Article 36 Changes to notifications

The notifying authority means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring; shall notify the Commission and the other Member States of any relevant changes to the notification of a notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; via the electronic notification tool referred to in Article 30(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 paragraphs (3) to (9) shall apply.

Where a notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; decides to cease its conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; activities, it shall inform the notifying authority means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring; 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 means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; may remain valid for a period of nine months after cessation of the notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation;’s activities, on condition that another notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; has confirmed in writing that it will assume responsibilities for the high-risk AI systems covered by those certificates. The latter notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; shall complete a full assessment of the high-risk AI systems affected by the end of that nine-month-period before issuing new certificates for those systems. Where the notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; has ceased its activity, the notifying authority means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring; shall withdraw the designation.

Where a notifying authority means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring; has sufficient reason to consider that a notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; no longer meets the requirements laid down in Article 31, or that it is failing to fulfil its obligations, the notifying authority means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring; shall without delay investigate the matter with the utmost diligence. In that context, it shall inform the notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; concerned about the objections raised and give it the possibility to make its views known. If the notifying authority means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring; comes to the conclusion that the notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; 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.

Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; shall inform the providers concerned within 10 days.

In the event of the restriction, suspension or withdrawal means withdrawal as defined in Article 3, point (23), of Regulation (EU) 2019/1020; of a designation, the notifying authority means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring; shall take appropriate steps to ensure that the files of the notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; concerned are kept, and to make them available to notifying authorities means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring; in other Member States and to market surveillance authorities means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020; at their request.

1. assess the impact on the certificates issued by the notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation;;

2. submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the designation;

3. require the notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; 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 continuing conformity of high-risk AI systems on the market;

4. inform the Commission and the Member States about certificates the suspension or withdrawal means withdrawal as defined in Article 3, point (23), of Regulation (EU) 2019/1020; of which it has required;

5. provide the national competent authoritiesas defined in Article 46 of the Member State in which the provider has its registered place of business with all relevant information about the certificates of which it has required the suspension or withdrawal means withdrawal as defined in Article 3, point (23), of Regulation (EU) 2019/1020;; that authority shall take the appropriate measures, where necessary, to avoid a potential risk means the potential for loss or disruption caused by an incident and is to be expressed as a combination of the magnitude of such loss or disruption and the likelihood of occurrence of the incident; to health, safety or fundamental rights.

1. the notifying authority means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring; has confirmed, within one month of the suspension or restriction, that there is no risk means the potential for loss or disruption caused by an incident and is to be expressed as a combination of the magnitude of such loss or disruption and the likelihood of occurrence of the incident; to health, safety or fundamental rights in relation to certificates affected by the suspension or restriction, and the notifying authority means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring; has outlined a timeline for actions to remedy the suspension or restriction; or

2. the notifying authority means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring; 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 means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; 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 notifying authority means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring; determines that the notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; does not have the capability to support existing certificates issued, the provider of the system covered by the certificate shall confirm in writing to the national competent authoritiesas defined in Article 46 of the Member State in which it has its registered place of business, within three months of the suspension or restriction, that another qualified notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; is temporarily assuming the functions of the notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; to monitor and remain responsible for the certificates during the period of suspension or restriction.

1. the national competent authorityas defined in Article 46 of the Member State in which the provider of the high-risk AI system covered by the certificate has its registered place of business has confirmed that there is no risk means the potential for loss or disruption caused by an incident and is to be expressed as a combination of the magnitude of such loss or disruption and the likelihood of occurrence of the incident; to health, safety or fundamental rights associated with the high-risk AI systems concerned; and

2. another notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; has confirmed in writing that it will assume immediate responsibility for those AI systems and completes its assessment within 12 months of the withdrawal means withdrawal as defined in Article 3, point (23), of Regulation (EU) 2019/1020; of the designation.

In the circumstances referred to in the first subparagraph, the national competent authorityas defined in Article 46 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 authorityas defined in Article 46 or the notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; assuming the functions of the notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; affected by the change of designation shall immediately inform the Commission, the other Member States and the other notified bodies means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; thereof.