Article 111: Transitional Provisions for AI Systems and GPAI Models Already on the Market
Article 111 provides transitional rules for AI systems already placed on the market or put into service and GPAI models already placed on the market before the relevant application dates. Key rules: (1) The Regulation does not apply to high-risk AI systems already on the market before 2 August 2026 — unless they undergo a significant change in design after that date; (2) Providers of GPAI models already on the market must comply with Chapter V by 2 August 2027; (3) High-risk AI systems under Annex I legislation already on the market must comply by the sectoral application date but no later than 31 December 2030 if the conformity assessment procedure is modified; (4) Large-scale IT systems under Annex X must comply by 31 December 2030. Always verify on EUR-Lex.
Who does this apply to?
- -Providers of high-risk AI systems already on the market or in service before 2 August 2026
- -Providers of GPAI models already on the market before 2 August 2025
- -Providers of AI systems under Annex I product legislation already CE-marked
- -Operators of large-scale EU IT systems under Annex X
- -Legal and compliance teams managing legacy system transitions
Scenarios
A high-risk employment screening AI was placed on the market in January 2026. No significant design change is made after August 2026.
A large language model was already widely available in the EU before August 2025. The provider continues to offer it.
A medical device AI was CE-marked under MDR before the AI Act application date. The MDR conformity assessment is not yet due for renewal.
Paragraph-by-paragraph guide
Article 111(1) — High-risk AI systems on the market before 2 Aug 2026: - The Regulation does not apply to these systems *unless* they undergo a significant change in design after that date - If a significant change occurs, the system must meet Chapter III requirements as if newly placed
Article 111(2) — GPAI models on the market before 2 Aug 2025: - Providers must comply with Chapter V obligations by 2 August 2027 - This gives a 2-year compliance window from entry into force
Article 111(3) — Annex I product-law AI systems: - AI systems that are components of products already CE-marked under Annex I legislation have transitional treatment - Compliance required no later than 31 December 2030 where the conformity assessment procedure needs modification
Article 111(4) — Large-scale EU IT systems (Annex X): - Systems listed in Annex X (e.g., SIS, VIS, Eurodac) must comply by 31 December 2030
Always read the full paragraphs on EUR-Lex Article 111.
What counts as a significant change in design
Article 111(1) uses the concept of significant change in design. While the Act does not define a bright-line threshold, practical markers include:
- Re-training on substantially different data that changes the system's behaviour profile
- Changing the intended purpose to a different Annex III category
- Architecture changes that materially alter risk characteristics
- Expanding the system's operational domain (new geographies, new user populations)
If in doubt, treat the change as significant and bring the system into conformity — the enforcement risk of guessing wrong is high.
How Article 111 connects to the rest of the Act
- Article 113 — Application dates that trigger Article 111 transitional windows.
- Article 6 — Classification of high-risk systems subject to Article 111.
- Article 25 — Re-qualification as provider after substantial modification (related concept).
- Article 53 — GPAI model obligations subject to Article 111(2) transition.
- Annex I — Product legislation referenced in Article 111(3).
- Annex III — High-risk categories for Article 111(1).
Compliance checklist
- Inventory all AI systems on the market before the relevant application dates.
- Classify each as: (a) high-risk under Annex III, (b) GPAI model, (c) Annex I product, or (d) Annex X IT system.
- For legacy high-risk systems: implement change-monitoring to detect significant design changes.
- For GPAI models: plan Chapter V compliance by 2 August 2027.
- For Annex I products: coordinate AI Act conformity with sectoral CE renewal cycles.
- Document the transitional provision relied upon for each legacy system.
- Set calendar alerts for all transitional deadlines (2026, 2027, 2030).
- Brief product teams: any significant redesign re-triggers full compliance.
Assess your legacy AI systems' compliance path—free assessment.
Start Free AssessmentRelated Articles
Article 6: Classification Rules for High-Risk Systems
Article 25: Responsibilities Along the AI Value Chain
Article 53: Obligations for Providers of General-Purpose AI Models
Article 99: Penalties for AI Act Infringements
Article 113: Entry into Force and Application Dates
Annex I: Union Harmonisation Legislation — Product Law List
Annex III: High-Risk AI System Areas
Related annexes
- Annex I — Union harmonisation legislation
- Annex III — High-risk AI system areas
- Annex X — Large-scale EU IT systems
Frequently asked questions
Does Article 111 mean old systems never need to comply?
Only if they remain unchanged. Any significant design change after the application date triggers full compliance. Products that stay static are exempt, but monitoring for changes is mandatory.
What's the GPAI transition timeline?
GPAI rules apply from 2 August 2025, but pre-existing models have until 2 August 2027 to fully comply with Chapter V (Article 111(2)).
Do the prohibitions in Article 5 also have transitional provisions?
No. Article 5 prohibitions apply from 2 February 2025 with no transitional exemption — they are not subject to Article 111.
What about updates, patches, and retraining?
Routine patches typically do not constitute significant design changes. But substantial retraining, architecture changes, or purpose changes likely do. Document your assessment.