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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

Advancing Medical Technology Evaluation Across Europe

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

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EU4MEDTECH

About the Project

EU4MEDTECH is an ambitious Horizon Europe initiative aimed at revolutionizing the evaluation and regulation of innovative medical devices and in vitro diagnostic tools across Europe.

The project introduces the EU4MEDTECH Framework, a comprehensive and lifecycle-oriented approach that supports the generation, evaluation, and validation of clinical and performance evidence for high-risk medical devices and software.

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Consortium

Collaborating Across Borders: Meet the Organizations Driving EU4MEDTECH

More About the Consortium
4
Years
14
Partners
3
Use Cases
3
Clinical Studies

Main Results

EU4MEDTECH Framework

A lifecycle-oriented framework for generating and evaluating clinical and performance evidence of high-risk medical devices. It includes standardized methodologies, multi-domain criteria, and tools for both pre- and post-market stages.

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Interactive Digital Platform

A cloud-based platform operationalizing the EU4MEDTECH Framework. It features a regulatory communication channel, global regulatory search functionality, a user training module, and a data repository to streamline medical device evaluation processes.

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Validated Use Cases

Application and testing of the framework in three distinct use cases: Class III and Implantable Devices. Class C/D In Vitro Diagnostics. Software-based Medical Devices and Innovative Tools.

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Comprehensive Exploitation Roadmap

A strategy ensuring widespread adoption, scalability, and sustainability of project results, supported by stakeholder engagement and co-design principles.

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Clinical Studies and Proof-of-Concept Evaluation

Conducting three clinical studies and a proof-of-concept evaluation of the digital platform to validate its effectiveness in real-world scenarios.

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Recommendations for Common Specifications

Development of new guidelines and specifications to enhance the regulatory environment, fostering innovation while maintaining safety and compliance.

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METHODOLOGY

Project Phases

Pre-study (WP1-2)

Establishment of the evidence foundation for the EU4MEDTECH framework and digital platform and theoretical support for subsequent project activities.

Development (WP3-5)

We will craft the EU4MEDTECH framework and recommendations for new CS, develop the digital plaftorm with its associated features, and devise the evaluation strategy and protocols for the next phase.

Testing and evaluation (WP6)

Dedicated to demonstrating, assessing, and validating the EU4MEDTECH framework through 3 UCs and carrying out a PoC study for digital platform.

News & Events

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

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