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Medical devices – single identifier for similar highly individualised devices
Kommissionens delegerede forordning (EU) 2023/2197 af 10. juli 2023 om ændring af Europa-Parlamentets og Rådets forordning (EU) 2017/745 for så vidt angår tildeling af unik udstyrsidentifikation vedrørende kontaktlinser
The Unique Device Identification (UDI) system for medical devices was introduced in the European legislation to ensure an adequate level of traceability. The high variety of ‘highly individualised devices’ result in the assignment of a high amount of unique identifiers, with little value for regulatory and safety purposes. Therefore, the concept of “Master UDI” was elaborated to group under a single identifier several highly individualised devices presenting specific similarities.