Regulatory Open Forum

Good Day, 

As a class I (non sterile, non measuring) medical devices manufacturer, what are the requirements as per ISO 13485, UK MDR, EU MDR and FDA.

Currently, we do use two labeling:

Packaging label that goes to shipper box - one chair per box
Labelling on device itself - water repellent, etc.

Currently our packaging labels contained all information in it. However, we are going to implement SAP and SAP implementer enquiring. can we split the packaging labels information such as machine readable UDI barcode and  SN will go the packing slip which we attach to shipper box?
And rest of the information would already pre-printed in the shipper box. 

SAP implementer is saying "the spirit is traceability of device" which we can do through the labels on the device itself.
So why we need packaging label that should have all information on it?

Note: we are selling chairs to distributor and then they ship to end user.

Please provide me references as per ISO standards and regulations with your justifications?

Thanks in advance

Arslan,

You have quite a few items going on there and not quite sure the exact nature of the question.  Labelling can be done a variety of ways depending on the type of device, levels of packaging, direct marking, etc.  I believe you might want to seek some expert advice on this because citing individual regulations and guidance for ISO 13485, UK, EU, and US can be quite expansive and would be well suited for you to review these in detail yourself.  There are nuisances related to Good Manufacturing Practices (GMP) when it comes to packaging and labelling, as this also takes experience in the different areas and how labelling is applied.  There are also different content which may be required at the different levels of packaging depending on how this is done and how the distribution chain needs each of those label information provided. 

Good Day, 

As a class I (non sterile, non measuring) medical devices manufacturer, what are the requirements as per ISO 13485, UK MDR, EU MDR and FDA.

Currently, we do use two labeling:

Packaging label that goes to shipper box - one chair per box
Labelling on device itself - water repellent, etc.

Currently our packaging labels contained all information in it. However, we are going to implement SAP and SAP implementer enquiring. can we split the packaging labels information such as machine readable UDI barcode and  SN will go the packing slip which we attach to shipper box?
And rest of the information would already pre-printed in the shipper box. 

SAP implementer is saying "the spirit is traceability of device" which we can do through the labels on the device itself.
So why we need packaging label that should have all information on it?

Note: we are selling chairs to distributor and then they ship to end user.

Please provide me references as per ISO standards and regulations with your justifications?

Thanks in advance

Hello Richard, 

Thanks for your response. As I told you we are just using two layers, one direct marking and one packaging layer. 

Unfortunately, I could not find clear regulations on splitting the packaging labels
I was trying to form an opinion, what is the general rule regarding the packaging label?

Thanks

Arslan,

You have quite a few items going on there and not quite sure the exact nature of the question.  Labelling can be done a variety of ways depending on the type of device, levels of packaging, direct marking, etc.  I believe you might want to seek some expert advice on this because citing individual regulations and guidance for ISO 13485, UK, EU, and US can be quite expansive and would be well suited for you to review these in detail yourself.  There are nuisances related to Good Manufacturing Practices (GMP) when it comes to packaging and labelling, as this also takes experience in the different areas and how labelling is applied.  There are also different content which may be required at the different levels of packaging depending on how this is done and how the distribution chain needs each of those label information provided. 

Good Day, 

As a class I (non sterile, non measuring) medical devices manufacturer, what are the requirements as per ISO 13485, UK MDR, EU MDR and FDA.

Currently, we do use two labeling:

Packaging label that goes to shipper box - one chair per box
Labelling on device itself - water repellent, etc.

Currently our packaging labels contained all information in it. However, we are going to implement SAP and SAP implementer enquiring. can we split the packaging labels information such as machine readable UDI barcode and  SN will go the packing slip which we attach to shipper box?
And rest of the information would already pre-printed in the shipper box. 

SAP implementer is saying "the spirit is traceability of device" which we can do through the labels on the device itself.
So why we need packaging label that should have all information on it?

Note: we are selling chairs to distributor and then they ship to end user.

Please provide me references as per ISO standards and regulations with your justifications?

Thanks in advance

Generally the device label and the packaging label have the same information.  Again, depending on the packaging levels (need to see label content) the packaging level might only have basic product identification information, i.e. part number, serial number, product name.

Hello Richard, 

Thanks for your response. As I told you we are just using two layers, one direct marking and one packaging layer. 

Unfortunately, I could not find clear regulations on splitting the packaging labels
I was trying to form an opinion, what is the general rule regarding the packaging label?

Thanks

Arslan,

You have quite a few items going on there and not quite sure the exact nature of the question.  Labelling can be done a variety of ways depending on the type of device, levels of packaging, direct marking, etc.  I believe you might want to seek some expert advice on this because citing individual regulations and guidance for ISO 13485, UK, EU, and US can be quite expansive and would be well suited for you to review these in detail yourself.  There are nuisances related to Good Manufacturing Practices (GMP) when it comes to packaging and labelling, as this also takes experience in the different areas and how labelling is applied.  There are also different content which may be required at the different levels of packaging depending on how this is done and how the distribution chain needs each of those label information provided. 

Good Day, 

As a class I (non sterile, non measuring) medical devices manufacturer, what are the requirements as per ISO 13485, UK MDR, EU MDR and FDA.

Currently, we do use two labeling:

Packaging label that goes to shipper box - one chair per box
Labelling on device itself - water repellent, etc.

Currently our packaging labels contained all information in it. However, we are going to implement SAP and SAP implementer enquiring. can we split the packaging labels information such as machine readable UDI barcode and  SN will go the packing slip which we attach to shipper box?
And rest of the information would already pre-printed in the shipper box. 

SAP implementer is saying "the spirit is traceability of device" which we can do through the labels on the device itself.
So why we need packaging label that should have all information on it?

Note: we are selling chairs to distributor and then they ship to end user.

Please provide me references as per ISO standards and regulations with your justifications?

Thanks in advance