The EU4MEDTECH project consortium has successfully completed Work Package 2 (WP2), marking a key milestone in laying the groundwork for the development of the EU4MEDTECH digital platform.
WP2 focused on generating the evidence base, stakeholder insights, and regulatory intelligence required to ensure that the platform effectively responds to real user needs and evolving regulatory and Health Technology Assessment (HTA) requirements.
Key Objectives of WP2
WP2 aimed to:
- Identify and prioritise stakeholder pain points and user requirements to be addressed through the digital platform;
- Analyse user experience with EUDAMED in Finland, including implementation barriers and facilitators;
- Lay the groundwork for Integrated Regulatory and HTA Pathways (IRHTAP);
- Support the design of the platform’s global regulatory search feature.
Overview of the Work Performed
To achieve these objectives, WP2 implemented a mixed-methods approach across four core tasks:
- Stakeholder needs and requirements analysis, combining desk research, surveys, in-depth interviews and focus groups to capture and prioritise pain points across stakeholder groups.
- EUDAMED Finland case study, assessing real-world user experience since its 2021 implementation and identifying challenges, opportunities, and training needs to support EU-wide rollout.
- IRHTAP groundwork, analysing regulatory and HTA requirements for medical devices (MDs) and in vitrodiagnostic medical devices (IVDs), in EU, US and China and designing a protocol for the parallel HTA and regulatory Joint Scientific Consultations, supported by living regulatory maps.
- Regulatory screening for the digital platform, analysing regulatory frameworks in the EU, USA, and China to inform the design of the global regulatory search feature.
Main Deliverables Submitted
WP2 concluded with the successful submission of three key deliverables:
- D2.1 – EUDAMED: Recommendations for EU Application and Report on Barriers/Facilitators, providing practical, evidence-based recommendations addressing technical, training, data handling, and implementation challenges.
- D2.2 – Report on IRHTAP Pathways and Living Regulatory Maps for the EU, USA, and China, although not initially conceived as a living document, project partners agreed to maintain and update this report to ensure alignment with evolving regulatory and HTA landscapes beyond WP2 timeline. The first report is related to early scientific consultation processes on MDs and IVDs in the three territories.
- D2.3 – Stakeholder Needs and Functional Requirements Synthesis Report, consolidating stakeholder insights to directly inform the design and functionality of the EU4MEDTECH digital platform.
With WP2 completed, the project now moves forward with a strong, stakeholder-driven and regulation-informed foundation to support the next stages of platform development.
