A digital label is a form of e-labelling provided as an array of elements supporting a medical technology product, which is additional to critical information on the printed label (identification and traceability of the device, warnings and precautions, handling and use information). Access to the digital label is achieved, for example in the form of barcodes, 2D data matrix, QR codes, etc., which provides a scannable link to curated digital landing pages (websites) where the additional information will be displayed.

While many medical technology products are decreasing in physical size, mandatory requirements for additional product compliance information are growing, which leads to various problems. Users might find it difficult to locate the desired information on the label due to the extensive text and small print.
Manufacturers have to update their entire physical label if they change an economic operator. Such label changes have an impact on the environment, product availability and inventory and they cause inefficiencies and ultimately raise costs. Local requirements for the label regarding device disposal are rising and lead to increased amounts of packaging (and therefore later increased amounts of waste). In case of new environmental legislation, the physical label needs also to be updated during the device’s lifetime.

• Note that this topic does not cover medicinal products, except combination products that fall under the scope of MDR/IVDR regulations and are, therefore, regulated as devices.
• Furthermore, this topic does not directly address the electronic provision of IFU (instructions for use) as this is already allowed for certain medical devices and IVDs in the EU. Access to eIFU through the digital label is only an additional benefit to facilitate access to all relevant information in one place (on top of the means of delivery allowed currently by MDR/IVDR).
• The scope of this topic does not address post market surveillance aspects.

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.

Applicants should develop a strategy and plan for generating appropriate evidence as well as for engaging and formally consulting with regulators (e.g. national competent authorities).