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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

Bill Healthcare & Pharma PUBLISHED
Date: 27th Jan, 2025 Source: Register of Delegated and Implementing Acts Country: European Union Original Source

Brief

The Commission Implementing Regulation (EU) 2024/2563 amends Implementing Regulation (EU) 2022/1646 regarding national risk-based control plans and surveillance plans. The regulation clarifies that Member States should submit their surveillance plan to the Commission, transmit data to EFSA, and includes justifications for selected substances and species in the control plans. This amendment aims to improve consistency and transparency in official controls, particularly with regard to pharmacologically active substances. Compliance considerations include submitting updated national risk-based control plans by 30 June each year and transmitting relevant data to EFSA by 31 August.

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Register of Delegated and Implementing Acts

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