Kommisjonens gjennomføringsbeslutning (EU) 2024/2120 av 30. juli 2024 om fornyelse av utpeking av utstedende enheter til å drifte et system for tildeling av entydig utstyrsidentifikasjon (UDI) på området medisinsk utstyr
Utpeking av utstedende enheter for drift av unike utstyrsidentifikatorer (UDI) på området medisinsk utstyr: fornyelse 2024-2029
Commission Implementing Decision (EU) 2024/2120 of 30 July 2024 renewing the designation of issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices
Kommisjonsbeslutning publisert i EU-tidende 1.8.2024
Nærmere omtale
BAKGRUNN (fra kommisjonsbeslutningen)
(1) Commission Implementing Decision (EU) 2019/939 (3) designated four issuing entities that satisfied the relevant criteria for designation under both Regulations (EU) 2017/745 and (EU) 2017/746 to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices. According to Article 2 of the Implementing Decision (EU) 2019/939, those designations shall each remain valid for a period of time of five years from 27 June 2019, and the end of that period, each of those designations may be renewed for a further period of five years if the issuing entity remain in compliance with the criteria for designation and the terms of designation.
(2) By the end of the period of validity of those designations, the Commission assessed the compliance of the four designated entities with the relevant criteria for designation and the terms of designation. The Commission established that each of the four designated entities remains in compliance with the criteria for designation and the terms of designation.
(3) It is therefore appropriate to renew each of those designations for a further period of five years, starting from the end of validity of the previous designations in order to ensure full continuity in the operation of the UDI system,