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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
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