Manage Notified-Body Cessation, Restriction, Suspension or Withdrawal Impacts

Sub-obligations

These are independently assessable parts of the parent requirement.

1. Article 36(3)

   Current

   Notify Authorities and Providers of Planned or Actual Cessation of Notified-Body Activities

   Tracker Guidance

   Inform the notifying authority and affected providers as soon as possible when conformity-assessment activities will cease and, for planned cessation, at least one year before cessation.

   Official text

   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 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 high-risk 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.

2. Article 36(5)

   Current

   Notify Affected Providers Within Ten Days of Designation Restriction, Suspension or Withdrawal

   Tracker Guidance

   Inform affected providers within ten days when the notified body's designation is suspended, restricted or fully or partially withdrawn.

   Official text

   5. Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the providers concerned within 10 days.

3. Article 36(8)-(9)

   Current

   Secure Replacement Notified-Body Responsibility for Affected Certificates When Required

   Tracker Guidance

   If a notified body's designation is suspended or restricted and the notifying authority determines that the body cannot support existing certificates, confirm in writing to the national competent authority within three months that another qualified notified body is temporarily assuming responsibility for monitoring and maintaining those certificates. If a designation is withdrawn, certificate continuity for the permitted provisional period depends on the national authority confirming that the affected systems present no relevant risk and another notified body confirming in writing that it will assume immediate responsibility and complete its assessment within the required period. Coordinate the transfer and retain evidence of the required confirmations; the replacement notified body, not the provider, performs the conformity assessment.

   Official text

   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: (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 for actions 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 notifying authority determines that the notified body 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 authorities 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 is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction. 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: [Excerpt - see official source for complete provision]

   Excerpt stored at a complete legal-unit boundary. See the official source for the full provision.