Let’s Talk Labeling: MedTechLabel Framework specification for unified MD and IVD digital labeling

MedTechLabel public-private partnership will prepare the MedTechLabel framework specification to standardize and harmonize digital device labelling information for global use, in compliance with EU regulations, adaptable to national variations and alignment with future legislation and relevant standards. This can be a universal Digital Labelling system that can cover all categories and classes of medical technology products; MDs and IVDs. MedTechLabel address two key challenges: i) scalability and efficiency by more digitalization of device labelling information, and ii) more accessible device labelling information for diverse users, exploring curated displays that support different roles, needs and levels of a user's MD/IVD knowledge. MedTechLabel framework specification seeks for broad consensus across the device labelling value chain, spanning manufacturers, notified bodies (NB), regulators, health authorities, to healthcare professionals, patients, and more.

What You’ll Learn

This session is for professionals who create, review, approve, or rely on medical device and IVD labeling, including:

• Regulatory affairs and labeling teams at MD and IVD manufacturers
• Quality and compliance leaders who manage labeling processes and change control
• Teams planning or running eIFU, UDI, or digital labeling projects
• Packaging, artwork, and technical documentation specialists
• Notified bodies, regulators, and health authority representatives

Speakers

• Dr. Anne Moen - Professor at the University of Oslo and Scientific Coordinator at IHI MedTechLabel