Issue with Labelling of Outer Container - help needed for clarification

U

UNISURGE1

#1
Dear all

Excuse my apparent ignorance, i currently work for a company that buys CE Marked XRD/woven swabs, sterile and non sterile. We at present have an issue with labelling, the inner packaging has the correct infomation on it with the manufacturer's name and address and CE mark and number along with lot, DOM and Expiry. The outer packaging is my concern, it has our name and address, states we are ce registered, some have CE Mark and number of manufacturer (some do not) Lot details, expiry etc but where the manufacturer's number is used, we do not show their address, nor do we have any OBL Agreement in place. My question is are we in breech of the regulations, do we have to have an OBL agreement, or is their another way round to achieve compliance?

Any help would be greatly appreciated :)
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Dear all

Excuse my apparent ignorance, i currently work for a company that buys CE Marked XRD/woven swabs, sterile and non sterile. We at present have an issue with labelling, the inner packaging has the correct infomation on it with the manufacturer's name and address and CE mark and number along with lot, DOM and Expiry. The outer packaging is my concern, it has our name and address, states we are ce registered, some have CE Mark and number of manufacturer (some do not) Lot details, expiry etc but where the manufacturer's number is used, we do not show their address, nor do we have any OBL Agreement in place. My question is are we in breech of the regulations, do we have to have an OBL agreement, or is their another way round to achieve compliance?

Any help would be greatly appreciated :)
Any CE Mark experts who can help?

Thank you!

Stijloor.
 
G

George Weiss

#3
If you are purely a distributor of the OEM’s product.
It does not seem that way.
There is some re-branding?
It sounds as if there is an OBL void here.
Your packaging has several problems.
You might fall into problem(s) with some lot(s) of the product with labeling issues.
No labeling issue is to small for the FDA or your local regulatory agency.
The longer you wait, the worse it gets.
What is your business agreement with the OEM for this situation? Any agreement(s)?
There has been some discussion about this OBL issue, distributor and manufacturer
here at Elsmar
.
Basic comments
Better advice/comments to follow
 
U

UNISURGE1

#4
We buy the products and they are labelled with our logo and product code on them and are sold as supplementary items to our product range. We also include them within our own procedure packs. There is to my knowledge no agreement between the manufacturer or ourselves in regards to labelling. We are currently registered under article 12 as an assembler but under our own brand name.
 
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