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International working group on medical devices regulatory sciences

In May 2019, the World Health Assembly of the World Health Organization (WHO) decided to start working on a free international nomenclature of medical devices, including IVDs, for facilitating and harmonising the work of regulators, procurers, supply and user around the globe. According to the WHO, this nomenclature must be a "Public Good", not subject to copyright, freely accessible to everyone, and designed to consider the real need of healthcare professionals (e.g., nurses, clinical engineers), facilitating their daily work. For instance, WHO considered aligning the nomenclature with the International Classification of Diseases 11th Revision (ICD11). This does not seem to be the case for the 2 major international nomenclatures: GMDN, developed by the European GMDN Agency, which is widely used internationally and UMDNS, developed by ECRI.

The European Union has decide to change its official nomenclature adopting the Italian nomenclature, which will be renamed EMDN (European Medical Devices Nomenclature).

However, a lot of work remains to be done, in order to male this nomenclature accessible and universal, especially to protect users from LMICs.

In order to offer a support to WHO and to the EU Commission, the EAMBES set a working group. This presentation will offer a preliminary view of the conclusions achieved from this working group.

The University of Warwick is hosting the first meeting of this working group, which will kick-off meeting the Task force in March 2020.

Experts from 8 European Countries will join this meeting, which will result in a recommendations that will be presented to the European Parliament and to the World Health Organization (WHO).

Fri 28 Feb 2020, 12:28 | Tags: medical device, Regulatory Science