CORDIS
EU research results

CORDIS

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Medical Device Obligations Taskforce

Project information

Grant agreement ID: 814654

Status

Ongoing project

  • Start date

    1 January 2019

  • End date

    31 December 2023

Funded under:

H2020-EU.2.1.3.

H2020-EU.2.1.2.

  • Overall budget:

    € 8 944 243,75

  • EU contribution

    € 8 348 633,50

Coordinated by:

FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V.

Germany

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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Coordinator

FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V.

Address

Hansastrasse 27c
80686 Munchen

Germany

Activity type

Research Organisations

EU Contribution

€ 1 392 682,50

Participants (12)

DEMCON MACAWI RESPIRATORY SYSTEMS BV

Netherlands

EU Contribution

€ 735 875

UNIVERSITAT BAYREUTH

Germany

EU Contribution

€ 621 725

BORM NANOCONSULT HOLDING BV

Netherlands

EU Contribution

€ 227 500

FUNDACION CIDETEC

Spain

EU Contribution

€ 600 500

MANEGOLD CHRISTOPH

Germany

EU Contribution

€ 323 750

MEDIZINISCHE HOCHSCHULE HANNOVER

Germany

EU Contribution

€ 829 902,50

ACMIT GMBH

Austria

EU Contribution

€ 863 437,50

UNIVERSITY OF SOUTHAMPTON

United Kingdom

EU Contribution

€ 546 610

UNIVERSITAT LINZ

Austria

EU Contribution

€ 696 515

UNIWERSYTET MEDYCZNY IM KAROLA MARCINKOWSKIEGO W POZNANIU

Poland

EU Contribution

€ 896 921,25

UNIVERSITY OF LEEDS

United Kingdom

EU Contribution

€ 510 582,50

MATHYS AG BETTLACH

Switzerland

EU Contribution

€ 102 632,25

Project information

Grant agreement ID: 814654

Status

Ongoing project

  • Start date

    1 January 2019

  • End date

    31 December 2023

Funded under:

H2020-EU.2.1.3.

H2020-EU.2.1.2.

  • Overall budget:

    € 8 944 243,75

  • EU contribution

    € 8 348 633,50

Coordinated by:

FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V.

Germany