HORIZON-JU-IHI-2025-10-01-two-stage: Digital label: one source of comprehensive information for medical technology products

16 January 2025|
Expected Impact:

The action to be funded under this topic is expected to achieve the following impacts:

1.Streamlined and 'green' delivery of information

  • Key information as well as additional information is easily (and more) visible, accessible and identifiable to users (HCPs, patients) and health authorities equipped with a simple smart device (e.g., phone or tablet device);
  • Significant reduction of carbon footprint and avoidance of over-labelling, hereby contributing to the European Green Deal.
  • 2.Improved accessibility of information for users (HCPs and patients) and regulators. All the information that users might need is available in one place in their language of choice, thus increasing equal access of users to medical technologies.

  • Targeted information based on user location: in the EU: summary of safety and clinical performance (SSCP), the European database for medical devices (EUDAMED) modules when available1; globally: electronic instructions for use (eIFU);
  • Crucial information from the printed label is additionally visible upon scanning (e.g. expiry date);
  • Connection to technical support in case of problems;
  • Reducing risk of use errors;
  • Real time updates;
  • Avoidance of cluttered labels.
  • 3.Increased alignment between MDR and other EU and national legislations and streamlined compliance for all. One digital carrier will directly link the user with the up-to-date information required by the Digital Product passport

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