Question 1

What is the purpose of a conformity assessment for high-risk AI systems?

Accepted Answer

Article 43 requires that providers of high-risk AI systems conduct a conformity assessment to demonstrate that the system complies with all AI Act requirements before it is placed on the market or put into service.

Question 2

What does the CE marking on a high-risk AI system signify?

Accepted Answer

The CE marking is a declaration by the provider that the AI system complies with all applicable EU requirements, including the AI Act. It's similar to CE marking for other products and is required before a high-risk system may be placed on the market.

Question 3

What is a 'notified body' in the context of the AI Act?

Accepted Answer

A notified body is an independent organization designated by national authorities and notified to the Commission to conduct conformity assessments for certain high-risk AI systems. They fulfill a similar role as for medical devices.

Question 4

Which two procedures exist for conformity assessments of high-risk AI?

Accepted Answer

Article 43 provides two procedures: (1) internal control based on technical documentation (for most high-risk systems), or (2) assessment by a notified body (for specific categories like biometric identification).

Question 5

When is involvement of a notified body mandatory?

Accepted Answer

A notified body is mandatory for: (1) AI systems for biometric identification and categorization of natural persons, and (2) when providers have not (fully) applied harmonized standards. Article 43(1) determines this.

Question 6

What must happen if a high-risk AI system is substantially modified?

Accepted Answer

Article 43(4) states that substantial modifications to a high-risk AI system require a new conformity assessment. This ensures that changes don't lead to non-compliant systems.

Question 7

How long must technical documentation be retained after CE marking?

Accepted Answer

Articles 11 and 18 require that providers retain technical documentation for 10 years after placing the AI system on the market or putting it into service. This enables authorities to conduct retrospective checks.

Question 8

What is the 'EU declaration of conformity'?

Accepted Answer

The EU declaration of conformity is a formal document in which the provider declares that the high-risk AI system complies with all AI Act requirements. This document must be drafted before the CE marking may be affixed (Article 47).

Conformity Assessment Quiz

What is the purpose of a conformity assessment for high-risk AI systems?