Adverse Events: what should MD and IVD Manufacturers do according to FDA?

In the United States, according to the Medical Device Reporting: Electronic Submission Requirements (eMDR), the Food and Drug Administration (FDA) requires Manufacturers of Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD) selling in the U.S., to report any occurred or potential adverse events related to their Medical Devices.

Adverse Events what should MD and IVD Manufacturers do according to FDA?
Adverse Events: what should MD and IVD Manufacturers do according to FDA?

The reporting must be sent to the FDA in two cases, that is, if evidence suggests that the device has caused or has contributed to a patient’s death or serious injury, or if the device has malfunctioned and would be likely to cause or contribute to a death or serious injury if these malfunctions were to recur.

We point out that FDA considers an adverse event any undesirable experience or side effect associated with the use of a medical device or product that results in unintentional and undesirable harm to the patient.

Why and how to report adverse events to FDA

As set forth by the regulation, Manufacturers of Medical Devices and In Vitro Diagnostic Medical Devices shall inform the FDA when one of their devices may have caused or contributed to a patient’s death or serious injury.

In all of these cases Manufacturers must submit adverse events reports in an electronic format (Electronic Medical Device eMDR Reporting) by installing specific software and applying a very complex and sometimes problematic approval procedure.

One of the most valid tools is the eSubmitter software, which allows the creation of various electronic documents, such as the file for reporting adverse events related to Medical Devices.

Instead, Manufacturers shall send their reports through MedWatch, that is the FDA Safety Information and Adverse Event-Reporting Program.

Thanks to the Medical Device Reporting: Electronic Submission Requirements (eMDR) it is possible to monitor device problems in post-market surveillance and to take action in good time.

In complying with FDA requirements, another important aspect to consider is the timing of reporting of adverse events, which varies depending on the severity of the incident. If the device has caused or contributed to a patient’s serious injury or death, it is necessary to make an electronic Medical Device Report (eMDR) to the FDA within 30 days. On the other hand, where corrective action is required to prevent a reasonable risk of substantial harm to public health, FDA requires adverse eventsto  be reported within only 5 days.

Do you want specialists to do the Adverse Event Reporting for you?

Choose Thema as your US Electronic Medical Device Reporting delegate!

Thema is equipped with all the necessary tools and resources to provide the service of US Electronic Medical Device Reporting, in order to carry out on your behalf all the activities required by the FDA.

If you appoint Thema as your US Electronic Medical Device Reporting delegate, you will receive full support in the activities required by the FDA and enjoy these benefits:

  • Thema will create for you the Adverse Events Reporting file as required by the FDA.
  • Thema will send your Adverse Events Reporting using a dedicated platform, in full compliance with the regulation.

You can already subscribe to the US Electronic Medical Device Reporting (eMDR) service.

For more information and costs contact us: t. 0542643496 /  sales@thema-med.com