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Medical Device Regulation – focusing on the unique device identifier

Regulation 2017/745 EU introduces measures supporting transparency and traceability in the field of medical devices. More specifically, a unique device identifier – UDI – was introduced. This is a code made of a sequence of alphanumeric characters where specific information regarding the device is coded.

This system has already been adopted internationally, but never in Europe.  The European Commission has already designated the companies responsible for the release of the basic identification codes. For a full operability of the UDI the activation of the European database EUDAMED will be essential. This was also introduced by Reg. 2017/745 EU: through this, UDIs and information on economic operators and medical devices will be included and stored. In this way, the system will acquire an added value on the subject of traceability.

The identification system, that could appear simple, is actually made by more code levels, each of them associated with specific features of the device itself. The UDI code materially associated to the product is made of two parts: the UDI-DI and the UDI-PI.

The UDI-DI (device identifier) is the “static” part of the code, has a maximum length of 25 characters and is assigned to a determined product in the catalogue. It constitutes the main information for the registration of the UDI data into the database, and will be therefore reported in certificates and EU conformity declarations. This code can be subject to changes depending on any change intervened on the MD, such as variations in the trade name, MD number in a single pack or acquisition of specific features.

On the other hand, the UDI-PI (production identifier) is the dynamic part of the code, where variable information is coded, such as serial number, expiry date, batch, etc. …

The code made of the two parts as described above will be placed on the medical devices and/or the relevant labels, on all levels of packaging. The text of Regulation 2017/745 EU specifies when the obligation to include the UDI will be in force: in 2021 for class III MDs, in 2023 for class IIa/b and in 2025 for class I, respectively. For re-usable devices (such as some surgical instruments), the obligation is in force to place it on the device itself.

The UDI code will be present, with some specific exceptions, in two formats: AIDC (Automatic Identification and Data Capture) and HRI (Human-readable Interpretation). Both formats shall be visible; the first will allow the scanning of the code, and the relevant data acquisition; the second will provide readability to the code. In case it is not materially possible to report both codes in the label, the sole AIDC can appear.

UDI implementation will therefore require huge organisational and financial efforts by the operators of this field, who should get ready on time, also from a practical point of view, in order to be able not only to manage the UDI but also to include it correctly, scheduling this activity in the MD manufacturing process.

Written by: Riccardo del Signore

Foto di Bruno /Germany da Pixabay