The Euro­pean Com­mis­sion has opened two stake­hold­er con­sul­ta­tions on draft AI Act guide­lines — both rel­e­vant to man­u­fac­tur­ers of AI-enabled med­ical devices.

The first, pub­lished 8 May 2026, cov­ers trans­paren­cy oblig­a­tions. From 2 August 2026, peo­ple in the EU must be informed when inter­act­ing with AI sys­tems or exposed to cer­tain AI-gen­er­at­ed or manip­u­lat­ed con­tent. Providers must add machine-read­able marks enabling detec­tion of AI-gen­er­at­ed con­tent. Feed­back closed 3 June 2026. 

The sec­ond, pub­lished 19 May 2026, con­cerns clas­si­fi­ca­tion of high-risk AI. The guide­lines help providers and deploy­ers deter­mine whether a sys­tem is high-risk, with prac­ti­cal exam­ples. Crit­i­cal­ly for this sec­tor, AI sys­tems embed­ded in med­ical devices and requir­ing a noti­fied body for con­for­mi­ty assess­ment, are des­ig­nat­ed high-risk. This con­sul­ta­tion clos­es 23 June 2026. 

Source: Euro­pean Commission

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