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CORE-MD

financed

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Coordinating Research and Evidence for Medical Devices

CORE–MD will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators, to achieve an appropriate balance between innovation, safety, and effectivenes... see more

31/03/2024

ESC/ SEC

2M€

Project Budget: 2M€

Project leader

SOCIETE EUROPEENNE DE CARDIOLOGIE No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

PARTICIPATION DEPralty Sin fecha límite de participación.

Ver 23 Participantes

Financing granted El organismo H2020 notifico la concesión del proyecto The day 2024-03-31

SC1-HCO-18-2020: Developing methodological approache... Specific Challenge:In May 2017, a new Regulation on medical devices, Regulation (EU) 2017/745[1] ent...

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characteristics of the participant

Este proyecto no cuenta con búsquedas de partenariado abiertas en este momento.

Private Information

No hay información privada compartida para este proyecto. Habla con el coordinador.

23 Participantes

ESC/ SEC

448.14K€ | Leader

KEMIRA IBERICA

300.54K€ | participant

UOXF

135.57K€ | participant

KU Leuven

100.03K€ | participant

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Project duration: 38 months Date Start: 2021-01-15
End date: 2024-03-31

Project leader

SOCIETE EUROPEENNE DE CARDIOLOGIE No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Project Budget 2M€

participation deadline Sin fecha límite de participación.

Project description CORE–MD will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators, to achieve an appropriate balance between innovation, safety, and effectiveness. A unique collaboration between medical associations, regulatory agencies, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies, will systematically review methodologies for the clinical investigation of high-risk medical devices (Work Package 1), recommend how new trial designs can contribute (Work Package 2), and advise on methods for aggregating real-world data from medical device registries with experience from clinical practice (Work Package 3). Multidisciplinary workshops will propose a hierarchy of levels of evidence from clinical investigations; educational and training objectives for all stakeholders, to build expertise in regulatory science in Europe; and an ethics charter for medical device innovation (Work Package 4). Industry participation will be invited. Specific CORE–MD tasks will advise on optimal statistical methods, the utility of patient-reported outcomes, the conduct of registry trials, clinical criteria for evaluating artificial intelligence as a medical device, and how to evaluate medical devices used in children. The essential principles of medical device trials will be considered jointly with the Good Clinical Trials Collaborative. Links between CORE–MD partners will catalyse sustainable networks for research. The consortium is led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, and involves all 33 specialist medical associations that are members of the Biomedical Alliance in Europe. Final recommendations will be submitted to the Working Group on Clinical Investigation and Evaluation of the European Commission to be considered when developing EU guidance or common specifications.

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