FDA Releases Final MDR Guidance for Medical Device Manufacturers

November 28, 2016

By Sparta Editorial


On November 8, 2016, the FDA released final guidance on Medical Device Reporting (MDRs).  MDR is a critical quality component of a company’s complaints management system. All manufacturers of legally marketed medical devices in the US, including foreign manufacturers who export devices to the US, are subject to it.  

This guidance explains and describes the current MDR regulations found in Title 21 CFR Part 803, and clarifies sections that were previously ambiguous. Under the MDR regulation, the FDA and device manufacturers need to identify and monitor adverse events (deaths and serious injuries). And certain malfunctions of devices to detect and correct problems in a timely manner. 

Some of the key clarifications found in the guidance cover the nature and classification of reportable events.  Where the responsibility for reporting lies. When reports need to be submitted. And, how to handle special cases.

When it comes to the timing, manufacturers:

  • Must submit within 30 calendar days of becoming aware of a reportable device-related death or serious injury, or a reportable malfunction

  • Must submit within 5 working days of becoming aware of an MDR reportable event, including one that necessitates remedial action to prevent an “unreasonable risk of substantial harm to public health.” Or one for which the FDA has made a written request

  • Must provide supplemental or follow-up reports with information unknown or unavailable to manufacturers at the time of the initial 30 or 5-day report.

Under these new requirements, companies should take steps to ensure they are positioned to submit reports quickly and efficiently. The FDA has mandated electronic submission of reports since August 2015.  And while that makes the submission of reports as easy as pushing a button, creating reports still poses a challenge for some.

Many companies are lagging in their implementation of automated systems.  Instead, they still rely on manual or disjointed systems to create reports. So, what should be a simple process still requires far too much work up front.

These companies should consider implementing an eMDR system. These systems are proven to improve the accuracy and timeliness of reports, and eliminate the need for costly manual efforts.

To learn why so many Medical Device Manufacturers are implementing eMDR systems, read “What You Need to Know to Comply with eMDR.”  See how you can use these latest regulations to your competitive advantage.

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