Artificial Intelligence Regulations 2025

Jurisdiction:
Malta
enforcing
Effective:
Oct 10, 2025
Authority:
Malta Digital Innovation Authority
Official text Verified Mar 28, 2026

Obligations Covered

Risk Assessment Human Oversight

Provisions (2)

AI System Classification and Market Surveillance #

Obligation:
Risk Assessment
enforcing
Effective:
Oct 10, 2025
Risk tier:
all (enhanced for high-risk)
Scope:
deployers, providers
high-impact
Malta's dual-authority model (MDIA for market surveillance, IDPC for fundamental rights) creates a practical enforcement structure that other small EU member states may follow. The early classification requirement means deployers must proactively assess whether their AI systems fall under Annex III high-risk categories before placing them on the Maltese market — not wait for a regulator to classify them.

Requirements

RequirementDetails
Early classificationDeployers must proactively classify AI systems to determine if they fall under Annex III high-risk categories
MDIA notificationMarket surveillance notifications to MDIA for AI systems placed on the Maltese market
Sandbox participationMDIA operates a national AI regulatory sandbox for testing and development
Notified body designationMDIA serves as notifying authority for conformity assessment bodies

High-Risk AI Oversight and Biometric Controls #

Obligation:
Human Oversight
enforcing
Effective:
Oct 10, 2025
Risk tier:
high
Scope:
deployers

Requirements

RequirementDetails
IDPC supervisionInformation and Data Protection Commissioner supervises high-risk AI systems (Annex III) and prohibited practices
High-risk AI registryIDPC maintains a registry of high-risk AI systems
Biometric authorizationReal-time remote biometric identification in public spaces for law enforcement requires prior Magistrate authorization
IDPC notificationLaw enforcement must notify IDPC of biometric identification use (excluding sensitive data)
Corrective powersIDPC can issue warnings, impose corrective measures, and order withdrawal of non-compliant AI systems