Digitalisation of conformity assessment procedures of medical devices and in vitro diagnostic medical devices

The grant opportunity titled HORIZON-HLTH-2025-01-IND-02 focuses on the digitalization of conformity assessment procedures for medical devices and in vitro diagnostic medical devices under the Horizon Europe program, specifically within the Health Cluster. This Coordination and Support Action aims to enhance regulatory processes, making them more efficient and predictable for manufacturers, especially small and medium-sized enterprises (SMEs).

Eligible applicants include research institutes, universities, regulatory bodies, notified bodies, device developers, manufacturers, expert panels, and agencies involved in the consultation activities. Participation from entities based in the United States is permitted under specific circumstances.

The funding mechanism is a HORIZON Lump Sum Grant with a total budget of 4 million euros, allocated to a single project. The application process is a single-stage open call, with submissions required by September 16, 2025.

The project targets the health sector, focusing on improving the digitalization of the conformity assessment procedures impacted by the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Device Regulations (IVDR). Proposals should include feasibility studies, pilot projects, and a roadmap for implementing the digitalization strategy.

Key activities include reviewing existing initiatives, evaluating processes in other jurisdictions, developing a pilot, and creating a comprehensive roadmap for scaling digitalization efforts. This initiative aims to reduce administrative burdens and enhance communication between manufacturers and regulatory bodies, facilitating quicker market access for innovative devices.

Eligibility extends to applicants from EU member states and associated countries, with a likelihood that collaboration across multiple stakeholders will be necessary. Without the need for co-funding due to the lump sum grant structure, the call prioritizes actionable solutions rather than exploratory research. The average success rates for Horizon Europe grants typically vary between 10% and 39%.

Overall, this grant represents a significant opportunity to streamline compliance processes in the medical devices sector while fostering innovation within the European Union's health industry. The deadline for applications is firm at September 16, 2025, with the aim of improving safety and efficiency in medical device regulation.

This is a description of the EU funding opportunity HORIZON-HLTH-2025-01-IND-02, titled "Digitalisation of conformity assessment procedures of medical devices and in vitro diagnostic medical devices". This call falls under the Horizon Europe (HORIZON) program, specifically the Cluster 1 - Health (Single stage - 2025) call. It is a HORIZON Coordination and Support Action (HORIZON-CSA) and uses the HORIZON Lump Sum Grant [HORIZON-AG-LS] model grant agreement. The call is currently open for submission with a deadline of 16 September 2025, 17:00:00 Brussels time. The opening date was 22 May 2025.

The expected outcome of this topic is to support activities that enable or contribute to several expected impacts of maintaining an innovative, sustainable, and competitive EU health industry. Proposals should aim to deliver results that contribute to the following expected outcomes: Notified Bodies (NBs), device developers, and manufacturers adopt digitalisation in their conformity assessment procedures, facilitating device development. Digitalisation of steps involving regulatory authorities (e.g., consultation of medicines authorities) would also bring relevant benefit. Device developers and manufacturers have access to digitalised conformity assessment procedures, making these procedures more efficient, less onerous, and more predictable, reducing costs and shortening time to market. Device developers and manufacturers, particularly SMEs, can direct a larger part of their resources towards the research and development of innovative devices.

The scope of this topic addresses the challenges faced by manufacturers, especially SMEs, in implementing the stricter regulatory requirements introduced by the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). A key issue is the complexity and unpredictability of the conformity assessment procedure involving a Notified Body. The Medical Device Coordination Group (MDCG) assists in harmonizing the implementation of MDR and IVDR. Current conformity assessment procedures rely on the exchange of complex technical documentation in electronic formats (e.g., pdf, excel) between NBs and manufacturers, requiring multiple iterations. Digitalisation aims to improve efficiency, accuracy, and transparency, leading to a more predictable and harmonized assessment process. This is expected to reduce administrative burden, certification timelines, and facilitate conformity assessment, particularly for SMEs, contributing to a business-friendly environment and benefiting patients. Digitalisation can simplify processes through reduced administrative burden and a single-entry point for information exchange. Potential improvements include pre-defining mandatory data elements, alerts for data completeness, identification of missing parts and inconsistencies, and reduced error rates. Improved communication is anticipated with digitalisation. Actions must be performed under the current regulatory framework without changing MDR/IVDR requirements and should present a major step towards digitalisation in Europe and Associated Countries. Governance of a potential IT infrastructure is outside the scope.

Proposals should cover all steps of the MDR/IVDR procedures, from manufacturer's preparation to certificate issuance; all actors involved, including manufacturers, NBs, EU reference laboratories, expert panels, and agencies involved in consultation; and a good representation of different NBs, focusing on consensus building.

