In this session we will learn about the Why, the What, the Who, and the How for Medical Device Reporting to FDA through eMDR Submissions. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.

1. Alireza Hemmati
Senior Product Assessment Expert
Active Implantable Medical Devices
Health and Medical Devices
TÜV SÜD America
E-mail: alireza.Hemmati@tuvsud.com
November 1st, 2022
eMDR Program and Process
The Why, the What, the Who, and the How for Medical Device Reporting to FDA through eMDR Submissions
TÜV SÜD LEGAL ENTITY | PRESENTATION TITLE 22-11-01

2. Resources for More Information
The How: How to Enroll in eMDR Program
The Who: Mandatory and Voluntary Reporters
The What: MDR Reportable Events
The Why: Value of Medical Device Reports and FDA’s Authority
Presentation Agenda
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3. The Why: Value of Medical Device Reports and FDA’s Authority
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Value of Medical Device Reports:
• Consumers and Industry:
• Understand device safety and performance
• Design Improvement
• FDA:
• Monitor device safety and performance
• Assess need for regulatory action
• FDA inspection of manufacturer
• Changes to device labeling
• Notices to the public
• Device recall

4. The Why: Value of Medical Device Reports and FDA’s Authority
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FDA’s Regulatory Authority:
• Section 519 of the Food, Drug, and Cosmetic Act
• Pertains to records and reports on medical devices
• Grants FDA authority to require mandatory medical device reports
Medical Device Reporting Regulation
• Title 21 of Code of Federal Regulations (CFR), Part 803
• Establishes regulatory pathway for collecting reportable adverse event data
• Defines critical reporting roles, responsibilities, and deadlines

5. The What: MDR Reportable Events
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21 CFR 803.3 (o)
• An MDR reportable event reasonably suggests a marketed device:
• May have caused or contributed to a death or serious injury,
Or
• The marketed device malfunctioned, and
• Likely to cause or contribute to death or serious injury were it to recur
Definitions
• Malfunction:
The failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made
in labeling for the device (21 CFR 803.3(k))
• Serious Injury: (21 CFR 803.3(w))
Refers to an injury or illness that:
• Is life-threatening
• Results in permanent impairment of a body function
• Results in permanent damage to a body structure
• Necessitates medical or surgical intervention

6. The Who: Mandatory and Voluntary Reporters
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Mandatory Reporters
• Manufacturers (21 CFR 803.3(l)) and Importers (21 CFR 803.3(j))
• Electronic submission only
• Electronic Medical Device Reporting (eMDR) Final Rule effective August 14, 2015
• Device User Facilities (e.g., Hospitals and Nursing Homes) (21 CFR 803.3(d))
• Electronic submission encouraged
• eMDR Final Rule permits written reports (Form 3500A)
Voluntary Reporters
• Patients, Healthcare Professionals, and Caregivers
• Online through MedWatch
• By postal mail (Form 3500 and 3500B)

7. Summary of Mandatory Reporting Requirements for Manufacturers and Importers
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Source: Mandatory Reporting Requirements: Manufacturers, Importers and Device User
Facilities

8. Summary of Mandatory Reporting Requirements for User Facilities
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Source: Mandatory Reporting Requirements: Manufacturers, Importers and Device User
Facilities

9. The How: How to Enroll in eMDR Program
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• eMDR and Electronic Submissions Gateway (ESG) support two different submission methods, which are commonly referred to as low-volume and
high-volume.
• Both options are open to all submitters.
• The low-volume submission method typically requires more manual action to file each report, but the high-volume submission method typically
requires more effort to stand-up.
Low-volume submitters report a new MDR electronically by using eSubmitter, supplied by the FDA, to create a MedWatch 3500A electronic submission
zip file and then logging into the WebTrader internet site to submit the file.
High-volume submitters use their own AS2 gateway software systems to submit MDRs electronically.

10. Low-Volume Enrollment Process
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Step 1: Obtain pre-production WebTrader account from ESG
• Visit the ESG account checklist page and begin the process outlined there.
Step 2: Prepare a guidance-compliant test submission for eMDR
• Download the eSubmitter application and install it on your computer.
• Open the application and select Create New Submission > CDRH: MedWatch Form 3500A.
• Fill out the form completely but describe a fictional adverse event.
Step 3: Send a guidance-compliant test submission to eMDR
• Log into the pre-production WebTrader site using the credentials supplied by the ESG.
• Follow the instructions provided here and send the submission.
Step 4: Request low-volume eMDR approval
• Once you have successfully completed the guidance-compliant test submission, send an email to the eMDR Helpdesk (eMDR@fda.hhs.gov) following
the instructions for Step 3 and 4 here.
Step 5: Send submissions to production eMDR
• To submit a real MDR electronically, create a new 3500A submission in eSubmitter and complete the form. View the eMDR eSubmitter and WebTrader
tutorial video on how to prepare a low-volume submission for electronic medical device reporting (eMDR) and how to submit.

11. High-Volume Enrollment Process
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Step 1: Begin software acquisition
• High-volume submitters should first decide whether to develop or purchase an HL7 ICSR XML and AS2 gateway software system.
• For firms that decide to develop their own systems, the eMDR implementation package describes the HL7 ICSR XML message expected by eMDR.
• The ESG guide describes the headers and other transport-layer configuration needed to submit a file through the ESG’s AS2 gateway.
Step 2: Schedule final high-volume testing and approval
• Send an email to eMDR@fda.hhs.gov notifying them of their intent to enroll as a high-volume eMDR submitter.
• When the eMDR helpdesk receives the firm’s email, they will send an email response to confirm receipt.
Step 3: Obtain pre-production ESG account
• Request a pre-production ESG account by following the steps on the ESG checklist.
Step 4: Perform initial high-volume testing
• Using pre-production ESG account configure your AS2 software system to submit to pre-production eMDR. The ESG guide contains information on
the required configuration parameters.

12. High-Volume Enrollment Process
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Step 5: Submit final high-volume guidance-compliant tests
• When your firm is ready to submit the final high-volume tests, make the submissions referred to in Step 5 for high-volume enrollment process here in
the pre-production environment
Step 6: Request high-volume eMDR approval
• Once you have made all of the submissions, send an email to the eMDR helpdesk. The eMDR team will manually review your test submissions and
notify you to resubmit if there are any discrepancies. Once all concerns have been addressed, you will receive an approval email from eMDR
instructing the ESG to grant your firm a production account.
Step 7: Send submissions to production eMDR
• Once you receive approval to begin high-volume submission to production eMDR, reconfigure your AS2 system to connect to the production ESG
environment.
• Then begin submitting real MDRs using your AS2 software.

13. § Medical Device Reporting Regulation History
§ Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities
§ eMDR – Electronic Medical Device Reporting
§ How to Enroll in eMDR Program
§ Medical Device Reporting for Manufacturers
§ Medical Device Reporting: Electronic Submission Requirements
§ FDA Electronic Submissions Gateway (ESG)
§ eMDR Help and FAQs
§ Questions and Answers about eMDR - Electronic Medical Device Reporting
Resources for More Information
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14. TÜV SÜD America | eMDR Program and Process 22-11-01
Thank you for your attention.
Questions?