6 November 2026, we presented first research resuls on labelling practices and use cases. With 34 participants from manufacturing, labelling consulting and research, we explored the real-world status and future potentials for digital labelling in practice.
Lene Lunde (University of Oslo) moderated the webinar, framing it as an important early research output enabling the project to meet manufacturers’ needs.
Carla Scarlato presented initial findings from MedTechLabel’s research into current digital labelling practices, based on 30 practices identified through desk research and survey responses by manufacturers and Notified Bodies. Results show that digital labelling is growing but remains far from widespread adoption. Digital instructions for use (eIFUs) are the most common application, often provided as PDFs rather than structured, machine-readable information. Access methods remain fragmented, including manufacturer websites, QR codes and barcodes. While regulatory compliance, cost savings and sustainability drive adoption, unclear requirements, technical complexity and limited resources remain major barriers. The findings highlight the need for common standards, structured information and a single point of access to reliable device information. The survey remains open for answers by manfucturers and can be accessed here.
Per Kjærsgaard-Andersen presented 36 Use Scenarios for digital medical labelling developed to date, covering manufacturers, Notified Bodies and regulators, health authorities and procurers, and healthcare professionals. Examples illustrated how digital labelling could simplify packaging, support conformity assessment and procurement, and improve access to critical implant information in clinical practice. The scenarios will now be consolidated and evaluated through a three-round Delphi process in November–December 2026, involving experts from different stakeholder groups. The results will inform the development and validation of the MedTechLabel Framework. Stakeholders can get in touch to participate in the Delphi process via email to Anouck.Barba[at]efort.org
Input from the audience during the webinar highlighted that they perceive unclear rules as the biggest factor that is holding back digital labelling, which would greatly be accelerated by clear legal requirements. They see the biggest potential for digital labelling in having one single access point for all device information and would prefer to access this information by scanning a code on the package. Audience also suggested some additional use scenarios to cover – such as procurement, customs requirements and patients.
With this webinar, we link the regulatory and standards basis presented in September to the real-world practices for labelling currently in use. This gives us a solid basis in the next steps towards developing a unified digital labelling information framework for medical technology products.
