Challenge

Medical device and in vitro diagnostic labelling across the EU remains fragmented, largely paper-based, and inconsistently implemented across Member States. This creates compliance burdens for manufacturers, inefficiencies for regulators and notified bodies, and usability challenges for healthcare professionals and patients. Existing labelling practices also struggle to keep pace with digital transformation, evolving EU legislation, and sustainability objectives, including the reduction of waste linked to printed labels. A harmonised yet flexible digital labelling approach is needed to support regulatory compliance, market efficiency, and future-proof innovation.

Solutions

The project develops and validates the MedTechLabel Framework, a universal digital labelling system applicable to all categories and classes of medical devices and in vitro diagnostic devices. The framework is designed to be fully compliant with EU regulations while remaining adaptable to national specificities and future legislative developments. Its development is grounded in a comprehensive review of existing legislation, standards, current labelling practices, and scientific evidence, combined with systematic stakeholder engagement involving manufacturers, notified bodies, regulators, healthcare professionals, patients, health authorities, and procurers. To verify the framework, the project establishes a sandbox environment that uses existing technologies to test digital labelling content across multiple real-world use cases. This verification process assesses usability, regulatory relevance, and added value for different stakeholder groups. The results feed into a CEN Workshop Agreement (CWA), providing a consensus-based foundation for standardisation and future EU and national policy development.

Results

The project delivers a validated, consensus-driven digital labelling framework that supports harmonisation across the EU medical device ecosystem. It demonstrates the operational, regulatory, and usability benefits of digital labels for manufacturers, regulators, notified bodies, healthcare professionals, and patients. The framework contributes to increased efficiency, improved access to up-to-date device information, and reduced administrative burden. In addition, it supports EU Green Deal objectives by reducing reliance on printed labels, thereby lowering material use, carbon footprint, and water waste. The resulting recommendations provide a concrete basis for future standardisation efforts and legislative initiatives.