Regulatory Open Forum

Hello RAPS Expert,

Does anybody have "end of life" plan for the medical device product(s) that defines warranty periods, use periods, complaint handling, adverse event handling, GUDID, listings, regulatory queries, etc.?

Actually, we are class I (non sterile, non measuring) Medical devices manufacturer  and our devices can use for many years. However, we do provide warranty for 2 years only and have expected device life for 10 years.

Thanks

An end of life plan is based on the device.  As an example, electronical device sold in Europe needs to be disposed of in accordance with the WEEE directive.   The warranty has nothing do to with the End of Life.

Hello RAPS Expert,

Does anybody have "end of life" plan for the medical device product(s) that defines warranty periods, use periods, complaint handling, adverse event handling, GUDID, listings, regulatory queries, etc.?

Actually, we are class I (non sterile, non measuring) Medical devices manufacturer  and our devices can use for many years. However, we do provide warranty for 2 years only and have expected device life for 10 years.

Thanks

The QMS and DHF should cover the necessary activities across the full product lifecycle.

At the end of commercial distribution of a device type, the process should make sure you know to de-register it in the applicable jurisdictions.

At the end of life, the customer should know if the device can go in an ordinary waste stream or if special decommissioning is needed, e.g. for electronics, batteries, radioactive materials...

An end of life plan is based on the device.  As an example, electronical device sold in Europe needs to be disposed of in accordance with the WEEE directive.   The warranty has nothing do to with the End of Life.

Hello RAPS Expert,

Does anybody have "end of life" plan for the medical device product(s) that defines warranty periods, use periods, complaint handling, adverse event handling, GUDID, listings, regulatory queries, etc.?

Actually, we are class I (non sterile, non measuring) Medical devices manufacturer  and our devices can use for many years. However, we do provide warranty for 2 years only and have expected device life for 10 years.

Thanks

Good day Anon,

I posted previously concerning a basic structure of an "end of life" plan for a medical device if you search a little. The end of life plan needs to be structured according to type of device because it can vary significantly between single-use-disposable product, a durable piece of equipment, or an implant.  There are many considerations to be made such as inventory, complaints, adverse event reporting, servicing, support, registrations, etc.

The QMS and DHF should cover the necessary activities across the full product lifecycle.

At the end of commercial distribution of a device type, the process should make sure you know to de-register it in the applicable jurisdictions.

At the end of life, the customer should know if the device can go in an ordinary waste stream or if special decommissioning is needed, e.g. for electronics, batteries, radioactive materials...

An end of life plan is based on the device.  As an example, electronical device sold in Europe needs to be disposed of in accordance with the WEEE directive.   The warranty has nothing do to with the End of Life.

Hello RAPS Expert,

Does anybody have "end of life" plan for the medical device product(s) that defines warranty periods, use periods, complaint handling, adverse event handling, GUDID, listings, regulatory queries, etc.?

Actually, we are class I (non sterile, non measuring) Medical devices manufacturer  and our devices can use for many years. However, we do provide warranty for 2 years only and have expected device life for 10 years.

Thanks

The QMS and DHF should cover the necessary activities across the full product lifecycle.

At the end of commercial distribution of a device type, the process should make sure you know to de-register it in the applicable jurisdictions.

At the end of life, the customer should know if the device can go in an ordinary waste stream or if special decommissioning is needed, e.g. for electronics, batteries, radioactive materials...

An end of life plan is based on the device.  As an example, electronical device sold in Europe needs to be disposed of in accordance with the WEEE directive.   The warranty has nothing do to with the End of Life.

Hello RAPS Expert,

Does anybody have "end of life" plan for the medical device product(s) that defines warranty periods, use periods, complaint handling, adverse event handling, GUDID, listings, regulatory queries, etc.?

Actually, we are class I (non sterile, non measuring) Medical devices manufacturer  and our devices can use for many years. However, we do provide warranty for 2 years only and have expected device life for 10 years.

Thanks

Anne:

I agree with you regarding the DHF, and in particular the need of a disposable plan needs to come out of the Health Hazard Analyse where the entire life cycle is evaluated.

The QMS and DHF should cover the necessary activities across the full product lifecycle.

At the end of commercial distribution of a device type, the process should make sure you know to de-register it in the applicable jurisdictions.

At the end of life, the customer should know if the device can go in an ordinary waste stream or if special decommissioning is needed, e.g. for electronics, batteries, radioactive materials...

An end of life plan is based on the device.  As an example, electronical device sold in Europe needs to be disposed of in accordance with the WEEE directive.   The warranty has nothing do to with the End of Life.

Hello RAPS Expert,

Does anybody have "end of life" plan for the medical device product(s) that defines warranty periods, use periods, complaint handling, adverse event handling, GUDID, listings, regulatory queries, etc.?

Actually, we are class I (non sterile, non measuring) Medical devices manufacturer  and our devices can use for many years. However, we do provide warranty for 2 years only and have expected device life for 10 years.

Thanks