DIRECT ANSWERClose MDR and vendor-document comments against the exact document revision, reviewer instruction, corrected evidence and acceptance response. Distinguish technical open items from formatting corrections before final dossier issue.
Comment-closeout fields
- Document number, revision and comment
- Owner and required corrective action
- Reissued evidence and cross-reference
- Reviewer response and final status
Relevant manufacturing capability
- Drawing, datasheet and equipment-list manufacturability review
- Self-manufactured and coordinated-supply scope identification
- Technical, quality, document and delivery clarification
Key notes
- Marking a comment resolved in email without revised evidence is not documented closure.