MDCG 2024-2 about update of EMDN codes

📣🇪🇺 New document "MDCG 2024-2 Procedures for the updates of the European Medical Device Nomenclature (EMDN)"

This incredibly interesting document 😆 outlines the annual review and ad-hoc update processes for the EMDN. It details the roles of various actors, including the MDCG Nomenclature working group, EMDN-TT, and users, in these processes.

The annual revision involves a four-phase cycle:

1️⃣ Collection of requests for amendments, where stakeholders submit proposals for updates;

2️⃣ Evaluation of the proposals by the working group, assessing their necessity and impact;

3️⃣ Decision-making on the proposed updates, where approved changes are finalized; and

4️⃣ Publication and implementation of the updates, making the revised nomenclature available to users.

This structured process ensures the EMDN remains accurate, relevant, and reflective of current medical device taxonomy.

Ad-hoc procedure, meant for urgent updates by competent authorities and notified bodies, includes a specific submission and review process for new code requests.

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Since the arrival of Regulation 2017/745, new requirements are requested and form part of the documentation to be presented to the notified body (e.g. review of the in-depth clinical evaluation, PMS procedure, QC results from validation products, proof of staff skills, etc.).

CSDmed brings its expertise and a methodical approach to its clients, start-ups, manufacturers, importers and distributors of medical devices, thanks to a team of specialized experts and consultants, who will be able to address the MDR transition in its entirety

🔗 Contact us and find out how we can help you.