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Devices like drugs, what will change with the UDI code

The application of the new Regulation EU 2017/745 o medical devices was postponed of one year, but some of the novelties it has introduced are still the subject of great interest by the manufacturers and other operators of this sector. These include the traceability of medical devices and the application of the UDI code.

The UDI system (Unique Device Identifier) is at the basis of the devices tracking managed through the Eudamed database. According to the definition of the Regulation, the UDI code is ‘a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market’.

The above said traceability system is complex and articulated; in fact, what is usually referred to as unique identification is made in turn by a stratification of more sub-codes.

These appear in more forms and levels and, depending on these, specific information is codified, such as model, size, quantity per package, registration number, catalogue number, sterility, number of reuses, classification, storage and/or handling conditions, any critical warnings or contra-indications, as well as the data of the manufacturers and the authorised representative and more.

The UDI code can be used as key to access the information regarding the device, registered in the dedicated UDI database, collecting and making available to the public any information that would otherwise remained codified. It should be specified that not all the obligations of UDI application will be enforced as of May 2021. The manufacturer shall attribute the UDI code, depending on the class of the device and therefore within the different deadlines provided for by the Regulation, to the device and its packaging before putting it on the market; more specifically, this shall be reported in the label and in all packaging materials of the device, excluding the transportation container.

In this way, the device will be traceable as early as the manufacturing steps (the UDI code will in fact appear in its different forms in the product documentation, – such as the Declaration of Conformity) up to its availability on the market, making the device identification easier for the purposes of serious incidents reporting as well as taking any safety corrective measure.

Manufacturers shall keep an updated list of all the UDIs applied to their devices in the technical documentation provided for by Annex II of the Regulation.

Along with the UDI code and the relevant database, the traceability of medical devices is also ensured by a series of further obligations that manufacturers, authorised representatives, importers and distributers must comply with. To this purpose, the European database Eudamed will have special relevance: all information on devices and economic operators will be uploaded here. This database is not operative yet and it should start working as of 26 May 2022. In the period preceding this date, the provisions on traceability and surveillance of Directive 93/42/EEC will still apply.

The traceability system of medical devices configured according to the Regulation will be a huge contribution to post-marketing safety of devices. Thanks to a more effecting reporting of incidents, focused corrective actions will be taken, supported by a better surveillance by the competent authorities. Moreover, it will be possible to contribute to the prevention of medical errors and, just as with the antifraud sticker (‘bollino ottico’) of medicines, it will be possible to avail oneself of this tool to prevent and contrast the presence of falsified medical devices on the European market.

Written by: Maria Pia Felici