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Document 32025R2086
Health technology assessment - Joint clinical assessments of medical devices and in vitro diagnostic medical devices
Regolament ta’ Implimentazzjoni tal-Kummissjoni (UE) 2025/2086 tas-17 ta’ Ottubru 2025 li jistabbilixxi, skont ir-Regolament (UE) 2021/2282 dwar il-valutazzjoni tat-teknoloġija tas-saħħa, ir-regoli ta’ proċedura għall-interazzjoni matul it-tħejjija u l-aġġornament tal-valutazzjonijiet kliniċi konġunti ta’ apparati mediċi u apparati mediċi dijanjostiċi in vitro fil-livell tal-Unjoni, għall-iskambju ta’ informazzjoni dwarhom, u għall-parteċipazzjoni fihom, kif ukoll il-mudelli għal dawk il-valutazzjonijiet kliniċi konġunti
- Legal basis:
- 32021R2282 - A15P1PTB) ; 32021R2282 - A15P1PTC) ; 32021R2282 - A26P1 ; 32021R2282 - A25P1PTB)
- 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:
- politika tas-saħħa; apparat mediku; teknoloġija tas-saħħa; kooperazzjoni xjentifika; skambju ta' informazzjoni; prova klinika
-
- 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 - A15P1PTB) ; 32021R2282 - A15P1PTC) ; 32021R2282 - A26P1 ; 32021R2282 - A25P1PTB)
- 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)