fit4translation Medical Informatics infrastructure "Expansion of competence and support in the development of medical software under the regulatory framework of the MDR & IVDR in an academic environment"

In cooperation with the University Hospital of Aachen, the University Hospital of Bonn and the TMF -Technology and Method platform for networking medical research e.V., the MeDIC Münster would like to strengthen the competence in the academic environment in developing medical software in accordance with the regulatory framework of the European Medical Devices Regulation (MDR) or the In Vitro Diagnostics Regulation (IVDR).

If clinical decision support systems (CDSS) are developed for diagnostic and/or therapeutic purposes, they must be treated as medical devices. These systems may only be evaluated or used exclusively in healthcare if they fulfil the essential safety and performance requirements. Therefore, many medical developments, especially in the field of AI from CDSS in the academic environment, are subject to regulatory requirements that inherently change the research and development process. Our fit4translation project aims to address these challenges by pursuing the following goals:

1) Raise researchers’ awareness of regulatory aspects of clinical decision support and artificial intelligence systems at the
interface between medical research and clinical routine
2) Strengthening competencies in translational research in medicine and the medical informatics community
3) Support in planning and applying for research projects in which the European Medical Device Regulation (MDR) or the
Regulation on In Vitro Diagnostic Devices (IVDR) applies
4) Building an open knowledge base on MDR-related topics to support researchers on regulatory issues The MeDIC Münster
focuses on quality and software lifecycle management and on the development of corresponding teaching, workshop and
other publication material.

The MeDIC Münster as part of the Institute of Medical Informatics is one of the few academic institutions that has established a quality management system, which has been successfully certified by TÜV-SÜD according to DIN EN ISO 13485 since 2021. Therefore, the MeDIC Münster regularly undergoes internal and external audits.

Further information

Contact:  Dr. Michael Storck, Alexander Brenner

Principal Investigator: Univ.-Prof. Dr. Julian Varghese


Project number: 01ZZ2310C