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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

Work Packages

EU4MEDTECH

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.

Framework & platform development

Clinical validation & testing

Regulatory compliance support

Stakeholder engagement & impact

WP1

Exploring the regulatory landscape

Methods for generation and evaluation clinical and performance evidence

WP1 aims to provide the evidence base for the creation of EU4MEDTECH framework and support future project activities, synthesising, and mapping evidence for:

Methodologies for the generation and evaluation of evidence for clinical performance of MDs, including RWD and registries.

Methodologies for integrating different types of evidence for high-risk and innovative MDs.

Existing CS, standards, and regulations.

Digital tools and solutions for regulatory compliance.

In addition, we will provide a broader landscape assessment of the economic and temporal impact MD/IVD regulations in EU.

WP2

EU4MEDTECH digital platform

Laying the Foundation for the EU4MEDTECH digital platform

WP2 aims to carry out the groundwork necessary for the development of the digital platform. Objectives include:

Identifying stakeholder pain points and requirements to be addressed through the digital platform.

Analysing user experience with EUDAMED in Finland and implementation barriers/facilitators.

Laying groundwork for IRHTAP.

Supporting the design of the regulatory search feature.

WP3

Methodology benchmarking

Optimising methods for generating and evaluating clinical and performance evidence

WP3 sets to benchmark clinical and performance evidence generation and evaluation methodologies, and seeks to optimise them for better effectiveness and efficiency. Specific objectives include:

Performing a gap assessment in existing methodologies to draw a decision-making workflow.

Optimising clinical/performance evidence generation/evaluation methods, including use of RWD and registries, methods for evidence integration and bridging studies, and determination of acceptable benefit-risk ratios and post-market surveillance strategies to mitigate uncertainty at the time of market entry.

Generating a global knowledge model (ontology) for the technological and clinical validation of MDs/IVDs.

Validating methods and results generated in WP2-WP3 with Stakeholder Forum.

The main outputs of WP3 will be the refined and optimised evidence generation and evaluation methods which, once validated with the Stakeholder Forum, will create EU4MEDTECH framework’s 1st building block.

WP4

FRAMEWORK DEVELOPMENT

EU4MEDTECH framework and CS development

WP4 sets to develop and refine EU4MEDTECH framework and recommendations for new CS, both at the design phase, at market release, as well as throughout their operational lifecycle. Specific objectives are:

Development EU4MEDTECH framework and 5 domains.

Development of the evaluation component of CS.

Generation of new knowledge and integration into the ontology model, including new technological advances that emerge throughout the duration of the project.

Iterative evolution and improvement of the different items developed in WP4.

Validation and evaluation of the framework developed in WP4 with Stakeholder Forum.

In WP4, EU4MEDTECH framework will reach its full form, undergo another validation round with the Stakeholder Forum, thereby resulting in EU4MEDTECH framework version 1.0, ready for digital platform integration.

WP5

PLATFORM DEVELOPMENT

Digital platform development

This WP aims to design and develop the EU4MEDTECH Digital Platform, aligned with the conceptual model and specifications of the EU4MEDTECH Framework.

The design and development will be performed considering current standards ISO13485, IEC6203, ISO29110-5-6-1, therefore secondary objectives for this WP regarding the Digital Platform are:

Requirement Analysis based on results from WP1-4.

Architectural design.

Construction.

Integration and Verification.

Delivery.

WP6

Testing and evaluation

EU4MEDTECH framework and digital platform

WP6 will build on the work of previous WPs enabling the testing and evaluation of the digital version of EU4MEDTECH framework in 3 Use Cases (UCs) as well as of the digital platform through a Proof of Concept (PoC) study, to ascertain their robustness.

This will allow the identification of possible improvements and enable their optimisation.

UC testing and feedback will further refine EU4MEDTECH framework thereby leading to version 2.0 (final version), ensuring its effectiveness and alignment with the MedTech sector, guided throughout by the Stakeholder Forum.

WP7

Leadership

Project management and coordination

The main objective of WP7 is to ensure the timely and qualitative achievement of the project results through effective administration and leadership.

The WP ensures the quality control of the project results and the risk management of the project.

The WP provides timely and efficient financial management of the project and the compliance with contractual commitments.

