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Coordinating Research and Evidence for Medical Devices

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.

Call for proposal

H2020-SC1-BHC-2018-2020

See other projects for this call

Sub call

H2020-SC1-2020-Single-Stage-RTD

Coordinator

SOCIETE EUROPEENNE DE CARDIOLOGIE
Net EU contribution
€ 448 140,00
Address
Route Des Colles 2035
06903 Biot Sophia Antipolis
France
Activity type
Other
Non-EU contribution
€ 0,00
Region
Provence-Alpes-Côte d’Azur Provence-Alpes-Côte d’Azur Alpes-Maritimes

Participants (22)

EFORT
Switzerland
Net EU contribution
€ 199 168,75
Address
Za La Piece 2
1180 Rolle
Activity type
Research Organisations
Non-EU contribution
€ 0,00
Region
Schweiz/Suisse/Svizzera Région lémanique Vaud
 
BIOMEDICAL ALLIANCE IN EUROPE
Belgium
Net EU contribution
€ 52 023,75
Address
Square Meeus 29
1000 Bruxelles
Activity type
Other
Non-EU contribution
€ 0,00
Region
Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest
 
EUROPEAN ACADEMY OF PAEDIATRICS
Belgium
Net EU contribution
€ 58 562,50
Address
Avenue De La Couronne 20
1050 Bruxelles
Activity type
Other
Non-EU contribution
€ 0,00
Region
Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest
FORUM DES PATIENTS EUROPEENS
Belgium
Net EU contribution
€ 57 650,00
Address
Chaussee D Etterbeek 180
BRUSSELS 1040
Activity type
Other
Non-EU contribution
€ 0,00
ACADEMISCH ZIEKENHUIS LEIDEN
Netherlands
Net EU contribution
€ 367 895,00
Address
Albinusdreef 2
2333 ZA Leiden
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Region
West-Nederland Zuid-Holland Agglomeratie Leiden en Bollenstreek
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
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Region
South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire
REGION UPPSALA
Sweden
Net EU contribution
€ 92 220,00
Address
Po Box 602
751 25 Uppsala
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
Region
Östra Sverige Östra Mellansverige Uppsala län
ROYAL COLLEGE OF SURGEONS IN IRELAND
Ireland
Net EU contribution
€ 109 900,00
Address
Saint Stephen's Green 123
2 Dublin
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
INSEL GRUPPE AG
Switzerland
Net EU contribution
€ 106 400,00
Address
Freiburgstrasse 18
3010 Bern
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Region
Schweiz/Suisse/Svizzera Espace Mittelland Bern / Berne
KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
Net EU contribution
€ 100 026,25
Address
Oude Markt 13
3000 Leuven
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Region
Vlaams Gewest Prov. Vlaams-Brabant Arr. Leuven
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
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Region
Westösterreich Tirol Innsbruck
 
GOETEBORGS UNIVERSITET
Sweden
Net EU contribution
€ 48 248,75
Address
Vasaparken
405 30 Goeteborg
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Region
Södra Sverige Västsverige Västra Götalands län
POLITECNICO DI MILANO
Italy
Net EU contribution
€ 108 750,00
Address
Piazza Leonardo Da Vinci 32
20133 Milano
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 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
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
Region
Ireland Northern and Western Border
 
LAEGEMIDDELSTYRELSEN
Denmark
Net EU contribution
€ 21 250,00
Address
Axel Heides Gade 1
2300 Kobenhavn S
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
Region
Byen København Hovedstaden
 
URZAD REJESTRACJI PRODUKTOW LECZNICZYCH, WYROBOW MEDYCZNYCH I PRODUKTOW BIOBOJCZYCH
Poland
Net EU contribution
€ 10 000,00
Address
Aleje Jerozolimskie 181 C
02-222 Warsaw
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
Region
Makroregion województwo mazowieckie Warszawski stołeczny Miasto Warszawa
 
RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU
Netherlands
Net EU contribution
€ 86 605,00
Address
Antonie Van Leeuwenhoeklaan 9
3721 MA Bilthoven
Activity type
Research Organisations
Non-EU contribution
€ 0,00
ISTITUTO SUPERIORE DI SANITA
Italy
Net EU contribution
€ 64 427,50
Address
Viale Regina Elena 299
00161 Roma
Activity type
Research Organisations
Non-EU contribution
€ 0,00
HTA AUSTRIA - AUSTRIAN INSTITUTE FOR HEALTH TECHNOLOGY ASSESSMENT GMBH
Austria
Net EU contribution
€ 52 968,75
Address
Garnisongasse 7/20
1090 Wien
Activity type
Research Organisations
Non-EU contribution
€ 0,00
FUNDACION PUBLICA ANDALUZA PROGRESO Y SALUD
Spain
Net EU contribution
€ 45 775,00
Address
Avenida Americo Vespucio 15 Edif S2
41092 Sevilla
Activity type
Research Organisations
Non-EU contribution
€ 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
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
EUROPEAN ASSOCIATION OF NOTIFIED BODIES FOR MEDICAL DEVICES
Belgium
Net EU contribution
€ 39 000,00
Address
Rue Bawepuce 20
4140 Sprimont
Activity type
Other
Non-EU contribution
€ 0,00
Region
Région wallonne Prov. Liège Arr. Liège