MedTechLabel: A Universal Digital Labelling Framework for Medical Devices and In Vitro Diagnostics

Manufacturers of medical devices (MDs) and in vitro diagnostic devices (IVDs) must comply with increasingly complex and evolving requirements regarding the labeling information to be included with MD/IVD. At the same time, devices are becoming smaller, more sophisticated, and increasingly connected, adding challenges for users to access, understand, and correctly interpret essential labelling information. MedTechLabel is a three-year (2026–2029) Innovative Health Initiative (IHI) project set out to develop a universal, digital labelling framework specification for all categories and classes of MDs and IVDs. To reshape labelling practices, improve user experience, reduce administrative burden, and enhance operational efficiency and regulatory compliance for industry, MedTechLabel addresses two key challenges: (1) scalability and efficiency through greater digitalisation of labelling information; and (2) more accessible information for diverse users, with curated displays that support different roles and needs. To achieve this, the digital labelling framework specification seeks consensus among all involved stakeholders: manufacturers, notified bodies (NB), regulators, health authorities, healthcare professionals, patients, and others. This poster presents how MedTechLabel aims to fulfil this mission and invites input from MEDICON participants on how best to address their needs in the MD/IVD ecosystem.