01 Jul

[Blog] EMDN – what stands behind the new official nomenclature in the EU?

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EMDN – principles, structure, access

EMDN (European Medical Devices Nomenclature) is the official nomenclature, established by the European Commission for use for registration of medical devices by manufacturers in the EUDAMED database. The very first version of it was released on 4^th May 2021. In general, the nomenclature is intended to support all of the activities under MDR and IVDR, as well as to provide the patients/ customers with important information about the devices. Based on expert`s opinions, the adoption of EMDN nomenclature is the most effective and successful choice for European healthcare structures at the moment.

What is EMDN based on?

According to the official information released by European Commission, EMDN has 8 key principles behind itself:
Regulator-led – the management, validation, as well as the processes of updating and advising on nomenclature is supported and controlled by the regulators

Structured – transparent hierarchies which could be clustered into groups and types

Predictable – stable structure with opportunity for various uses and technology development

Transparent – the healthcare and patients` needs reflected on the updates

Inclusive – wide openness of periodic reviews

Available – the terms, descriptions and codes are fully available for everyone

Accessible – the nomenclature could be used by any manufacturer without a fee/ commission

International – identified on the international level since the date of application of MDR/IVDR

How is structured EMDN?

The EMDN has an alphanumeric structure that has seven levels. Medical devices are positioned into three main levels:

The alphanumeric code is for concreate medical device is a combination of letters and numbers of each level, as the maximum is 13 digits.

How to access it?

As it was mentioned in the principles, the EMDN is available and accessible for all stakeholders*. You could access it here >>

*Manufacturers, patients, research organizations, practitioners, hospitals, pharmacies, etc.

If your company has to deal with registration on EUDAMED or any other business- related to MDR regulation – schedule a free meeting with our experts >>

Sources:

https://ec.europa.eu/health/md_eudamed/latest_updates_en

https://link.springer.com/article/10.1007/s12553-021-00567-1