Regulatory Open Forum

I am trying to determine the record retention period of a device for QMS record retention purposes, including MDR Files.  The device in question is a Class II software device (in the US) to be used with a Class I hardware component. It does not have an EOL date.  The following is what I have been able to find but it doesn't help for a device that does not have an EOL date.  Any insight would be greatly appreciated. 

-------------------

Both ISO 13485 and QSR say something similar in that records shall be retained for a period of time at least equivalent to the lifetime/expected life of the medical device but not less than two years from the date of product release.

FDA's draft guidance on Medical Device Reporting says:

"MDR files should be maintained for two years from the date of the event or a period equivalent to the expected life of the device, whichever is greater [see 21 CFR 803.18(c)]. 

The "expected life of a device" is the time that a device is expected to remain functional after it is placed into use [21 CFR 803.3]. Certain implanted devices have specified "end of life" (EOL) dates. Other devices are not labeled with EOL dates, but are expected to remain operational through activities such as maintenance, repairs, or upgrades.

Thanks in advance,

I am trying to determine the record retention period of a device for QMS record retention purposes, including MDR Files.  The device in question is a Class II software device (in the US) to be used with a Class I hardware component. It does not have an EOL date.  The following is what I have been able to find but it doesn't help for a device that does not have an EOL date.  Any insight would be greatly appreciated. 

-------------------

Both ISO 13485 and QSR say something similar in that records shall be retained for a period of time at least equivalent to the lifetime/expected life of the medical device but not less than two years from the date of product release.

FDA's draft guidance on Medical Device Reporting says:

"MDR files should be maintained for two years from the date of the event or a period equivalent to the expected life of the device, whichever is greater [see 21 CFR 803.18(c)]. 

The "expected life of a device" is the time that a device is expected to remain functional after it is placed into use [21 CFR 803.3]. Certain implanted devices have specified "end of life" (EOL) dates. Other devices are not labeled with EOL dates, but are expected to remain operational through activities such as maintenance, repairs, or upgrades.

Thanks in advance,

In determining device record retention periods, there are four different requirements that apply to all manufacturers of devices marketed in the US. (Other parts have additional record keeping requirements, such as tracked devices, but don't apply broadly.)

QSR (820.180(b)) - The retention period is the design and expected life of the device or the date of release for commercial distribution, whichever is longer. Notice that the record retention period does not depend on the device class.

MDRs (803.18(c)) - The retention period is the expected life of the device or 2 years from the event, which ever is longer.

C&R (806.20(c)) - The retention period is 2 years beyond the expected life of the device.

UDI (830.360(a)) - Three years from the date you stop marketing the version or model.

In record retention you need two pieces of data - when the clock starts and how long it runs.

Three of these require setting the expected life. If the device doesn't have an End of Life date, then the easiest way is to determine how long you expect to support it.

ISO 13485:2003 will not provide any help, because it is an International Standard; it doesn't "know" the regulatory system in which it operates. For example, the record retention requirements for the EU MDD, under Annex II, is 5 years in general and 15 years for implantable devices after the last product has been manufactured.

I am trying to determine the record retention period of a device for QMS record retention purposes, including MDR Files.  The device in question is a Class II software device (in the US) to be used with a Class I hardware component. It does not have an EOL date.  The following is what I have been able to find but it doesn't help for a device that does not have an EOL date.  Any insight would be greatly appreciated. 

-------------------

Both ISO 13485 and QSR say something similar in that records shall be retained for a period of time at least equivalent to the lifetime/expected life of the medical device but not less than two years from the date of product release.

FDA's draft guidance on Medical Device Reporting says:

"MDR files should be maintained for two years from the date of the event or a period equivalent to the expected life of the device, whichever is greater [see 21 CFR 803.18(c)]. 

The "expected life of a device" is the time that a device is expected to remain functional after it is placed into use [21 CFR 803.3]. Certain implanted devices have specified "end of life" (EOL) dates. Other devices are not labeled with EOL dates, but are expected to remain operational through activities such as maintenance, repairs, or upgrades.

Thanks in advance,

In determining device record retention periods, there are four different requirements that apply to all manufacturers of devices marketed in the US. (Other parts have additional record keeping requirements, such as tracked devices, but don't apply broadly.)

QSR (820.180(b)) - The retention period is the design and expected life of the device or the date of release for commercial distribution, whichever is longer. Notice that the record retention period does not depend on the device class.

MDRs (803.18(c)) - The retention period is the expected life of the device or 2 years from the event, which ever is longer.

C&R (806.20(c)) - The retention period is 2 years beyond the expected life of the device.

UDI (830.360(a)) - Three years from the date you stop marketing the version or model.

In record retention you need two pieces of data - when the clock starts and how long it runs.

Three of these require setting the expected life. If the device doesn't have an End of Life date, then the easiest way is to determine how long you expect to support it.

ISO 13485:2003 will not provide any help, because it is an International Standard; it doesn't "know" the regulatory system in which it operates. For example, the record retention requirements for the EU MDD, under Annex II, is 5 years in general and 15 years for implantable devices after the last product has been manufactured.

I am trying to determine the record retention period of a device for QMS record retention purposes, including MDR Files.  The device in question is a Class II software device (in the US) to be used with a Class I hardware component. It does not have an EOL date.  The following is what I have been able to find but it doesn't help for a device that does not have an EOL date.  Any insight would be greatly appreciated. 

-------------------

Both ISO 13485 and QSR say something similar in that records shall be retained for a period of time at least equivalent to the lifetime/expected life of the medical device but not less than two years from the date of product release.

FDA's draft guidance on Medical Device Reporting says:

"MDR files should be maintained for two years from the date of the event or a period equivalent to the expected life of the device, whichever is greater [see 21 CFR 803.18(c)]. 

The "expected life of a device" is the time that a device is expected to remain functional after it is placed into use [21 CFR 803.3]. Certain implanted devices have specified "end of life" (EOL) dates. Other devices are not labeled with EOL dates, but are expected to remain operational through activities such as maintenance, repairs, or upgrades.

Thanks in advance,