Updated on April 10th 2024 based on the version and article numbering approved by the EU Parliament on March 13th 2024.
1. The notifying authority shall notify the Commission and the other Member States of any relevant changes to the notification of a notified body via the electronic notification tool referred to in Article 30(2).
2. The procedures laid down in Articles 29 and 30 shall apply to extensions of the scope of the notification.
For changes to the notification other than extensions of its scope, the procedures laid down in the following paragraphs shall apply.
3. Where a notified body decides to cease its conformity assessment activities, it shall inform the notifying authority and the providers concerned as soon as possible and, in the case of a planned cessation, at least one year before ceasing its activities. The certificates of the notified body may remain valid for a temporary period of nine months after cessation of the notified body’s activities, on condition that another notified body has confirmed in writing that it will assume responsibilities for the high risk AI systems covered by those certificates. The latter notified body shall complete a full assessment of the AI systems affected by the end of that nine-month-period before issuing new certificates for those systems. Where the notified body has ceased its activity, the notifying authority shall withdraw the designation.
4. Where a notifying authority has sufficient reason to consider that a notified body no longer meets the requirements laid down in Article 31, or that it is failing to fulfil its obligations, the notifying authority shall without delay investigate the matter with the utmost diligence. In that context, it shall inform the notified body concerned about the objections raised and give it the possibility to make its views known. If the notifying authority comes to the conclusion that the notified body ▌ no longer meets the requirements laid down in Article 31 or that it is failing to fulfil its obligations, it shall restrict, suspend or withdraw ▌the designation as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall ▌ immediately inform the Commission and the other Member States accordingly.
5. Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the providers concerned at the latest within 10 days.
6. In the event of the restriction, suspension or withdrawal of a designation, the notifying authority shall take appropriate steps to ensure that the files of the notified body concerned are kept, and to make them available to notifying authorities in other Member States and to market surveillance authorities at their request.
7. In the event of the restriction, suspension or withdrawal of a designation, the notifying authority shall:
8. With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the certificates shall remain valid in one of the following circumstances:
9. With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months under the following circumstances:
In the circumstances referred to in the first subparagraph, the national competent authority of the Member State in which the provider of the system covered by the certificate has its place of business may extend the provisional validity of the certificates for additional periods of three months, which shall not exceed 12 months in total.
The national competent authority or the notified body assuming the functions of the notified body affected by the change of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof.
[Previous version]
Updated on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd
-1. The notifying authority shall notify the Commission and the other Member States of any relevant changes to the notification of a notified body via the electronic notification tool referred to in Article 32(2).
-1a. The procedures described in Article 31 and 32 shall apply to extensions of the scope of the notification. For changes to the notification other than extensions of its scope, the procedures laid down in the following paragraphs shall apply.
Where a notified body decides to cease its conformity assessment activities it shall inform the notifying authority and the providers concerned as soon as possible and in the case of a planned cessation one year before ceasing its activities. The certificates may remain valid for a temporary period of nine months after cessation of the notified body's activities on condition that another notified body has confirmed in writing that it will assume responsibilities for the AI systems covered by those certificates. The new notified body shall complete a full assessment of the AI systems affected by the end of that period before issuing new certificates for those systems. Where the notified body has ceased its activity, the notifying authority shall withdraw the designation.
1. Where a notifying authority has sufficient reasons to consider that a notified body no longer meets the requirements laid down in Article 33, or that it is failing to fulfil its obligations, the notifying authority shall without delay investigate the matter with the utmost diligence. In that context, it shall inform the notified body concerned about the objections raised and give it the possibility to make its views known. If the notifying authority comes to the conclusion that the notified body no longer meets the requirements laid down in Article 33 or that it is failing to fulfil its obligations, it shall restrict, suspend or withdraw notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.
2a. Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the manufacturers concerned at the latest within 10 days.
2b. In the event of restriction, suspension or withdrawal of a notification, the notifying authority shall take appropriate steps to ensure that the files of the notified body concerned are kept and make them available to notifying authorities in other Member States and to market surveillance authorities at their request.
2c. In the event of restriction, suspension or withdrawal of a designation, the notifying authority shall:
2d. With the exception of certificates unduly issued, and where a notification has been suspended or restricted, the certificates shall remain valid in the following circumstances:
2e. With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months in the following circumstances:
In the circumstances referred to in the first subparagraph, the national competent authority of the Member State in which the provider of the system covered by the certificate has its place of business may extend the provisional validity of the certificates for further periods of three months, which altogether shall not exceed twelve months.
2f. The national competent authority or the notified body assuming the functions of the notified body affected by the change of notification shall immediately inform the Commission, the other Member States and the other notified bodies thereof.
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