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 HADEA/2024/OP/0026-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.

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