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MDD Article 12 Labeling for Class IIa Medical Device - Please Advise

hornet456

Starting to get Involved
#1
Hello,

I'm looking for some advise from fellow members with regards to packaging requirements for our medical device, where Article 12 seems to apply. We are seeking re-certification of our device and the assessor has raised some labeling concerns. Please see the details below:

1. We are a manufacturer of a class II a medical device in the US. Our device is typically applied to the body using some accessory such as a tape or a cotton wrap etc. The accessory has no function other than to hold the device in place. The assessor has identified this combination as a "procedure pack"

2. The assessor indicates that although the accessory might be a class I non-sterile device and that our medical device is a class IIa device, they both can be packaged into an outer carton but that the outer carton cannot bear the CE mark for the device. We asked whether clarifying on the outer carton that the device only is CE marked might be helpful, but the assessor said no.

3. The assessor did suggest that we can CE mark the accessories too, but that they would be treated as a class IIa device and that the relevant biocompatibility assessment and such need to be conducted. We do not have access to this data.

With this in mind, can anyone here share some ideas on labeling the combination? Can use some dual box design, where the medical device is placed in a labeled section and the accessory is placed in a different section? We are happy to place the labeled medical device and the class I accessory into an outer carton without the CE mark, but we are concerned that this won't pass customs requirement when shipping to European countries from the US.

Any advice that can be provided will be greatly appreciated. Thank you so much for your time and guidance.
 
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YellowQCPro

Starting to get Involved
#2
Hello hornet456,

I am also wondering about how to label procedures packs. I have a "pack" that contains devices that are manufactured by and OEM supplier with their own CE Mark. They are then shipped in one carton to the distributor. The only label that we apply is on the outer shipping carton. None of the individual devices have modified labels. Have you considered self certify Class I device compliance for your tape or a cotton wrap? That way, the device could be imported and labeled separately along with the medical device with its own device label.
I do know that you cannot place both products into one pouch and put a CE mark on the label. That would be non-compliant to the MDD regulations.
Interested to know what others think about the procedure pack labeling.

Hope to get some feedback from the team out there!
 

hornet456

Starting to get Involved
#3
Hello hornet456,

I am also wondering about how to label procedures packs. I have a "pack" that contains devices that are manufactured by and OEM supplier with their own CE Mark. They are then shipped in one carton to the distributor. The only label that we apply is on the outer shipping carton. None of the individual devices have modified labels. Have you considered self certify Class I device compliance for your tape or a cotton wrap? That way, the device could be imported and labeled separately along with the medical device with its own device label.
I do know that you cannot place both products into one pouch and put a CE mark on the label. That would be non-compliant to the MDD regulations.
Interested to know what others think about the procedure pack labeling.

Hope to get some feedback from the team out there!

Thanks for your response! It appears that self certifying a class I device is an option, but we intend to provide the cotton wrap as a convenience to consumers in the same package. By offering it as a separate product, the concern is that we are not only placing additional financial burden on the consumer but we also have to point them to where the wrap would be available.

I do look forward to some insights/advice from labeling experts in the group :)
 

SKM.Sunil

Involved In Discussions
#4
Thanks for your response! It appears that self certifying a class I device is an option, but we intend to provide the cotton wrap as a convenience to consumers in the same package. By offering it as a separate product, the concern is that we are not only placing additional financial burden on the consumer but we also have to point them to where the wrap would be available.

I do look forward to some insights/advice from labeling experts in the group :)

I afraid so. The assessor is right, and as per the regulation. if you certify separately and still recommend in primary claim to use in combination, still you have to comply with requirements of devices working in combination.

better you certify the primary device and mark it CE not the accessory or outer cartoon box.
 
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