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)

Last updated: 16.7.2025
Grant

This Horizon Europe funding initiative aims to develop comprehensive EU methodological frameworks for the clinical and performance evaluation, as well as post-market follow-up, of medical devices and in vitro diagnostic medical devices (IVDs). The program directly supports the new Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), reinforcing safety and performance requirements for high-risk devices to ensure faster patient access to innovative technologies.

Who is Funded

This section details the primary beneficiaries and the geographical scope of the funding program, emphasizing its broad impact on the European health ecosystem and beyond. The program aims to foster innovation in medical device and IVD evaluation by engaging a diverse range of stakeholders.

What is Funded

This section outlines the types of projects, thematic areas, and activities eligible for funding, focusing on advancing the methodological frameworks for medical device and IVD evaluation, including crucial aspects like cost management and project maturity.

Type and Scope of Funding

This section describes the nature of the financial support, including the instrument used, the financial limits for projects, and general information about project duration, providing a clear picture of the investment scope.

Conditions and Requirements

This section outlines the essential stipulations governing applications and project implementation, including procedural, collaborative, and budgetary guidelines, ensuring adherence to the program's rigorous standards.

Application Procedure

This section outlines the structured process for submitting proposals and the subsequent evaluation and selection mechanisms, ensuring transparency and fairness in the allocation of funding.

This section provides the foundational legal and official documents that legitimize and govern the funding program, along with information on how to access these critical texts.

Similar Programs

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Funding Overview

Funding Status

Funding Status:

Closed

Maximum Amount

Maximum Amount:

10,000,000 €

Allocated Budget

Allocated Budget:

10,000,000 EUR

Deadline

Deadline:

11.04.2024

Award Channel

Award Channel:

Framework Programme Call

Region

Region:

European Union, Associated Countries, United States of America

Sectors

Sectors:

Healthcare, Medical Technology, Research and Development, Software Development, Information and Communication Technology

Beneficiaries

Beneficiaries:

Patients, regulators, notified bodies, health technology developers, EU health industry

Application Type

Application Type:

Consortium Required

Funding Stages

Funding Stages:

Applied Research, Experimental Development, Pilot Testing, Market Introduction

Funding Provider

Program Level:

European Union

Funding Body:

European Union (European Commission)

Managed By:

European Health and Digital Executive Agency (HaDEA)

Additional Partners:

National competent authorities, notified bodies, IVD laboratories, Health Technology Assessment bodies, patients’ representatives

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