$297 — Premium Tier

MDR & Vigilance Reporting Toolkit: FDA 21 CFR Part 803 + EU MDR Articles 87-89

MDR and Vigilance Reporting Toolkit — FDA reportability decision framework, MedWatch 3500A template, EU MDR serious incident checklist, trend reporting template, FSCA/FSN package, and annual summary report.

Get the Toolkit — $297

7-day money-back guarantee • One-time purchase • Instant download

What's Included

FDA MDR Reportability Decision Framework (21 CFR Part 803)
MedWatch 3500A Submission Template
EU MDR Serious Incident Reporting Checklist (Article 87)
EU MDR Vigilance Trend Reporting Template (Article 88)
FSCA and FSN Templates (FDA + EU MDR Article 89)
MDR/Vigilance Annual Summary Report Template

Benefits

FDA MDR three-part reportability test with decision algorithm
MedWatch 3500A template with guidance notes for each required field
EU MDR 15-day and 2-day serious incident reporting checklists
FSCA/FSN template package covers both FDA recall and EU MDR Article 89 requirements

Is This For You?

This toolkit is designed for teams facing these challenges:

MDR reportability determination inconsistent and undocumented
MedWatch submissions generating RFIs from FDA
EU MDR serious incident reports missing required elements
FSCA scope and customer notification process not defined

Who This Is For

QA managers responsible for MDR and vigilance reportingRA leads coordinating FDA and EU MDR adverse event submissionsPost-market surveillance teams managing complaint-to-MDR workflowRegulatory consultants supporting clients through enforcement situations

Frequently Asked Questions

What is the FDA MDR reporting timeline?

30 days for deaths and serious injuries, 5 days for events requiring immediate remedial action to prevent unreasonable risk of substantial harm.

When is EU MDR trend reporting required?

When a statistically significant increase in non-serious incidents compared to the established baseline is detected. The threshold must be defined in your PMS plan.

Related Toolkits

Complaint Handling and MDR

$247

Post-Market Surveillance

$247

CAPA System

$247

Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $297

7-day money-back guarantee