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Document 32025R0117
Health technology assessment – Joint scientific consultations on medical devices
Izvedbena uredba Komisije (EU) 2025/117 z dne 24. januarja 2025 o določitvi pravil za uporabo Uredbe (EU) 2021/2282 v zvezi s postopki za skupna znanstvena posvetovanja o medicinskih pripomočkih in in vitro diagnostičnih medicinskih pripomočkih
- Legal basis:
- 32021R2282 - A20P1PTD) ; 32021R2282 - A20P1PTA) ; 32021R2282 - A20P1PTB)
- Initiative summary:
- EU rules on health technology assessment (Regulation 2021/2282) support cooperation by EU countries to clinically assess new health technologies. The aim is to contribute to a good use of health system resources, while respecting national competences. This initiative concerns joint scientific consultations on medical devices. It set outs implementing rules detailing how developers can receive early guidance on the evidence and data needed to carry out a joint clinical assessment of their product.
- EuroVoc thesaurus:
- zdravstvena politika; znanstveno sodelovanje; medicinski in kirurški instrumenti; inovacija; izmenjava informacij; klinično preskušanje; zdravstvena tehnologija; zdravniška diagnoza; zdravstveno varstvo; javno zdravje
-
- Leading service:
- Directorate-General for Health and Food Safety
- Committee:
- C118400
- Planned adoption period:
- 01/10/2024 - 31/12/2024
- Check the status of this initiative on the Better Regulation Portal
-
- Documents:
- Ares(2024)7679161 (Draft implementing regulation)Ares(2024)7679161 (Draft implementing regulation)
- Legal basis:
- 32021R2282 - A20P1PTD) ; 32021R2282 - A20P1PTA) ; 32021R2282 - A20P1PTB)
- Leading service:
- Directorate-General for Health and Food Safety
- Committee:
- C118400
- Check the status of this initiative on the Better Regulation Portal
-
- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 4
-
- Documents:
- C/2025/0388 final (Implementing regulation)
- Leading service:
- Directorate-General for Health and Food Safety
-
- Documents:
- 32025R0117 (Implementing regulation)