New EU4Health contracts signed: strengthening the European Health Data Space and harmonising European and international medical device nomenclature

The European Health and Digital Executive Agency (HaDEA) has signed two new contracts under the 2024 EU4Health work programme. 

Support to stakeholders on secondary use of data within the European Health Data Space 

This contract will assist stakeholders in complying with the European Health Data Space (EHDS) requirements and technical specifications, contributing to providing a safe, trustworthy and interoperable legal framework and infrastructure to facilitate the access to health data for research, innovation and policy-making purposes. 

The actions carried out within this contract will support stakeholders and HealthData@EU participants by: 

• Creating a collaborative ecosystem for the secondary use of health data by fostering a community of practice and cooperation and knowledge sharing among stakeholders;
• Supporting governance procedures related to the secondary use of health data in the context of the EHDS. 

Signed on 7 November 2025, this contract will have a duration of 36 months and a total financial support of €1 200 000.04 under the EU4Health programme. 

Read more in the contract award notice. 

Translation and validation of the European medical device nomenclature and the international medical device regulators forum adverse event terminologies 

This service contract aims to translate, validate and harmonise the European medical device nomenclature (EMDN) and the International medical device regulators forum (IMDRF) adverse event (AE) terminologies in 22 official EU languages. 

This action includes the review and harmonisation of the existing translated versions of the EMDN and the translation and validation of the seven IMDRF AE terminologies.  

Signed on 13 November 2025, the contract will have a duration of 30 months and a total financial support of €763 492.82 under the EU4Health programme. 

Read more in the contract award notice. 

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.