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Document Ares(2023)2068096
Medical devices – single identifier for similar highly individualised devices
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 contact lenses
- 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:
- health policy; database; optical industry; market supervision; market approval; marketing standard; product designation; traceability; labelling
- 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:
- 01/04/2022 - 30/06/2022
- Check the status of this initiative on the Better Regulation Portal
-
- Documents:
- Ares(2023)2068096 (Draft delegated regulation)Ares(2023)2068096 (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/2023/4568 final (Delegated regulation)
- Leading service:
- Directorate-General for Health and Food Safety
-
- Foreseen end of objection period:
- 10/10/2023
-
- Documents:
- 32023R2197 (Delegated regulation)