While many medical devices are shrinking, the list of information that has to be included on the printed label is growing. As a result, labels are packed with text, often in tiny fonts, and users (such as patients and healthcare professionals) struggle to find and read the information they need. What’s more, updates to just one element of a leaflet require the whole thing to be reprinted. On the manufacturers’ side, keeping up to date with the rules on what has to be included on labels represents a significant administrative burden.
The goal: a consensus, based universal digital labelling framework
The aim of MedTechLabel is to develop and verify a universal digital labelling framework for medical devices (MDs) of all categories and classes, including in vitro diagnostic devices (IVDs). The MedTechLabel framework seeks to harmonise and standardise digital labelling process in compliance with EU rules and will be adaptable to local rules as well as future legislation. Users would be able to access the digital label quickly and easily by scanning a QR code with their smartphone, for example.
'With the MedTechLabel public-private partnership, we set out to deliver a consensus-based digital labelling framework specification with required information for digital labelling of MDs and IVDs of all categories and classes,’ said the project’s scientific coordinator, Anne Moen of the University of Oslo. ‘Our ambition is to reshape MD and IVD labelling practices, improve user experience and add value by addressing pressing needs for consistent and comprehensive digital labelling.’
Keys to success: strong stakeholder engagement and collaboration
The MedTechLabel Framework necessitates robust stakeholder engagement, effective collaboration for the creation of user-friendly digital labelling standards, seamless integration with existing systems, and compliance with relevant MD/IVD regulations. The project will start by reviewing existing rules and standards relating to labelling, as well as the latest research on the subject. They will systematically explore the needs and expectations of key stakeholder groups, namely manufacturers and supply chain partners, notified bodies (NB) and regulators, health authorities and procurers, healthcare professionals, and patients.
The team will then draw on this information, as well as existing technologies, to create a modular, interoperable sandbox to test the framework. The project will validate its work via four use scenarios (manufacturers; NBs and regulators; health authorities and procurers; and healthcare professionals and patients) with a set of use cases for each scenario focusing on different stakeholder groups. The results will allow the project to refine and improve the framework.
Finally, the project will prepare a strategy to implement the framework. Part of this will focus on EU level decision makers, national authorities and regulators.
A framework that is ‘born in Europe, applicable worldwide’
The project’s ambition is to deliver a framework that is ‘born in Europe, applicable worldwide’. To this end, it will target an International Organization for Standardization (ISO) international workshop agreement (IWA) to boost standards development and uptake of the MedTechLabel framework internationally.
‘From the industry perspective, there is an urgent need to harmonise and standardise digital labelling to significantly enhance operational efficiency and regulatory compliance,’ explained Roger Petersen of Arthrex, the project’s industry lead. ‘The collaboration in MedTechLabel promises strong and unique results that will progress much-needed evolution; harmonisation and standardisation of the medical technology products (MD/IVD) labelling practices.’
MedTechLabel is set to have a wide range of impacts. Patients and healthcare professionals will have easier access to up-to-date, targeted information in the language of their choice. Manufacturers will benefit from a streamlined approach to packaging and labelling requirements. And finally, reducing the size of the printed label would make the delivery of product information much greener.