The Euro­pean Commission’s Arti­fi­cial Intel­li­gence (AI) Act looks as if it will be adopt­ed after 13 amend­ments were agreed on by mem­bers of the Euro­pean Par­lia­ment. This mile­stone leg­is­la­tion will have a huge effect on all AI prod­ucts, includ­ing many med­ical devices as it will mean new com­pli­ance require­ments for many devices.

Fol­low­ing accep­tance by the par­lia­ment, tri­logue dis­cus­sions will begin between the Com­mis­sion, the Par­lia­ment and the Coun­cil of the EU. 

Although many of the con­tro­ver­sial fea­tures of the AI Act draft do not direct­ly involve the med­ical device sec­tor, it is essen­tial that the sec­tor take heed of the pro­posed reg­u­la­tion as it ascends moves through the Euro­pean polit­i­cal and legal sys­tem. As a hor­i­zon­tal reg­u­la­tion, the AI Act impos­es strin­gent require­ments for any prod­uct that is an AI sys­tem, or which has an AI com­po­nent meant to be used as a safe­ty com­po­nent of the product. 

Accord­ing to the draft text any med­ical device with AI com­po­nents which entails the involve­ment of a noti­fied body dur­ing a con­for­mi­ty assess­ment under Reg­u­la­tion (EU) 2017/745 on Med­ical Devices or Reg­u­la­tion (EU) 2017/746 on In Vit­ro Diag­nos­tic Med­ical Devices (MDR or IVDR) would auto­mat­i­cal­ly be clas­si­fied as a high-risk device under the AI Act. 

Source: Medtech Insight (an Infor­ma product)

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