Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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The Medical Device Coordination Group (MDCG) released a procedure for the updates of the European Medical Device Nomenclature (EMDN). The EMDN, as established by Article 26 of Regulation (EU) 2017/745 – MDR and Article 23 of Regulation (EU) 2017/746 - IVDR, will be annually reviewed and updated based on the practical use of the EMDN and feedback from its users (MDCG 2024-02).
MDCG 2024-02 – Procedures for the updates of the European Medical Device Nomenclature.
This document lays out the procedures for the annual revision as well as the procedure for ad-hoc requests requiring an expedited review.
Annual review
- Actor involved are the MDCG Nomenclature working group, the EMDN Technical team or EMDN-TT and the users
- The procedure for the annual revision is in 4 phases
- Phase I: collection of requests (January)
- Phase II: Evaluation of requests and analysis of practical use (February-July)
- Phase III: Validation and endorsement (August -October)
- Phase IV: MDCG endorsement and publication (November -December)
Pilot procedure for ad-hoc updates
- Only requests submitted by the competent authority and the notified bodies qualify under the ad-hoc procedure
- Only new codes requests may be submitted
What Does This Mean To You?
MDCG 2024-02 provides insights in the process how the EMDN remains up to date and how ad-hoc requests can be done.
关于作者
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
Navigate Regulatory Complexity with Confidence
Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.
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