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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.


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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Net EU contribution
€ 1 392 682,50
80686 Munchen

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Bayern Oberbayern München, Kreisfreie Stadt
Activity type
Research Organisations
Total cost
€ 1 392 682,50

Participants (21)