Horizon Europe 'Health' - EU methodological frameworks for medical devices and in vitro diagnostic medical devices (IVDs)

HORIZON-HLTH-2024-IND-06-08 - Developing EU methodological frameworks for clinical/performance evaluation and post-market clinical/performance follow-up of medical devices and in vitro diagnostic medical devices (IVDs)

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry”. To that end, proposals under this topic should aim to deliver results that are directed, tailored towards and contributing to all of the following expected outcomes:

• Patients gain faster access to innovative, safe and well-performing medical devices;
• Regulators have access to sound scientific resources for clinical/performance evaluation guidance and development of common specifications as foreseen in Article 9 of the Medical Device Regulation (MDR);
• Notified bodies, by their direct participation to the production of documents, will have a harmonised way of assessing the clinical evidence in the pre-market and post-market phases; furthermore their network, will be enhanced;
• Health technology developers gain insight on the evidence needed to demonstrate that their devices meet MDR clinical requirements throughout their lifetime. They will also have more guidance on the use of real-world data for their clinical development strategies.

Deadline: 24 April 2024, 17:00 CEST