The proposals should address the following activities:

Feasibility study: Review existing digitalisation initiatives for MDR/IVDR conformity assessment, investigate procedures in other jurisdictions (e.g., US FDA), and consider lessons learned from other areas. Examine basic processes/workflows of individual NBs. Identify key steps for digitalisation, actors involved, and essential elements. Collect stakeholder feedback on challenges and feasibility, identify interoperability with existing workflows, determine technical specifications, and analyse facilitating factors, challenges, solutions, and resources.

Pilot: Develop a pilot for the whole or part of the MDR/IVDR conformity assessment procedure, including Key Performance Indicators (KPIs), in collaboration with stakeholders, including NBs, manufacturers, the European Commission, and other involved parties. Develop a dedicated platform or identify an existing platform suitable for the pilot.

Roadmap towards digitalisation: Based on pilot lessons, identify steps to scale up the pilot for digitalising MDR/IVDR conformity assessment procedures, addressing challenges and solutions. Present a roadmap, including alternatives, actors involved, and resources needed.

The call specifies that the term "devices" includes both medical devices and in vitro diagnostic medical devices, unless otherwise specified. It also references a study commissioned by the European Commission’s Directorate-General for Health and Food Safety via the European Health and Digital Executive Agency regarding monitoring the availability of medical devices in the EU market.

The general conditions for this funding opportunity include: Admissibility Conditions (Annex A and Annex E of the Horizon Europe Work Programme General Annexes), Proposal page limits and layout (Part B of the Application Form), Eligible Countries (Annex B of the Work Programme General Annexes), Other Eligible Conditions (Annex B of the Work Programme General Annexes, including US National Institutes of Health participation), Financial and operational capacity and exclusion (Annex C of the Work Programme General Annexes), Evaluation and award criteria, scoring, and thresholds (Annex D of the Work Programme General Annexes, with thresholds of 4 for Excellence, Impact, and Implementation, and a cumulative threshold of 12), Submission and evaluation processes (Annex F of the Work Programme General Annexes and the Online Manual), Indicative timeline for evaluation and grant agreement (Annex F of the Work Programme General Annexes), and Legal and financial set-up of the grants (Annex G of the Work Programme General Annexes). Eligible costs will take the form of a lump sum.

Application and evaluation form templates, guidance documents, model grant agreements, and additional documents are available in the Submission System and the Funding & Tenders Portal.

The budget overview lists several topics under the same call, each with its own budget, stage, opening date, deadline, contribution amounts, and indicative number of grants. The topic described here, HORIZON-HLTH-2025-01-IND-02, has a budget of 4,000,000 EUR for the year 2025, is a single-stage call, opened on 22 May 2025, with a deadline of 16 September 2025, and an indicative contribution of around 4,000,000 EUR with one indicative grant.

There are 30 partner search announcements related to this topic.

In summary, this funding opportunity aims to improve the efficiency and predictability of conformity assessment procedures for medical devices and in vitro diagnostic medical devices by promoting digitalisation. It seeks proposals that address the challenges faced by manufacturers, particularly SMEs, in complying with MDR and IVDR regulations. The projects should conduct feasibility studies, develop pilot programs, and create roadmaps for scaling up digitalisation efforts across Europe and Associated Countries. The funding is provided as a lump sum, and the call is open to legal entities from EU Member States and Associated Countries, with certain exceptions for US entities. The deadline for submission is September 16, 2025.

Eligible Applicant Types: The eligible applicant types include notified bodies, device developers, manufacturers, EU reference laboratories, expert panels of medical devices, agencies involved in the consultation activities, and SMEs. The call aims for a good representation of different notified bodies, including small and large, public and private, and a representative mix focusing on medical devices and in vitro diagnostic medical devices. Coordinators of projects must be legal entities established in an EU Member State or Associated Country. Legal entities established in the United States of America may exceptionally participate as a beneficiary or affiliated entity, and are eligible to receive Union funding.

Funding Type: The funding type is a grant, specifically a HORIZON Lump Sum Grant, under HORIZON Coordination and Support Actions (CSA) and HORIZON Research and Innovation Actions (RIA) and Innovation Actions (IA).

Consortium Requirement: The opportunity requires a consortium. The proposals should include all actors involved in the conformity assessment procedure, including manufacturers, NBs, EU reference laboratories, expert panels of medical devices, as well as agencies involved in the consultation activities and a good representation of different NBs, including representation from small and large NBs, public and private NBs and a representative mix focusing on medical devices and in vitro diagnostic medical devices.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility includes EU Member States and Associated Countries. A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. Legal entities established in the United States of America may exceptionally participate as a beneficiary or affiliated entity, and are eligible to receive Union funding.

