Article (Scientific journals)
Toward A Regulatory Pathway for the Use of in Silico Trials in the CE Marking of Medical Devices.
Pappalardo, Francesco; Wilkinson, John; Busquet, Francois et al.
2022In IEEE Journal of Biomedical and Health Informatics, 26 (11), p. 5282-5286
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Abstract :
[en] 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.
Disciplines :
Engineering, computing & technology: Multidisciplinary, general & others
Author, co-author :
Pappalardo, Francesco
Wilkinson, John
Busquet, Francois
Bril, Antoine
Palmer, Mark
Walker, Barry
Curreli, Cristina
Russo, Giulia
Marchal, Thierry
Toschi, Elena
Alessandrello, Rossana
Costignola, Vincenzo
Klingmann, Ingrid
Contin, Martina
Staumont, Bernard ;  Université de Liège - ULiège > Département d'aérospatiale et mécanique > Génie biomécanique
Woiczinski, Matthias
Kaddick, Christian
Salvatore, Valentina Di
Aldieri, Alessandra
Geris, Liesbet  ;  Université de Liège - ULiège > Département d'aérospatiale et mécanique > Génie biomécanique
Viceconti, Marco
More authors (11 more) Less
Language :
English
Title :
Toward A Regulatory Pathway for the Use of in Silico Trials in the CE Marking of Medical Devices.
Publication date :
November 2022
Journal title :
IEEE Journal of Biomedical and Health Informatics
ISSN :
2168-2194
eISSN :
2168-2208
Publisher :
Institute of Electrical and Electronics Engineers, Us
Volume :
26
Issue :
11
Pages :
5282-5286
Peer reviewed :
Peer Reviewed verified by ORBi
European Projects :
H2020 - 101016503 - ISW - In Silico World: Lowering barriers to ubiquitous adoption of In Silico Trials
Funders :
Union Européenne [BE]
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since 28 April 2023

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