New MDCG Guidance documents released
New MDCG Guidance documents released
Regulatory Affairs Medical Devices In Vitro Diagnostics
Thursday, 06 February 2025
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On 28 January 2025, the Medical Device Coordination Group (MDCG) released its first revision of two key documents related to the European Medical Device Nomenclature (EMDN).
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MDCG on EMDN codes | QbD Group Regulatory Update
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MDCG 2024-2 rev 1, updates the procedures for revising the European medical device nomenclature, now including a table for the ad hoc procedure aligned with the newly published submission template. MDCG 2024-12 rev 1, revises the FAQ on the European Medical Device Nomenclature (EMDN), featuring additional questions and a clearer categorization of topics.
In addition to these revisions, MDCG published three new guidance documents. An excel file showing the EMDN version history (MDCG 2025-3), a presentation including the summary of EMDN 2024 Submissions and outcome of annual revision (MDCG 2025-2) and the EMDN ad hoc procedure (MDCG 2025-1).
A key update is the European Commission’s introduction of a pilot procedure for urgent updates to the European Medical Device Nomenclature (EMDN). While most requests follow an annual review process, this expedited pathway is strictly limited to new code requests submitted by competent authorities and notified bodies. Requests involving modifications or splits of existing codes will be redirected to the standard annual review. Applicants must complete a designated form, now available in the revised MDCG 2024-2 and the newly published MDCG 2025-1.
The latest revision of MDCG 2024-12 also brings new guidance on EMDN assignment and the annual review process. It clarifies the steps to take when no suitable code is available for a device and explains how to submit proposals for EMDN updates.
Together, the newly published guidance documents, MDCG 2025-1, MDCG 2025-2 and MDCG 2025-3, offer an overview of the changes made to the EMDN codes in 2024 and introduce a new form for submitting ad hoc update requests.
What does it mean to you?
These updates streamline the process and provide greater clarity on the use of EMDN codes. The revised FAQ offers guidance on what to do if no suitable code exists and how to propose updates. By enhancing transparency and efficiency, these changes help ensure the EMDN remains accurate and aligned with industry needs.
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