The Euro­pean Par­lia­ment has adopt­ed its posi­tion on a pack­age of amend­ments to the EU Arti­fi­cial Intel­li­gence Act (AIA), push­ing back key com­pli­ance dead­lines and intro­duc­ing a new pro­hi­bi­tion on non-con­sen­su­al AI-gen­er­at­ed inti­mate images. On 26 March 2026, MEPs vot­ed 569 in favour, 45 against, and 23 absten­tions to adopt the posi­tion on the sim­pli­fi­ca­tion (“omnibus”) pro­pos­al amend­ing the AIA, com­mon­ly referred to as Dig­i­tal Omnibus on AI. 

Delayed appli­ca­tion dates for high-risk AI

The core ratio­nale is prag­mat­ic: key tech­ni­cal stan­dards may not be finalised in time for the orig­i­nal dead­line of 2 August 2026. To pro­vide legal cer­tain­ty, MEPs pro­pose 2 Decem­ber 2027 for high-risk AI sys­tems explic­it­ly list­ed in the reg­u­la­tion — includ­ing those involv­ing bio­met­rics, crit­i­cal infra­struc­ture, edu­ca­tion, employ­ment, and law enforce­ment — and 2 August 2028 for AI sys­tems cov­ered by EU sec­toral safe­ty leg­is­la­tion. Providers of AI-gen­er­at­ed con­tent sub­ject to water­mark­ing require­ments would have until 2 Novem­ber 2026 to comply. 

Rel­e­vance for med­ical device manufacturers

Notably, MEPs argue that oblig­a­tions under the AIA can be less strin­gent for prod­ucts already reg­u­lat­ed under sec­toral laws, includ­ing med­ical devices. This prin­ci­ple — avoid­ing dou­ble reg­u­la­tion — will be a crit­i­cal point to mon­i­tor dur­ing upcom­ing tri­logue negotiations.

Next steps

With Parliament’s man­date con­firmed, interin­sti­tu­tion­al nego­ti­a­tions with the Coun­cil can now begin. The orig­i­nal August 2026 dead­line cre­ates a tight time­line — a polit­i­cal agree­ment will like­ly be need­ed before June 2026.

Crit­i­cism from bsi

In the mean­time, noti­fied body bsi pub­lished a white paper on its posi­tion regard­ing the changes. They raised con­cerns on dif­fer­ent aspects, e.g. a lim­i­ta­tion of over­sight in con­for­mi­ty assess­ments and unclear pro­vi­sions in the con­text of par­al­lel con­for­mi­ty assess­ment pro­ce­dures. The white paper can be down­loaded here.

Source: bsi 

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