Medical Device Re-Labeling question - Customer has modified the labels

M

medicalcomp

#1
:confused: I'm not quite sure where to post this. Hope this is acceptable. We package and label (all levels) a product for a customer then send product for sterilization. Product is then shipped from sterilizer to customer.

However, customer has modified the labels (added a new CE mark) and would like us to print them and send to them so they can re label the finished sterilized product.

I don't know how to control this so open to any suggestions including direction to a reg/other that might tell me this can't be done.

Thanks very much in advance.
 
Elsmar Forum Sponsor

ScottK

Not out of the crisis
Staff member
Super Moderator
#2
Re: label question

You print the labels too?

Sounds to me like it's on their shoulders. You are simply selling them a label, it's up to them what they are going to use it for.

But I would think they are in the wrong if they are replacing a sterilized label with non sterilized label unless they are going to re-sterilize the whole product.
But again, you would have no liability because you're just selling them a label.
Just document it well to CYA.
 
Last edited:
M

medicalcomp

#3
Re: label question

They would only be replacing the label on the product package (and shipper as well I think), meaning the inner box that holds the product that has been sterilized. The actual product would not be affected by this relabeling operation. But yes, we do all the label printing.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Re: label question

They would only be replacing the label on the product package (and shipper as well I think), meaning the inner box that holds the product that has been sterilized. The actual product would not be affected by this relabeling operation. But yes, we do all the label printing.

I don't see a problem on your end.

My company makes labels. We give the customer what they want (usually :notme: ). If we give them a product that meets the specification and they apply it incorrectly it's not our problem.
 
M

medicalcomp

#5
Re: label question

Issue is, among other things, that our DHR confirms that we have released this label (original one we normally use), accounts for all quantity, etc., as well as everything else that goes in DHR.

I'm looking for what "rules" allow me to send them new labels, and how I properly document this for the DHR. Again, if it can even be done.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#6
Re: label question

Issue is, among other things, that our DHR confirms that we have released this label (original one we normally use), accounts for all quantity, etc., as well as everything else that goes in DHR.

I'm looking for what "rules" allow me to send them new labels, and how I properly document this for the DHR. Again, if it can even be done.
I dunno - I haven't run across this exact situation, but as far as my past experience the rule is that they are the customer and they want a new label so I send them a new label.
Since they are doing the relabeling it's up them to do a DHR to show it matches their modified DMR. Not me.

I'm eager to hear other perspectives.
 
M

medicalcomp

#7
Re: label question

Thanks Scott. Yes, I also am looking forward to other perspectives. Seems like an interesting topic.
 

somashekar

Staff member
Super Moderator
#9
:confused: I'm not quite sure where to post this. Hope this is acceptable. We package and label (all levels) a product for a customer then send product for sterilization. Product is then shipped from sterilizer to customer.

However, customer has modified the labels (added a new CE mark) and would like us to print them and send to them so they can re label the finished sterilized product.

I don't know how to control this so open to any suggestions including direction to a reg/other that might tell me this can't be done.

Thanks very much in advance.
Is your customer the legal manufacturer, and you have his name and address as the manufacturer on the label ?
Do the already affixed labels have lot number / batch number / Sl number / date of manufacture details ?
Well, you can follow his instructions and get the exact number of labels printed out with the above details on them (if the above applies) and make a mention within your DHR based on customer communication.
Follow up with the customer (the legal manufacturer) to issue you with an engineering change notice that matches with the lot number for which you have issued the labels prior to the ECN.
 
Last edited:
M

MIREGMGR

#10
Maybe your original description is incomplete or I'm not understanding it correctly, but I don't see a problem here, other than that you and they didn't have a proper mutual understanding up front of your and their business relationship, and particularly regulatory responsibility.

At your end, that shortcoming would call for better contract review, and a
Sales department that pays attention to regulatory responsibility as an essential parameter of every sale. Your customer needs to improve their purchasing in that regard as well, of course.

I assume from your original description that you thought you would be the regulatorily responsible Manufacturer, and your customer would be a distributor without regulatory responsibility. It sounds as if your customer thought...either up front, or as an in-course change...that they would be the regulatorily responsible Manufacturer, and you were performing secondarily-responsible contract manufacturing for them. The labeling approach they now want is consistent with that second scenario, which is a regulatorily acceptable approach, and in fact quite common.

The fast dancing you need to do to transition from the prior plan to the new plan is no big deal. Just document what you do and why it was necessary.

