Medical Device Quality Series: Reporting Adverse Events to the FDA with Ease – A CQ Guide

What is an e-MDR?

It refers to electronic-Medical Device Report. It consists of sending electronic versions of MedWatch information (reports of adverse events) to the FDA. MedWatch is the FDA program that collects adverse events data coming from healthcare professionals and consumers.

Why are e-MDR submissions important?

Since August 2015, the FDA no longer accepts paper or emailed pdf reports. Medical device manufacturers and importers are required to submit MDRs to the FDA in an electronic format that the FDA can process, review, and analyze.

Typically, a U.S. based medical device company submits anywhere between 50 to 10,000 MDRs a month depending on the types of products it manufactures and the volume that is sold. The process is both time-consuming and labor-intensive.

Moreover, regulatory bodies in other countries are expanding to allow e-MDR submissions as well such as EU MIR reporting into the Eudamed database.

Currently, there are two ways for medical device companies to submit e-MDRs to the FDA’s electronic submissions gateway (ESG);

• FDA ESG WebTrader Interface through a web browser
• FDA ESG AS2 Gateway-to-Gateway or system-to-system

Option #1: Submit e-MDRs through the FDA ESG WebTrader Interface application. In this case, the process is manual and files are submitted via the app.

Option #2: Submit e-MDRs through FDA ESG AS2 Gateway into the FDA ESG database. This requires an Applicability Statement 2 submission system. The system must generate an HL-7 XML file and this process is automated.

Of course, there are challenges with both options.

Challenges with using WebTrader

Here are the steps that a customer (that uses a modern EQMS like ComplianceQuest) would have to take in order to submit an e-MDR using WebTrader.

• Step 1: Download e-MDR file from EQMS (CQ Complaints Module, for instance)
• Step 2: Launch browser and sign in to WebTrader
• Step 3: Upload e-MDR file to WebTrader
• Step 4: Submit file to FDA
• Step 5: Download received ACKs from WebTrader
• Step 6: Upload ACKs to Submission Record

Now, with the right solution, all these steps can be replaced with the click of a button through the automated process of the MDR e-Gateway. But, more on that later.

Overall, using WebTrader is inefficient and manual. Specifically, these are the disadvantages:

• Manually move files to and from the tool, which is labor-intensive
• Too time-consuming for large companies
• Can lead to compliance issues

Need of the hour

Pain points for the Regulatory Team

• Lack of real-time visibility into the performance of e-MDR submissions
• Risk of non-compliance (filing error or late submission)
• e-MDR submission is a labor-intensive task for the regulatory team

The Need: An efficient solution that reduces the need for more people, while also ensuring compliance. It must also be a solution that provides visibility to the regulatory and quality team.

Pain points for the IT Team

• Internal team might not have the expertise to develop a B2B solution
• High level of support needed for the internal system
• Out-of-the-box solutions might be too expensive

The Need: A simple, cloud-based solution that reduces IT costs and the need for resources.

ComplianceQuest’s MDR e-Gateway: The Ideal Solution

Let’s talk about some of the major advantages of CQ’s MDR e-Gateway:

Advantage #1:

With CQ’s MDR e-Gateway, clients can submit their MedWatch reports with the click of a button and automatically get updates on the status of their submissions.

Key Benefits:

• Speed to Compliance: Save time and labor related to e-MDR
• Real-Time Updates: Notifications keep customers updated
• Scalable: With a transactional subscription payment model
• Less Errors: Thanks to automatic file generation
• Cost Saving: No need for complex IT systems or IT support
• Visibility: Submissions records give an overview of MDR submissions

Advantage #2:

Complaint reports that are prepared within CQ are submitted automatically once a day at a time specified by the customer. Users also have the option to submit individual reports immediately.

Advantage #3:

Customers automatically receive important acknowledgements generated by the FDA after they submit their report, and the relevant documents are also automatically generated.

CQ’s gateway delivers the following acknowledgements:

• Acknowledgement 1 (ACK1): Generates the Date/Time the eMDR is received
• Acknowledgement 2 (ACK2): The CDRH received the MDR
• Acknowledgement 3 (ACK3): Pass or Fail

Advantage #4:

The e-MDR Gateway also comes with reports and dashboards so that the regulatory teams can keep track of all their submissions and get key insights into their performance.

• Reports Submissions: Customers can see the status of all their submitted reports in one place
• Built-In Dashboards: To answer questions like: How many submissions per month? And, how many reports were delayed?

If you are looking for an easier and efficient way for e-MDR filing then look no further. ComplianceQuest’s MDR eGateway can be the perfect solution for you.

To know more, request for a demo here: https://www.compliancequest.com/online-demo