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Medical Device Obligations Taskforce

Project description

A new platform for innovation in medical technologies

The new Medical Device Regulation (MDR) requires testing that is costly and may threaten the competitiveness of Europe’s innovation SMEs. The EU-funded MDOT project will develop a series of coordinated procedures to support SMEs to bring testbeds and device innovations to the level of clinical evaluation. The project will enable conformity assessment using a database procedure and access to medical device testing data through a secure and transparent platform. MDOT will perform joint evaluations of commonly used parts and devices and develop advanced testing methods focusing on inhalation technology, neural implants and orthopaedic devices. The project envisages the platform as a meta-network aiming to protect medical technologies’ innovation and economic vigour, limit animal testing and support MDR’s vision of patient safety.

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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Keywords

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Programme(s)

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Topic(s)

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Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

IA - Innovation action

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) H2020-NMBP-TO-IND-2018-2020

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Coordinator

FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANGEWANDTEN FORSCHUNG EV
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 1 392 682,50
Address
HANSASTRASSE 27C
80686 MUNCHEN
Germany

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Region
Bayern Oberbayern München, Kreisfreie Stadt
Activity type
Research Organisations
Links
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 1 392 682,50

Participants (20)

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