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Coordinating Research and Evidence for Medical Devices

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.

Field of science

  • /medical and health sciences/clinical medicine/orthopaedics
  • /natural sciences/computer and information sciences/artificial intelligence

Call for proposal

H2020-SC1-2020-Single-Stage-RTD
See other projects for this call

Funding Scheme

CSA - Coordination and support action

Coordinator

SOCIETE EUROPEENNE DE CARDIOLOGIE
Address
Route Des Colles 2035
06903 Biot Sophia Antipolis
France
Activity type
Other
EU contribution
€ 448 140

Participants (21)

EFORT
Switzerland
EU contribution
€ 199 168,75
Address
Za La Piece 2
1180 Rolle
Activity type
Research Organisations
ALLIANCE FOR BIOMEDICAL RESEARCH IN EUROPE
Belgium
EU contribution
€ 52 023,75
Address
Avenue E. Mounier, 83
1000 Brussels
Activity type
Other
EUROPEAN ACADEMY OF PAEDIATRICS
Belgium
EU contribution
€ 58 562,50
Address
Avenue De La Couronne 20
1050 Bruxelles
Activity type
Other
FORUM DES PATIENTS EUROPEENS
Belgium
EU contribution
€ 57 650
Address
Chaussee D Etterbeek 180
BRUSSELS 1040
Activity type
Other
ACADEMISCH ZIEKENHUIS LEIDEN
Netherlands
EU contribution
€ 367 895
Address
Albinusdreef 2
2333 ZA Leiden
Activity type
Higher or Secondary Education Establishments
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
EU contribution
€ 101 966,25
Address
Wellington Square University Offices
OX1 2JD Oxford
Activity type
Higher or Secondary Education Establishments
REGION UPPSALA
Sweden
EU contribution
€ 92 220
Address
Po Box 602
751 25 Uppsala
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
ROYAL COLLEGE OF SURGEONS IN IRELAND
Ireland
EU contribution
€ 109 900
Address
Saint Stephen's Green 123
2 Dublin
Activity type
Higher or Secondary Education Establishments
INSEL GRUPPE AG
Switzerland
EU contribution
€ 140 000
Address
Freiburgstrasse 18
3010 Bern
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
EU contribution
€ 100 026,25
Address
Oude Markt 13
3000 Leuven
Activity type
Higher or Secondary Education Establishments
UMIT- PRIVATE UNIVERSITAT FUR GESUNDHEITSWISSENSCHAFTEN, MEDIZINISCHEINFORMATIK UND TECHNIK GMBH
Austria
EU contribution
€ 103 400
Address
Eduard Wallnoefer Zentrum 1
6060 Hall In Tyrol
Activity type
Higher or Secondary Education Establishments
GOETEBORGS UNIVERSITET
Sweden
EU contribution
€ 48 248,75
Address
Vasaparken
405 30 Goeteborg
Activity type
Higher or Secondary Education Establishments
POLITECNICO DI MILANO
Italy
EU contribution
€ 108 750
Address
Piazza Leonardo Da Vinci 32
20133 Milano
Activity type
Higher or Secondary Education Establishments
HEALTH PRODUCTS REGULATORY AUTHORITY
Ireland
EU contribution
€ 50 000
Address
Earlsfort Centre Block A Kevin O Malley House Earlsfort Terrace
2 Dublin
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
LAEGEMIDDELSTYRELSEN
Denmark
EU contribution
€ 21 250
Address
Axel Heides Gade 1
2300 Kobenhavn S
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
URZAD REJESTRACJI PRODUKTOW LECZNICZYCH, WYROBOW MEDYCZNYCH I PRODUKTOW BIOBOJCZYCH
Poland
EU contribution
€ 10 000
Address
Aleje Jerozolimskie 181 C
02-222 Warsaw
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU
Netherlands
EU contribution
€ 86 605
Address
Antonie Van Leeuwenhoeklaan 9
3721 MA Bilthoven
Activity type
Research Organisations
ISTITUTO SUPERIORE DI SANITA
Italy
EU contribution
€ 64 427,50
Address
Viale Regina Elena 299
00161 Roma
Activity type
Research Organisations
HTA AUSTRIA - AUSTRIAN INSTITUTE FOR HEALTH TECHNOLOGY ASSESSMENT GMBH
Austria
EU contribution
€ 52 968,75
Address
Garnisongasse 7/20
1090 Wien
Activity type
Research Organisations
FUNDACION PUBLICA ANDALUZA PROGRESO Y SALUD
Spain
EU contribution
€ 48 775
Address
Avenida Americo Vespucio 15 Edif S2
41092 Sevilla
Activity type
Research Organisations
EUROPEAN ASSOCIATION OF NOTIFIED BODIES FOR MEDICAL DEVICES
Belgium
EU contribution
€ 39 000
Address
Rue Bawepuce 20
4140 Sprimont
Activity type
Other