On 7 May 2026, the Euro­pean Par­lia­ment and Coun­cil reached a pro­vi­sion­al agree­ment on the Dig­i­tal Omnibus on AI (Omnibus VII) — after a first tri­logue col­lapsed briefly before.

One of the cen­tral dis­putes: how the EU AI Act’s high-risk require­ments inter­act with sec­toral leg­is­la­tion such as reg­u­la­tions (EU) 2017/745 and 2017/746 (MDR and IVDR). Par­lia­ment pushed for a full sec­toral carve-out; fol­low­ing con­cerns expressed by mul­ti­ple par­ties, the Coun­cil resist­ed, fear­ing frag­men­ta­tion of the AI Act’s hor­i­zon­tal framework.

The com­pro­mise for med­ical devices (MDR/IVDR): There will beno blan­ket exemp­tion — but the Com­mis­sion gains pow­er to lim­it AI Act appli­ca­tion through imple­ment­ing acts and Com­mis­sion guid­ance where sec­toral law already address­es equiv­a­lent requirements. 

Key date for med­ical device man­u­fac­tur­ers: high-risk AI embed­ded in reg­u­lat­ed prod­ucts now tar­gets 2 August 2028 and 2 Decem­ber 2027 for stand-alone high-risk AI systems.

The agree­ment is pro­vi­sion­al — for­mal adop­tion and legal-lin­guis­tic revi­sion are still pending.

The full press release can be found here. 

In the con­text of the above, indus­try asso­ci­a­tion MedTech Europe expressed its dis­ap­point­ment on the agree­ment. MedTech Europe pre­vi­ous­ly vot­ed for a com­plete exclu­sion of med­ical devices from the AI Act. Accord­ing to the asso­ci­a­tion, it is hoped “to address the reg­u­la­to­ry coher­ence gap left by today’s deal.” Specif­i­cal­ly, MedTech Europe requests “that high-risk AI require­ments for med­ical tech­nolo­gies be imple­ment­ed through the sec­toral frame­work, with no dupli­ca­tion of con­for­mi­ty assess­ment obligations”.

Source: Euro­pean Par­lia­ment and Coun­cil, MedTech Europe 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

EU AI Act: Par­lia­ment votes to delay high-risk rules