Project description
A unified digital labelling framework for all types of medical devices
Medical device labelling has evolved from basic product names and simple printed warnings into lengthy documents. Today, labelling includes written instructions and/or printed or graphic designs on the device, its packaging or accompanying materials. There is a need for harmonised, standardised labelling information that leverages digital access and meets EU rules for safety, transparency, sustainability and recycling. With this in mind, the EU-funded MedTechLabel project is developing a universal digital labelling framework specification for all medical devices, including in vitro diagnostics. Through a public-private partnership, the project brings together key stakeholders to review current practices, define requirements and secure consensus about the specification. The specification will be tested in real-world use cases in a sandbox environment, showing benefits for manufacturers, regulators and healthcare users.
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)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
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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)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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HORIZON.2.1 - Health
MAIN PROGRAMME
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HORIZON.2.1.7 - Innovative Health Initiative
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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.
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.
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.
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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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.
0313 Oslo
Norway
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Participants (19)
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81249 MUNCHEN
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08018 Barcelona
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9050 GENTBRUGGE
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1050 Bruxelles / Brussel
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H91 Galway
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1000 Bruxelles / Brussel
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265 04 PATRAS
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53111 Bonn
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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.
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.
7471 WW GOOR
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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.
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3521 AZ Utrecht
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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.
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.
8400 Winterthur
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4140 Sprimont
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11415 TALLIN
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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.
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1180 ROLLE
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69280 Marcy-l'Etoile
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2340 Beerse
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3001 LEUVEN
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R35 H9O3 Tullamore
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93101 Santa Barbara
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Partners (6)
Partner organisations contribute to the implementation of the action, but do not sign the Grant Agreement.
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34108-1945 Naples
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Partner organisations contribute to the implementation of the action, but do not sign the Grant Agreement.
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6300 Zug
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Partner organisations contribute to the implementation of the action, but do not sign the Grant Agreement.
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118222 Singapore
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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.
Partner organisations contribute to the implementation of the action, but do not sign the Grant Agreement.
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3821 AB Amersfoort
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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.
Partner organisations contribute to the implementation of the action, but do not sign the Grant Agreement.
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1831 MACHELEN
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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.
Partner organisations contribute to the implementation of the action, but do not sign the Grant Agreement.
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.
NJ 08807 Bridgewater
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