Kommisjonens gjennomføringsbeslutning (EU) 2025/1324 av 7. juli 2025 om endring av beslutning (EU) 2019/1396 når det gjelder visse administrative aspekter knyttet til ekspertpaneler og når det gjelder utpeking av et ekstra ekspertpanel innen medisinsk utstyr
Medisinsk utstyr: endringsbestemmelser om ekspertpanel for sjeldne legemidler og pediatriske legemidler
Commission Implementing Decision (EU) 2025/1324 of 7 July 2025 amending Implementing Decision (EU) 2019/1396 as regards certain administrative aspects related to expert panels and as regards the designation of an additional expert panel in the field of medical devices
Kommisjonsbeslutning publisert i EU-tidende 8.7.2025
Tidligere
- Utkast til forordning lagt fram av Kommisjonen 19.5.2025 med tilbakemeldingsfrist 16.6.2025
Bakgrunn
(fra kommisjonsbeslutningen)
(1) Article 1 of Commission Implementing Decision (EU) 2019/1396 (2) designates expert panels in several medical areas. The tasks of those expert panels are set out in Article 106(9) and (10) of Regulation (EU) 2017/745.
(2) In order to provide scientific and clinical advice in relation to medical devices and in vitro diagnostics intended for small size patient populations, such as for patients with a rare disease or for children, an additional expert panel should be designated in that field.
(3) Since 1 March 2022, pursuant to Article 30 of Regulation (EU) 2022/123 of the European Parliament and of the Council (3), the European Medicines Agency, on behalf of the Commission, provides the secretariat for the expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745. Implementing Decision (EU) 2019/1396 should therefore be amended to reflect that change.
(4) Experience with the application of Implementing Decision (EU) 2019/1396 has demonstrated the need to adapt some of its technical or administrative aspects, such as the timing of the publication of scientific opinions and the remuneration of experts for the development and review of guidance, common specifications and standards.
(5) The Medical Device Coordination Group has been consulted.
(6) Implementing Decision (EU) 2019/1396 should therefore be amended accordingly,