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EU4MEDTECH

A comprehensive framework to support the lifecycle of innovative medical devices.

DURATION

48 months
(December 2024 - December 2028)

PARTICIPATING ORGANISATIONS

14

TOTAL BUDGET

7.676.743,75 €

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EU4MEDTECH

Transforming Medical Technology Evaluation Across Europe

A comprehensive framework to support the lifecycle of high-risk and innovative medical devices.

About EU4MEDTECH
EU4MEDTECH

About the Project

EU4MEDTECH (European Framework for Advanced Medical Technology Evaluation and Follow-up) is an ambitious Horizon Europe project advancing the evaluation and regulation of high-risk medical devices (MDs) and in-vitro diagnostic medical devices (IVDs) across Europe.

The project introduces the EU4MEDTECH Framework, a lifecycle-oriented approach to improving clinical and performance evidence generation, evaluation, and validation for innovative MDs, IVDs, and medical software.

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4
Years
14
Partners
3
Use Cases
3
Clinical Studies

Main Results

EU4MEDTECH Framework

A lifecycle-oriented methodology for clinical and performance evidence generation, ensuring regulatory compliance for high-risk MDs and IVDs across pre- and post-market stages.

Interactive Digital Platform

A cloud-based platform providing regulatory support, real-time communication tools, and global search functionalities to streamline MDR/IVDR compliance for key stakeholders.

Testing & Validation

The framework and platform will undergo testing in three use cases, ensuring effectiveness in regulatory decision-making and industry adoption.

Long-term adoption & impact

A sustainability roadmap will facilitate widespread adoption, enabling industry, regulators, and healthcare providers to integrate project outcomes effectively.

Clinical studies & evidence generation

Three clinical studies will generate real-world data to support regulatory processes, improving safety and performance evaluation of high-risk medical devices.

Regulatory alignment & Standards

Development of new methodologies and Common Specifications to enhance regulatory efficiency, ensuring harmonization with MDR/IVDR requirements.

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Consortium

Collaborating Across Borders: Meet the Organizations Driving EU4MEDTECH

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Stakeholders forum

The EU4MEDTECH Stakeholders Forum serves as a key platform for engagement, collaboration, and knowledge exchange among regulators, industry leaders, healthcare professionals, researchers, and patient organizations.

By actively involving diverse stakeholders, the Forum ensures that project outcomes align with real-world needs, regulatory expectations, and industry challenges.

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News & Events

Updates on project milestones, upcoming events, and stakeholder meetings.

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WP1 Completed

Mapping the Evidence and Regulatory Landscape for High-Risk and Innovative Medical Devices and IVDs The
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Contact Us

Get in touch with us if you have any questions or comments! We will get back to you as soon as possible.

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Be the first to know about groundbreaking advancements in medical device evaluation!

Get involved by joining our Stakeholders Forum and subscribing to our newsletter to receive insights, project updates, and opportunities for collaboration across the EU4MEDTECH ecosystem.