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UDIs: New system comes into force
By Fabien Roy & Jessica Koffel, Hogan Lovells*
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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.
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.
Manufacturers are responsible for complying with UDI related requirements. These include the 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.
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.
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
levels of device packaging (eg cartons or cases), except shipping containers.
The UDI carrier allows the transmission of the UDI information. In principle, it must appear in a form that uses Automated Identification for Data Capture (AIDC) (eg barcodes, smart cards, biometrics and RFID), and a human readable information (HRI) form consisting of a legible interpretation of data characters encoded in the UDI carrier that can be read by people. Under specific circumstances, these format requirements may be adapted to accommodate space constraints.
The manufacturer will need to ensure the readability of the UDI carrier throughout the normal use of a device’s entire lifetime.
In addition, the MDR foresees specific UDI requirements for certain types of devices, including: • Reusable devices: the UDI carrier must be permanently affixed on the device itself. It should not however interfere with the safety or performance of the device and should remain technically feasible. • Implantable devices: the UDI must be identifiable before implantation, be marked on the lowest level of packaging, include at least the serial number for active implantable devices, or else, the serial number or lot number. • Systems and procedure packs: as a general rule, the UDI carrier should be affixed to the outer packaging. Device contents must also bear a UDI carrier on the packaging or on the device itself, with exceptions provided for certain individual single-use disposable devices contained in a system of procedure pack and devices that are exempt from bearing a UDI carrier. • Configurable devices: a UDI must be assigned to the entire configurable device and the
UDI carrier must be placed on the assembly that is most unlikely to be exchanged during the lifetime of the device.
Components that are otherwise commercially available will need to be assigned a separate
UDI. • Device software: a UDI must be assigned at the system level of the software which is commercially available on its own and constitutes a device in itself. The UDI must be affixed on each packaging level where a physical medium is provided or otherwise be available through electronic means. • Single use class I and IIa devices packaged and labelled individually: the UDI carrier must only appear on the higher level of packaging, unless the healthcare provider would not have access to this higher level of packaging, in which case, the
UDI carrier must appear on the device packaging. • Devices exclusively intended for retail point of sale: the UDI-PIs in
AIDC are not required to appear on the point-of-sale device packaging.
Timeline While the obligation to assign a UDI has been applicable since 26 May 2021, the requirement to place UDI carriers on devices, labels or packaging will be phased in over several years in accordance with the following periods and device classes: • Class III and implantable: from 26 May 2021 • Class IIa and IIb: from 26 May 2023 • Class I: from 26 May 2025 For reusable devices which must bear the UDI on the device itself, the labelling requirement will apply two years after the date of application, ie 26 May 2023, 2025 or 2027.