WP8

DISSEMINATION AND EXPLOITATION

Dissemination, communication, and exploitation of project results

The main objective of WP8 is to ensure transparent and successful dissemination, communication, and exploitation of the project results. This includes:

to develop stakeholders’ engagement, dissemination, exploitation, and communication plans and implement them. Raising awareness of the project to prepare for their exploitation by participating and organising outreach activities and events,

promote synergies between public and private sectors around the project, building a network of stakeholders of the scientific and industrial community, end-users/beneficiaries, policymakers, and other relevant stakeholders,

design a long-term sustainability plan to define an effective exploitation plan, paying attention to IPR protection in the innovation management and knowledge transfer phases,

develop and maintain the project's visual identity, including conventional information material, tools and audio-visual material.

WP1

Exploring the regulatory landscape

Methods for generation and evaluation clinical and performance evidence

WP1 aims to provide the evidence base for the creation of EU4MEDTECH framework and support future project activities, synthesising, and mapping evidence for:

Methodologies for the generation and evaluation of evidence for clinical performance of MDs, including RWD and registries.

Methodologies for integrating different types of evidence for high-risk and innovative MDs.

Existing CS, standards, and regulations.

Digital tools and solutions for regulatory compliance.

In addition, we will provide a broader landscape assessment of the economic and temporal impact MD/IVD regulations in EU.

WP2

EU4MEDTECH digital platform

Laying the Foundation for the EU4MEDTECH digital platform

WP2 aims to carry out the groundwork necessary for the development of the digital platform. Objectives include:

Identifying stakeholder pain points and requirements to be addressed through the digital platform.

Analysing user experience with EUDAMED in Finland and implementation barriers/facilitators.

Laying groundwork for IRHTAP.

Supporting the design of the regulatory search feature.

WP3

Methodology benchmarking

Optimising methods for generating and evaluating clinical and performance evidence

WP3 sets to benchmark clinical and performance evidence generation and evaluation methodologies, and seeks to optimise them for better effectiveness and efficiency. Specific objectives include:

Performing a gap assessment in existing methodologies to draw a decision-making workflow.

Optimising clinical/performance evidence generation/evaluation methods, including use of RWD and registries, methods for evidence integration and bridging studies, and determination of acceptable benefit-risk ratios and post-market surveillance strategies to mitigate uncertainty at the time of market entry.

Generating a global knowledge model (ontology) for the technological and clinical validation of MDs/IVDs.

Validating methods and results generated in WP2-WP3 with Stakeholder Forum.

WP3 efforts will focus on high risk, innovative MDs/IVDs.

WP4

Medtech innovation

EU4MEDTECH framework and CS development

WP4 sets to develop and refine EU4MEDTECH framework and recommendations for new CS, both at the design phase, at market release, as well as throughout their operational lifecycle. Specific objectives are:

Development EU4MEDTECH framework and 5 domains.

Development of the evaluation component of CS.

Generation of new knowledge and integration into the ontology model, including new technological advances that emerge throughout the duration of the project.

Iterative evolution and improvement of the different items developed in WP4.

Validation and evaluation of the framework developed in WP4 with Stakeholder Forum.

WP5

Digital Medtech

Digital platform development

This WP aims to design and develop the EU4MEDTECH Digital Platform, aligned with the conceptual model and specifications of the EU4MEDTECH Framework.

The design and development will be performed considering current standards ISO13485, IEC6203, ISO29110-5-6-1, therefore secondary objectives for this WP regarding the Digital Platform are:

Requirement Analysis based on results from WP1-4.

Architectural design.

Construction.

Integration and Verification.

Delivery.

WP6

Testing and evaluation

EU4MEDTECH framework and digital platform

WP6 will build on the work of previous WPs enabling the testing and evaluation of the digital version of EU4MEDTECH framework in 3 UCs as well as of the digital platform through a PoC study, to ascertain their robustness.

This will allow the identification of possible improvements and enable their optimisation.

WP7

Project Delivery

Project management and coordination

The main objective of WP7 is to ensure the timely and qualitative achievement of the project results through effective administration and leadership.

Another focus is to ensure the quality control of the project results and the risk management of the project.

The WP provides timely and efficient financial management of the project and the compliance with contractual commitments.