Maps to
21 CFR Part 803 (MDR): §803.17 What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
ISO 13485: §8.2.3 Reporting to regulatory authorities, §8.2.2 Complaint handling
Requirement text
User facilities, importers, and manufacturers must develop, maintain, and implement written MDR procedures. These procedures must address internal systems for timely identification, communication, and evaluation of events that may be subject to MDR requirements; a standardized review process for determining when an event meets the criteria for reporting; timely transmission of complete reports; documentation and recordkeeping for information evaluated for reportability; and systems ensuring access to information for timely followup and FDA inspection.