FDA published a final rule on Electronic Medical Device Reporting ((eMDR) on February 13, 2014,) that requires manufacturers and importers to submit MDRs to the FDA in an electronic format that the FDA can process, review, and archive. Manufacturers and importers will have until Aug. 13, 2015 to begin submitting all MDR reports electronically.
The two options for submitting eMDRs are: eSubmitter or Health Level 7 Individual Case Safety Reports (HL7 ICSR. If you are unable to meet this date, you must request and obtain an exemption from electronic reporting to continue to report via hardcopy past Aug. 13, 2015.
Why Should you Attend:
Medical Device Reporting receives much scrutiny from the FDA so it is very important to perform it correctly in a timely and efficient manner. Failures to report correctly not only result in compliance issues but can create significant risks for your customers as well.
This webinar will cover the following significant areas:
Objectives of the Presentation:
- Changes to reporting requirements: Final Rule
- Timing of changes
- Requirements for submitting MDR reports electronically
- How to prepare for the coming changes
- Inspection Readiness
- Best Practices
The objectives of the presentation are to:
Who can Benefit:
- Understand the changes
- Share best practices
- Identify actions for your company to take
- Ensure inspection readiness
Individuals in the following roles at Medical Device Companies:
- Complaint Handling Units
- Compliance and Audit professionals
- Regulatory Affairs Professionals
- IT Support for Complaint Handling Units