Malta - Digital Innovation Authority (XIX/2024)
Malta Digital Innovation Authority (Amendment) Act, Act No. XIX of 2024
Malta
RAI-MT-NA-MDIAAXX-2024Malta - Digital Innovation Authority (XIX/2024) is In Force in Malta as of 9 Sep 2026, according to legislation.mt.
ActGovernance and OversightConformity Assessment and RegistrationEnforcement and PenaltiesThe Malta Digital Innovation Authority (Amendment) Act (Act No. XIX of 2024) expands the supervisory remit of the MDIA over providers of innovative digital technologies, including AI systems. It establishes updated recognition rules, administrative sanctions, and an appeals process. Enforced by the MDIA, the law took effect on 14 June 2024.
Summary
The Malta Digital Innovation Authority (Amendment) Act (Act No. XIX of 2024), published 14 June 2024, amends the principal Malta Digital Innovation Authority Act (Cap. 591) to enlarge the MDIA’s statutory remit and modernise the legislative framework governing Malta’s primary regulator for digital innovation. Key changes include: substitution of gendered terminology ("Chairman" to "Chairperson"); expansion and clarification of definitions (including an extended definition of "innovative technology" and recognition instruments); restructured table of contents and sections to introduce new headings such as a dedicated enforcement and sanctions Part and an Administrative Review Tribunal Part; new powers and enforcement measures for the MDIA including broader recognition, registration and supervisory authorities; and the removal or revision of provisions that previously constrained the Authority’s operations.
The Act replaces and reorganises the principal Act’s sections, inserts updated definitions to ensure the MDIA’s competence covers a broad set of digital technologies, formalises the MDIA’s function to protect public and user interests (domestically and internationally), clarifies scope exclusions (public safety, national defence and criminal law), and establishes procedural and institutional arrangements for governance, staffing, finance, and technology schedules. It establishes an Administrative Review Tribunal pathway for appeals and review of MDIA decisions, refines the MDIA’s powers to issue recognitions (licenses, registrations, approvals and similar instruments), and strengthens the infraction, enforcement and sanctions regime (administrative measures, suspension and revocation powers). The Act also repeals and consequentially amends related subordinate instruments and cross-references to align with the updated structure.
Practically, the amendment equips the MDIA to operate as Malta’s designated authority for emergent EU digital frameworks (for example, as a national competent authority for aspects of EU Acts relating to digital or AI systems where so designated by separate secondary instruments), to undertake conformity-assessment and recognition functions, and to exercise market surveillance and enforcement powers. The law therefore has implications for providers and deployers of innovative digital technologies (including AI, distributed ledger, IoT and related systems), market operators, conformity assessors, and entities that seek recognition or registration for digital technology products and services in Malta.
For legal practitioners, compliance officers and regulated entities, the Act increases obligations around registration/recognition, strengthens administrative oversight and surveillance, and provides expanded enforcement tools for the MDIA while also offering an administrative review process for aggrieved parties. The primary official sources are the parliamentary publication (PDF) of Act No. XIX of 2024 and the Maltese Legislation ELI entry; the Malta Digital Innovation Authority website provides complementary guidance on services and subsequent secondary instruments.
Full article
Read full text ↗Overview
The Malta Digital Innovation Authority (Amendment) Act, Act No. XIX of 2024 (published 14 June 2024), amends the principal Malta Digital Innovation Authority Act (Cap. 591) to modernise the statute, expand institutional powers and provide a clearer enforcement framework. The amendment restructures the Act into thematic Parts (Preliminary, Principles, Establishment and Functions, Staff, Finance, Recognition, Enforcement & Sanctions, Administrative Review, Miscellaneous, and Schedules), revises core definitions (including "innovative technology" and "recognition"), substitutes outdated terminology and creates new statutory mechanisms to support a proactive regulatory approach. The text and official PDF are available from the Parliament of Malta and the national legislation portal; see the official parliamentary PDF Act No. XIX of 2024 (PDF) and the ELI entry hosted by the Maltese legislation portal at legislation.mt.
Definitions
The Amendment expands and harmonises statutory definitions to reflect contemporary technology and regulatory practice. Notable definitional changes include: replacement of gendered terms (e.g., "Chairman" to "Chairperson"); an expanded definition of "innovative technology" to explicitly include a broad non-exhaustive list of digital technologies and their associated products, solutions and services (referencing the First Schedule); clarification that "recognition" encompasses licences, registrations, authorisations, approvals, certifications and other formal instruments the Authority may issue; inclusion of definitions for "Board", "Authority", "user", "Minister" and cross-references to other Maltese Acts (notably Cap. 490 – Administrative Justice, and Cap. 586 – Data Protection). The new definitions emphasise the MDIA’s role in protecting public and user interests, and confirm that the Authority’s remit extends beyond users in Malta to public/users in other jurisdictions if relevant.
