Article 36, Changes to notifications, Artificial Intelligence Act (Proposal 25.11.2022)
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).
2. 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.
3. 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, provided that the the notified body had the opportunity to make its views known, 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.
4. Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the manufacturers concerned at the latest within 10 days.
5. 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.
6. In the event of restriction, suspension or withdrawal of a designation, the notifying authority shall:
a) assess the impact on the certificates issued by the notified body;
b) submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the notification;
c) require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any certificates which were unduly issued in order to ensure the conformity of AI systems on the market;
d) inform the Commission and the Member States about certificates of which it has required their suspension or withdrawal;
e) provide the national competent authorities of the Member State in which the provider has its registered place of business with all relevant information about the certificates for which it has required suspension or withdrawal. That competent authority shall take the appropriate measures, where necessary, to avoid a potential risk to health, safety or fundamental rights.
7. 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:
a) the notifying authority has confirmed, within one month of the suspension or restriction, that there is no risk to health, safety or fundamental rights in relation to certificates affected by the suspension or restriction, and the notifying authority has outlined a timeline and actions anticipated to remedy the suspension or restriction; or
b) the notifying authority has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor and remain responsible for existing certificates issued for the period of the suspension or restriction.
In the event that the authority responsible for notified bodies determines that the notified body does not have the capability to support existing certificates issued, the provider shall provide to the national competent authorities of the Member State in which the provider of the system covered by the certificate has its registered place of business, within three months of the suspension or restriction, a written confirmation that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction.
8. 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:
a) where the national competent authority of the Member State in which the provider of the AI system covered by the certificate has its registered place of business has confirmed that there is no risk to health, safety and fundamental rights associated with the systems in question; and
b) another notified body has confirmed in writing that it will assume immediate responsibilities for those systems and will have completed assessment of them within twelve months of the withdrawal of the designation.
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. 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.
Important note: This is not the final text of the Artificial Intelligence Act. This is the text of the proposal from the Council of the European Union (25.11.2022).
The Articles of the EU Artificial Intelligence Act, proposal from the Council of the European Union (25.11.2022):