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

The digital label is an innovative concept offering benefits to all healthcare stakeholders and society at large. Currently, no regulatory basis exists for the medical technology industry anywhere in the world. There is therefore a need to test this concept with users, gather evidence for regulatory decision making and build regulators’ as well as users’ trust as a basis for a common standard and policy recommendations.

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 IVDs, making use of existing technologies that will be further improved to suit medical technology products specifically.

To fulfil the overall aim, the action funded under this topic must:
• deliver a framework for:
 mapping of data elements that must be physically present on the label and those that the manufacturer can provide digitally. The framework will consider the requirements of EU Regulations (MDR General Safety and Performance Requirement (GSPR) 23.1, IVDR GSPR 20.1; the Packaging and Packaging Waste (PPWD) Directive; Digital Product passport, waste and packaging, battery, etc.) and is meant to also support future EU legislation (or transposition thereof in Member States).
 a standardised concept in providing digital content and structure for the medtech manufacturers taking into account the different device types.
• define and make publicly available key performance indicators (KPIs) (e.g. trends of access and digital content type) or other measures to assess the acceptability and workability of the potential digital label solution(s), provided by manufacturers, and to be tested with end users (HCPs and patients).
• generate evidence on the acceptability and usability of digital label solutions through testing in a variety of use environments that will be defined by the full consortium. This will include user feedback on behaviour changes in a variety of use environments. The action should also make the results of testing, analysis and conclusions public.
 conducting usability studies will support end-user age demographics and capture metrics on the acceptability/usability of end-user participants' potential disabilities related to interacting with digital technologies.
• engage with all relevant stakeholders (e.g. HCPs, patients, national competent authorities, notified bodies) throughout the project lifetime to get robust input through consultations, surveys, workshops and testing in order to:
 maximise end user adoption (and understanding) of digital labels;
 ensure that concerns and demands of end users and regulators are met.
• based on the results of testing and body of evidence gathered, develop recommendations on digital labels to inform relevant stakeholders, regulators, policy makers, and the relevant ISO/IEC bodies for the possible development of ISO/ IEC standards for digital labelling for medical devices and IVDs (or for the update of an existing standard) – note that the standard itself will NOT be developed during the lifetime of the project.
• ensure appropriate knowledge dissemination via:
 developing training materials;
 subsequently finetuning training material for deployment to the public at large in all EU national languages: end users (HCPs, patients) / regulators (national competent authorities) / notified bodies in the EU Member States and any other relevant stakeholders;
 facilitating awareness and communication with other global jurisdictions’ digital label initiatives.

The indicative duration of the action is 36 months.

Further information:
https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/HORIZON-JU-IHI-2025-10-01-two-stage?isExactMatch=true&status=31094502&frameworkProgramme=43108390&order=DESC&pageNumber=1&pageSize=50&sortBy=startDate