Tue 4 June 2024, 12:30 - 18:00 Erasmus MC Na-2602, 3015 GD
The afternoon of June 4th was all about MDR and what researchers who develop software should know about it. The symposium was hosted on behalf of the ICAI Stroke Lab and the Imaging Office of the Radiology & Nuclear Medicine department of the Erasmus MC. There was more enthusiasm than anticipated on, which made the room somewhat less suitable. However, instead of looking at this from a negative perspective, it definitely showed the need to open up this MDR box for researchers (both within and outside the Erasmus MC). We had some very insightful and practical talks from:
- Sebastiaan Notenboom, showing a generalized overview of the processes that are in place at the Erasmus MC for in house development of medical devices to comply with the MDR
- Vincent van der Meer (MD Project), showing the most important focus areas and pitfalls from the perspective of an external MDR consultancy company
- Jan van den Brand (DataHub), showing how researchers can actually benefit from the MDR
- Danny Ruijters (Philips), showing how to comply with MDR at a medical device company
- Lisa Hoogendam, showing an example of translating research software to clinical practice in the Rehabilitation department
- Wilco Schillemans, showing how in-house software is developed and maintained at the Radiotherapy department
We closed the session with some more insightful (and less insightful ) discussions during the afternoon drinks.
A big thank you to the presenters and attendees!
Contact the Imaging Office for the recordings or suggestions for follow-up sessions.
>Information regarding the program
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. The new MDR 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, it’s implications for research software, and to discuss 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. Can we take 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.