European Commission 24 January 2025, Commission Implementing Regulation (EU) 2025/117 of 24 January 2025 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

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Commission Implementing Regulation (EU) 2025/117 establishes rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices, aiming to facilitate cooperation between Member States and health technology developers. Key provisions include the establishment of a timetable for consultation requests, the use of an IT platform for information exchange, and the involvement of individual experts to ensure comprehensive assessments. The regulation is binding and directly applicable across all Member States, entering into force twenty days after publication.AI

European Union · · · Cited by 6 · 24-01-2025

Official Journal
of the European Union

EN

L series

2025/117

27.1.2025

COMMISSION IMPLEMENTING REGULATION (EU) 2025/117

of 24 January 2025

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

(Text with EEA relevance)

THE EUROPEAN

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