(Under forberedelse) Kommisjonens gjennomføringsforordning (EU) …/… om fastsettelse av regler for anvendelse av forordning (EU) 2021/2282 med hensyn til framgangsmåtene for felles vitenskapelige konsultasjoner om medisinsk utstyr og medisinsk utstyr for in vitro-diagnostikk
Europeisk samarbeid om medisinske metodevurderinger: utfyllende bestemmelser om framgangsmåtene for felles vitenskapelige konsultasjoner om medisinsk utstyr
(In preparation) Commission Implementing Regulation (EU) …/… laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices
Utkast til forordning lagt fram av Kommisjonen 29.10.2024 med tilbakemeldingsfrist 26.11.2024
Bakgrunn
BAKGRUNN (fra Kommisjonens initiativ 29.10.2024)
Health technology assessment – joint scientific consultations on medical devices & in vitro diagnostic 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 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.
Draft act
Feedback period: 29 October 2024 - 26 November 2024
Draft implementing regulation - Ares(2024)7679161