Maps to
FDA QMSR (Part 820): §820.198
ISO 13485: ISO 13485 §8.2.3
Requirement text
The organization shall document procedures for reporting to regulatory authorities in accordance with applicable requirements.
Atomic constraints
- •MDR reporting criteria must be defined
- •Reportability assessment procedures must exist
- •Reporting timelines must be documented
- •Vigilance reporting must be addressed
Evidence signals
- •
FILE_EXISTS
(MDR.*Report|Vigilance|Reportab|Adverse.*Event|Regulatory.*Report)
- •
CONTENT_MATCH
Does this document describe MDR reporting, vigilance procedures, or adverse event reporting requirements?
Audit defense
Regulatory reporting for [your product] is governed by [your document ID]. MDR reportability criteria and timelines are defined, reportability assessments are documented for each qualifying event, and vigilance reporting requirements are addressed per ISO 13485 8.2.3.