Frameworks · Malta

AI governance frameworks and AI regulation in Malta

Malta governs AI through the EU AI Act, implemented nationally by Legal Notices 226 and 227 of 2025, which make the Malta Digital Innovation Authority the lead authority and give the data protection commissioner a role over sensitive uses. The GDPR applies to AI that uses personal data, the MFSA sets AI expectations for financial services, and the national AI strategy and Ethical AI Framework guide policy.

Who regulates AI here

Malta Digital Innovation AuthorityMalta's lead market surveillance authority and single point of contact for the EU AI Act, and the authority for the national AI regulatory sandbox.
Information and Data Protection CommissionerEnforces the GDPR in Malta and supervises high-risk AI in biometrics, law enforcement, migration and justice under the AI Act.
Malta Financial Services AuthoritySupervises financial services licence holders and has set expectations for how they govern AI as a prudential risk.

Malta

Malta applies the EU AI Act through its own implementing regulations, with the Malta Digital Innovation Authority as lead authority, the data protection commissioner covering sensitive uses, and AI expectations for financial services from the MFSA.

LawMalta AI Act implementationMalta's Artificial Intelligence Regulations (EU AI Act implementation)How Malta implements the EU AI Act. The MDIA and IDPC roles under Legal Notices 226 and 227 of 2025, national penalties and what organisations must do.In force. Supervision and enforcement powers exercisable since 2 August 2026 Regulator guidanceMFSA AI expectationsMFSA Dear CEO letter: AI governance, risk and prudential expectationsThe MFSA's June 2026 Dear CEO letter sets AI governance, third-party, model risk and data expectations for Maltese licence holders, with a self-assessment.Issued 4 June 2026, in use in supervision Voluntary frameworkMalta AI strategyMalta's national AI strategy and Ethical AI FrameworkMalta's AI strategy, its 2025 realignment and the Ethical AI Framework, Malta – Towards Trustworthy AI. What they set out and how they fit together.2019 strategy and Ethical AI Framework published. Realigned strategy released for public consultation

All Malta frameworks

European Union

The EU AI Act sets risk-based obligations for AI placed on the EU market or used in the EU, alongside the GDPR's rules on automated decisions.

LawEU AI ActEU AI Act (Regulation (EU) 2024/1689)The EU AI Act sets risk-based rules for AI used in the EU. What it requires of providers and deployers, and the dates as amended by the 2026 Digital Omnibus.In force, applying in stages to 2028In Aicura from Enterprise LawGDPR Article 22GDPR Article 22 and automated decision-makingGDPR Article 22 limits solely automated decisions with legal or similarly significant effects. Who it applies to, the exceptions, safeguards and AI duties.In force since May 2018, amendment proposed Voluntary frameworkGPAI Code of PracticeGeneral-Purpose AI Code of PracticeThe EU GPAI Code of Practice is how model providers show they meet AI Act duties on transparency, copyright and systemic risk. What it covers and who signs.Published July 2025, in use Voluntary frameworkTrustworthy AI and ALTAIEthics Guidelines for Trustworthy AI and the Assessment List (ALTAI)The EU's Ethics Guidelines for Trustworthy AI set seven requirements, and ALTAI turns them into a self-assessment checklist. What they cover and who uses it.Published 2019 and 2020, voluntary

All European Union frameworks

International

Standards and frameworks that apply across borders. Most organisations use one of these as the backbone of their AI governance, whatever their jurisdiction.

