Regulatory Open Forum

Hello RAPS Expert,

We are Canadian based reusable class I (self declared) medical devices manufacturer (non sterile, non measuring) and mainly selling devices to US, EU, UK, Canada, AUS.

We do sell our devices to distributor and they can keep them for couple of months before finishing the stock and ordering new stock from us/manufacturer. We do mention manufacturing date on our packaging labelling but not shelf life. 
Keeping above scenario in mind, do we need to mention shelf life?

We also provide warranty of our (manual wheel chair) parts for one year and for stainless/alumni frame for two years in user manuals.

We did mention expected device life 10+ years (with proper replacement of damaged/defective parts because of wear and tear issue) in our technical files such as device specification.
Unfortunately, we are not communicating expected device life 10+ years to end users using user and dealer manual.

And as per my experience and observations, end users are still using our devices for many years (may be 15 to 20 years) without getting replacement of damaged/defective parts. I'm bit concerned if something happened to end user what to do at this situation.

Please find gaps related to me enquiry and provide your valuable feedback to tackle these all points.

Thanks 

If somebody is using a 15 year old chair and it has a damaged part, can they find your website and figure out how to get a suitable replacement part?

Hello RAPS Expert,

We are Canadian based reusable class I (self declared) medical devices manufacturer (non sterile, non measuring) and mainly selling devices to US, EU, UK, Canada, AUS.

We do sell our devices to distributor and they can keep them for couple of months before finishing the stock and ordering new stock from us/manufacturer. We do mention manufacturing date on our packaging labelling but not shelf life. 
Keeping above scenario in mind, do we need to mention shelf life?

We also provide warranty of our (manual wheel chair) parts for one year and for stainless/alumni frame for two years in user manuals.

We did mention expected device life 10+ years (with proper replacement of damaged/defective parts because of wear and tear issue) in our technical files such as device specification.
Unfortunately, we are not communicating expected device life 10+ years to end users using user and dealer manual.

And as per my experience and observations, end users are still using our devices for many years (may be 15 to 20 years) without getting replacement of damaged/defective parts. I'm bit concerned if something happened to end user what to do at this situation.

Please find gaps related to me enquiry and provide your valuable feedback to tackle these all points.

Thanks 

Hello RAPS Expert,

We are Canadian based reusable class I (self declared) medical devices manufacturer (non sterile, non measuring) and mainly selling devices to US, EU, UK, Canada, AUS.

We do sell our devices to distributor and they can keep them for couple of months before finishing the stock and ordering new stock from us/manufacturer. We do mention manufacturing date on our packaging labelling but not shelf life. 
Keeping above scenario in mind, do we need to mention shelf life?

We also provide warranty of our (manual wheel chair) parts for one year and for stainless/alumni frame for two years in user manuals.

We did mention expected device life 10+ years (with proper replacement of damaged/defective parts because of wear and tear issue) in our technical files such as device specification.
Unfortunately, we are not communicating expected device life 10+ years to end users using user and dealer manual.

And as per my experience and observations, end users are still using our devices for many years (may be 15 to 20 years) without getting replacement of damaged/defective parts. I'm bit concerned if something happened to end user what to do at this situation.

Please find gaps related to me enquiry and provide your valuable feedback to tackle these all points.

Thanks 

A device has a shelf life when some part of the device degrades while sitting before use on the shelf. If the product has a shelf life, then you need to measure it and provide the user with that information.

I don't think your product has a shelf life.

The warranty period is important for the customer to know. You need to be clear when it starts. Some companies start the warranty period at the manufacturing date, while companies start it at the first customer use. That means the manufacturer needs to determine it; a common approach is to register the product on the company web site. If it comes from a distributer, then the distributor should have the records.

I know of no requirement to inform the user of the expected device life. In the US, for example, the expected device life sets the record retention period.

Hello RAPS Expert,

We are Canadian based reusable class I (self declared) medical devices manufacturer (non sterile, non measuring) and mainly selling devices to US, EU, UK, Canada, AUS.

We do sell our devices to distributor and they can keep them for couple of months before finishing the stock and ordering new stock from us/manufacturer. We do mention manufacturing date on our packaging labelling but not shelf life. 
Keeping above scenario in mind, do we need to mention shelf life?

