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In forceBinding · Regulation / implementing rule
Artificial Intelligence Regulations, 2025 (Legal Notice 226 of 2025 under the Malta Digital Innovation Authority Act, Cap. 591)
Record MT-01 · L.N. 226 of 2025 (Government Gazette Supplement No. 21,519, 10 October 2025)
- Issued by
- Minister responsible for the Malta Digital Innovation Authority, acting on the advice of the MDIA
- Jurisdiction
- Malta
- Level · region
- National · Europe
- Published / adopted
- 2025-10-10
- In force
- 2025-10-10
- Language
- English
- Official identifier
- L.N. 226 of 2025 (Government Gazette Supplement No. 21,519, 10 October 2025)
Summary
Subsidiary legislation implementing the EU AI Act in Malta. The Malta Digital Innovation Authority (MDIA) is the default market surveillance authority, single point of contact and notifying authority (conformity assessment bodies are assessed by the National Accreditation Board), coordinates with the MFSA and sectoral authorities, publishes the list of fundamental-rights authorities, registers Annex III point 2 high-risk systems and runs the national AI regulatory sandbox with priority for SMEs. Anyone may complain to the MDIA. Infringements carry penalties of up to EUR 350,000 per infringement or 1% of worldwide turnover, plus EUR 12,000 per day, on top of the AI Act's own penalties.
Safety topics
accountability & liabilityrisk-based classificationevaluation & testingcritical infrastructure
Status notes
Made under article 58 of the Malta Digital Innovation Authority Act and published in Government Gazette Supplement No. 21,519 of 10 October 2025. Regulation 1(3) deferred regulations 4, 5, 6, 8, 9 and 10 (fundamental-rights authorities, documentation, language requirements, high-risk registration, sandbox, complaints) to 2 August 2026; the designations and penalty provisions are not deferred. The Minister may designate further market surveillance authorities by order in the Gazette. Penalties on a public authority or body are capped at EUR 50,000 per infringement plus EUR 50 a day; proceedings are time-barred two years after the alleged infringement, and MDIA decisions can be appealed under Part IX of the MDIA Act. Regulation 12 adds the regulations, as S.L. 591.05, to the Second Schedule to the Administrative Justice Act. Legal Notice 227 of 2025, in the same Gazette, makes the Information and Data Protection Commissioner the market surveillance authority for high-risk systems used in law enforcement, biometrics, migration, justice and democratic processes.
Local copy
Archived. Last attempt 2026-10-17 20:42:33 UTC
Official source (third-party copy, not published) archive/MT-01/2026-10-12/official.pdf
Retrieved 2026-10-12 04:36:40 UTC
SHA-256 b42da6592d99632ea607848bd8ac01d4666818a172284324a8d2b5bfdd81a13e
Secondary source (third-party copy, not published) archive/MT-01/2026-10-17/secondary.html
Retrieved 2026-10-17 19:20:15 UTC
SHA-256 3d5f34300c56e79ab1af64283ffb0e5a0e243e2fab3203fb046009ac9c603bfb
Verification
AThe instrument's own official text, or an official register, was stored and confirms the title, date and status. checked 2026-10-17 · official-url-fetched
Stored and read in this run: the legal notice as published (legislation.mt PDF, 8 pages), which gives the Gazette supplement and date, the title, the enabling power, the commencement rule in regulation 1(3) and regulations 2 to 12; the legislation.mt ELI page, stored again on 17 October 2026 (its legal content is unchanged; only the site's list of latest updates differs), which gives the Gazette number and date; and the file legislation.mt serves as the Maltese-language version, which has the same SHA-256 as the English PDF, so the legal notice exists in English only (the ELI page's metadata titles the Maltese expression '(English Version only)'). The ELI metadata also gives 10 October 2025 as the first date of entry into force. The Commission's list of market surveillance authorities cited in version 1 is not stored, and its mention was removed.
Second check: Independent check by Claude Code (claude-sonnet-5-5), 2026-10-17: 8 field(s) supported.
History
- 2026-10-17notes: Made under article 58 of the MDIA Act and published on 10 October 2025. Regulati → Made under article 58 of the Malta Digital Innovation Authority Act and publishe — rewritten from the legal notice: the commencement rule, the public-body penalty cap, prescription, appeal route and the S.L. 591.05 entry added; the Commission's list of 7 September 2026 is not stored and was removed2026-10-17-recheck-europe-2 · Claude Code (claude-opus-5-5)
- 2026-10-17language: English, Maltese → English — 'English, Maltese' changed to 'English': the file legislation.mt serves as the Maltese version (eli/ln/2025/226/mlt/pdf) is byte-identical to the English PDF (SHA-256 b42da659...), and the ELI page's metadata titles the Maltese expression '(English Version only)'2026-10-17-recheck-europe-2 · Claude Code (claude-opus-5-5)
- 2026-10-17date_last_updated: 2026-08-02 → – — set to null: 2 August 2026 is the commencement of regulations 4, 5, 6, 8, 9 and 10 under regulation 1(3), a partial commencement that belongs in the notes, not an amendment or new version; no amending legal notice is shown2026-10-17-recheck-europe-2 · Claude Code (claude-opus-5-5)
Citation
Minister responsible for the Malta Digital Innovation Authority, acting on the advice of the MDIA. Artificial Intelligence Regulations, 2025 (Legal Notice 226 of 2025 under the Malta Digital Innovation Authority Act, Cap. 591) [L.N. 226 of 2025 (Government Gazette Supplement No. 21,519, 10 October 2025)]. 2025-10-10. https://legislation.mt/eli/ln/2025/226/eng/pdf. Status: In force; verified 2026-10-17 (level A). Local copy archive/MT-01/2026-10-12/official.pdf retrieved 2026-10-12 04:36:40 UTC, SHA-256 b42da6592d99632ea607848bd8ac01d4666818a172284324a8d2b5bfdd81a13e. Every AI Policy Ever, version 1.18 (snapshot 2026-10-18), record MT-01.
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