Why FDA Medical Device Reporting Is Essential for Medical Devices in the US
Legal background
Medical Device Reporting (MDR) is a cornerstone of the FDA’s post-market surveillance system. It helps detect, evaluate, and respond to potential safety risks associated with medical devices available on the US market. While submitting an MDR does not imply a device defect, it enables the FDA to monitor trends and prevent future harm.
If you fail to comply, you risk:
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- Regulatory action: FDA warning letters, fines, or product seizures
- Import delays: Customs holds preventing US market entry
- Market disruption: Mandatory recalls or product removals
- Legal liability: Litigation and reputational damage if patients are affected
Our services
How Obelis Ensures Your Medical Device Meets FDA MDR Requirements
Navigating FDA Medical Device Reporting obligations can be complex, especially with varying timelines and reporting responsibilities. Obelis provides comprehensive MDR compliance solutions tailored to your device type and business model:
- Complaint Monitoring: We assess and classify complaints to determine whether they are reportable under FDA rules.
- eMDR Submission: Our team prepares and submits Electronic Medical Device Reports through the FDA eMDR system.
- Timely Reporting: We guide you through the correct reporting timelines—5, 10, or 30 days depending on event type and severity.
- Corrective Actions: We help you design effective corrective and preventive measures to address identified issues.
- US Agent Representation: Acting as your Official Correspondent, we communicate directly with the FDA on your behalf.
With Obelis as your trusted US Agent, you can ensure every report is filed correctly and on time, keeping your company compliant, your products safe, and your reputation protected.
FAQ
Frequently Asked Questions
MDR is a legal obligation under FDA regulations requiring manufacturers, importers, and user facilities to report adverse events and malfunctions related to medical devices.
All manufacturers, importers, and device user facilities marketing products in the US must comply with MDR regulations.
The eMDR (Electronic Medical Device Reporting) system is the FDA’s platform for electronically submitting MDR reports.
Depending on the type of event, reports must typically be submitted within 5, 10, or 30 days from the time the issue is identified.
Obelis can serve as your US Agent and Official Correspondent to facilitate MDR compliance and direct FDA communication.
