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Non CE Marked Products
I have been send some samples os surgical clamps from Pakistan (nearly all of the clamps used world wide are manufactured in pakistan). However they do now have a CE mark on them. What does this mean? Does it mean I can not resell them in this country. What about using them? Am I allowed to use them/
Thank you
Thank you
Answers
Best Answer
No best answer has yet been selected by Hustle. Once a best answer has been selected, it will be shown here.
For more on marking an answer as the "Best Answer", please visit our FAQ.I suspect these may be subject to the EU Medical Device Directive, (MDD) and would therefore need to be CE marked. This is the responsibilty of the Manufacturer or his agent in the EU. Contact with BIS, previously DTI should confirm this and also give you information on the CE marking process, which may include Independent Testing and Certification Bodies. British Standards Institute (BSI) in Hemel Hempstead might also be a good source of information, they might even be an Notified Body able to CE mark to the MDD.
A useful starting point:
http://www.bis.gov.uk...ation/ce-marking-faqs
http://www.bis.gov.uk...ation/ce-marking-faqs
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