(Under forberedelse) Kommisjonens gjennomføringsforordning (EU) …/… om fastsettelse av prosedyreregler for samhandling, utveksling av informasjon og deltakelse i utarbeidelse og oppdatering av felles kliniske vurderinger av medisinsk utstyr og in vitro-diagnostiske medisinsk utstyr på unionsnivå i henhold til forordning (EU) 2021/2282 om helseteknologivurdering, samt maler for disse felles kliniske vurderingene
Helseteknologivurderinger: felles kliniske vurderinger av medisinsk utstyr
(In preparation) Commission Implementing Regulation (EU) …/… laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medical devices and in vitro diagnostic medical devices at Union level, as well as templates for those joint clinical assessments
Utkast til forordning lagt fram av Kommisjonen 28.5.2025 med tilbakemeldingsfrist 25.6.2026
Bakgrunn
(fra Kommisjonens inititativ 28.5.2025)
Health technology assessment - joint clinical assessments of medical devices
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 clinical assessments of medical devices and in vitro diagnostic medical devices. It sets out implementing rules to ensure that EU-level assessments are conducted in good time and that the relevant experts are involved or consulted.
Draft act
Feedback period: 28 May 2025 - 25 June 2025
Draft implementing regulation - Ares(2025)4300616