Fraunhofer Institute for Toxicology and Experimental Medicine
Fraunhofer Institute for Toxicology and Experimental Medicine

EU project MDOT

Open-innovation test bed to support the certification of medical devices

Open-innovation test bed

Starting in January 2019, 13 partners from 7 European countries, including research institutes, universities and small and medium-sized enterprises, have been collaborating in the European Horizon 2020 project MDOT (Medical Device Obligations Taskforce). 

This project is being coordinated by Fraunhofer ITEM, with a grant size of 8.3 million euros and 5 years overall duration. In contrast to the majority of Horizon 2020 EU projects, MDOT is planned to evolve into an established open-innovation test bed (OITB), a new European instrument that will allow the projects to be transferred into an association or company after the grant phase. 

 

© Shutterstock - Yurchanka Siarhei

Further information

MDOT in brief

 

The aim of the EU project MDOT is to reduce the burden on medical device manufacturers: the regulatory requirements they have to meet have increased considerably, since the Medical Device Regulation (MDR) came into force.

Funded with 8.3 million euros over a period of five years, a platform shall be developed to support small and medium-sized manufacturers of medical devices in the conformity assessment of their products. This will include development of three demonstrator technologies in the fields of inhalers, neural implants, and coatings for hip replacement implants.

Comprehensive database to facilitate the assessment process

MDOT is addressing medical device manufacturers’ need for support with the obligatory conformity assessment, which has been exacerbated by the EU regulation 2017/745 (Medical Device Regulation, MDR for short). Under this regulation, coming into force at the end of May 2020 and replacing the Medical Device Directive (MDD), all existing medical devices need to undergo reassessment of their risk class, require more comprehensive documentation and increased clinical testing. To reduce the burden on medical device manufacturers, the consortium is developing a platform aimed at simplifying the process by establishing a database that will include data on regulatory affairs and testing up to clinical evaluation and clinical studies.

To demonstrate usability of the platform, it is addressing three technologies as a starting point: inhalers for pre- and early-term neonates, 3D-printed neural implants, and coatings for orthopedic prostheses that reduce the wear of particles in the patient’s tissue. Test beds for these technologies are being developed and upgraded to ensure safety and long-term stability of devices and materials – aspects particularly important for implants. Future extension of the platform towards other medical device sectors is planned. 

13 Partner im EU-Projekt MDOT
© Fraunhofer ITEM, Ulrich Froriep
Thirteen European partners from Germany, the Netherlands, Poland, Spain, the UK, Switzerland and Austria are developing a platform aimed at supporting small and medium-sized manufacturers of medical devices in the conformity assessment of their products.

MDOT Platform

© Fraunhofer ITEM

Fraunhofer ITEM Division of Translational Biomedical Engineering leading the project

In addition to project coordination, Fraunhofer ITEM is involved in biocompatibility testing in accordance with ISO 10993 and database development. Together with two affiliate projects, TBMED and Safe-N-MedTech, MDOT is part of the European "Safety of Medical Devices" cluster.

While the main focus of TBMED is on high-risk medical devices, Safe-N-MedTech is addressing devices involving nanoparticles. These efforts on the European level directly link to an ongoing certification in the Fraunhofer ITEM business area Translational Biomedical Engineering, targeting the institute’s support with regulatory processes and documentation under the ISO 13485 quality standard for medical devices. In this context, routines are being developed and processed that can be embedded into the platform development, enabling manufacturers to estimate their regulatory requirements and follow testing strategies and testing in accordance with the MDR. The initial certification audit by a notified body has already been successfully passed, the final certification is expected for April 2020.

Your contact for the EU project MDOT at Fraunhofer ITEM

Ulrich Froriep

Contact Press / Media

Dr. Ulrich Froriep

Division Co-Director of Safety Assessment and Toxicology & Head of Department of Biomedical Engineering

Phone +49 511 5350-294