Unique device identification system comes into force By Fabien Roy & Jessica Koffel, Hogan Lovells*
The recent implementation in the EU of the Medical Devices Regulation has introduced new labelling and packaging requirements. he Medical Devices Regulation 2017/745 (MDR) entered into application on 26 May 2021 and establishes new requirements for medical devices, including the Unique Device Identification System, intended to allow the identification of medical devices and increase traceability. While the system is already used in other jurisdictions, its implementation is novel in the EU and implies additional labelling and packaging requirements, an overview of which is provided in this article.
assignment of a UDI to a device or its packaging, the registration of information within the UDI database in EUDAMED, including a Basic UDI-DI, which is essentially an access key intended to identify and connect device groups, and the affixing of UDI carriers. Manufacturers must also ensure that a new UDI-DI is generated following certain changes impacting the identification or traceability of a device and periodically update the information contained in the UDI database.
New responsibilities The UDI System rests upon the use of a Unique Device Identifier (UDI) for all medical devices placed on the EEA market, other than custommade and investigational devices. A UDI is as a series of numeric or alphanumeric characters, created through a globally accepted identification and coding standard which allows the identification of a specific device. It is composed of a UDI Device Identifier (UDI-DI), specific to a device model and manufacturer, and a UDI Product Identifier (UDI-PI), relating to information on the unit of device production such as the lot number, serial number or expiration date.
Importers and distributors in turn are required to verify that a UDI has been assigned prior to placing or making available devices on the market. Moreover, all economic operators, healthcare institutions and healthcare professionals will need to comply with storage requirements for UDIs.
Manufacturers are responsible for complying with UDI related requirements. These include the
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In addition to improving device identification and traceability, the UDI System will further ease the sharing of information, enhance the effectiveness of post-market surveillance and improve monitoring by competent authorities. Packaging requirements Following the assignment of a UDI,, as a general rule, manufacturers must place a UDI carrier on the label or on the device itself and on all higher
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