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Document 32023R2197
Medical devices – single identifier for similar highly individualised devices
Komission delegoitu asetus (EU) 2023/2197, annettu 10 päivänä heinäkuuta 2023, Euroopan parlamentin ja neuvoston asetuksen (EU) 2017/745 muuttamisesta siltä osin kuin on kyse yksilöllisten laitetunnisteiden antamisesta piilolinsseille
- 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:
- terveyspolitiikka; tietokanta; optinen teollisuus; markkinavalvonta; myyntilupa; markkinointia koskeva normi; tuotenimitys; jäljitettävyys; merkinnät
- 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)