S.L. 591.5 Art. 3Designation of market surveillance authority and single point of contact.

(1) The Malta Digital Innovation Authority shall, unless otherwise provided in these regulations or any other law, be designated as a market surveillance authority for the purpose of

Regulation (EU) 2024/1689:

Provided that:

(a) irrespective of the above, for the purposes of regulation 9, the Malta Digital Innovation Authority shall be the sole national competent Authority responsible for the establishment and functioning of a national AI regulatory sandbox;

(b) for high-risk AI systems placed on the market, put into service, or used by financial institutions regulated by Union financial services law, coordination shall be ensured between the Malta Digital Innovation Authority and the Malta Financial Services Authority, and the Malta Digital Innovation Authority shall seek to report any information identified in the course of the market surveillance activities that may be of potential interest for the prudential supervisory tasks of the Malta Financial Services Authority and the Malta Financial Services Authority shall provide any information requested by the Malta Digital Innovation Authority for the purposes of carrying out its responsibilities, duties, powers and functions as market surveillance authority;

(c) for high-risk AI systems related to products covered by the Union harmonisation legislation listed in Section A of Annex I of Regulation (EU) 2024/1689, coordination shall be ensured between the Malta Digital Innovation Authority and the relevant sectoral market surveillance authorities responsible for the enforcement of the Union harmonisation legislation listed in Section A of Annex I of Regulation (EU) 2024/1689 shall provide any information requested by the Malta Digital Innovation Authority for the purposes of carrying out its responsibilities, duties, powers and functions as a market surveillance authority;

(d) without prejudice to any other law designating any other body or person as a market surveillance authority for the purposes of Regulation (EU) 2024/1689, the Minister may by order in the Gazette designate other bodies or persons as a market surveillance authority for different provisions and for different purposes of these regulations and Regulation (EU) 2024/1689 as may be amended from time to time:

Provided further, that where no market surveillance authority has been designated for the purpose of Regulation (EU) 2024/1689, the Malta Digital Innovation Authority shall be automatically designated as the market surveillance authority.

(2) The Malta Digital Innovation Authority shall be designated as the single point of contact for the purposes of Regulation

(EU) 2024/1689.

(3) Without prejudice to any other law providing for the responsibilities, duties, powers and functions of the Malta Digital Innovation Authority, the Malta Digital Innovation Authority shall have all the responsibilities, duties, powers and functions granted to the market surveillance authorities by virtue of Regulation (EU) 2024/ 1689.

(4) For the purpose of implementing the requisites of Regulation (EU) 2024/1689, the Malta Digital Innovation Authority shall facilitate coordination between market surveillance authorities and other relevant national authorities or bodies which supervise the application of Union harmonisation legislation listed in Annex I, or in other Union law, that may be relevant for the high-risk AI systems referred to in Annex III.

(5) The Malta Digital Innovation Authority may call upon experts of the scientific panel established under Article 68 of Regulation (EU) 2024/1689 to support national enforcement activities under Regulation (EU) 2024/1689.