We also provide warranty of our (manual wheel chair) parts for one year and for stainless/alumni frame for two years in user manuals.

We did mention expected device life 10+ years (with proper replacement of damaged/defective parts because of wear and tear issue) in our technical files such as device specification.
Unfortunately, we are not communicating expected device life 10+ years to end users using user and dealer manual.

And as per my experience and observations, end users are still using our devices for many years (may be 15 to 20 years) without getting replacement of damaged/defective parts. I'm bit concerned if something happened to end user what to do at this situation.

Please find gaps related to me enquiry and provide your valuable feedback to tackle these all points.

Thanks 

Hello Dan, 

Thanks for your feedback. 
Could you please provide useful tips, how we can handle that? 

if something happened/incident to end user after the warranty period and after the expected device life.

Thanks

A device has a shelf life when some part of the device degrades while sitting before use on the shelf. If the product has a shelf life, then you need to measure it and provide the user with that information.

I don't think your product has a shelf life.

The warranty period is important for the customer to know. You need to be clear when it starts. Some companies start the warranty period at the manufacturing date, while companies start it at the first customer use. That means the manufacturer needs to determine it; a common approach is to register the product on the company web site. If it comes from a distributer, then the distributor should have the records.

I know of no requirement to inform the user of the expected device life. In the US, for example, the expected device life sets the record retention period.

Hello RAPS Expert,

We are Canadian based reusable class I (self declared) medical devices manufacturer (non sterile, non measuring) and mainly selling devices to US, EU, UK, Canada, AUS.

We do sell our devices to distributor and they can keep them for couple of months before finishing the stock and ordering new stock from us/manufacturer. We do mention manufacturing date on our packaging labelling but not shelf life. 
Keeping above scenario in mind, do we need to mention shelf life?

We also provide warranty of our (manual wheel chair) parts for one year and for stainless/alumni frame for two years in user manuals.

We did mention expected device life 10+ years (with proper replacement of damaged/defective parts because of wear and tear issue) in our technical files such as device specification.
Unfortunately, we are not communicating expected device life 10+ years to end users using user and dealer manual.

And as per my experience and observations, end users are still using our devices for many years (may be 15 to 20 years) without getting replacement of damaged/defective parts. I'm bit concerned if something happened to end user what to do at this situation.

Please find gaps related to me enquiry and provide your valuable feedback to tackle these all points.

Thanks 

Hello Dan, 

Thanks for your feedback. 
Could you please provide useful tips, how we can handle that? 

if something happened/incident to end user after the warranty period and after the expected device life.

Thanks

A device has a shelf life when some part of the device degrades while sitting before use on the shelf. If the product has a shelf life, then you need to measure it and provide the user with that information.

I don't think your product has a shelf life.

The warranty period is important for the customer to know. You need to be clear when it starts. Some companies start the warranty period at the manufacturing date, while companies start it at the first customer use. That means the manufacturer needs to determine it; a common approach is to register the product on the company web site. If it comes from a distributer, then the distributor should have the records.

I know of no requirement to inform the user of the expected device life. In the US, for example, the expected device life sets the record retention period.

Hello RAPS Expert,

We are Canadian based reusable class I (self declared) medical devices manufacturer (non sterile, non measuring) and mainly selling devices to US, EU, UK, Canada, AUS.

We do sell our devices to distributor and they can keep them for couple of months before finishing the stock and ordering new stock from us/manufacturer. We do mention manufacturing date on our packaging labelling but not shelf life. 
Keeping above scenario in mind, do we need to mention shelf life?

We also provide warranty of our (manual wheel chair) parts for one year and for stainless/alumni frame for two years in user manuals.

We did mention expected device life 10+ years (with proper replacement of damaged/defective parts because of wear and tear issue) in our technical files such as device specification.
Unfortunately, we are not communicating expected device life 10+ years to end users using user and dealer manual.

And as per my experience and observations, end users are still using our devices for many years (may be 15 to 20 years) without getting replacement of damaged/defective parts. I'm bit concerned if something happened to end user what to do at this situation.

Please find gaps related to me enquiry and provide your valuable feedback to tackle these all points.

Thanks