EU AI Act / Digital Omnibus
The AI Act's high-risk deadlines moved: 2nd December 2027, 2nd August 2028
- The EU's Digital Omnibus, adopted in 2026, postponed the AI Act's high-risk conformity obligations.
- Standalone high-risk systems (Annex III) now have until 2nd December 2027.
- AI embedded in already-regulated products (Annex I — medical devices, machinery) now has until 2nd August 2028.
- The Article 50 transparency rules were not touched and still apply from 2nd August 2026.
Last updated 15th August 2026 · By Vas Parshin and Anabel Amar
What the Digital Omnibus changed
The Digital Omnibus pushes back the AI Act's high-risk obligations by a significant margin: Annex III standalone systems move from 2nd August 2026 to 2nd December 2027, a 16-month extension. Annex I embedded systems move from 2nd August 2027 to 2nd August 2028, a 12-month extension. Nothing else in the Act was reopened by this change.
Annex III — standalone high-risk systems, 2nd December 2027
Annex III lists specific standalone high-risk use cases: recruitment and employee management, creditworthiness assessment, biometric identification and categorisation, education and vocational training access, migration and border control, law enforcement, and administration of justice. If a product or system falls into one of these categories on its own — not as part of another regulated product — this is the deadline that applies.
Annex I — AI embedded in a regulated product, 2nd August 2028
Annex I covers AI that is a safety component of, or is itself, a product already regulated under EU product-safety law — most relevantly for our clients, medical devices and machinery. The extension gives an extra year, but it doesn't decouple the AI Act obligation from the underlying CE/UKCA conformity programme for the product itself. A device that's already mid-certification under MDR or the Machinery Regulation should fold this into the same technical file, not track it separately.
What didn't move
The Digital Omnibus postpones high-risk obligations only. Article 50's transparency rules — labelling AI-generated content, disclosing chatbot interactions — were left exactly where they were: in force from 2nd August 2026. A product that has both a high-risk AI component and a transparency-triggering feature (e.g. a customer-facing chatbot) still has the transparency piece due this month, even while the high-risk conformity work has more runway.
Questions
What did the Digital Omnibus change?
The Digital Omnibus postpones the AI Act's high-risk conformity obligations: standalone high-risk systems under Annex III move from 2nd August 2026 to 2nd December 2027 (a 16-month extension), and AI that is a safety component of, or is itself, an already-regulated product under Annex I moves from 2nd August 2027 to 2nd August 2028 (a 12-month extension).
Does this affect our medical-device or machinery clients?
Yes — Annex I covers AI embedded in products already regulated under EU product-safety law, including medical devices and machinery. Those high-risk AI obligations now land on 2nd August 2028 rather than 2nd August 2027, but they still have to be worked into the same CE/UKCA conformity programme, not treated as a separate deadline that can slip.
What is Annex III and who does it cover?
Annex III lists standalone high-risk AI use cases: recruitment and employee management, creditworthiness assessment, biometric identification and categorisation, education and vocational training access, migration and border control, law enforcement, and administration of justice. These now have until 2nd December 2027 to comply.
Has anything stayed on the original schedule?
Yes. The Digital Omnibus postpones the high-risk obligations only — it leaves the Article 50 transparency rules (AI-generated content labelling, chatbot disclosure) exactly where they were: 2nd August 2026, unchanged.
Where we fit
The extra runway is real, but it's runway for a programme that still has to be built — mapping which of your products fall under Annex I versus Annex III, folding high-risk AI conformity into an existing CE/UKCA technical file rather than running it as a separate track, and keeping the unmoved Article 50 transparency items on their original date. We scope the gap and manage the programme end to end.
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