reusch­law White­pa­per: Medi­cal Devices and Arti­fi­ci­al Intel­li­gence (AI)

The inte­gra­ti­on of arti­fi­ci­al intel­li­gence (AI) has beco­me an inte­gral part of a lar­ge num­ber of medi­cal devices. AI sup­ports dia­gno­stics or pro­vi­des medi­cal pro­fes­sio­nals with decision-making aids for the­ra­pies and medi­ca­ti­on. Medi­cal apps often only achie­ve full func­tion­a­li­ty through the use of AI. At the same time, howe­ver, the inte­gra­ti­on of AI com­pon­ents into medi­cal devices also har­bours risks that the Euro­pean legis­la­tor wants to coun­ter through sec­to­ral and hori­zon­tal legal acts.

The ali­gnment of the AI Regu­la­ti­on with the MDR/IVDR will be of par­ti­cu­lar rele­van­ce for medi­cal device manu­fac­tu­r­ers, as the exci­ting field of self-learning, dyna­mic AI sys­tems is not uni­form­ly con­side­red in the regu­la­ti­ons. The sim­pli­fi­ca­ti­ons pro­vi­ded for in the AI Regu­la­ti­on with regard to the (unneces­sa­ry) repeat con­for­mi­ty assess­ment pro­ce­du­re, which does not con­sider dyna­mic soft­ware adapt­a­ti­ons to be a sub­stan­ti­al chan­ge, do not bene­fit medi­cal device manu­fac­tu­r­ers under the MDR and IVDR.

In this white paper, Miri­am Schuh informs you about the spe­cial requi­re­ments of the AI Regu­la­ti­on for high-risk AI sys­tems that go bey­ond the pro­vi­si­ons of the MDR and IVDR.

You can down­load the full white­pa­per here.