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MDOT SIGNED

Medical Device Obligations Taskforce

Total Cost €

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EC-Contrib. €

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Partnership

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Project "MDOT" data sheet

The following table provides information about the project.

Coordinator
FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V. 

Organization address
address: HANSASTRASSE 27C
city: MUNCHEN
postcode: 80686
website: www.fraunhofer.de

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Germany [DE]
 Total cost 8˙944˙243 €
 EC max contribution 8˙348˙633 € (93%)
 Programme 1. H2020-EU.2.1.3. (INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Advanced materials)
2. H2020-EU.2.1.2. (INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies)
 Code Call H2020-NMBP-HUBS-2018
 Funding Scheme IA
 Starting year 2019
 Duration (year-month-day) from 2019-01-01   to  2023-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V. DE (MUNCHEN) coordinator 1˙392˙682.00
2    UNIWERSYTET MEDYCZNY IM KAROLA MARCINKOWSKIEGO W POZNANIU PL (POZNAN) participant 896˙921.00
3    ACMIT GMBH AT (WIENER NEUSTADT) participant 863˙437.00
4    MEDIZINISCHE HOCHSCHULE HANNOVER DE (HANNOVER) participant 829˙902.00
5    DEMCON MACAWI RESPIRATORY SYSTEMS BV NL (ENSCHEDE) participant 735˙875.00
6    UNIVERSITAT LINZ AT (LINZ) participant 696˙515.00
7    UNIVERSITAT BAYREUTH DE (BAYREUTH) participant 621˙725.00
8    FUNDACION CIDETEC ES (SAN SEBASTIAN) participant 600˙500.00
9    UNIVERSITY OF SOUTHAMPTON UK (SOUTHAMPTON) participant 546˙610.00
10    UNIVERSITY OF LEEDS UK (LEEDS) participant 510˙582.00
11    MANEGOLD CHRISTOPH DE (DUSSELDORF) participant 323˙750.00
12    BORM NANOCONSULT HOLDING BV NL (MEERSSEN) participant 227˙500.00
13    MATHYS AG BETTLACH CH (BETTLACH) participant 102˙632.00

Map

 Project objective

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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The information about "MDOT" are provided by the European Opendata Portal: CORDIS opendata.

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