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Article 34a

[Deleted]

Removed on May 8th 2024 based on the version and article numbering in the EU Parliament's 'Corrigendum' version dated April 19th 2024.

[Previous version]

Removed on April 10th 2024 based on the version and article numbering approved by the EU Parliament on March 13th 2024.

Updated on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd

Operational Obligations of Notified Bodies

1. Notified bodies shall verify the conformity of high-risk AI system in accordance with the conformity assessment procedures referred to in Article 43.

2. Notified bodies shall perform their activities while avoiding unnecessary burdens for providers, and taking due account of the size of an undertaking, the sector in which it operates, its structure and the degree of complexity of the high risk AI system in question. In so doing, 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. Particular attention shall be paid to minimising administrative burdens and compliance costs for micro and small enterprises as defined in Commission Recommendation 2003/361/EC.

3. Notified bodies shall make available and submit upon request all relevant documentation, including the providers’ documentation, to the notifying authority referred to in Article 30 to allow that authority to conduct its assessment, designation, notification, monitoring activities and to facilitate the assessment outlined in this Chapter.

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