To understand whether MDR reporting is required for an "internal event" discovered during the "manufacturing/servicing/reprocessing" process, it is necessary to carefully consider some fundamental principles anchoring FDA's requirements for complaint handling, MDR reporting, device servicing, and device acceptance requirements.
First, remember that the general complaint screening requirements [21 CFR 820.198(a) first paragraph] are what give rise to the MDR evaluation and reporting requirements of 820.198(a)(3) and, in turn, 21 CFR part 803. Accordingly, all MDR reportable events are complaints, while all complaints are not MDR reportable events. In other words, if an issue doesn't meet the definition of "complaint", then it doesn't meet the definition of MDR reportable event. Therefore, as one examines the MDR reportability of an "internal event" discovered during the "manufacturing/servicing/reprocessing" process, it is first prerequisite to screen the issue against FDA's definition of "complaint".
On that note, it is important to remember that during the proposed rule phase of FDA's Quality System Regulation, FDA initially proposed an overly broad definition for "complaint". Specifically, "…Any written, electronic, or oral communication that relates to or concerns the unacceptability of the identity, quality, durability, reliability, safety, effectiveness, or performance of a device…", period. Well, by that definition, any "internal event" discovered during the "manufacturing/servicing/reprocessing" process could trigger the complaint threshold (and thus possible MDR reporting). Not surprisingly, objections about that very notion were in fact submitted to FDA regarding the proposed "complaint" definition. Specifically, objections stated that the definition was unclear and could be interpreted to include routine service requests and "internal communications". Luckily for us, FDA thereafter clarified that (with one exception on which I elaborate in my next paragraph) it didn't intend for "in-house indications of dissatisfaction" to be within the intended scope of 820.198 (nor by default, Part 803). FDA stated that information generated in-house relating to quality problems should instead be documented and processed under 820.100. [This would presumably be via, for example, 820.90 (nonconforming product), 820.22 (quality audit), 820.20(c) (management review), etc]. To ultimately settle these objections, FDA modified the "complaint" definition to clarify that complaints (and thus MDR reporting) only apply to a device after it is released for distribution. This is because the fundamental intent of complaint handling and MDR reporting is to help better understand and control a device's risk profile and usage characteristics organically in light of the dynamic factors and forces involved with the real-life distribution and use of the product. Therefore, we can safely conclude that nonconforming product discovered during receiving, in-process, and finished device acceptance or associated rework/reprocessing prior to release for distribution are not generally subject to complaint handling nor MDR reporting. Instead, such nonconformities are to be handled via 820.80 in conjunction with 820.90 and as needed, 820.100.
However, due to the intrinsic scope of "complaint" (and thus "MDR reportable event") being limited to devices after release for distribution, there is an important caveat that applies if the nonconforming product is discovered in association with the device servicing process. This seems to be because a device getting serviced is presumed to have been previously distributed and/or used. The caveat is that, as part of the aforementioned preamble resolution of the "complaint" definition, FDA made it clear that service requests/reports are not viewed by FDA, for the purposes of complaint/MDR screening, to be "internal / in-house communications" even when such feedback could be, and often is, lodged internally, such as by the firm's service department [which happens most often when, during "routine servicing" (21 CFR 806.2), a service technician discovers other nonconformities exceeding the threshold of "routine servicing"]. Indeed, there is a large body of supporting precedent showing us that FDA requires all service requests/reports (including ones originating from internal analyses/evaluation) to be screened for complaints (and thus MDR reportable events). For example, FDA stated in its old Medical Device Quality Systems Manual (written for the Quality System Regulation) that even if the feedback comes from internal sources like service representatives and internal analyses, the feedback could be a "complaint" (and thus be subject to MDR reportability evaluation). In fact, FDA investigators are trained (see the QSIT guide and FDA Investigations Operations Manual) to look for complaints in service data. These precedents are principally driven by 820.200(c) (stating that MDR-reportable service requests must be processed as complaints) for which, despite its misleading language, FDA has officially stated is not limited to just MDR-reportable events. Instead, 820.200(c) requires that any service request/report containing a complaint must be processed according to 820.198 (and in turn, 803 as needed). For additional examples of such precedents, feel free to raise further corresponding inquiries.
Finally, when it comes time to assess the MDR reportability of malfunctions noted during the servicing process (or other post-release contexts), be mindful of the potentially-broad scope of the basic MDR reporting threshold for malfunctions: Specifically, if the device has malfunctioned and the device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, then an MDR report is required.
Hope this helps,
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Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com© Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 20-Feb-2019 18:22
From: Anonymous Member
Subject: MDR Malfunction Reporting Requirements 21 CFR 803 (Internal Event)
This message was posted by a user wishing to remain anonymous
So if the malfunction is observed in the final test for release, which identifies the malfunction (serving the purpose of release testing) and prevents release to the field, in this scenario MDR for the malfunction is still required? It seems odd that reporting is required if the malfunction is identified prior to release. This seems like it would fall under manufacturing controls and would be considered an NCR rather than an MDR. Anyone have a different interpretation?
Original Message:
Sent: 20-Feb-2019 07:59
From: Lee Leichter
Subject: MDR Malfunction Reporting Requirements 21 CFR 803 (Internal Event)
I think you answered your own question. If the malfunction observed is an artifact of the manufacturing, reprocessing, servicing activities (i.e. malfunction is due to process such as the case melts when subjected to welding), and could not occur in the field, then you do not need to submit. However, regardless as to where the malfunction is observed, if it is a type of malfunction or a specific failure that could occur in the field (and is likely to cause injury if it were to reoccur), then it s reportable.
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Lee Leichter RAC
President
Fort Myers FL
United States
Original Message:
Sent: 19-Feb-2019 17:38
From: Anonymous Member
Subject: MDR Malfunction Reporting Requirements 21 CFR 803 (Internal Event)
This message was posted by a user wishing to remain anonymous
My question is about the intent and scope of 21 CFR 803. Specifically, if the 803 malfunction reporting requirement applies to devices that aren't in the field and are being serviced/reprocessed/manufactured at the manufacturing facility. For example, if a manufacturer observes a malfunction during the manufacturing/servicing/reprocessing process i.e., the device is in house and not in the field, is medical device reporting required? If the malfunction were to occur externally it would be likely to cause or contribute to death or serious injury. The rationale for not reporting is that since the device is not a finished good and not released, the chances of the observed in process malfunction causing death or serious injury are remote and MDR reporting is not required. Additionally, malfunctions that are observed during the manufacturing/reprocessing process might not be indicative of malfunctions that would occur with finished devices. It seems that the intent of 21 CFR 803 is to report adverse events and malfunctions that occur externally, with released devices. If the malfunction is isolated, would tracking and trending be an appropriate approach? I am interested if anyone else has ever submitted an MDR for a malfunction that was observed internally after servicing or reprocessing. I would appreciate feedback from any seasoned professionals that have worked with Class III devices.
Thank you.