Updated on May 21st 2024 based on the version and article numbering approved by the EU Parliament on May 14th 2024.
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 Article 29(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 Article 29(2), or within two months of a notification by the notifying authority where it includes documentary evidence referred to in Article 29(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.
[Previous version]
Updated on May 8th 2024 based on the version and article numbering in the EU Parliament's 'Corrigendum' version dated April 19th 2024.
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 Article 29(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 Article 29(2), or within two months of a notification by the notifying authority where it includes documentary evidence referred to in Article 29(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.
Updated on April 10th 2024 based on the version and article numbering approved by the EU Parliament on March 13th 2024.
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 Article 29(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 Article 29(2), or within two months of a notification by the notifying authority where it includes documentary evidence referred to in Article 29(3).
5. Where objections are raised, the Commission shall, without delay, enter into consultations with the relevant Member States and the conformity assessment body. Having regard thereto, the Commission shall decide whether the authorisation is justified. The Commission shall address its decision to the Member State concerned and the relevant conformity assessment body.
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