Regulations EU 2017/745 on medical devices (MDR) and 2017/746 on in vitro diagnostic devices (IVDR) have introduced two significant tools aimed at ensuring better traceability, transparency, and exchange of information relating to all devices within the European Union.
These tools are:
- UDI, a unique device identification system;
- EUDAMED, an IT system or, rather, a database, containing all the information regarding the devices.
But what are they and why can they be useful to the final users? Let's examine both in greater detail.
UDI system
The unique device identification system, or UDI system, is a numeric or alphanumeric code that is associated with a specific device, whether it be a medical device or an in vitro diagnostic device, which allows its identification unambiguously. The UDI gathers all the necessary information to ensure the precise and unequivocal recognition of a particular medical device placed on the European Union market for:
- guaranteeing the most efficient and full traceability, from the manufacturer to the final user;
- improving market monitoring by the Competent Authorities;
- make any product recall simpler and faster;
- ensuring the safety of the final users.
The UDI consists of two components: a device identifier (UDI-DI) and a production identifier (UDI-PI). In particular, the UDI-DI is a fixed and invariable part that represents the device model or type, while the UDI-PI is a variable part that contains additional information about the specific device, such as lot number, manufacturing date, expiration date, or both dates. The UDI-PI may be composed of one or more of these elements, each of which is identified by a "placeholder" that allows us to understand the information that the manufacturer is providing us with. The UDI-DI has a placeholder as well, in fact, it can be recognized as the number that follows (01). Some examples of placeholders for additional UDI-PI information include (10) for the lot number or (17) for the expiration date.
The UDI is positioned clearly visible on the label of the medical device. The UDI carrier is the way you can see the UDI on the label. It is represented by a machine-readable part (AIDC), such as a barcode or a QR code, and a human-readable part (HRI), which is a string of numeric or alphanumeric characters.
Below is an example of a UDI carrier that can be found on a device label:
EUDAMED database
Eudamed is the single IT system that the European Commission has decided to establish to collect all the information about the devices present in the European Union. Eudamed aims to enhance the transparency and sharing of information, ensuring its disclosure to the public, thus being accessible also to the final users.
The database is divided into six sections, called modules, each with a specific function and connected to each other. Currently, not all the sections are active, however, they are under development and will be available soon. Once Eudamed is complete and fully functional, registration will become mandatory for all economic operators and devices.
The six sections allow the registration of the actors (manufacturers, representatives, importers, and distributors, etc.), as well as devices and UDI, notified bodies and certificates, information regarding clinical investigations and performance studies, vigilance and post-market surveillance, and Market surveillance.
In addition to these six modules, a public access section is available and can be visited at the following link: https://ec.europa.eu/tools/eudamed/#/screen/home