Medical Device Reporting Guides
Official routes, current rules, evidence practices, identity boundaries, and clear limits on what a report can prove.
How to Report a Medical Device Problem to the FDA
Choose between MedWatch, a CDRH regulatory-misconduct allegation, and mandatory Medical Device Reporting, then prepare a useful evidence packet.
How to Report an EU Medical Device Concern
A practical guide to national competent-authority routes, incident reports, market-surveillance concerns, evidence, and careful MDR citations.
What Can Happen When a Medical Device Does Not Comply with the EU MDR?
A source-based guide to MDR market-surveillance checks, risk evaluation, corrective action, other non-compliance, and national penalties.
Confidential and Anonymous Medical Device Reporting: Know the Difference
A practical guide to identity options when reporting a medical device concern to FDA, an EU authority, an employer, or MD Watchdog.
Need to report a concern?
Use the official authority route in the relevant guide, or create a free structured submission in MD Watchdog.
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