StandardISO/IEC 42001ISO/IEC 42001:2023 AI management systemsISO/IEC 42001 is the certifiable international standard for an AI management system. What it requires, how Annex A works and how to get ready to certify.Published December 2023, current editionIn Aicura from Pro StandardISO/IEC 42005ISO/IEC 42005:2025 AI system impact assessmentISO/IEC 42005 is international guidance on assessing how an AI system affects people and society, when to assess, what to record and how it links to 42001.Published May 2025, current edition Voluntary frameworkNIST AI RMFNIST AI Risk Management Framework (AI RMF 1.0)The NIST AI RMF is a voluntary framework for managing AI risk through four functions, Govern, Map, Measure and Manage. What it asks and who uses it worldwide.Version 1.0 current, revision under wayIn Aicura from Pro Voluntary frameworkNIST Generative AI ProfileNIST AI RMF Generative AI Profile (NIST AI 600-1)NIST AI 600-1 applies the AI Risk Management Framework to generative AI. Its 12 risks, the suggested actions behind them and who uses the profile and why.Final, published July 2024 StandardISO/IEC 23894ISO/IEC 23894:2023 Guidance on AI risk managementISO/IEC 23894 adapts the ISO 31000 risk process to AI. What the guidance covers, its AI risk sources and lifecycle mapping, and how it fits with ISO 42001.Published February 2023, current edition StandardISO/IEC 38507ISO/IEC 38507:2022 Governance implications of the use of AI by organizationsISO/IEC 38507 is guidance for boards on governing an organisation's use of AI. What it asks of directors, how it links to ISO/IEC 38500 and who uses it.Published April 2022, current edition Voluntary frameworkOECD AI PrinciplesOECD Recommendation of the Council on Artificial Intelligence (OECD AI Principles)The OECD AI Principles are the intergovernmental standard for trustworthy AI, adopted 2019 and revised 2024. The five principles and how to apply them.Adopted May 2019, revised May 2024 Voluntary frameworkHUDERIAHUDERIA: Risk and impact assessment of AI systems for human rights, democracy and the rule of lawHUDERIA is the Council of Europe's method for assessing AI risks to human rights, democracy and the rule of law. Its four elements, scoring and who uses it.Methodology and Model adopted, non-binding LawCouncil of Europe AI ConventionCouncil of Europe Framework Convention on Artificial Intelligence and Human Rights, Democracy and the Rule of Law (CETS No. 225)The Council of Europe AI Convention is the first binding international treaty on AI. Who has signed and ratified, what it asks of parties and when it applies.Open for signature, not yet in force Voluntary frameworkG7 Hiroshima Code of ConductHiroshima Process International Code of Conduct for Organizations Developing Advanced AI SystemsThe G7 Hiroshima Code of Conduct sets 11 voluntary actions for advanced AI developers, with OECD HAIP reporting. What it asks and who reports under HAIP 2.0.Voluntary, reporting framework v2.0 live Voluntary frameworkUNESCO AI Ethics RecommendationUNESCO Recommendation on the Ethics of Artificial IntelligenceUNESCO's Recommendation on the Ethics of AI is the global standard its member states adopted in 2021. Its values, principles and Ethical Impact Assessment.Adopted November 2021

All International frameworks

Questions

Does Malta have an AI law?

Yes, through the EU. The EU AI Act applies directly in Malta, and the Artificial Intelligence Regulations (Legal Notice 226 of 2025) and Legal Notice 227 of 2025 implement it, designating the authorities, setting national penalties and adding a few procedural duties. They create no obligations beyond the AI Act itself.

When do the EU AI Act's high-risk rules apply in Malta?

Obligations for high-risk systems listed in Annex III apply from 2 December 2027, and for high-risk AI embedded in regulated products from 2 August 2028, after the EU's Digital Omnibus on AI. Prohibited practices, AI literacy and the Article 50 transparency duties already apply.

What are the penalties under Malta's AI regulations?

Without prejudice to the AI Act's own fines, the MDIA can impose up to €350,000 per infringement, or 1% of worldwide annual turnover for an undertaking if higher, plus a daily penalty of €12,000 while an infringement continues. Public authorities face lower caps.

Does the MFSA have rules on AI?

The MFSA set out its expectations in a Dear CEO letter on 4 June 2026. It covers board accountability, third-party and concentration risk, validation and drift monitoring, data governance and systemic risk, with a self-assessment that firms must complete and take to the board but do not have to submit.

Start with the AI you run.

Every framework begins with knowing which AI systems and agents you have. The AI register is free to start.