Prior information notice: translation of the EU medical device nomenclature and of the international medical device regulators forum's adverse events terminologies

HaDEA has published the Prior Information Notice (PIN) for a call for tenders to translate into all EU official languages the European medical device nomenclature and the international medical device regulators forum's adverse events terminologies. 

HADEA/2024/OP/0026-PIN

This action aims to facilitate the use of European harmonised medical device nomenclatures (EMDN) and the International medical device regulators forum’s adverse event (IMDRF AE) terminologies by all stakeholders. It includes the review and harmonisation of the existing translated versions of the EMDN and the translation and validation of the seven IMDRF AE terminologies from English into the 23 other EU official languages. Specialised expertise in the medical sector (medical equipment and clinical aspects) is necessary to conduct both tasks.

Maximum budget: €800 000

Interested stakeholders are invited to check the Funding and Tenders Portal for the publication of the call in September.

Background: 

EU4Health is the fourth and largest of the EU health programmes. The EU4Health programme goes beyond an ambitious response to the COVID-19 crisis to address the resilience of European healthcare systems. The programme provides funding to national authorities, health organisations and other bodies through grants and public procurement, contributing to a healthier Europe. 

HaDEA manages the vast majority of the total EU4Health budget and implements the programme by managing calls for proposals and calls for tenders from 2021 to 2027.