The Innovative Health Initiative (IHI) funded research project MedTechLabel is launched as a public-private partnership that aims to unify, standardize and harmonize Medical Devices (MD) and In Vitro Diagnostic (IVD) labelling. Our goal is to specify and test a framework for a unified digital labelling system for Medical Devices and IVDs. This unique public-private partnership is co-led by the University of Oslo (scientific coordinator) and Arthrex GmbH (industry lead) and has 20 consortium partners from 11 countries across Europe and the US.
MedTechLabel: Unified Digital Labelling for Medical Technology Products
MedTechLabel’s mission is to create and verify a unified digital labelling framework for medical technology products (MD/IVD). The project will develop the MedTechLabel framework specification that covers all categories and classes of MDs and IVDs. The framework will harmonize and standardize digital labelling processes in compliance with EU regulations, while being adaptable to national variations, future legislation, and global development.
With the MedTechLabel public-private partnership, we set out to deliver a consensus-based digital labelling framework specification with required information for digital labelling of MDs and IVDs of all categories and classes. Our ambition is to reshape MD and IVD labelling practices, improve user experience and add value by addressing pressing needs for consistent and comprehensive digital labelling.
MedTechLabel will address two key challenges: i) scalability and efficiency by more digitalization of labelling information, and ii) more accessible information for diverse users, with curated displays that support different roles and needs. MedTechLabel digital labelling framework specification seeks for consensus among all involved stakeholders: from manufacturers, notified bodies (NB), regulators, health authorities, to healthcare professionals, patients, and more.
From the industry perspective, there is an urgent need to harmonize and standardize digital labelling to significantly enhance operational efficiency and regulatory compliance. The collaboration in MedTechLabel promises strong and unique results that will progress much-needed evolution; harmonization and standardization of the medical technology products (MD/IVD) labelling practices.
This project will specify, test and assess the usefulness of the framework specification in a set of use cases with MD/IVD digital content, and demonstrate the added value of our approach for digital labelling to manufacturers, label users, NBs, regulators, and other stakeholders. We will progress to an International Workshop Agreement (IWA) for further consensus on ISO standards and policy recommendations, offering a foundation for further progress. Digital labelling can also reduce carbon footprint and water waste of physical labels, aligning with the EU Green Deal goals.
Supported by a Grant from IHI
The MedTechLabel project is supported by the Innovative Health Initiative Joint Undertaking (IHI JU), under grant agreement No 101251320. The JU receives support from the European Union’s Horizon Europe research and innovation programme and COCIR, EFPIA, Europa Bío, MedTech Europe, and Vaccines Europe.
Project facts:
- Name: MedTechLabel: Unified Digital Labelling for Medical Technology Products
- Grant Agreement Number: 101251320
- Start date: 01/04/2026
- Duration: 36 months
- Budget: 11 704 133 Euro (Horizon Europe and IHI Private members)
A Robust Public-Private Partnership
MedTechLabel brings together 14 public and 6 private partners from 11 countries, including University and Research Institutes, Notified Bodies (NBs), Standard Development Organisations (SDOs), SMEs, health authorities and procurers, and IHI private members representing MD/IVD manufacturers.
This positions the consortium with its diverse expertise and broad network to address challenges and leverage opportunities in the MD/IVD digital labelling landscape to ensure real-world relevance of the MedTechLabel framework specifications.
WRFA’s Contribution
The WRFA will be contributing to multiple project activities. The largest contributions will focus on stakeholder engagement and value articulation, where we will help ensure, the project develops a robust, consensus-based framework and subsequently maximises its acceptance and sustainability across diverse ecosystems. This includes organizing a series of structured consultations to align with real-world expectations, for ideation, verification, and sustainability of the MedTechLabel Framework. Furthermore, given our experience, we will play a key role in ensuring the project results are communicated and disseminated effectively, while also helping to position the project strategically within relevant networks and among key stakeholders.
Partnership – Consortium Members
- Universitet i Oslo (Scientific coordinator and Grant administrator) (Norway)
- Arthrex GmbH (Industry Lead) (Germany)
- empirica Gesellschaft für Kommunikations- und Technologieforschung GmbH (Germany)
- PredictBy Research and Consulting S.L. (Spain)
- The European Institute for Innovation Through Health Data (Belgium)
- GS1 AISBL (Belgium)
- HL7 Europe (Belgium)
- The European Association of Medical Devices-Notified Bodies (Belgium)
- Janssen Pharmaceutica NV (Belgium)
- Terumo Europe (Belgium)
- University of Galway (Ireland)
- Cardinal Health Ireland Manufacturing Ltd (Ireland)
- Institoyto Bioiatrikis Texnologias (Greece)
- Better Standards for E-Health B.V. (Netherlands)
- Orcha Health B.V. (Netherlands)
- World Resources Forum Association (Switzerland)
- European Federation of National Associations of Orthopaedics and Traumatology (Switzerland)
- Bridg OÜ (Estonia)
- bioMérieux SA (France)
- US Data Management, LLC (USA)
