D8. Regulatory Interaction Log Record of every substantive communication with competent authorities, notified bodies, and market surveillance authorities. Each entry is timestamped and attributed, recording meeting minutes, document submissions, questions raised, responses provided, and interim findings. Internal SLAs: five business days for routine queries, two business days for urgent queries. Serves as evidence of cooperative engagement, a mitigating factor under Article 99(7). Responsible party: Conformity Assessment Coordinator maintains. Regulations addressed: Article 21 (cooperation with competent authorities); Article 99(7) (mitigating factors); Annex VII (notified body interaction, where applicable). Key outputs

• Per-interaction timestamped record with document exchange log
• SLA compliance tracking