In a contract manufacturing role, you have fewer responsibilities, which you might view as meaning lesser costs. If you make the same revenue, it's not a bad way to do business.
 
Thread starter Similar threads Forum Replies Date
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
Z Labeling for Medical Device Samples - Surgical instruments 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S How to decide which medical device symbols go on label and labeling? US Food and Drug Administration (FDA) 5
M MDR Legacy Medical Device Labeling compliance timeline EU Medical Device Regulations 3
M Labeling for off-label use - Prevention of off-label use of a medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Professional Use Medical Software French Labeling for Canada -- Not Considered Medical Device Canada Medical Device Regulations 2
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
M UDI labeling MDR requirement for reusable medical device accessories EU Medical Device Regulations 12
T Change to Country of Origin on Medical Device Labeling Other Medical Device Regulations World-Wide 0
I Medical Device Packaging Multilingual Labeling EU Medical Device Regulations 3
K UDI Labeling for Medical Device Samples 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Labeling and UDI requirements for medical device kits 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Labeling Requirements for Acquired Medical Device Inventory Other US Medical Device Regulations 2
F MDD Article 12 Labeling Requirements for CE Marked Medical Device - Help CE Marking (Conformité Européene) / CB Scheme 4
D Sterile Medical Device Temperature and Humidity (Storage) Labeling Requirements EU Medical Device Regulations 5
R Medical Device Smartphone App Regulatory Requirement and Labeling US Food and Drug Administration (FDA) 1
G Medical Device Power Inlet/Outlet Voltage Labeling IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
F China Medical Device Labeling - Not approved for use, is for an exhibition EU Medical Device Regulations 4
A Japan Medical Device Labeling Requirements Japan Medical Device Regulations 5
M When is a Manufacturing Date required on Medical Device Labeling? Other Medical Device Regulations World-Wide 12
P Medical Device OEM, OBL and Private Labeling Questions EU Medical Device Regulations 5
M Identification and labeling medical device replacement system components Other Medical Device and Orthopedic Related Topics 12
F 2015 Sudan Medical Device Registration and Labeling Language Requirements Other Medical Device Regulations World-Wide 3
J Medical Device Labeling and Symbols - US and EU Requirements CE Marking (Conformité Européene) / CB Scheme 6
B Medical Device Labeling - Order No. 6 Effective Oct 01, 2014 China Medical Device Regulations 7
J Labeling for Repair Parts of a Medical Device Other Medical Device and Orthopedic Related Topics 1
K Medical Device Labeling Requirement in Mexico Other Medical Device Regulations World-Wide 2
K Medical Device Labeling Requirement - Manufacturer Name 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D US-EU Medical Device Labeling Consistency 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B Brazil ANVISA Medical Device Labeling/IFU Requirements Other Medical Device Regulations World-Wide 1
S Three Questions on Finished Medical Device Traceability, Labeling and Packaging US Food and Drug Administration (FDA) 3
J Sterile Medical Device Labeling Requirments - ISO 1041 Other Medical Device and Orthopedic Related Topics 1
A Are Medical Device Servicing Instructions Part of Labeling? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
M Medical Device Labeling Content Development ISO 13485:2016 - Medical Device Quality Management Systems 3
P Thailand Medical Device Labeling Content Requirements Other Medical Device Regulations World-Wide 3
G Labeling Requirements - Medical Device is Rx in USA, non-Rx in EU 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Y Medical Device Accessory Labeling Requirements Other Medical Device Regulations World-Wide 1
P Class 1 Medical Device Labeling and CE Marking Requirement EU Medical Device Regulations 8
L Labeling Requirements in Part A Class IIb Medical Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
T Requirements for Private Labeling a Class III (PMA) Medical Device in the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
L Medical Device Battery Labeling Requirements in the US US Food and Drug Administration (FDA) 1
S Private Labeling Regulations - Medical Device from Canada into India Other Medical Device Regulations World-Wide 3
C Timescales for Changing Medical Device Labeling EU Medical Device Regulations 4
E Labeling Requirements for an Implantable Medical Device Distributor 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
D CE Mark Labeling Requirements for a Class II Medical Device EU Medical Device Regulations 3
J Labeling Software for Medical Device Product and Packaging Labels for Production Use Other Medical Device Regulations World-Wide 5
M Labeling a Small Class IIb Medical Device EU Medical Device Regulations 8
L Medical Device Labeling Requirements - EN:980:2008 Other Medical Device Regulations World-Wide 2

Similar threads

Top Bottom