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MedTechLabel
BRIEF
The Challenge
Medical devices (MDs) and in vitro diagnostic devices (IVDs) are currently subject to complex, fragmented labelling requirements across EU Member States, with no universal digital standard in place. Physical print labels are costly, environmentally burdensome, and struggle to keep pace with evolving EU regulations and national variations. There is an urgent need to standardise and digitise MD/IVD labelling in a way that is regulation-compliant, globally interoperable, and adaptable to future legislative changes.
FOCUS
The Approach
MedTechLabel aims to develop and verify a universal Digital Labelling Framework for all categories and classes of medical devices and IVDs, promoting a more efficient and sustainable MD/IVD ecosystem. The project will pursue this through:
• Legislative and standards review: mapping existing EU regulations and identifying gaps relevant to digital labelling
• Analysis of current labelling practices: benchmarking how manufacturers and stakeholders currently handle MD/IVD labelling
• Literature review: synthesising available research and knowledge on digital labelling solutions
• Stakeholder engagement: gathering requirements through consultation with manufacturers, notified bodies, regulators, health authorities, healthcare professionals, and patients
• Sandbox development and pilot testing: using existing technologies to verify the framework across a defined set of MD/IVD use cases
• Consensus-building: progressing findings toward an International Workshop Agreement (IWA) to support future ISO standardisation
CONCLUSIONS
The Envisioned Result
Upon completion, the project will deliver:
• A MedTechLabel Framework: a verified, consensus-driven specification for universal digital labelling of MDs and IVDs, compliant with EU regulations and adaptable to national and future legislative variations
• An International Workshop Agreement (IWA) as a stepping stone toward ISO standardisation
• Policy recommendations addressed to the European Commission and national authorities, focused on scaling digital labelling, future standardisation, and alignment with the EU Green Deal (reducing carbon footprint and waste from print labels)
• Dissemination outputs ensuring uptake across EU Member States and global exploitation of project results
PREDICTBY
Our Role
PredictBy is responsible for multiple tasks in this project as experts in research and literature review and impact evaluations and recommendations development
Our role in the project consists of conducting the following tasks:
Task 1: conducting systematic regulatory research, analysing industry white papers, mapping academic and grey literature on digital labelling
Task 2: structuring, launching and analysing questionnaires to manufacturers and Notified Bodies to gather information on the practices of digital labelling
Task 3: conducting impact evaluations and developing policy recommendations addressed to the European Commission and national authorities, focused on scaling digital labelling