Electronic Medical Device Reporting
(eMDR) Compliance Made Easy
Adverse events from medical devices must be reported electronically to the FDA. Paper forms were replaced in 2014 with strict eMDR standards. Non-compliance can trigger warnings, detentions, import alerts, or recalls. Formatting and accuracy are critical for every submission. Registrar Corp simplifies the entire eMDR process for you. Stay compliant with expert-guided, error-free reporting.
2,000+ Medical Device Manufacturers Trust Registrar Corp
Understanding eMDR and FDA Compliance Requirements
What is eMDR?
- eMDR (Electronic Medical Device Reporting) is the FDA’s required system for reporting device-related adverse events, malfunctions, and injuries.
Who Must Submit?
- US and foreign manufacturers
- Medical device importers
- US distributors acting as manufacturers/importers
When Is It Required?
- 5-Day Report: For events needing urgent corrective action
- 30-Day Report: For serious injury, death, or risk of recurrence
Common Challenges With eMDR Compliance
- Understanding complex MDR reporting requirements
- Ensuring submissions are correctly formatted
- Facing delays caused by submission errors
- Managing multiple MDRs efficiently
- Keeping up with evolving FDA regulations
We simplify eMDR compliance by handling every step of the process for you.
How Registrar Corp Can Help With eMDR Compliance
End-to-End Submission Support
We format, review, and submit your eMDR reports directly to FDA.
We format, review, and submit your eMDR reports directly to FDA.
Regulatory Contact & Compliance Guidance
Our experts provide one-on-one assistance to ensure your reporting process is seamless.
Our experts provide one-on-one assistance to ensure your reporting process is seamless.
AS2 Implementation Assistance
If you submit MDRs frequently, we help set up your AS2 submission system.
If you submit MDRs frequently, we help set up your AS2 submission system.
Error Resolution & Resubmission Support
We assist in correcting rejected submissions to prevent compliance delays.
We assist in correcting rejected submissions to prevent compliance delays.
Ongoing Compliance Monitoring
Stay up to date with changing FDA eMDR requirements.
Stay up to date with changing FDA eMDR requirements.
Registrar Corp simplifies eMDR compliance with fast, accurate, and hassle-free FDA submissions.
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