HORIZON EUROPE
Europeo
Specific Challenge:In May 2017, a new Regulation on medical devices, Regulation (EU) 2017/745[1] entered into force that will come into effect in spring 2020. This new Regulation sets forth reinforced rules for the generation of clinical evidence: for instance, clinical investigations [2] for high-risk devices will be compulsory [3] and the requirements regarding the clinical evaluation[4] throughout the product lifetime are more stringent.Medical devices have particularities that make the conduct of clinical investigations difficult. Taking into account these particularities, there is a need for methodologies that enable to generate improved clinical evidence. New developments in medical technologies such as mHealth, artificial intelligence, and combination products, pose additional challenges and opportunities for developers[5] to generate high-quality clinical evidence.Owing to rapid scientific progress and lack of knowledge on the regulatory frameworks among the scientific community, there is a need to raise awareness on new regulatory requirements in terms of clinical evidence. It is important to ensure a smooth transition from the former directive to the new regulatory framew... ver más
Specific Challenge:In May 2017, a new Regulation on medical devices, Regulation (EU) 2017/745[1] entered into force that will come into effect in spring 2020. This new Regulation sets forth reinforced rules for the generation of clinical evidence: for instance, clinical investigations [2] for high-risk devices will be compulsory [3] and the requirements regarding the clinical evaluation[4] throughout the product lifetime are more stringent.Medical devices have particularities that make the conduct of clinical investigations difficult. Taking into account these particularities, there is a need for methodologies that enable to generate improved clinical evidence. New developments in medical technologies such as mHealth, artificial intelligence, and combination products, pose additional challenges and opportunities for developers[5] to generate high-quality clinical evidence.Owing to rapid scientific progress and lack of knowledge on the regulatory frameworks among the scientific community, there is a need to raise awareness on new regulatory requirements in terms of clinical evidence. It is important to ensure a smooth transition from the former directive to the new regulatory framework, especially with regard to clinical evidence, by informing stakeholders involved in the clinical evaluation of high-risk medical devices (e.g. academic researchers, clinicians, manufacturers, notified bodies, contract research organisations). These challenges can be addressed by developing and promoting methodological approaches, including alternative statistical methodologies, adapted to the specificities of high-risk medical devices. These methodological approaches will improve the robustness of clinical data needed at different phases of the product’s lifetime, such as conformity assessment, post-market clinical follow-up, continuous clinical evaluation, post-market surveillance, and potentially relative effectiveness assessment.
Scope:To address these challenges, the proposals should focus on i) methods to generate clinical data both within the context of a clinical investigation and in daily practice (i.e. real-world data) so that robust clinical evidence is available for high-risk medical devices, and ii) aggregation methods that will allow to make optimal use of all available data taking into account its heterogeneity (e.g. meta-analysis methods using different statistical approaches, methods to combine data from different types of sources) and iii) promote exchange of best-practices and support network activities among developers. Proposals should in particular:
Analyse the particularities of high-risk medical devices and the potential resulting problems with regard to clinical evaluation, carry out a review of the currently used clinical investigation designs for the evaluation of such devices, provide a hierarchy of these approaches, identify gaps to be filled (in particular in view of new developments like e.g. mHealth, artificial intelligence, and combined products) and derive recommendations for the choice of clinical investigation methodology to obtain sufficient evidence.Develop methodologies for generating clinical data on high-risk medical devices enabling to collect sound data and to use data from different sources including real-world data. These methodologies should be adapted for the needs of conformity assessment and for continuous clinical evaluation throughout the lifetime of the device. Proposals should take into account the various specificities of high-risk medical devices and therapeutic areas if relevant.Contribute to the exchange of best practices among notified bodies with regard to the assessment of clinical data as provided by developers of high-risk medical devices.Support networking activities among developers and in particular academic centres with regard to regulatory requirements for assessing high-risk medical devices and foster a pool of scientific expertise on clinical evaluation of high-risk medical devices. Applicant consortia should bring together partners with relevant expertise from e.g. academia, competent national authorities, centres of expertise for clinical research and care, scientific and medical learned societies. The consortium should also seek input from relevant stakeholders such as technology developers, healthcare providers, health technology assessment agencies and patients, with special regard to endpoints that are relevant for patients. The composition of the consortium should ensure a broad geographical representation of European countries. Sex and gender aspects should be taken into account in carrying out the relevant activities.
