Orientations réglementaires
Basic Unique Device Identification - Device Identification (Basic UDI-DI)
Publié 6 sept. 2017
Référence
2017/GSCN_17-103_Basic_UDI.pdf
Source
GS1 GSCN
Statut
En vigueur
Publié
6 sept. 2017
Langues
EN
With the approval by the European Parliament on 5 April 2017, new medical device regulations for both general and in-vitro diagnostic devices are helping to advance the unique device identification (UDI) system in Europe. A new standard is needed to enable the implementation of the Basic UDI-DI for medical device companies worldwide and, as a result, allow them to use GS1 standards for UDI in Europe. The design needs to include the flexibility to allow additional industry sectors to potentially leverage this solution in the future.
Source : GS1 GSCN. Lire le document complet sur la source officielle.
Ce document s'ouvre sur le site de l'éditeur — sa licence ne permet pas de l'intégrer dans une visionneuse ici.
© GS1 AISBL. General Specifications Change Notifications reproduced for reference; see gs1.org for terms.
Clarification on use of AI (02) & (37)
Publié 1 juil. 2026
AIDC Application Standard Master UDI-DI for registration of certain type of devices with EUDAMED
Publié 1 juin 2026
Adjustments to language about truncated EAN/UPC barcodes
Publié 1 juin 2026
GSCN Updated Digital Product Passport (DPP) provisional standard after WR25-212 (ITIP) and WR26-108 (NFC)
Publié 1 juin 2026