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Document 32023R2197

    Legal basis:
    32017R0745 - A27P10PTB)
    Initiative summary:
    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.
    EuroVoc thesaurus:
    política sanitaria; norma de comercialización; etiquetado; autorización de venta; base de datos; vigilancia del mercado; industria óptica; rastreabilidad; denominación del producto
    See the lifecycle of this act on the Interinstitutional register of delegated acts