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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

About

EU4MEDTECH

Transforming Medical Technology Evaluation

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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7.676.743,75
Budget in €
14
Project Partners
01.12.2024.
Start Date
01.12.2028.
End date

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.

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.

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.

Comprehensive Exploitation Roadmap

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

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.

Recommendations for Common Specifications

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

Methodology

Project Phases

Pre-study (WP1-2)

Laying the groundwork for the EU4MEDTECH framework and digital platform by analyzing regulatory requirements, identifying stakeholder needs, and defining methodologies for clinical and performance evaluation.

Development (WP3-5)

Designing the EU4MEDTECH framework, developing recommendations for new Common Specifications (CS), and building the digital platform with integrated regulatory tools to support MDR/IVDR compliance.

Testing and evaluation (WP6)

Validating the framework and digital platform through three Use Cases (UCs) and a Proof-of-Concept (PoC) study to ensure optimized methodologies for clinical and performance evaluation.

Innovative Healthcare

Key Objectives

EU4MEDTECH enhances medical device evaluation through a standardized framework and digital platform, ensuring regulatory compliance, patient safety, and faster market access for innovative healthcare technologies.

Developing a standardized, lifecycle-oriented framework for clinical and performance evaluation of high-risk MDs and IVDs.
Building a cloud-based platform with regulatory tools, compliance guidance, and stakeholder training.
Testing the framework across three use cases: Class III MDs, high-risk IVDs, and medical software-based devices.
Establishing sustainability and regulatory adoption strategies to ensure widespread uptake of project outcomes.

Work Packages

The project is structured into eight interconnected work packages, each focusing on a key aspect of medical device evaluation, regulatory compliance, digital platform development, clinical validation, and stakeholder engagement.

WP1

Exploring the regulatory landscape: methods for generation and evaluation clinical and performance evidence

WP2

Laying the Foundation
for the EU4MEDTECH
digital platform

WP3

Methodology benchmarking: optimising methods for generating and evaluating clinical and performance evidence

WP4

EU4MEDTECH framework and CS development

WP5

Digital platform
development

WP6

Testing and evaluation: EU4MEDTECH framework and digital platform

WP7

Project Management and Coordination

WP8

Dissemination, communication, and exploitation of project
results

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EU Project

Funding and Support

The EU4MEDTECH project is funded under the Horizon Europe programme, the European Union’s primary initiative for research and innovation. The project is supported through the HORIZON-HLTH-2024-IND-06 call, which focuses on advancing health-related industries.

The project operates as a Horizon Research and Innovation Action (RIA) with a 48-month duration under the granting authority of the European Health and Digital Executive Agency (HADEA). With support from 14 international partners, EU4MEDTECH is developing a comprehensive framework for medical device evaluation, improving regulatory efficiency and patient safety across Europe.

Our Team

Our multidisciplinary team works collaboratively to develop cutting-edge solutions for medical device evaluation, ensuring safer, more efficient, and compliant healthcare technologies across Europe.

Meet the Team
View the Consortium

Project video (coming soon)

Watch the EU4MEDTECH explanatory video for an overview of the project's mission, objectives, and impact on medical device evaluation and regulatory innovation