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

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 in multiple languages (EU Packaging and Packaging Waste Regulation EU Battery regulation, information on spare parts, etc.), hereby contributing to the European Green Deal.

4.Increased competitiveness in the EU market thanks to improved supply management and streamlined packaging and labelling operations.

5.Driving acceptance through (voluntary) adoption of digital labels by medical device manufacturers and their use by end users, notified bodies, national competent authorities in the European market, supported by the developed training material. Digital label is considered an additional tool to requirements in current legislation (MDR, IVDR).

1 https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=OJ:L_202401860

Expected Outcome:The action under this topic must contribute to all of the following outcomes:

1. A consensus-based digital label concept/framework for medical devices and in vitro diagnostic medical devices (IVDs) is available to be used by manufacturers that meets end users’ requirements and addresses regulators’ demands.

2. Multiple valid and scalable digital label solutions based on a standardised approach are available and they:

• all work with the same enabler (label reader) for all medical technology product labels (all medical devices and IVDs, all types, all classes). This topic does not cover pharmaceutical products as such. Combination products that fall under the scope of regulations on medical devices and in vitro diagnostic medical devices (MDR/IVDR) are, therefore, regulated as devices and are considered to be part of this topic;
• serve as an up-to-date single point of access to all information about the specific device;
• are interoperable with other EU legislation (such as digital product passport) and national legislation (e.g. language requirements);
• consider accepted international standards for data carriers1;
• are acceptable after verification via user testing.

3. Evidence-based recommendations are available that may inform the European Commission’s and the national competent authorities’ policy recommendations.

4. Training materials on digital labels are available to the end users (healthcare professionals (HCPs) and patients), regulators (national competent authorities) and notified bodies in the EU Member States.

5. A basis towards future international acceptance is created via:

• documentation gathered that would be needed to launch a proposal for a new digital label standard or adaptation of an existing standard2 under the International Organisation for Standardisation / International Electrotechnical Commission (ISO/IEC) – note that development of a standard itself is not planned during the lifetime of the project;
• awareness raising with other international jurisdictions that consider digital label initiatives.

1 Note: The term data carrier is synonymous with the ISO 19762 definition of Automatic Identification and Data Capture (AIDC) technologies (e.g., bar codes, smart cards, radio frequency identification, (RFID), etc.

2 e.g. ISO 20417 already offers a segway for digital label. This standard is also foreseen for harmonisation with MDR.

Scope: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.

Under the current Regulations on medical devices and in vitro diagnostic medical devices (MDR/IVDR: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical) both critical information as well as additional information have to be included on the product’s printed label.

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.

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.

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). Finally, 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).