AML Map

AI Act role · Art. 3(7)

EU AI Act — Product manufacturer

You place on the market or put into service an AI system together with your product under your name or trademark — where the AI is a safety component or the product is itself a high-risk AI system under Annex I.

Key obligations apply from

2 August 2027

368d left

Risk tier

high risk

Full AI Act applies by Aug 2027 for remaining Annex I scope

Scope notes: Product manufacturers integrating AI into regulated products (machinery, medical devices, toys, etc.) inherit provider obligations for the AI component from Aug 2027 when Annex I fully applies.

First steps before 2 August 2027

  1. 1Identify AI safety components in products under Union harmonisation legislation
  2. 2Align AI conformity with existing product CE marking processes
  3. 3Coordinate with notified bodies on combined conformity assessment

Who supervises you?

Market surveillance authorities in each Member State enforce the AI Act. The European AI Office supports coordination, GPAI oversight, and cross-border cases.

AI Act implementation & AI Office

Priority mandates for you

2 instruments
GuidelinesIn developmentAML overlap3d leftArt. 96

High-risk AI systems — requirements and conformity

Guidelines on the practical implementation of Chapter III requirements — risk management, data governance, transparency, human oversight, accuracy, and robustness (Art. 96(1)(a)).

Why it matters: Primary interpretive guide for Chapter III conformity once published — distinct from the Art. 6 classification consultation now open.

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Harmonised standardsIn developmentAML overlap3d leftArt. 40

Harmonised standards for high-risk AI requirements

European standardisation requests to CEN/CENELEC for presumption-of-conformity standards covering risk management, data governance, transparency, and human oversight.

Why it matters: Following cited hENs is the main route to presumed conformity — your QMS and technical documentation will map to these.

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All rules for this roleAI Act on EUR-Lex

This page is an independent orientation guide — not legal advice. National implementation and sector-specific rules may apply. Always verify scope against the official AI Act text and your supervisor.