Target Sector: The target sector is health, specifically focusing on the medical devices and in vitro diagnostic medical devices industry. The program targets the digitalisation of conformity assessment procedures related to Medical Device Regulations (MDR) and In Vitro Diagnostic Medical Device Regulations (IVDR).

Mentioned Countries: United States of America, EU Member States, Associated Countries.

Project Stage: The project stage involves feasibility study, pilot, and roadmap towards digitalization. It encompasses reviewing existing initiatives, examining processes, identifying steps for digitalisation, collecting feedback, determining technical specifications, developing a pilot, and creating a roadmap for scaling up the pilot.

Funding Amount: The funding amounts vary depending on the specific topic within the call:
HORIZON-HLTH-2025-01-CARE-01: EUR 40,000,000 (Contributions: EUR 15,000,000 to EUR 20,000,000)
HORIZON-HLTH-2025-01-DISEASE-01: EUR 45,000,000 (Contributions: around EUR 15,000,000)
HORIZON-HLTH-2025-01-DISEASE-03: EUR 50,000,000 (Contributions: around EUR 10,000,000)
HORIZON-HLTH-2025-01-DISEASE-04: EUR 35,000,000 (Contributions: EUR 6,000,000 to EUR 8,000,000)
HORIZON-HLTH-2025-01-DISEASE-05: EUR 2,000,000 (Contributions: around EUR 2,000,000)
HORIZON-HLTH-2025-01-DISEASE-06: EUR 20,000,000 (Contributions: EUR 3,000,000 to EUR 4,000,000)
HORIZON-HLTH-2025-01-DISEASE-07: EUR 30,000,000 (Contributions: around EUR 6,000,000)
HORIZON-HLTH-2025-01-IND-01: EUR 40,000,000 (Contributions: EUR 6,000,000 to EUR 8,000,000)
HORIZON-HLTH-2025-01-IND-02: EUR 4,000,000 (Contributions: around EUR 4,000,000)
HORIZON-HLTH-2025-01-TOOL-01: EUR 50,000,000 (Contributions: EUR 8,000,000 to EUR 10,000,000)
HORIZON-HLTH-2025-01-TOOL-02: EUR 40,000,000 (Contributions: EUR 9,000,000 to EUR 13,000,000)
HORIZON-HLTH-2025-01-TOOL-03: EUR 50,000,000 (Contributions: EUR 15,000,000 to EUR 17,000,000)
HORIZON-HLTH-2025-01-TOOL-05: EUR 80,000,000 (Contributions: EUR 4,000,000 to EUR 8,000,000)

Application Type: The application type is an open call with a single-stage submission process.

Nature of Support: The beneficiaries will receive money in the form of a lump sum grant.

Application Stages: The application process involves a single stage.

Success Rates: The indicative number of grants varies per topic, ranging from 1 to 10.

Co-funding Requirement: The eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme.

Summary:
This Horizon Europe call focuses on the digitalisation of conformity assessment procedures for medical devices and in vitro diagnostic medical devices, aiming to support a more innovative, sustainable, and competitive EU health industry. The call, under the Cluster 1 Health, includes various topics (HORIZON-HLTH-2025-01-CARE-01, HORIZON-HLTH-2025-01-DISEASE-01, HORIZON-HLTH-2025-01-DISEASE-03, HORIZON-HLTH-2025-01-DISEASE-04, HORIZON-HLTH-2025-01-DISEASE-05, HORIZON-HLTH-2025-01-DISEASE-06, HORIZON-HLTH-2025-01-DISEASE-07, HORIZON-HLTH-2025-01-IND-01, HORIZON-HLTH-2025-01-IND-02, HORIZON-HLTH-2025-01-TOOL-01, HORIZON-HLTH-2025-01-TOOL-02, HORIZON-HLTH-2025-01-TOOL-03, HORIZON-HLTH-2025-01-TOOL-05), each with specific objectives and funding allocations. The primary goal is to streamline and improve the efficiency, accuracy, and transparency of conformity assessment procedures, particularly for SMEs, by transitioning from document-driven to data-driven processes. Eligible applicants include notified bodies, device developers, manufacturers, EU reference laboratories, expert panels, and relevant agencies from EU Member States and Associated Countries, with potential participation from US entities. The funding mechanism is a lump sum grant, and projects should include feasibility studies, pilot programs, and roadmaps for digitalisation. The call emphasizes the importance of consensus building among stakeholders and aims to reduce administrative burdens and certification timelines, fostering a business-friendly environment and benefiting patients through enhanced safety and public health.