Mar­ket surveil­lance

• Market surveillance under Annexes I and III to the AI Act

Article 3 point 3 of the Market Surveillance Regulation ((EU) 2019/1020) defines market surveillance as:

“the activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements set out in the applicable Union harmonisation legislation and to ensure protection of the public interest covered by that legislation”.

Aims of market surveillance:

• guaranteeing fair competition and the free movement of goods within the EU;
• ensuring that AI products placed on the European market comply with the EU rules;
• protecting European citizens from dangerous or unfair AI systems, in particular with regard to health and safety in general and at work, consumer protection, environmental protection and public security;
• protecting against unfair competition from players not complying with the rules.

A market surveillance authority under the AI Act is the national authority carrying out the activities and taking the measures pursuant to the AI Act. It carries out checks on samples of AI products on the market and on technical documentation such as declarations of conformity and works closely with other national authorities and the European Commission. It follows up complaints it receives from natural and legal persons, in particular consumer complaints, and takes them into account in its market surveillance activities and when planning checks and inspections. It imposes certain measures when it identifies non-compliances.

Market surveillance under Annexes I and III to the AI Act

Article 70 of the AI Act requires each Member State to establish and designate as a national competent authority at least one market surveillance authority in the field of AI. The AI Act allows the activities and tasks of a market surveillance authority to be performed by one or more designated authorities.

The market surveillance measures cover high-risk AI systems as defined in Article 6 of the AI Act.

Information about the requirements applicable to high-risk AI systems is available here.

• Market surveillance in fields covered by the harmonisation legislation listed in Annex I to the AI Act, for example medical devices, machinery and radio equipment: any market surveillance structures already in place for these fields will be used, unless decided otherwise by a new federal government or by the legislature in legislation implementing the AI Act. These structures will also take on the tasks under the AI Act vis-à-vis the market players.
• The Bundesnetzagentur is the competent market surveillance authority for the Directive relating to the making available on the market of radio equipment (2014/53/EU) listed in Annex I point 6 of the AI Act. It will therefore also carry out the associated activities and tasks under the AI Act.
• Market surveillance in fields covered by Article 43(1) in conjunction with Annex III to the AI Act, for example critical infrastructure and law enforcement: no structures are in place for market surveillance in these fields. The market surveillance tasks for these fields will be coordinated by the Bundesnetzagentur.

Important: The rules on the market surveillance activities and tasks for high-risk AI systems as referred to in Annex III to the AI Act will be applicable as from 2 August 2026 and for high-risk AI systems covered by Annex I as from 2 August 2027.