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.

Toward a Regulatory Pathway for the Use of in Silico Trials in The Ce Marking of Medical Devices / Pappalardo, F.; Wilkinson, J.; Busquet, F.; Bril, A.; Palmer, M.; Walker, B.; Curreli, C.; Russo, G.; Marchal, T.; Toschi, E.; Alessandrello, R.; Costignola, V.; Klingmann, I.; Contin, M.; Staumont, B.; Woiczinski, M.; Kaddick, C.; Salvatore, V. D.; Aldieri, A.; Geris, L.; Viceconti, M.. - In: IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS. - ISSN 2168-2194. - 26:11(2022), pp. 5282-5286. [10.1109/JBHI.2022.3198145]

Toward a Regulatory Pathway for the Use of in Silico Trials in The Ce Marking of Medical Devices

Aldieri A.;
2022

Abstract

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.
File in questo prodotto:
File Dimensione Formato  
Toward_A_Regulatory_Pathway_for_the_Use_of_in_Silico_Trials_in_the_CE_Marking_of_Medical_Devices.pdf

accesso aperto

Tipologia: 2a Post-print versione editoriale / Version of Record
Licenza: Creative commons
Dimensione 573.6 kB
Formato Adobe PDF
573.6 kB Adobe PDF Visualizza/Apri
Pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11583/2973392