UDI Registration Obligation for Healthcare Providers

Healthcare institutions and healthcare providers – if they do not practice their professional activity within a healthcare institution – must register and store the Unique Device Identifier (UDI) of the implantable medical devices they have supplied (implanted) or received.

The obligation for healthcare providers to register and store the UDI has been in effect since January 15, 2024.

We manage the CE marking process for implantable devices, therefore we also handle the obtaining and implementation of UDI codes on behalf of manufacturers, our clients.
Recently, they have been receiving multiple questions related to this topic. This article therefore represents a guide for healthcare providers that addresses the issue as comprehensively as possible.

The legislative decree that made the registration of UDI codes by healthcare providers effective is available here.

Manufacturers’ Responsibilities

For all devices certified under Regulation (EU) 2017/745, manufacturers must generate a complete UDI code.

On the other hand, for Legacy devices (i.e., all those devices certified under Directive 93/42/EEC that can continue to be placed on the market until their CE certificate expires), it is not mandatory to define a UDI code.

Adding another layer of complexity, considering the above, not all devices for which a UDI code is required must already display it on the label today.
Despite this, as of May 26, 2023, the UDI code must be affixed to the vast majority of medical devices (with the exception of class I medical devices).

The UDI Code

The multitude and similarity of terms used for the unique coding of devices leaves one, at first, baffled or at least confused.

Simplifying the matter: the UDI is an alphanumeric code that identifies a single product and is composed of a part that identifies a single device model and a part that collects the information necessary to ensure its traceability.
The alphanumeric code is then “translated” by the manufacturer and affixed to the label in the form of a barcode or data matrix (graphically similar to the more familiar QR code). This method of affixing is subject to validation by manufacturers who ensure its readability.

The alphanumeric code is what healthcare providers are required to register. Manufacturers, if multiple barcodes or data matrices appear on the product, must uniquely identify which of these is the UDI.

The UDI can be simply copied by reading the alphanumeric code, or “scanned” with optical systems suitable for automating the process.

UDI Code Registration by Healthcare Providers

Healthcare providers must register and store:

• The UDI of class III implantable devices that they have supplied or received;
• For class III devices, other than implantable devices, and for class IIb implantable devices (with some exceptions), healthcare providers register and store the UDIs of devices they have received.

Healthcare providers, on a voluntary basis, may register and store the UDIs of all devices they have received, other than those indicated above, also in order to uniquely identify the device subject to incidents, serious incidents, and more generally any vigilance communications received from manufacturers.

Registration must be in electronic format: it is sufficient to record the UDI code of the devices supplied (implanted) and received in a properly archived file subject to periodic backups.
Despite this, trade associations are making automated systems available for registration, which are recommended.

The obligation to register and store UDI codes applies exclusively to medical devices CE marked according to Regulation (EU) 2017/745. By virtue of what is expressed in the section above, dedicated to manufacturers’ duties, at present – and until 2028 at the latest – it is permissible for some products not to have a UDI code. The medical devices exempted are in fact those marked according to Directive 93/42/EEC which, although still saleable, do not fall under the duties expressed in this article.

Information on the regulatory scheme under which devices are CE marked can be found in the declaration of conformity and in the marking certificate. This documentation must be made available by the manufacturer.

Storage Times

For implantable devices, UDI codes must be kept for at least 15 years from the date of registration or, if longer, for a time equal to the expected useful life of the device indicated by the manufacturer – this information is available in the instructions for use provided by the manufacturer accompanying the product.

For other devices, the information is kept for a minimum period of 10 years from the date of registration of the information.