Regulatory Affairs Updates
Discover the latest news in Regulatory Affairs
New MDCG Guidance documents released: Procedure for the updates of the European Medical Device Nomenclature (EMDN)
- Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager
On February 6th, 2024, 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 – Medical Device Regulation (MDR) and Article 23 of Regulation (EU) 2017/746 – In Vitro Diagnostic medical devices Regulation (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.
Did you find this article interesting? Thanks for sharing it with your network:
Here you find all news related to Regulatory Affairs