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Document Ares(2025)725943
Unique Device Identifiers for spectacle frames, spectacle lenses and ready-made reading spectacles
COMMISSION DELEGATED REGULATION (EU) …/... amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for spectacle frames, spectacle lenses and ready-to-wear reading spectacles
- Legal basis:
- 32017R0745 - A27P10PTB)
- Initiative summary:
- EU rules provide for a Unique Device Identification (UDI) system to make the traceability of medical devices easier. However, the wide variety of types and clinical parameter combinations for certain highly individualised devices means that a disproportionately high number of identifiers are being assigned, with few regulatory and safety benefits. This initiative aims to group highly individualised devices with clear clinical similarities under the identifier called ‘Master UDI-DI’.
- EuroVoc thesaurus:
- sundhedspolitik; CE-overensstemmelsesmærkning; handelsnorm; medicinsk-kirurgisk udstyr; optisk industri; harmonisering af normer; sikkerhedsnorm; markedsovervågning; kvalitetsnorm; sundhedslovgivning; salgstilladelse
- See the lifecycle of this act on the Interinstitutional register of delegated acts
-
- Leading service:
- Directorate-General for Health and Food Safety
- Expert group:
- Medical Device Coordination Group
- Planned adoption period:
- 01/01/2025 - 31/03/2025
- Check the status of this initiative on the Better Regulation Portal
-
- Documents:
- Ares(2025)725943 (Draft delegated regulation)Ares(2025)725943 (Draft delegated regulation)
- Legal basis:
- 32017R0745 - A27P10PTB)
- Leading service:
- Directorate-General for Health and Food Safety
- Expert group:
- Medical Device Coordination Group
- Check the status of this initiative on the Better Regulation Portal
-
- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 4
-
- Documents:
- C/2025/3484 final (Delegated regulation)
- Leading service:
- Directorate-General for Health and Food Safety
-
- Foreseen end of objection period:
- 12/09/2025
-
- Documents:
- 32025R1920 (Delegated regulation)