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Medical devices – single identifier for similar highly individualised devices
Delegirana uredba Komisije (EU) 2023/2197 z dne 10. julija 2023 o spremembi Uredbe (EU) 2017/745 Evropskega parlamenta in Sveta glede dodeljevanja edinstvenih identifikatorjev pripomočka za kontaktne leče
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.