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Article 32

Presumption of Conformity with Requirements Relating to Notified Bodies

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

Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 31 in so far as the applicable harmonised standards cover those requirements.

[Previous version]

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

Wherea conformity assessment body demonstrates its conformity with the criteria laiddown in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of theEuropean Union, it shall be presumed to comply with the requirements set out inArticle 31 in so far as the applicable harmonised standards cover those requirements.

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

Notification Procedure

1. Notifying authorities may only notify conformity assessment bodies which have satisfied the requirements laid down in Article 33.

2. Notifying authorities shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission of each conformity assessment body referred to in paragraph 1.

3. The notification referred to in paragraph 2 shall include full details of the conformity assessment activities, the conformity assessment module or modules and the types of AI systems concerned and the relevant attestation of competence. Where a notification is not based on an accreditation certificate as referred to in Article 31 (2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body's competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 33.

4. The conformity assessment body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification by a notifying authority where it includes an accreditation certificate referred to in Article 31(2), or within two months of a notification by the notifying authority where it includes documentary evidence referred to in Article 31(3).

4a. Where objections are raised, the Commission shall without delay enter into consultation with the relevant Member States and the conformity assessment body. In view thereof, the Commission shall decide whether the authorisation is justified or not. The Commission shall address its decision to the Member State concerned and the relevant conformity assessment body.

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