19 January, 2022

White paper: Clinical evidence for medical device software

Curious to find out about clinical evidence for medical device software under the new EU regulations?
Look no further than our brand new white paper.

This is the fourth white paper in a series published by Clarvin, Morris Law, Devicia and Kickfile. And for the second time, also in collaboration with Sweden BIO, the national association for the life science industry in Sweden.

Clinical evaluation/performance evaluation is required for CE marking of a medical device/in vitro diagnostic medical device. The purpose of such an evaluation is to provide sufficient clinical evidence to demonstrate conformity with the applicable general safety and performance requirements (“GSPRs”) under normal conditions of the device’s intended purpose. The evaluation requirement also applies to medical device software (“MDSW”). The unique characteristics of MDSW – such as the lack of contact with the human body – means that although clinical/performance evaluation of MDSW is based on the same regulatory requirements as other types of medical devices, there are special considerations to bear in mind when determining the type and amount of data needed to support the intended purpose and clinical claims. This is why the EU Medical Device Coordination Group (“MDCG”) has issued guidance specifically for clinical/performance evaluation of MDSW, MDCG 2020-1.

Here you find the white paper: White paper – Clinical evidence for medical device software