AI Regulation ReferenceDoes Artificial Intelligence Regulations 2025 require Risk Assessment?
Malta • enforcing
Yes — 1 provision
Requirements at a glance
This regulation imposes 4 specific requirements for Risk Assessment across 1 provision:
- Early classification — Deployers must proactively classify AI systems to determine if they fall under Annex III high-risk categories
- MDIA notification — Market surveillance notifications to MDIA for AI systems placed on the Maltese market
- Sandbox participation — MDIA operates a national AI regulatory sandbox for testing and development
- Notified body designation — MDIA serves as notifying authority for conformity assessment bodies
AI System Classification and Market Surveillance #
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
| Requirement | Details |
|---|---|
| Early classification | Deployers must proactively classify AI systems to determine if they fall under Annex III high-risk categories |
| MDIA notification | Market surveillance notifications to MDIA for AI systems placed on the Maltese market |
| Sandbox participation | MDIA operates a national AI regulatory sandbox for testing and development |
| Notified body designation | MDIA serves as notifying authority for conformity assessment bodies |