Project description
New ways to test high-risk medical devices
Manufacturers of medical devices need to test their products before being allowed to market them. Specifically, they require clinical data showing their medical device is safe and efficient. In this context, the EU-funded CORE-MD project will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators. The project will propose how new trial designs can contribute and suggest ways to aggregate real-world data from medical device registries. It will also conduct multidisciplinary workshops to propose a hierarchy of levels of evidence from clinical investigations, as well as educational and training objectives for all stakeholders, to build expertise in regulatory science in Europe.
Objective
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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CSA - Coordination and support actionCoordinator
06903 Biot Sophia Antipolis
France
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Participants (22)
1180 Rolle
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1000 Bruxelles / Brussel
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1050 Bruxelles / Brussel
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BRUSSELS Brussels / Bruxelles
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2333 ZA Leiden
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OX1 2JD Oxford
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751 25 Uppsala
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2 Dublin
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3010 Bern
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3000 Leuven
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6060 HALL IN TYROL
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405 30 Goeteborg
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20133 Milano
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2 Dublin
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2300 Kobenhavn S
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02-222 Warsaw
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3721 MA Bilthoven
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00161 Roma
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1090 Wien
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41092 Sevilla
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
18071 Granada
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4140 Sprimont
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