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European Union Publishes Brochure with Frequently Asked Questions about European Medical Device Nomenclature
  >  
European Union Publishes Brochure with Frequently Asked Questions about European Medical Device Nomenclature

European Union Publishes Brochure with Frequently Asked Questions about European Medical Device Nomenclature

The European Commission released a brochure related to European Medical Device Nomenclature (EMDN) issues. The brochure contains information about EMDN that is represented in questions and corresponding answers.

It was decided to create the EMDN as a supporting device that helps in operating the European database on medical devices (EUDAMED) within Medical Device Regulation (MDR) and in vitro diagnostic medical devices Regulation (IVDR) requirements. Manufacturers should use the EMDN to register a medical device in EUDAMED and this information will be available not only to the regulation authority but also to the patients where they can get the description of the device.

Please note that the access to the EMDN is free and available for any interested party. The information from this system can be downloaded as pdf and excel at webgate.ec.europa.eu/dyna2/emdn and on the European Commission’s website.

The European Commission notes that the updated version of the EMDN will soon be released. In the updated version, some suggestions received within online consultation will be considered as well as detected errors will be revised.

The brochure describes the key principles of the EMDN and its structure.

The brochure itself you can find here.

The information has been prepared by the GMA Consult Group team.

GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom, and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side.

Need your own guide to the world of certification and approvals? Don't hesitate to contact us via info@gma.trade.

July 19, 2021

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