Regulatory Cooperation
Notified-Body Regulatory Reporting and Continuity
What this control does
Report required information to notifying authorities and peer notified bodies and manage continuity when designation changes or activities cease.
How to implement
For notified bodies, track events that require information to notifying authorities, peer bodies or affected providers. Keep the event, recipient, required timing and evidence of delivery in a reporting log. Maintain the applicable confidentiality controls. When activities cease or designation changes, identify affected certificates and the required continuity arrangements. Distinguish the provider's confirmations from the regulator's decisions and the replacement notified body's assessment. Continued certificate validity depends on the relevant conditions, not merely on starting a transfer.
Suggested timing and triggers
At the relevant reporting, cessation or designation-change trigger; within the route-specific deadlines; periodic continuity readiness review.
Evidence examples
Regulatory and peer-notification log Affected-provider and certificate inventory Delivery records and confidentiality checks Cessation or designation-change plan Authority decisions, written confirmations and transfer records
How to check this control
Trace a reportable event to the right recipients and timing. For a continuity scenario, verify each required confirmation and assessment responsibility separately, including any conditions supporting continued certificate validity.
Related EU AI Act obligations
Article 34(3)
Provide Relevant Assessment Documentation to the Notifying Authority on Request
Sub-obligation of Article 34: Perform Notified-Body AI Conformity Assessment Activities in Accordance With the Act
Article 36
Manage Notified-Body Cessation, Restriction, Suspension or Withdrawal Impacts
Article 36(3)
Notify Authorities and Providers of Planned or Actual Cessation of Notified-Body Activities
Sub-obligation of Article 36: Manage Notified-Body Cessation, Restriction, Suspension or Withdrawal Impacts
Article 36(5)
Notify Affected Providers Within Ten Days of Designation Restriction, Suspension or Withdrawal
Sub-obligation of Article 36: Manage Notified-Body Cessation, Restriction, Suspension or Withdrawal Impacts
Article 36(8)-(9)
Secure Replacement Notified-Body Responsibility for Affected Certificates When Required
Sub-obligation of Article 36: Manage Notified-Body Cessation, Restriction, Suspension or Withdrawal Impacts
Article 45
Meet Notified-Body Information-Sharing and Reporting Obligations
Article 45(1)
Report Required Certificate, Approval and Notification Information to the Notifying Authority
Sub-obligation of Article 45: Meet Notified-Body Information-Sharing and Reporting Obligations
Article 45(2)-(4)
Share Required Conformity-Assessment Information With Peer Notified Bodies
Sub-obligation of Article 45: Meet Notified-Body Information-Sharing and Reporting Obligations