EU Favors Italian Medtech Nomenclature Over GMDN For Revamped Eudamed
European authorities have opted for Italy's medical device classification codes (CMD) instead of the Global Medical Device Nomenclature in the revamped medtech database Eudamed to ensure that manufacturers have free access to an internationally recognized nomenclature.
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It seems to be game over for anyone who might have been hoping the European Commission would do a U-turn on its decision to use the Italian CND nomenclature as the basis for communication in Eudamed, instead of the well-established GMDN. But GMDN is strong in its resolve to remain a vital global nomenclature service.
IVDR And Brexit Outlook For IVD Firms: EU Themes To The Fore At Asian Medtech Associations Reg Networking
This month’s Asian Medtech Associations Regulatory Networking discussions is split into two parts, the first being a guest presentation on EU themes, specifically a UK Brexit outlook and an update on the progress of the EU IVDR, which comes into full effect on 26 May 2022. Both have potentially far-reaching effects for Asian and other global medtech markets. Part two will feature AHWP and Asean updates, as usual. This editorial feature is hosted by Medtech Insight, along with the Asia Regulatory and Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).
The risk of psychiatric disorders with chloroquine and hydroxychloroquine-containing medicines received renewed attention in the EU after they were being used as potential treatments for COVID-19.