamed database.
The Basic UDI-DI will need to be made available on specific documentation (Declaration of Conformity, Summary of Safety and Clinical Performance, Certificates) however it shall not show on the packaging or label of the device.
The Basic UDI-DI will be made up of a number of elements which shall include reference to the issuing agency, the manufacturer, the device group, and a number of check digits.
Guidance on Basic UDI-DI and changes to UDI-DI
In its implementing decision on 6 June 2019, the European Commission (EC) designated 4 issuing entities to operate a UDI assignment system for medical devices: (1) GS1 AISBL; (2) Health Industry Business Communications Council (HIBCC); (3) ICCBBA; and (4) Informationsstelle für Arzneispezialitäten — IFA GmbH. Each of the issuing entities use a specific coding system in accordance with their own standards; however, these coding systems are translatable to the EU Regulations requirements on UDI. E.g. GS1 have developed the term Global Model Number (GMN) for the Basic UDI-DI, Global Trade Item Number (GTIN) for UDI-DI, and Application Identifier (AI) for UDI-PI.
Commission Implementing Decision (EU) 2019/939