Journal
IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS
Volume 26, Issue 11, Pages 5282-5286Publisher
IEEE-INST ELECTRICAL ELECTRONICS ENGINEERS INC
DOI: 10.1109/JBHI.2022.3198145
Keywords
Medical devices; Computational modeling; Europe; Biological system modeling; Animals; Safety; Drugs; Medical devices; in Silico Trials; regulatory system; notified bodies
Categories
Funding
- European Commission through the H2020 Project In Silico World: Lowering barriers to ubiquitous adoption of In Silico Trials [101016503]
- European Commission [777123]
- H2020 Societal Challenges Programme [777123] Funding Source: H2020 Societal Challenges Programme
Ask authors/readers for more resources
In Silico Trials methodologies will have a significant impact on the development and risk reduction of medical devices in the future. The regulatory pathway for Digital Patient and Personal Health Forecasting solutions is clear, but more complex for In Silico Trials solutions. It is suggested that the European regulatory system should start an innovation process to avoid companies focusing on other markets like the USA.
In Silico Trials methodologies will play a growing and fundamental role in the development and de-risking of new medical devices in the future. While the regulatory pathway for Digital Patient and Personal Health Forecasting solutions is clear, it is more complex for In Silico Trials solutions, and therefore deserves a deeper analysis. In this position paper, we investigate the current state of the art towards the regulatory system for in silico trials applied to medical devices while exploring the European regulatory system toward this topic. We suggest that the European regulatory system should start a process of innovation: in principle to limit distorted quality by different internal processes within notified bodies, hence avoiding that the more innovative and competitive companies focus their attention on the needs of other large markets, like the USA, where the use of such radical innovations is already rapidly developing.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available