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Document C(2025)6884
Health technology assessment - Joint clinical assessments of medical devices and in vitro diagnostic medical devices
РЕГЛАМЕНТ ЗА ИЗПЪЛНЕНИЕ (ЕС) .../… НА КОМИСИЯТА за установяване, съгласно Регламент (ЕС) 2021/2282 относно оценката на здравните технологии, на процедурни правила за взаимодействието по време на изготвянето и актуализацията на съвместни клинични оценки на медицински изделия и медицински изделия за инвитро диагностика на равнището на Съюза, за обмена на информация във връзка с това изготвяне и тази актуализация и за участието в тях, както и за установяване на образци за тези съвместни клинични оценки
- Legal basis:
- 32021R2282 - A15P1PTC) ; 32021R2282 - A25P1PTB) ; 32021R2282 - A26P1 ; 32021R2282 - A15P1PTB)
- Initiative summary:
- Regulation (EU) 2021/2282 on health technology assessment (HTA) establishes a framework to support Member State cooperation and the measures needed for clinical assessment of health technologies. It requires the Commission to adopt implementing rules to ensure that joint clinical assessments of medical devices and in vitro diagnostic medical devices at EU level are conducted in a timely manner and that relevant experts are involved or consulted appropriately on these assessments.
- EuroVoc thesaurus:
- здравна политика; клинично изпитване; обмен на информация; здравни технологии; медикотехническо оборудване; научно сътрудничество
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- Leading service:
- Directorate-General for Health and Food Safety
- Committee:
- C118400
- Planned adoption period:
- 01/10/2025 - 31/12/2025
- Check the status of this initiative on the Better Regulation Portal
-
- Documents:
- Ares(2025)4300616 (Draft implementing regulation)Ares(2025)4300616 (Draft implementing regulation)
- Legal basis:
- 32021R2282 - A15P1PTC) ; 32021R2282 - A25P1PTB) ; 32021R2282 - A26P1 ; 32021R2282 - A15P1PTB)
- 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/2025/6884 final (Implementing regulation)
- Leading service:
- Directorate-General for Health and Food Safety
-
- Documents:
- 32025R2086 (Implementing regulation)