This is a follow-up to earlier coverage of the EU AI Act Omnibus deadline extensions. The committee vote on March 18 adds material new detail that wasn’t part of the prior brief.
The headline development: medtech companies get relief. Medtech Insight reported that MEPs voted to allow companies to avoid “double certification” with notified bodies, meaning AI systems already certified under EU Medical Device Regulation won’t face a separate, duplicative certification process under the AI Act. This is a direct response to medtech industry feedback that the compliance overlap was creating an unworkable burden.
The IAPP confirmed a preliminary political agreement was reached on the broader AI Act Omnibus package. DPO Centre confirmed the amendments moved forward following that agreement.
On scope: the Omnibus package is reported to include a prohibition on AI-generated non-consensual intimate images, according to coverage of the committee agreement. That detail, if confirmed in the plenary vote, extends the AI Act into an area that’s been the subject of separate national legislation across several EU member states.
On deadlines: under the proposed amendments, Annex III high-risk systems would face compliance requirements from December 2, 2027, and Annex I systems from August 2, 2028, pending a plenary vote expected in late March, according to Medtech Insight. These are not enacted deadlines. They’re proposed amended dates that require plenary approval to take effect.
For medtech compliance teams: the double certification relief is the most immediately practical development here. The plenary vote is the next gate.