CHAPTER III

Article 30: Notification procedure

Plain English Summary

What this article does: Establishes the procedure for notifying conformity assessment bodies to the Commission and other Member States. Who it applies to: Notifying authorities of Member States. Key requirements: Para 1: Notifying authorities may only notify bodies that satisfy the requirements in Article 31. Para 2: Must notify the Commission and other Member States using the electronic notification tool developed by the Commission. Para 3: The notification must include full details of the conformity assessment activities, modules, types of AI systems, and relevant attestation of competence. Para 4: The body may only perform notified body activities if no objections are raised by the Commission or other Member States within one month of notification. Para 5: The notifying authority must inform the Commission and other Member States of any subsequent relevant changes.

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

31. 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 of this Article shall include full details of the conformity assessment activities, the conformity assessment module or modules, 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 (2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the competence of the conformity assessment body and to the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article

31. 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 (2), or within two months of a notification by the notifying authority where it includes documentary evidence referred to in (3).

5. Where objections are raised, the Commission shall, without delay, enter into consultations with the relevant Member States and the conformity assessment body. In view thereof, the Commission shall decide whether the authorisation is justified. The Commission shall address its decision to the Member State concerned and to the relevant conformity assessment body.

Cross-referenced Articles

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