MDOT
Financiado
Medical Device Obligations Taskforce
The new Medical Device Regulation (MDR) bears the potential to hamper Europe’s innovation competitiveness since reiterated, widened testing efforts are required. Especially SMEs must plan with early exits in the face of costly cli...
The new Medical Device Regulation (MDR) bears the potential to hamper Europe’s innovation competitiveness since reiterated, widened testing efforts are required. Especially SMEs must plan with early exits in the face of costly clinical studies. A structural remedial action reinstates the balance between economy and safety. The MDOT working group develops a set of coordinated measures: 1) Support with mandatory conformity assessment using a database approach based on device risk class. 2) Data exchange forum: A mutual, cross-enterprise exchange of medical device testing data on a safe and transparent platform, which aims at saving costs and streamlining clinical tests as far as possible. 2) Test foundry: Joint evaluations of commonly used parts and devices. 3) Development of advanced testing methods with a focus on in vitro and in silico data. This is all performed with regulatory support taking test beds and device innovations towards the level of clinical trials (TRL 4 – 7). This platform realizes one-stop-shop processing reducing complexity and individual costs. The operability of MDOT will be demonstrated within medical product segments growing fastest and with urgent medical need. The initial consortium consists of MD industry R&D, translational institutions and networks as well as clinical research centers. It will grant open access to new clients already during the funding period. Goal of the project is to implement the platform as a meta-network to preserve MedTech innovation and economic strength, reduce animal testing, and support MDR’s new level of patient safety.
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Duración del proyecto: 66 meses
Fecha Inicio: 2018-12-19
Fecha Fin: 2024-06-30
Fecha Fin: 2024-06-30
Línea de financiación: concedida
El organismo H2020 notifico la concesión del proyecto el día 2024-06-30
Línea de financiación objetivo
El proyecto se financió a través de la siguiente ayuda:
Presupuesto
El presupuesto total del proyecto asciende a
9M€
Líder del proyecto
FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANG...
No se ha especificado una descripción o un objeto social para esta compañía.
Perfil tecnológico
TRL
4-5
Perfil tecnológico
TRL
4-5
461.69K€ |
Participante
22.70K€ |
Participante