Per Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 23 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), the European Medical Device Nomenclature (EMDN) aims at supporting the functioning of the European database on medical devices (EUDAMED).
The website of the European Union displays the most up to date of the European Medical Device Nomenclature (EMDN): European Medical Device Nomenclature (EMDN).
The Medical Device Coordination Group (MDCG) at its meeting of 14 February 2019 decided to identify the Italian classification of medical devices, the National Classification of Medical Devices (CND), as a basis for the implementation of the EMDN nomenclature, in reason of its structure, purposes, usability and updating methodology.
The Italian Working Group (Medical Device Technical Team), with the support of representatives of trade associations, experts and users operating in the National Health Service, has drawn up a proposal, presented to the Nomenclature Working Group during the meeting of 30 April 2021.
During the meeting the Nomenclature working group expressed great satisfaction for the work done by Italy and approved the final and official EMDN version in Italian and the draft of the EMDN in English.
On May 4th 2021, the final and official Italian version of the nomenclatore EMDN and the draft of the English version were published.
A consultation is currently ongoing by the European Commission on the English version of the EMDN nomenclature, available on the page: European Medical Device Nomenclature (EMDN).
To find out more information see the following pages on the Commission’s website:
- Guidance - MDCG endorsed documents and other guidance
- EUDAMED UDI/Devices registration module - Relevant documents and information
- European Medical Device Nomenclature (EMDN) - Questions and Answers
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