Countries reject the WHO proposal on adopting the EMDN

The WHO Secretariat were asked to think again about their nomenclature choice at the World Health Assembly meeting on 28 & 29 May 2021. The WHO Secretariat has recently switched its proposal from creating a new nomenclature to the adoption of the currently draft EMDN.

While all countries agreed that medical device nomenclature should be harmonised, there were several including the USA, Russia, Canada & UK that strongly recommended that the WHO should use the GMDN as the predominant nomenclature used by regulators and to consider that the introduction of an alternative would increase costs both for the WHO and stakeholders, especially industry which in turn adds unnecessary cost to patient care.

Dr Mariângela Simão, WHO Assistant Director General, Access to Medicines and Health Products, the department responsible for the WHO’s proposal to adopt the draft EMDN, concluded “WHO will not be creating a new nomenclature, but will work with existing nomenclatures and with countries to select from the available ones which ones are best to work towards convergence”. Further consultation maybe considered by WHO.

The ninth and tenth WHA Committee A sessions were recorded and can be viewed on the WHO website.