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.
Fields of science
Programme(s)
Funding Scheme
CSA - Coordination and support actionCoordinator
SOCIETE EUROPEENNE DE CARDIOLOGIE
Net EU contribution
€ 448 140,00
Address
Route Des Colles 2035
06903 Biot Sophia Antipolis
France
06903 Biot Sophia Antipolis
France
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Region
Provence-Alpes-Côte d’Azur Provence-Alpes-Côte d’Azur Alpes-Maritimes
Activity type
Other
Other funding
€ 0,00
Participants (22)
EFORT
Switzerland
Net EU contribution
€ 199 168,75
Address
Za La Piece 2
1180 Rolle
1180 Rolle
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Region
Schweiz/Suisse/Svizzera Région lémanique Vaud
Activity type
Research Organisations
Other funding
€ 0,00
BIOMEDICAL ALLIANCE IN EUROPE
Belgium
Net EU contribution
€ 52 023,75
Address
Square Meeus 29
1000 Bruxelles
1000 Bruxelles
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Region
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Activity type
Other
Other funding
€ 0,00
EUROPEAN ACADEMY OF PAEDIATRICS
Belgium
Net EU contribution
€ 58 562,50
Address
Avenue De La Couronne 20
1050 Bruxelles
1050 Bruxelles
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Region
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Activity type
Other
Other funding
€ 0,00
FORUM DES PATIENTS EUROPEENS
Belgium
Net EU contribution
€ 57 650,00
Address
Chaussee D Etterbeek 180
BRUSSELS 1040
BRUSSELS 1040
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Activity type
Other
Other funding
€ 0,00
ACADEMISCH ZIEKENHUIS LEIDEN
Netherlands
Net EU contribution
€ 367 895,00
Address
Albinusdreef 2
2333 ZA Leiden
2333 ZA Leiden
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Region
West-Nederland Zuid-Holland Agglomeratie Leiden en Bollenstreek
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
Net EU contribution
€ 135 566,25
Address
Wellington Square University Offices
OX1 2JD Oxford
OX1 2JD Oxford
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Region
South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
REGION UPPSALA
Sweden
Net EU contribution
€ 92 220,00
Address
Po Box 602
751 25 Uppsala
751 25 Uppsala
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Region
Östra Sverige Östra Mellansverige Uppsala län
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 0,00
ROYAL COLLEGE OF SURGEONS IN IRELAND
Ireland
Net EU contribution
€ 109 900,00
Address
St Stephen's Green 123
2 Dublin
2 Dublin
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Region
Ireland Northern and Western Border
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
INSEL GRUPPE AG
Switzerland
Net EU contribution
€ 106 400,00
Address
Freiburgstrasse 18
3010 Bern
3010 Bern
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Region
Schweiz/Suisse/Svizzera Espace Mittelland Bern / Berne
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
Net EU contribution
€ 100 026,25
Address
Oude Markt 13
3000 Leuven
3000 Leuven
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Region
Vlaams Gewest Prov. Vlaams-Brabant Arr. Leuven
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UMIT TIROL - PRIVATE UNIVERSITAT FUR GESUNDHEITSWISSENSCHAFTEN UND TECHNOLOGIE GMBH
Austria
Net EU contribution
€ 103 400,00
Address
Eduard Wallnoefer Zentrum 1
6060 Hall In Tyrol
6060 Hall In Tyrol
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Region
Westösterreich Tirol Innsbruck
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
GOETEBORGS UNIVERSITET
Sweden
Net EU contribution
€ 48 248,75
Address
Vasaparken
405 30 Goeteborg
405 30 Goeteborg
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Region
Södra Sverige Västsverige Västra Götalands län
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
POLITECNICO DI MILANO
Italy
Net EU contribution
€ 108 750,00
Address
Piazza Leonardo Da Vinci 32
20133 Milano
20133 Milano
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Region
Nord-Ovest Lombardia Milano
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
HEALTH PRODUCTS REGULATORY AUTHORITY
Ireland
Net EU contribution
€ 50 000,00
Address
Earlsfort Centre Block A Kevin O Malley House Earlsfort Terrace
2 Dublin
2 Dublin
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Region
Ireland Northern and Western Border
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 0,00
LAEGEMIDDELSTYRELSEN
Denmark
Net EU contribution
€ 21 250,00
Address
Axel Heides Gade 1
2300 Kobenhavn S
2300 Kobenhavn S
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Region
Danmark Hovedstaden Byen København
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 0,00
URZAD REJESTRACJI PRODUKTOW LECZNICZYCH, WYROBOW MEDYCZNYCH I PRODUKTOW BIOBOJCZYCH
Poland
Net EU contribution
€ 10 000,00
Address
Aleje Jerozolimskie 181 C
02-222 Warsaw
02-222 Warsaw
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Region
Makroregion województwo mazowieckie Warszawski stołeczny Miasto Warszawa
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 0,00
RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU
Netherlands
Net EU contribution
€ 86 605,00
Address
Antonie Van Leeuwenhoeklaan 9
3721 MA Bilthoven
3721 MA Bilthoven
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Region
West-Nederland Utrecht Utrecht
Activity type
Research Organisations
Other funding
€ 0,00
ISTITUTO SUPERIORE DI SANITA
Italy
Net EU contribution
€ 64 427,50
Address
Viale Regina Elena 299
00161 Roma
00161 Roma
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Region
Centro (IT) Lazio Roma
Activity type
Research Organisations
Other funding
€ 0,00
HTA AUSTRIA - AUSTRIAN INSTITUTE FOR HEALTH TECHNOLOGY ASSESSMENT GMBH
Austria
Net EU contribution
€ 52 968,75
Address
Garnisongasse 7/20
1090 Wien
1090 Wien
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Region
Wien Wien
Activity type
Research Organisations
Other funding
€ 0,00
FUNDACION PUBLICA ANDALUZA PROGRESO Y SALUD M.P.
Spain
Net EU contribution
€ 45 775,00
Address
Avenida Americo Vespucio 15 Edif S2
41092 Sevilla
41092 Sevilla
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Region
Andalucía Sevilla
Activity type
Research Organisations
Other funding
€ 0,00
Third-party
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.
UNIVERSIDAD DE GRANADA
Spain
Net EU contribution
€ 3 000,00
Address
Cuesta Del Hospicio Sn
18071 Granada
18071 Granada
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Region
Andalucía Granada
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
EUROPEAN ASSOCIATION OF NOTIFIED BODIES FOR MEDICAL DEVICES
Belgium
Net EU contribution
€ 39 000,00
Address
Rue Bawepuce 20
4140 Sprimont
4140 Sprimont
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Region
Région wallonne Prov. Liège Arr. Liège
Activity type
Other
Other funding
€ 0,00