MDR & Vigilance Reporting Toolkit
FDA MDR and EU MDR vigilance reporting templates — reportability decisions, MedWatch submissions, serious incident reports, FSCA packages, and trend reporting.
What You Get
FDA MDR Reportability Decision Framework (21 CFR Part 803)
Structured decision algorithm for determining whether an event requires an MDR report. Covers the three-part reportability test (malfunction, injury, death), the 30-day vs 5-day reporting timelines, the supplement and correction reporting requirements, and the documentation FDA inspectors review during MDR audits.
MedWatch 3500A Submission Template
Pre-formatted MedWatch 3500A template with guidance notes for each required field. Covers manufacturer information, device identification, event description, patient information, and the narrative section that FDA reviewers focus on. Includes common deficiency patterns and the language standard that reduces RFI follow-up.
EU MDR Serious Incident Reporting Checklist (Article 87)
Complete checklist for EU MDR serious incident and field safety corrective action reporting. Covers the reportability criteria, 15-day vs 2-day timelines, initial vs final report requirements, EUDAMED reporting obligations, and coordination with your authorized representative.
EU MDR Vigilance Trend Reporting Template (Article 88)
Template for EU MDR trend reporting obligations — the requirement that catches most manufacturers off guard. Covers the statistical significance threshold, analysis period, incident clustering detection, and the summary trend report format competent authorities expect.
Field Safety Corrective Action (FSCA) and Field Safety Notice (FSN) Templates
Complete FSCA and FSN template package for both FDA (recall notifications) and EU MDR (Article 89) requirements. Covers action scope determination, recall strategy documentation, customer notification letters, effectiveness check procedures, and competent authority submission packages.
MDR/Vigilance Annual Summary Report Template
Template for annual MDR and vigilance activity summaries for management review and regulatory submission. Covers event totals by type, trends analysis, CAPA linkage, comparison to industry benchmarks, and the forward-looking risk mitigation commitments that demonstrate a proactive safety culture to FDA and NBs.
FAQ
What is the MDR reporting timeline?
FDA MDR requires reports within 30 days of becoming aware of a death or serious injury, and within 5 days for events requiring immediate remedial action. EU MDR requires serious incident reports within 15 days (2 days for deaths or unanticipated serious public health threats).
When is an EU MDR trend report required?
Trend reports are required when a statistically significant increase in incidents that are not serious is detected compared to the established baseline. The threshold must be defined in your PMS plan.
What format are the documents?
All documents are editable Word and Excel templates ready for direct use.
Ready to get started?
6 templates. Instant access. FDA MDR + EU MDR vigilance reporting in one kit.
For informational purposes only. Not legal or regulatory advice. Legal