MedTechLabel workplan with 6 highly interlinked work packages (WPs) adopts a dynamic, co-creation approach. It elicits insights and user feedback to specify and validate the MedTechLabel Framework for digital labelling.
Work Package 1
Regulatory Requirements, Standards, User Needs, Verification
Analyze the legal, regulatory, and standardization landscape, co-create KPIs, and consolidate knowledge on the current digitalization status to identify gaps and opportunities for the MedTechLabel Framework.
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Work Package 2
Development of the Digital Labelling Framework
Deliver a comprehensive, streamlined, and harmonized concept to generate the digital labelling framework, inclusive of all types of MDs/IVDs, serving the needs and concerns of manufacturers, regulators, procurers, and end users of medical devices.
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Work Package 3
MedTechLabel
Sandbox
Prepare the operational demonstrator as a digital sandbox, leveraging existing technologies and AI tools, providing infrastructure to support validation of the MedTechLabel Framework in WP4 and WP5.
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Work Package 4
Validation, Impact, and Recommendations
Validate the MedTechLabel Framework through proof-of-concept testing, assessing utility, usability, and acceptance across user groups, evaluate the socio-economic and environmental impact, and develop comprehensive recommendations that guide standardization efforts and foster best practices uptake for the MedTechLabel Framework / in MD/IVD labelling.
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Work Package 5
Stakeholder Engagement and Value Articulation
Engage stakeholders and create value propositions to maximize the framework’s acceptance and sustainability across diverse ecosystems. Establish the Forum for Digital Medical Labelling.
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Work Package 6
Coordination, Communication, and Dissemination
Ensure effective management and coordination of the project, build networks, and stimulate wide dissemination, exploitation, and overall communication to achieve MedTechLabel objectives within set timelines and budget, supporting all other WPs.
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