Our new position paper on in silico evidence in the regulatory approval of medical devices is out!

The Avicenna Alliance is proud to announce the recent publication of its new position paper entitled Ensuring the Quality of in silico Evidence: Application to Medical Devices. This document provides a broad explanation of the opportunities and benefits of in silico methods while also drawing attention to the urgent need for a harmonised regulatory approach supporting the acceptance of in silico evidence included in device submissions. The paper then outlines a risk-based framework for establishing the credibility requirements of in silico evidence used during regulatory decision-making.

Given that the medical device industry mostly serves a global population, harmonization of the guidance for acceptance of in silico evidence by global regulatory authorities is all the more important.  Therefore, this document was developed to inform industry, academic researchers and regulators in competent authorities about a potential pathway enabling the inclusion and consideration of in silico evidence as part of the regulatory approval of medical devices.

Currently, the maturity of in silico evidence presented by industry to the regulatory agencies, as well as the ability of regulators to conduct an appropriate review, differs significantly between jurisdictions.  As it is generally accepted that in silico evidence accelerates medical device innovation without negatively impacting safety and efficacy, broader and more predictable acceptance of in silico evidence is a commonly expressed goal.

In light of the above, the position paper also recommends that the development and implementation of Good Simulation Practice (GSP) become a priority of international regulators, so that countries can rely on the best international practices to implement and utilize in silico methods.

Please find the position paper here.

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