European Union: Conformity assessment and business registration requirement for "high-risk AI systems" in Regulation laying down harmonised rules on artificial intelligence (AI Act)

Progress

Current status
in grace period
02 Aug 2027 in force
02 Aug 2026 in force
01 Aug 2024 in grace period
21 May 2024 adopted
13 Mar 2024 under deliberation
09 Dec 2023 under deliberation
14 Jun 2023 under deliberation
11 May 2023 under deliberation
06 Dec 2022 under deliberation
21 Apr 2021 under deliberation

Scope

Implementers
Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
Policy Area
Authorisation, registration and licensing
Policy Instrument
Business registration requirement
Regulated Economic Activity
ML and AI development
Government Branch
legislature
executive
Government Body
parliament
central government
Implementation Level
supranational

Timeline of events

02 Aug 2027
in force

Implemented AI Act including conformity assessment and business registration requirement for Article 6(1) "high-risk AI systems"

On 2 August 2027, the regulation laying down harmonised rules on Artificial Intelligence (Artificial Intelligence Act) comes into effect for "high-risk AI systems" referred to in Article 6(1) of the Act. The Act includes conformity assessment and bu…

Source
Event type law
Action type implementation
Government branch legislature
Government body parliament
02 Aug 2026
in force

Implemented AI Act including conformity assessment and business registration requirement for Annex III "high-risk AI systems"

On 2 August 2026, the regulation laying down harmonised rules on Artificial Intelligence (Artificial Intelligence Act) comes into effect for "high-risk AI systems" referred to in Annex III of the Act. The Act includes conformity assessment and busin…

Source
Event type law
Action type implementation
Government branch legislature
Government body parliament
01 Aug 2024
in grace period

Entry into force with grace period of AI Act including conformity assessment and business registration requirement for "high-risk AI systems"

On 1 August 2024, the regulation laying down harmonised rules on Artificial Intelligence (Artificial Intelligence Act) enters into force, 20 days following its publication in the Official Journal, with a grace period on its implementation. The Act i…

Source
Event type law
Action type in force with grace period
Government branch legislature
Government body parliament
21 May 2024
adopted

Adopted AI Act including conformity assessment and business registration requirement for "high-risk AI systems" by Council

On 21 May 2024, the Council of the European Union adopted the regulation laying down harmonised rules on Artificial Intelligence (Artificial Intelligence Act). The Act includes conformity assessment and business registration requirements for "high-r…

Source
Event type law
Action type adoption
Government branch legislature
Government body parliament
13 Mar 2024
under deliberation

Passed AI Act including conformity assessment and business registration requirement for "high-risk AI systems" by EU Parliament

On 13 March 2024, the European Parliament passed the regulation laying down harmonised rules on Artificial Intelligence (Artificial Intelligence Act). The Act includes conformity assessment and business registration requirements for "high-risk AI s…

Source
Event type law
Action type passage
Government branch legislature
Government body parliament
09 Dec 2023
under deliberation

Reached Council and Parliament agreement on AI Act including conformity assessment and business registration requirement for "high-risk AI systems"

On 9 December 2023, the Parliament and the Council of the European Union adopted a provisional agreement on the proposal on harmonised rules on artificial intelligence (AI Act). The compromise agreement clarifies the definition of an AI system by a…

Source
Event type law
Action type passage
Government branch legislature
Government body parliament
14 Jun 2023
under deliberation

Adopted EU Parliament position AI Act including business registration requirement for "high-risk AI systems"

On 14 May 2023, the European Parliament adopted its position on the Act on Harmonised Rules for Artificial Intelligence (AI Act), including conformity assessment and business registration requirements for "high-risk AI systems". Specifically, the s…

Source
Event type law
Action type passage
Government branch legislature
Government body parliament
11 May 2023
under deliberation

Adopted LIBRE and IMCO's position on AI Act including business registration requirement for "high-risk AI systems"

On 11 May 2023, the European Parliament Committee on Civil Liberties, Justice and Home Affairs (LIBE) and Internal Market and Consumer Protection Committee (IMCO) adopted their position on the Act on Harmonised Rules for Artificial Intelligence (AI …

Source
Event type law
Action type passage
Government branch legislature
Government body parliament
06 Dec 2022
under deliberation

Adopted Council general approach on AI Act including business registration requirement for "high-risk AI systems"

On 6 December 2022, the Council of the European Union adopted its general approach on the Artificial Intelligence Act (AI Act), including the obligation of registering the "high-risk AI systems" before they are placed on the European single market. …

Source
Event type law
Action type passage
Government branch executive
Government body central government
21 Apr 2021
under deliberation

Published AI regulation proposal includes conformity assessment and registration requirements for "high-risk" AI systems

The European Commission`s proposed regulation on a European approach to Artificial Intelligence includes a conformity assessment and registration requirement for so-called "high-risk AI systems" (from Art. 40). Member states shall designate or estab…

Source
Event type law
Action type introduction
Government branch executive
Government body central government