Tricky question. The ultimate answer is that you may be required to submit both an IDE Report and an MDR for the same event. Rationale below.
First let's take a quick look back in time: When promulgating the MDR regulations (21 CFR Part 803), FDA initially proposed regulatory language specifically exempting us from MDR reporting in cases where an IDE adverse event report was submitted. But then FDA removed that poorly worded exemption; not because the exemption no longer applied, but instead simply because it is inherently unnecessarily (and I think misleading) to state such an exemption (along with a million other intrinsic exemptions) since Part 803's basic scope only applies to marketed devices.
Yet even though Part 812 only applies to investigational use, while Part 803 only applies to legally marketed use, it remains that a particular adverse event might simultaneously trigger reporting criteria from both regulations. This means that if the event triggers both the IDE adverse event reporting criteria and the MDR reporting criteria, then both an IDE Report and an MDR are needed for the same event unless the Sponsor has received a special exemption from FDA to do otherwise. Note that an IDE Report is different than an MDR report, and the IDE adverse event reporting triggers are different than the MDR reporting triggers; therefore, be sure not to equate the two types of reporting or reports.
One example (others could apply too) where an IDE adverse event report and an MDR would be required is where the investigational device event meets the IDE reporting requirement and has also malfunctioned such that a similar device that is marketed would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Finally, here's what FDA says in its MDR guidance document:
"…If a device is legally marketed in the US and is also under an Investigational Device Exemption (IDE) [21 CFR part 812], any adverse events that involve the investigational use of the marketed device are subject to reporting under both the IDE regulation and the MDR regulation…there is no exception to MDR reportable events under 21 CFR part 803 for devices that are marketed lawfully in the US and that are also used under an IDE. Further, there is no exception to unanticipated adverse device effect reporting under 21 CFR part 812 for "unanticipated adverse device effects" associated with marketed devices that may be used as a control. Thus, certain events may be reportable under both IDE and MDR regulations…" [emphasis added]
Hope this helps.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 21-Jan-2022 03:53
From: Kenny Walsh
Subject: MDR reporting responsibilities for investigational use of marketed product
Hi All,
I would like your help to understand the requirements for MDR reporting for events that occur in a clinical trial with investigational product after the device has received clearance.
In this situation, there is an ongoing clinical study of a device. This study was not required for the 510k clearance but did commence under IDE regulations prior to the device clearance. As the device is now cleared but the clinical study is ongoing, I am reviewing our procedures for reporting Adverse Events that occur in the Clinical Study. I am specifically trying to understand if we need to consider MDR reporting for events that occur in the clinical study using the investigational product (I would note that all of the devices used in the study are labeled as investigational devices - they do not have the cleared device labeling).
My understanding is that, if a device is legally marketed in the US and is also under an IDE any adverse event that involves the investigational use of the marketed device are subject to reporting under the both the IDE regulation and the MDR regulation. What seems to be key here is, if the device is used in a manner that is consistent with its marketed indication for use, then it is MDR reportable, which in this case it is. However the devices used in the study are labeled as investigational devices (not the cleared, labeled devices).
I have received different interpretations of this regulation that, as the event is occurring with the previously supplied investigational product, it should only be reported under IDE regulations and not under MDR. I would appreciate if I could get feedback from this community.
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Kenny Walsh
Galway
Ireland
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