Toward a regulatory pathway for Using in Silico Trials in CE Marking of Medical Devices


A team of researchers of the In Silico World project, including several key Avicenna Alliance members, led by Prof. Francesco Pappalardo (University of Catania), Avicenna Alliance’ Pharmaceutical Strategy TF Co-Chair, recently published a Position Paper in IEEE Journal of Biomedical and Health Informatics (J-BHI).

In Silico Trials (IST) methodologies will play a growing and fundamental role in the development and de-risking of new medical devices in the future.

This position paper investigates 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.

The authors suggest that the European regulatory system should start a process of innovation to limit distorted quality by different internal processes, hence avoiding that the more innovative and competitive companies focus their attention on the needs of other large markets where the use of such radical innovations is already rapidly developing.

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