The Unique Device Identification (UDI) -in English, Unique Device Identifier– is a unique numeric or alphanumeric code associated with a specific item in the medical devices sector. This enables the clear and unambiguous identification of a specific product on the market and facilitates traceability.
According to the European Commission’s criteria, a UDI must include two components which will enable us to access useful information about the product:
- a product identifier (UDI-DI)
- a production identifier (UDI-PI).
Furthermore, the specific nature of the UDI:
- improves the efficiency of product traceability
- facilitates the recovery of products
- avoid counterfeits
- improves patient safety.
Unique Device Identification: What will the UDI system make possible?
In April 2013, the European Commission published a recommendation on a common framework for a unique identification system for medical devices in the EU. The aim was to lay the foundations for the EU’s future identification and traceability infrastructure, in line with recent global developments.
Since then, the European Commission has promoted, through the publication of the Article 26 of Regulation (EU) 2017/745 on Medical Devices, and the Article 23 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices, two essential initiatives aimed at providing coverage for the UDI system:
-
- The creation of the Medical Devices database Eudamed (whose name is an acronym for European Database on Medical Devices).
- The establishment of the organisation European Medical Device Nomenclature (EMDN), which is responsible for providing support and facilitating the creation of the Eudamed database.
In short, the new system of Unique Device Identification – UDI will facilitate the traceability of medical devices. At the same time, the post-market activities relating to product safety they will also be more robust and will allow for a better monitoring by the relevant authorities.
In addition, the European Commission, through the EMDN, has drawn up a document on FAQs relating to the Unique Device Identification (UDI) system. Check it out now!
Unique Device Identification (UDI) for Medical Devices
Click the link in the text button to visit the website of Unique Device Identifier – UDI from the European Commission, where you will find all the information about the initiative European Medical Device Nomenclature (EMDN) and from Eudamed, the new one European database of medical devices.
This website, created by the European Commission, is a platform that will enable you to find out, first-hand, all about the official information of the health authorities from the eurozone and all the latest news regarding the new Unique Product Identification, to the new identifier UDI and its implementation process. .