1. An AI system that is itself a product covered by the Union harmonisation legislation listed in Annex II shall be considered as high risk if it is required to undergo a third-party conformity assessment with a view to the placing on the market or putting into service of that product pursuant to the above mentioned legislation.

2. An AI system intended to be used as a safety component of a product covered by the legislation referred to in paragraph 1 shall be considered as high risk if it is required to undergo a third-party conformity assessment with a view to the placing on the market or putting into service of that product pursuant to above mentioned legislation. This provision shall apply irrespective of whether the AI system is placed on the market or put into service independently from the product.

3. AI systems referred to in Annex III shall be considered high-risk unless the output of the system is purely accessory in respect of the relevant action or decision to be taken and is not therefore likely to lead to a significant risk to the health, safety or fundamental rights.

In order to ensure uniform conditions for the implementation of this Regulation, the Commission shall, no later than one year after the entry into force of this Regulation, adopt implementing acts to specify the circumstances where the output of AI systems referred to in Annex III would be purely accessory in respect of the relevant action or decision to be taken. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 74, paragraph 2.