Regulatory Open Forum

Your company needs to be careful about language here. The correct word, from 820.198 is "evaluate" not "assess".

820.198(a)(3) requires evaluation of every complaint for reportability under Part 803. Presumably you evaluation criteria now says something like:
1. Is the compliant a malfunction? Y/N
2. If a malfunction, is there patient or user involvement? Y/N
3 If Yes to both 1 and 2 report as a Part 803 MDR, otherwise do not report.

I infer that you think that question 2 should not be part of the evaluation.

To analyze this, start with the definition of malfunction in 803.3(k) which says, in part, "Malfunction means the failure of a device to meet its performance specifications or otherwise perform as intended". Notice that this is silent about patient or user involvement.

To determine reportability look at 803.3(o)(2)(ii) which says, the device has "malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur". Notice that this is silent about patient or user involvement.

To test this, make a plausible scenario. Before the start of the day, the technician tests each device expected for use that day. When she tests your company's device it fails. She notes in the record that if it had failed on a patient it likely contribute to a serious injury. She repairs the device and puts it into service. Her health care organization files a complain with your company alleging a deficiency in reliability.

Your company evaluates the complaint using the new criteria and concludes that a malfunction occurred, since there was no patient involvement, the malfunction is not reportable.

Now apply the evaluation criteria in the regulations.
1 Is the compliant a malfunction? Y/N
2 If a malfunction were to recur could it cause or contribute to death or serious injury? Y/N
3 If Yes to both 1 and 2 report as a Part 803 MDR, otherwise do not report.

Your company evaluates the complaint using the regulation-based criteria and concludes that a malfunction occurred and it could have contributed to a serious injury so it is reportable.

As an aside, it is hard to imagine a complaint without, at least, user involvement. Perhaps the device conducts a periodic self test and reports a malfunction to the manufacturer using the Internet of Things.

In my experience, companies, incorrectly, look for ways to minimize MDR reporting. I suspect that management thinks it is a public admission of bad products. However, these minimization efforts often result in under reporting and, as part of an FDA Investigation, leads to a Warning Letter. A Warning Letter has a far more serious impact on the firm.

Consider searching the FDA Warning Letter database for cases of malfunctions so you help management understand the serious consequences from under reporting.

Your company needs to be careful about language here. The correct word, from 820.198 is "evaluate" not "assess".

820.198(a)(3) requires evaluation of every complaint for reportability under Part 803. Presumably you evaluation criteria now says something like:
1. Is the compliant a malfunction? Y/N
2. If a malfunction, is there patient or user involvement? Y/N
3 If Yes to both 1 and 2 report as a Part 803 MDR, otherwise do not report.

I infer that you think that question 2 should not be part of the evaluation.

To analyze this, start with the definition of malfunction in 803.3(k) which says, in part, "Malfunction means the failure of a device to meet its performance specifications or otherwise perform as intended". Notice that this is silent about patient or user involvement.

To determine reportability look at 803.3(o)(2)(ii) which says, the device has "malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur". Notice that this is silent about patient or user involvement.

To test this, make a plausible scenario. Before the start of the day, the technician tests each device expected for use that day. When she tests your company's device it fails. She notes in the record that if it had failed on a patient it likely contribute to a serious injury. She repairs the device and puts it into service. Her health care organization files a complain with your company alleging a deficiency in reliability.

Your company evaluates the complaint using the new criteria and concludes that a malfunction occurred, since there was no patient involvement, the malfunction is not reportable.

Now apply the evaluation criteria in the regulations.
1 Is the compliant a malfunction? Y/N
2 If a malfunction were to recur could it cause or contribute to death or serious injury? Y/N
3 If Yes to both 1 and 2 report as a Part 803 MDR, otherwise do not report.

Your company evaluates the complaint using the regulation-based criteria and concludes that a malfunction occurred and it could have contributed to a serious injury so it is reportable.

As an aside, it is hard to imagine a complaint without, at least, user involvement. Perhaps the device conducts a periodic self test and reports a malfunction to the manufacturer using the Internet of Things.

In my experience, companies, incorrectly, look for ways to minimize MDR reporting. I suspect that management thinks it is a public admission of bad products. However, these minimization efforts often result in under reporting and, as part of an FDA Investigation, leads to a Warning Letter. A Warning Letter has a far more serious impact on the firm.

Consider searching the FDA Warning Letter database for cases of malfunctions so you help management understand the serious consequences from under reporting.

Your company needs to be careful about language here. The correct word, from 820.198 is "evaluate" not "assess".

820.198(a)(3) requires evaluation of every complaint for reportability under Part 803. Presumably you evaluation criteria now says something like:
1. Is the compliant a malfunction? Y/N
2. If a malfunction, is there patient or user involvement? Y/N
3 If Yes to both 1 and 2 report as a Part 803 MDR, otherwise do not report.

I infer that you think that question 2 should not be part of the evaluation.

To analyze this, start with the definition of malfunction in 803.3(k) which says, in part, "Malfunction means the failure of a device to meet its performance specifications or otherwise perform as intended". Notice that this is silent about patient or user involvement.

To determine reportability look at 803.3(o)(2)(ii) which says, the device has "malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur". Notice that this is silent about patient or user involvement.

To test this, make a plausible scenario. Before the start of the day, the technician tests each device expected for use that day. When she tests your company's device it fails. She notes in the record that if it had failed on a patient it likely contribute to a serious injury. She repairs the device and puts it into service. Her health care organization files a complain with your company alleging a deficiency in reliability.

Your company evaluates the complaint using the new criteria and concludes that a malfunction occurred, since there was no patient involvement, the malfunction is not reportable.

Now apply the evaluation criteria in the regulations.
1 Is the compliant a malfunction? Y/N
2 If a malfunction were to recur could it cause or contribute to death or serious injury? Y/N
3 If Yes to both 1 and 2 report as a Part 803 MDR, otherwise do not report.

Your company evaluates the complaint using the regulation-based criteria and concludes that a malfunction occurred and it could have contributed to a serious injury so it is reportable.

As an aside, it is hard to imagine a complaint without, at least, user involvement. Perhaps the device conducts a periodic self test and reports a malfunction to the manufacturer using the Internet of Things.

In my experience, companies, incorrectly, look for ways to minimize MDR reporting. I suspect that management thinks it is a public admission of bad products. However, these minimization efforts often result in under reporting and, as part of an FDA Investigation, leads to a Warning Letter. A Warning Letter has a far more serious impact on the firm.

Consider searching the FDA Warning Letter database for cases of malfunctions so you help management understand the serious consequences from under reporting.