Digital label: one source of comprehensive information for medical technology products

Program Code:  HORIZON-JU-IHI-2025-10-01-two-stage

Program Type: Research and Innovation Action

The overall aim of this topic is to establish a consensus-based digital label concept applicable to all types and classes of medical devices and in vitro diagnostic medical devices, making use of existing technologies that will be further improved for medical technology products specifically. This will result in increased competitiveness in the EU market due to improved supply management and streamlined packaging and labelling operations.

Within a collaborative public-private partnership consortium reflecting the cross-sectoral nature of the Innovative Health Initiative, applicants will contribute to one or more of the following impacts:

• information is more visible, accessible and identifiable to users (health care providers, patients) equipped with a simple smart device (e.g., phone or tablet device)

• streamlined, green delivery of information
• targeted information based on user location

Actions will include delivering a framework for mapping data elements that must be present on the label, a standardized concept for providing digital content, define key performance indicators, usability studies, engagement with relevant stakeholders (including regulators), testing, and development of recommendations for standards.

The successful consortium from stage 1 will merge with the pre-identified industry consortium; then they will submit a full stage 2 application together.

Total Funding Available: $5.9M CAD for 1 grant.