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Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe.

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Regulation and Guidelines:

New: 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

This regulation establishes procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices under Regulation (EU) 2021/2282. It outlines processes for consultation requests, briefing package preparation, expert involvement, and coordination with expert panel consultations.

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New: MDCG 2025-1 EMDN Ad hoc procedure

This document provides a form for the submission of proposals under the ad-hoc update procedure for the European Medical Device Nomenclature (EMDN).

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New: MDCG 2025-2 EMDN update submissions from 2024 public consultation and the MDCG nomenclature working group

This document outlines the outcomes of the analysis of submissions for updates to the European Medical Device Nomenclature (EMDN). It includes accepted, partially accepted, and not accepted submissions from the 2024 public consultation and the MDCG Nomenclature working group. The document provides details on proposed changes to various medical device categories and codes within the EMDN system.

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New: MDCG 2025-3 EMDN Version History

This document outlines the changing history of EMDN codes.

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Updated: MDCG 2021-12 Rev.1 FAQ on the European Medical Device Nomenclature EMDN

This document provides frequently asked questions (FAQ) about the European Medical Device Nomenclature (EMDN).

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Updated: MDCG 2024-2 Rev.1 Procedures for the updates of the EMDN

This document outlines the procedures for annual revisions and ad-hoc expedited updates to the European Medical Device Nomenclature (EMDN). It lays out the processes for both the annual review and the procedure for ad-hoc requests requiring an expedited review.

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Updated: MDCG 2021-15 Rev.1 Applying for designation as notified body under the medical devices regulation (MDR)

This document is an application form and checklist for conformity assessment bodies applying to be designated as notified bodies under the EU Medical Device Regulation (MDR) 2017/745.

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