CHAPTER III

Article 34: Operational obligations of notified bodies

Plain English Summary

What this article does: Sets operational obligations for notified bodies when carrying out conformity assessments. Who it applies to: Notified bodies. Key requirements: Para 1: Notified bodies must verify the conformity of high-risk AI systems in accordance with the conformity assessment procedures in Article 43. Para 2: Must avoid unnecessary burdens on providers and act proportionately to the size and structure of the business. Para 3: Where a notified body finds that a provider has not met the requirements, it must require the provider to take appropriate corrective measures and must not issue a certificate of conformity.

1. Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment procedures set out in Article

43. 2. Notified bodies shall avoid unnecessary burdens for providers when performing their activities, and take due account of the size of the provider, the sector in which it operates, its structure and the degree of complexity of the high-risk AI system concerned, in particular in view of minimising administrative burdens and compliance costs for micro- and small enterprises within the meaning of Recommendation 2003/361/EC. The notified body shall, nevertheless, respect the degree of rigour and the level of protection required for the compliance of the high-risk AI system with the requirements of this Regulation.

3. Notified bodies shall make available and submit upon request all relevant documentation, including the providers’ documentation, to the notifying authority referred to in to allow that authority to conduct its assessment, designation, notification and monitoring activities, and to facilitate the assessment outlined in this Section.

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