Governance and Institutional Framework
The Act reconstitutes the statutory governance structure of the MDIA by updating the Board composition, appointment mechanics, and role descriptions. It clarifies the powers of the Chairperson and Board, formalises delegation and authorisation powers, and sets out the Authority’s fiduciary, staffing and financial arrangements. The Amendment provides for a dedicated section on officials and employees (appointment, duties and protections), and strengthens the statutory basis for issuing guidelines and regulations. The reorganisation supports administrative efficiency by enabling the MDIA to undertake delegated tasks, enter into cooperative arrangements with other national or EU authorities, and to represent Malta in international/regulatory fora. For the official institutional text, see the parliamentary publication Act No. XIX of 2024 (PDF) and the consolidated listing at legislation.mt.
Key Focus Areas
The Amendment emphasises a set of operational and regulatory priorities: (1) recognition and conformity assessment — empowering the MDIA to issue recognitions (licenses, registrations and approvals) and to supervise conformity assessment processes; (2) market surveillance and enforcement — introducing enhanced surveillance, inspection powers and administrative measures to address non-compliance; (3) risk-based oversight — enabling targeted supervision of higher-risk technologies and services; (4) accountability and documentation — requiring records, transparency and traceability for registered/recognised entities; (5) user protection and fundamental rights — consolidating safeguards and clarifying exclusions for defence or criminal law; (6) administrative review — establishing a Tribunal-oriented appeals route for administrative decisions; and (7) international cooperation — facilitating cross-border regulatory coordination. These priority areas align the MDIA’s remit with EU digital governance trends and facilitate Malta’s operational readiness for sectoral EU instruments and designation as a competent authority where applicable. The MDIA’s public pages summarise its services and priorities: Malta Digital Innovation Authority homepage and specific service pages such as MDIA – Artificial Intelligence.
Implementation Framework
The Act sets out an implementation pathway that relies on a combination of primary statutory powers and secondary instruments (regulations, rules and guidelines) to operationalise details such as application procedures, fees, recognition criteria and enforcement processes. The Amendment grants the Minister and the MDIA powers to make subsidiary legislation and guidance to fill technical requirements, and to remove or modify parts of the prior schedules to keep the legal framework adaptable to technological change. The MDIA may also enter into memoranda of understanding with other national authorities to coordinate functions such as data protection and sectoral supervision — complementing Malta’s broader approach to the EU Data Act and future AI governance responsibilities. For practical guidance, the MDIA publishes service guidance and templates at MDIA Services.
Monitoring and Evaluation
The Amendment imposes monitoring and evaluation responsibilities on the Authority to ensure the effectiveness of recognitions, compliance measures and market surveillance. The MDIA is empowered to collect information, require records, carry out inspections and commission assessments of recognised technologies. The Act anticipates periodic review of regulatory measures and the power to adjust enforcement intensity according to observed risk patterns. The availability of an Administrative Review mechanism provides an independent administrative oversight channel and supports transparency and accountability in decision-making.
Penalties, Liability, and Appeals
The Act strengthens enforcement by clarifying administrative sanctions and remedies the MDIA may impose (including suspension, revocation of recognitions, directions to comply, and administrative fines or measures as prescribed in subsidiary rules). It also preserves access to the Tribunal for administrative review and provides procedural safeguards for affected parties. Liability provisions cover revocation consequences and the Authority’s discretionary powers in the event of serious risks to users or the public. The Amendment is explicit that public safety, defence and criminal law matters remain outside the MDIA’s substantive regulatory reach, while administrative penalties are used for regulatory compliance enforcement.
Relationship to Other Instruments
The Amendment expressly amends Cap. 591 and makes consequential references to other Maltese statutes (including Cap. 490 Administrative Justice and Cap. 586 Data Protection) and revokes or replaces certain subordinate instruments (the ELI entry notes revocation of S.L. 592.1 and Cap. 592 related instruments). It is designed to be compatible with EU-level regulatory instruments affecting digital and data governance; subsequent subsidiary instruments (Legal Notices and Regulations) may designate the MDIA as Competent Authority for specific EU Acts where appropriate. For statutory cross-references see ELI: Act No. XIX of 2024.
