MedTechLabel | Unified Digital Labelling for MDs & IVDs

Harmonized digital labelling ensuring safe and effective use within medtech

Overview
of the Project

Overview of the Project

MedTechLabel is a three-year (2026-2029) Innovative Health Initiative (IHI) project, that aims to harmonize and standardize Medical Devices (MD) and In Vitro Diagnostic (IVD) labelling. Our goal is to prepare and test the MedTechLabel framework specification for a unified digital labelling system for MDs and IVDs.

The MedTechLabel project is a public-private partnership that aims to develop and verify the MedTechLabel Framework specification, for a universal Digital Labelling system for medical devices (MDs) of all categories and classes, including in vitro diagnostic devices (IVDs). The framework specification will streamline digital labelling processes in compliance with EU regulations, being adaptable to national variations and future legislation, and secure global alignment.

Born in Europe with global relevance

Ambitions & Mission

In addition to the core EU regulations and standards for Medical Devices (MDs) and In Vitro Diagnostics (IVDs), manufacturers must comply with additional national, European and international requirements – such as the ones on environment and AI use, where legislation is still evolving. This growing complexity challenges everyone – manufacturers and users.

MedTechLabel will address two key challenges:

scalability and efficiency through more digitalization of labelling information
more accessible information for diverse users, with curated displays that support different roles and needs.

The MedTechLabel digital labelling framework specification seeks for consensus among all involved stakeholders: manufacturers, notified bodies (NB), regulators, health authorities, healthcare professionals, patients, and more. The digital labelling framework specification will be proposed in the form of an IWA (International Workshop Agreement) under ISO.

Project
Phases

Project Phases

April 2026 - March 2027

Project month 1 - 12

Identification and Consolidation of Requirements

This phase will identify, analyze, and consolidate regulatory requirements, available standards, reported research, and user needs and expectations as a comprehensive foundation for effective framework specification.

December 2026 - December 2028

Project month 9 - 33

Development of testing Sandbox and Validation activities

The outcome of this phase is to set up test environment and validate the MedTechLabel framework specification through a modular and interoperable Sandbox.

September 2027 - March 2029

Project month 18 - 36

Formalization and Recommendations

This phase will develop a comprehensive implementation strategy for the MedTechLabel Framework specification. It will create recommendations to support decision-making on digital medical labelling: for the European Commission, Member States, and other stakeholders. The final MedTechLabel Framework specification will be formalized in an ISO IWA (International Workshop Agreement).

June 2026 - March 2029

Project month 4-36

Consensus-building

Constant stakeholder engagement, with iterative input for value articulation

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. 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 information.

Prof. Anne Moen | University of Oslo
MedTechLabel Scientific Coordinator

From the industry perspective, there is an urgent need to harmonize and standardize digital labelling to significantly enhance operational efficiency and regulatory compliance. The collaboration in MedTechLabel promises strong and unique results that will progress much-needed evolution; harmonization and standardization of the medical technology products (MD/IVD) labelling practices.

Roger Peterson | Arthrex GmbH
MedTechLabel Industry Lead