Regulatory and digital solutions work best when they are shaped together with the people who will ultimately develop, assess, regulate, use and be affected by them. This principle has been built into EU4MEDTECH from the very beginning.
The EU4MEDTECH Stakeholders Forum was established to create a direct link between the project and the wider MedTech community, ensuring that stakeholder perspectives are continuously reflected in project activities.
But building the Forum was only the first step. Since its establishment, stakeholder engagement has increasingly moved from outreach to active consultation, co-creation and validation.
Listening to the MedTech community
One of the first priorities of EU4MEDTECH was to understand the regulatory landscape not only through existing evidence, standards and policy documents, but also through the experiences of those navigating it in practice.
Stakeholders have therefore been invited to contribute their perspectives on topics such as regulatory requirements, MDR and IVDR implementation, and challenges associated with innovative and high-risk medical devices and in vitro diagnostic medical devices.
Across EU4MEDTECH activities to date, more than 450 stakeholder engagement instances have been recorded through surveys, interviews, focus groups and validation activities. Together, these interactions have brought a wide range of real-world perspectives into the project, providing insights into regulatory and administrative challenges, evidence-generation needs, operational workflows and expectations for future support tools.
The Stakeholders Forum, alongside consortium networks and other targeted outreach channels, has played an important role in enabling this continuous dialogue with the MedTech community. Rather than collecting stakeholder input as a one-off exercise, EU4MEDTECH uses these interactions to progressively inform the development and refinement of the project’s framework and digital solutions.
Turning stakeholder insights into project development
Stakeholder engagement has also helped the project better understand how different MedTech actors access and use regulatory information, where they encounter difficulties and what types of support could make these processes more effective.
Through surveys, focus groups and interviews, stakeholders have shared their experiences and expectations regarding regulatory information and digital support. Their feedback helps ensure that ongoing project development remains grounded in actual user practices and needs.
This is a key part of the EU4MEDTECH approach: stakeholder engagement is embedded in project development, helping ensure that emerging solutions reflect real-world needs.
From consultation to validation
As the project progresses, the role of stakeholders is evolving further.
EU4MEDTECH has already entered a stage in which stakeholders are being asked not only to describe their needs, but also to review and validate approaches developed within the project.
A first structured validation exercise has already been carried out using a modified Delphi methodology. In the first round, 24 stakeholders evaluated 25 statements derived from project outputs, providing feedback to support further refinement and consensus-building.
This marks an important transition for the Forum: from helping EU4MEDTECH understand the challenges faced by the MedTech community to helping assess whether the approaches being developed are moving in the right direction.
What comes next?
Stakeholder involvement will continue throughout the next stages of EU4MEDTECH.
Upcoming activities will create further opportunities to contribute to the validation and refinement of the EU4MEDTECH framework, the development and evaluation of the digital platform, participatory workshops, usability activities and future community testing.
For the project, this continuous dialogue is essential. It helps ensure that the solutions developed within EU4MEDTECH are not only scientifically and technically robust, but also relevant, usable and aligned with the realities of the European MedTech ecosystem.
And for members of the Stakeholders Forum, it means that joining the community is not simply about following project developments – it is an opportunity to contribute to them.
Be part of what comes next
The EU4MEDTECH Stakeholders Forum remains open to stakeholders interested in contributing their knowledge, experience and perspectives to the project.
Whether you are a medical device developer or company, researcher, healthcare professional, regulatory or HTA expert, patient or citizen representative, or another actor working within the MedTech ecosystem, we invite you to join the Forum and take part in upcoming EU4MEDTECH activities.
By joining, you will have opportunities to contribute to future consultations and validation activities, share your perspective on emerging project solutions, and be among the first stakeholders invited to test and provide feedback on tools designed to make navigating the MedTech regulatory landscape easier and more efficient.
Join the EU4MEDTECH Stakeholders Forum and help shape the next steps of EU4MEDTECH.
