Regulatory Open Forum

Yes, if there was any harm to patient-regardless of whether or not the device caused the harm. There is a 'malfunction' category that would need to be reported as an MDR if you determine that the continued usage of device would lead to patient injury or death.

I found this document useful, its a GHTF document from SG2 that includes representatives of the regulatory authorities and industry representatives of the USA, Europe, Canada, Japan and Australia. "Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices", 30 November 2006

I did not find an updated IMDRF guidance (because GHTF is essentially IMDRF now), but the concepts apply. Also, make sure your procedures dictate the investigational methods.

For the US, I advise caution here. Every allegation of a deficiency in the attributes listed in 820.3(b) is a complaint and must enter the 820.198 complaint system.

Every complaint must be evaluated, 820.198(a)(3), to determine if it is a reportable. There are no exceptions. (The Warning Letters are replete with cases in which manufacturers failed to prform an evaluation of every complaint.) However, evaluation is an often misunderstood concept. While there is no formal quality definition (such as ISO 9000:2015) the concept means to compare a situation against a set of criteria to make a decision. In this case the facts of the complaint are compared against the reportability criteria to decide on reportability. If yes, then follow Part 803 as well as 820.198. If not, continue to follow 820.198.

If the evaluation determines the complaint is potentially reportable, it must be investigated under 820.198(d). There are other cases in which the investigation is not required if there is a prior investigation. This does not hold for potentially reportable events.

I use the term potentially reportable, because the final decision on whether or not to report is made in Part 803 and documented in the MDR Event File, 803.18(b)(1)(i).

Yes, if there was any harm to patient-regardless of whether or not the device caused the harm. There is a 'malfunction' category that would need to be reported as an MDR if you determine that the continued usage of device would lead to patient injury or death.

I found this document useful, its a GHTF document from SG2 that includes representatives of the regulatory authorities and industry representatives of the USA, Europe, Canada, Japan and Australia. "Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices", 30 November 2006

I did not find an updated IMDRF guidance (because GHTF is essentially IMDRF now), but the concepts apply. Also, make sure your procedures dictate the investigational methods.

For the US, I advise caution here. Every allegation of a deficiency in the attributes listed in 820.3(b) is a complaint and must enter the 820.198 complaint system.

Every complaint must be evaluated, 820.198(a)(3), to determine if it is a reportable. There are no exceptions. (The Warning Letters are replete with cases in which manufacturers failed to prform an evaluation of every complaint.) However, evaluation is an often misunderstood concept. While there is no formal quality definition (such as ISO 9000:2015) the concept means to compare a situation against a set of criteria to make a decision. In this case the facts of the complaint are compared against the reportability criteria to decide on reportability. If yes, then follow Part 803 as well as 820.198. If not, continue to follow 820.198.

If the evaluation determines the complaint is potentially reportable, it must be investigated under 820.198(d). There are other cases in which the investigation is not required if there is a prior investigation. This does not hold for potentially reportable events.

I use the term potentially reportable, because the final decision on whether or not to report is made in Part 803 and documented in the MDR Event File, 803.18(b)(1)(i).

Yes, if there was any harm to patient-regardless of whether or not the device caused the harm. There is a 'malfunction' category that would need to be reported as an MDR if you determine that the continued usage of device would lead to patient injury or death.

I found this document useful, its a GHTF document from SG2 that includes representatives of the regulatory authorities and industry representatives of the USA, Europe, Canada, Japan and Australia. "Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices", 30 November 2006

I did not find an updated IMDRF guidance (because GHTF is essentially IMDRF now), but the concepts apply. Also, make sure your procedures dictate the investigational methods.

For the US, I advise caution here. Every allegation of a deficiency in the attributes listed in 820.3(b) is a complaint and must enter the 820.198 complaint system.

Every complaint must be evaluated, 820.198(a)(3), to determine if it is a reportable. There are no exceptions. (The Warning Letters are replete with cases in which manufacturers failed to prform an evaluation of every complaint.) However, evaluation is an often misunderstood concept. While there is no formal quality definition (such as ISO 9000:2015) the concept means to compare a situation against a set of criteria to make a decision. In this case the facts of the complaint are compared against the reportability criteria to decide on reportability. If yes, then follow Part 803 as well as 820.198. If not, continue to follow 820.198.

If the evaluation determines the complaint is potentially reportable, it must be investigated under 820.198(d). There are other cases in which the investigation is not required if there is a prior investigation. This does not hold for potentially reportable events.

I use the term potentially reportable, because the final decision on whether or not to report is made in Part 803 and documented in the MDR Event File, 803.18(b)(1)(i).

Yes, if there was any harm to patient-regardless of whether or not the device caused the harm. There is a 'malfunction' category that would need to be reported as an MDR if you determine that the continued usage of device would lead to patient injury or death.

I found this document useful, its a GHTF document from SG2 that includes representatives of the regulatory authorities and industry representatives of the USA, Europe, Canada, Japan and Australia. "Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices", 30 November 2006

I did not find an updated IMDRF guidance (because GHTF is essentially IMDRF now), but the concepts apply. Also, make sure your procedures dictate the investigational methods.

Section 820.198(a) sets forth the general requirement for

establishing and maintaining a complaint handling procedure and

includes a few items that the procedure needs to address. Section

820.198(b) discusses the initial review and evaluation of the

complaints in order to determine if complaints are ``valid.'' It is

important to note that this evaluation is not the same as a complaint

investigation. The evaluation is performed to determine whether the information is truly a complaint

or not and to determine whether the complaint needs to be investigated

or not. If the evaluation decision is not to investigate, the

justification must be recorded. Section 820.198(c) then describes one

subset of complaints that must be investigated, but explains that

duplicative investigations are not necessary. In cases where an

investigation would be duplicative, a reference to the original

investigation is an acceptable justification for not conducting a

second investigation. Section 820.198(d) describes another subset of

complaints that must be investigated (those that meet the MDR criteria)

and the information that is necessary in the record of investigation of

those types of complaints.

For the US, I advise caution here. Every allegation of a deficiency in the attributes listed in 820.3(b) is a complaint and must enter the 820.198 complaint system.

Every complaint must be evaluated, 820.198(a)(3), to determine if it is a reportable. There are no exceptions. (The Warning Letters are replete with cases in which manufacturers failed to prform an evaluation of every complaint.) However, evaluation is an often misunderstood concept. While there is no formal quality definition (such as ISO 9000:2015) the concept means to compare a situation against a set of criteria to make a decision. In this case the facts of the complaint are compared against the reportability criteria to decide on reportability. If yes, then follow Part 803 as well as 820.198. If not, continue to follow 820.198.

If the evaluation determines the complaint is potentially reportable, it must be investigated under 820.198(d). There are other cases in which the investigation is not required if there is a prior investigation. This does not hold for potentially reportable events.

I use the term potentially reportable, because the final decision on whether or not to report is made in Part 803 and documented in the MDR Event File, 803.18(b)(1)(i).

Yes, if there was any harm to patient-regardless of whether or not the device caused the harm. There is a 'malfunction' category that would need to be reported as an MDR if you determine that the continued usage of device would lead to patient injury or death.

I found this document useful, its a GHTF document from SG2 that includes representatives of the regulatory authorities and industry representatives of the USA, Europe, Canada, Japan and Australia. "Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices", 30 November 2006

I did not find an updated IMDRF guidance (because GHTF is essentially IMDRF now), but the concepts apply. Also, make sure your procedures dictate the investigational methods.