REG-010

AI Act rules reach AI inside regulated products

2 August 2027

in 331 days

AI that is a safety component of a product already covered by EU product law — machinery, lifts, toys, medical devices — becomes high-risk AI, and its conformity assessment folds into the CE marking the product already carries.

The sentence that fixes the date

Article 6(1) and the corresponding obligations in this Regulation shall apply from 2 August 2027.

Regulation (EU) 2024/1689, Article 113(c), with Article 6(1)Regulation (EU) 2024/1689, OJ text

Who is forced to spend

Who

Manufacturers of Annex I products that embed a model anywhere in the safety path, and the notified bodies that have to assess them.

What they spend today

These firms already run a technical file, a risk management file and a notified body relationship; the AI chapter is a new file inside a process they fund.

Sector

Industrial and medical products

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