Proposals should complement or build on existing work, including results of EU-funded research projects and Joint Actions in the field of medical devices evaluation, and related activities, like e.g. those of the Competent Authorities for Medical Devices (CAMD) and the successor Medical Devices Coordination Group (MDCG).
Proposals could consider the involvement of The European Commission Joint Research Centre (JRC) to provide added value regarding aspects like interfacing among the different stakeholders (e.g. developers and regulatory bodies) or contributing to European and international harmonization. In this respect the JRC is open to collaborate with any successful proposal.
The Commission considers that proposals requesting a contribution from the EU of between EUR 1 and 2 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amount.
Expected Impact:Higher quality and reliability of clinical data needed for conformity assessment and continuous market accessImproved knowledge of relevant legislative frameworks and regulatory requirements among all stakeholders involved in the development of high-risk medical devicesImproved evidence on safety and efficacy of high-risk medical devices for the benefit of the patient and health systems.
Cross-cutting Priorities:GenderOpen Innovation
[1]Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
[2]As defined in Article 2 (44) of the Regulation (EU) 2017/745
[3]as provided for in Article 61.4 of the Regulation (EU) 2017/745 : implantable and class III devices with the exceptions listed in Article 61.5 and 61.6. Those devices are referred to as “high-risk” devices in the text.
[4]As defined in Article 2 (45) of the Regulation (EU) 2017/745
[5]Developers include manufacturers and other entities active in the development of medical devices
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Características del consorcio
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La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Características del Proyecto
Los costes de personal subvencionables cubren las horas de trabajo efectivo de las personas directamente dedicadas a la ejecución de la acción. Los propietarios de pequeñas y medianas empresas que no perciban salario y otras personas físicas que no perciban salario podrán imputar los costes de personal sobre la base de una escala de costes unitarios
Los otros costes directos se dividen en los siguientes apartados: Viajes, amortizaciones, equipamiento y otros bienes y servicios. Se financia la amortización de equipos, permitiendo incluir la amortización de equipos adquiridos antes del proyecto si se registra durante su ejecución. En el apartado de otros bienes y servicios se incluyen los diferentes bienes y servicios comprados por los beneficiarios a proveedores externos para poder llevar a cabo sus tareas
La subcontratación en ayudas europeas no debe tratarse del core de actividades de I+D del proyecto. El contratista debe ser seleccionado por el beneficiario de acuerdo con el principio de mejor relación calidad-precio bajo las condiciones de transparencia e igualdad (en ningún caso consistirá en solicitar menos de 3 ofertas). En el caso de entidades públicas, para la subcontratación se deberán de seguir las leyes que rijan en el país al que pertenezca el contratante
Características de la financiación
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 2020 projects. See the information in the Online Manual.
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding to support its participation in projects supported under this topic.
2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme.
Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.
3. Evaluation:
Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
Submission and evaluation processes are described in the Online Manual.
The thresholds for each criterion in a single stage process will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
4. Indicative time for evaluation and grant agreements:
Information on the outcome of evaluation (single-stage call): maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submi... 1. Eligible countries: described in Annex A of the Work Programme.
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 2020 projects. See the information in the Online Manual.
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding to support its participation in projects supported under this topic.
2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme.
Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.
3. Evaluation:
Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
Submission and evaluation processes are described in the Online Manual.
The thresholds for each criterion in a single stage process will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
4. Indicative time for evaluation and grant agreements:
Information on the outcome of evaluation (single-stage call): maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
Coordination and Support Action:
Specific provisions and funding rates
Standard proposal template
Standard evaluation form
General MGA - Multi-Beneficiary
Annotated Grant Agreement
Essential information for clinical studies
6. Additional provisions:
Horizon 2020 budget flexibility
Classified information
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.
Members of consortium are required to conclude a consortium agreement, in principle prior to the signature of the grant agreement.
8. Additional documents:
Introduction WP 2018-20
Health, demographic change and well-being WP 2018-20
General annexes to the Work Programme 2018-2020
Legal basis: Horizon 2020 Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme
7. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.
Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.
Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.
Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.
Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.
Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.
The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.
Información adicional de la convocatoria
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