International Alignment
The Act aligns Malta’s national framework with prevailing EU objectives to regulate digital innovation responsibly and to support conformity assessment, market surveillance, and cross-border cooperation. By providing flexible recognition instruments and enhanced enforcement capacity, the statute prepares the MDIA to act where national designation is required under EU-level measures (for example, in areas touching upon AI and data governance). The MDIA’s public materials highlight engagement with EU processes and readiness to serve as national competent authority where designated; see MDIA guidance at MDIA.
Implementation Timeline
| Milestone | Date / Period |
|---|---|
| Parliamentary publication (Government Gazette) | 14 June 2024 |
| Entry into force (primary Act) | 14 June 2024 |
| Enabling subsidiary regulations and guidance (expected phased promulgation) | 2024–2025 (phased) |
| Designation as Competent Authority under EU instruments (where applicable) | as prescribed by separate legal notices/decisions |
Sources and References
| Source | Type |
|---|---|
| Act No. XIX of 2024 - Malta Digital Innovation Authority (Amendment) Act (PDF) | Primary Source |
| ELI: Act No. XIX of 2024 (legislation.mt) | Primary Source |
| Malta Digital Innovation Authority (MDIA) – official site | Primary / Regulator Guidance |
Requirements for a company
What an organisation has to do under Malta - Digital Innovation Authority (XIX/2024), at a glance. Not legal advice — the table below gives the provision and deadline for each item.
Must do
8- Maintain records, transparency, and traceability for your operations.Entities seeking or holding MDIA recognition.
- Seek recognition (license, registration, or approval) from the MDIA.Providers of innovative technologies subject to MDIA oversight.
- Cooperate with MDIA market surveillance, inspections, and assessments.Entities subject to MDIA oversight.
- Provide information and records as required by the MDIA.Entities subject to MDIA oversight.
- Consolidate safeguards for user protection and fundamental rights.Providers of innovative technologies.
- Implement risk-based oversight for higher-risk technologies and services.Providers of higher-risk innovative technologies.
- +2 more in the table below
Must not do
0Nothing in this category.
Should do
1- Update internal governance documents to reflect new statutory terms.Entities with MDIA recognition.
Should not do
0Nothing in this category.
Who must do what
The obligations under Malta - Digital Innovation Authority (XIX/2024), most serious first. Not legal advice — verify against the official text before relying on it.
| # | Who | Requirement | By when | Where | Severity |
|---|---|---|---|---|---|
| 1 | Entities seeking or holding MDIA recognition. | Maintain records, transparency, and traceability for your operations. “requiring records, transparency and traceability for registered/recognised entities;” | — | — | Critical |
| 2 | Providers of innovative technologies subject to MDIA oversight. | Seek recognition (license, registration, or approval) from the MDIA. “empowering the MDIA to issue recognitions (licenses, registrations and approvals) and to supervise conformity assessment processes;” | Before placing on market | — | Critical |
| 3 | Entities subject to MDIA oversight. | Cooperate with MDIA market surveillance, inspections, and assessments. “introducing enhanced surveillance, inspection powers and administrative measures to address non-compliance;” | — | — | Critical |
| 4 | Entities subject to MDIA oversight. | Provide information and records as required by the MDIA. “The MDIA is empowered to collect information, require records” | — | — | Critical |
| 5 | Providers of innovative technologies. | Consolidate safeguards for user protection and fundamental rights. “user protection and fundamental rights — consolidating safeguards” | — | — | Important |
| 6 | Providers of higher-risk innovative technologies. | Implement risk-based oversight for higher-risk technologies and services. “risk-based oversight — enabling targeted supervision of higher-risk technologies and services;” | — | — | Important |
| 7 | Entities subject to MDIA oversight. | Monitor subsidiary regulations, rules, and guidelines issued by the MDIA. “The Act sets out an implementation pathway that relies on a combination of primary statutory powers and secondary instruments” | — | — | Important |
| 8 | Entities holding existing MDIA recognitions. | Review existing MDIA recognitions for compliance with new criteria. | — | — | Important |
| 9 | Entities with MDIA recognition. | Update internal governance documents to reflect new statutory terms. | — | — | Recommended |
Related Regulations
More AI regulation in Malta
© Regulations.AI · updated on 20 Sep 2026 · reviewed against official sources on 9 Sep 2026 using Gemini 3.6 Flash