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MedTechLabel: UNIFIED DIGITAL LABELLING FOR MEDICAL TECHNOLOGY PRODUCTS

Objective

This public-private partnership will develop and verify the MedTechLabel Framework, a universal Digital Labelling system for medical devices (MDs) of all categories and classes, including in vitro diagnostic devices (IVDs). The framework specification will standardize digital labelling processes in compliance with EU regulations, being adaptable to national variations and future legislation and secure global alignment.
By engaging stakeholders, manufacturers, notified bodies (NB), regulators, health authorities and procurers as well as health care professionals (HCPs) and patients, MedTechLabel will promote an efficient MD/IVD ecosystem of manufacturers, regulators and medical device users. We will review legislation and standards, analyze labelling practices, summarize available research knowledge and gather stakeholder requirements to develop and verify a consensus-driven digital labelling framework for MDs/IVDs.
We will utilize existing technologies to create a sandbox for verification of the MedTechLabel Framework in a set of use cases with MD/IVD digital content. This will assess usefulness and benefits of the Framework by various stakeholders and demonstrate added value of a standardized approach for digital labelling to manufacturers, label users, NBs and regulators. The verification process will progress to an International Workshop Agreement (IWA) for further consensus on ISO standards and recommendations to inform future policies, offering a foundation for future legislation.
The recommendations will address the European Commission and national authorities, focus on future standardization and policies for scaling up efficiencies, reduce carbon footprint and water waste of MD print labels (Green Deal). Our consortium will ensure effective knowledge dissemination to key stakeholders across EU Member States, align with digital transformation efforts and exploit project outputs globally to effectively sustain MedTechLabel’s ambition to deliver a Framework for comprehensive MD/IVD labelling information.

Fields of science (EuroSciVoc)

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Keywords

Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)

Programme(s)

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Topic(s)

Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.

Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) HORIZON-JU-IHI-2025-10-two-stage

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Coordinator

UNIVERSITETET I OSLO
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 748 331,25
Address
PROBLEMVEIEN 5-7
0313 Oslo
Norway

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Region
Norge Oslo og Viken Oslo
Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 748 331,25

Participants (19)

Partners (6)

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