MedTechLabel will establish a harmonized digital labelling framework for medical devices (MD) and in vitro diagnostics (IVD). We 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.
Leveraging MedTechLabel consortium partners' diverse expertise we will deliver specifications for a unified framework that can be applied across all MD and IVD categories and classes. Through broad stakeholder engagement and evidence‑driven design, the project will demonstrate how a harmonized digital approach can reduce administrative burden, enhance usability for healthcare professionals and patients, and support a more sustainable and resilient medical device ecosystem.
Objectives
- Develop a unified, evidence based framework for digital labelling that applies across all MD and IVD categories and classes.
- Ensure alignment with MDR/IVDR and emerging EU legislation, including sustainability related requirements and future digital product provisions.
- Improve accessibility, usability and trust in MD and IVD labelling information for healthcare professionals, patients, regulators and other stakeholders.
- Reduce administrative burden by streamlining labelling creation, maintenance and conformity assessment processes. Prepare for future Digital Product Passport and EU circular economy – Green Deal, waste management and recycling
- Prepare the dossier for an international standardization process through an ISO/IEC International Workshop Agreement (IWA).
Outcomes
i. Scalability and efficiency by more digitalization of labelling information,
ii. More accessible and comprehensive information for diverse users, with curated views that support different roles and needs
iii. Support Green Deal; Digital Product passport (DPP), recycling, waste mangment
iv. Contributes to the foundation for inclusive and interoperable solutions in future EHR / EHDS ecosystems
Background
Digital labelling is emerging as a critical solution to longstanding challenges in the medical technology sector. Today, MD and IVD labels must satisfy a growing number of regulatory, linguistic and market specific requirements. This results in complex, cluttered and difficult to read physical labels, that can be hard for users to navigate, especially when essential details are buried in dense text, small, printed fonts, or distributed across multiple documents.
At the same time, increasing administrative burdens, supply chain inefficiencies and frequent reprints triggered by regulatory updates slow down innovation, limit access to products in smaller markets and increase environmental impact through paper use, packaging waste and repeated printing cycles.
Digital delivery of device information offers a powerful opportunity to simplify processes, improve safety, and strengthen trust.
By making labelling content dynamic, accessible and up to date, digital solutions can support real time updates, multilingual access, better user guidance and more transparent information for regulators and notified bodies.
Partners and Cooperation
The consortium brings together 14 public and 6 private partners from 11 countries, representing University and Research Institutes, Notified Bodies (NBs), Standard Development Organisations (SDOs), SMEs, health authorities and procurers, and IHI Private members (MedTechEurope and EFPIA). These partners bring regulatory expertise, digital infrastructure, and user centered design which is essential to demonstrate the value of digital labelling for manufacturers, notified bodies, authorities, healthcare professionals and patients.
Professor Anne Moen, UiO, is the Scientific Coordinator pf MedTechLabel. Mr. Roger Peterson, Arthrex GmbH, is the Industry lead.
In addition to the overall project management and coordination of the research and development work in MedTechLabel, the UiO team will lead the work on needs assessment, regulatory frameworks and standards, and will organize and lead the processes for broad cross-sectoral involvement of those who produce, approve, and use information about medical technology equipment.
