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Background

Since the ‘new’ Medical Device Regulations (MDR) are in place, software is also explicitly considered to be a medical device. As a consequence, the use of the in-house developed software in clinical care is subject to regulatory requirements and processes.

One of the motivations of performing (technologically oriented, software-based) research in a university medical centers is to, in the end, contribute to clinical care. This implies that results of potentially several years of research should undergo considerable (regulatory) assessment before in-house use can be granted.

Purpose

The main purpose of this symposium is to get informed on the MDR, and to initiate a discussion on whether (and how) medical device regulations should be taken into account in performing research in our field.

It is clear that following the complete QA and engineering requirements during research are way too much overhead for a PhD student. In addition, not all research and developments will end up in clinic. Still, can we arrange our research process such that translation to clinic is facilitated in case clinical application is wanted? And can we, as researchers in the field of software and computer applications, also benefit from elements from the MDR? Could we for example benefit from more stringent engineering principles and QA during our research? And if so, how can we integrate that in our research? And if we want to translate our results to clinical practice, how can that be done? Or should we, as researchers, forget about translation, and leave that to commercial partners? It is around these questions that we looked for experts that may share their knowledge and experience.

Programme

12:30-13:00 Walk-in and introduction

13:00-13:30 EMC-MISO: MDR and software, what every researcher should know
13:35-14:05 MD Project: MDR from an external perspective, most important focus areas and pitfalls
14:10-14:40 EMC-DataHub: MDR and the research process, how researchers can benefit from the MDR

14:45-15:15: Break/networking

15:15-15:45 Philips, IGT systems: MDR and software development in a medical device company
15:50-16:20 EMC-Rehabilitation: Translation of research software to clinic, an example from rehabilitation
16:25-16:55 EMC-Radiotherapy: Developing and maintaining in-house developed software for clinical care

17:00-18:00: Drinks/networking