Non CE Marked Products

[Hustle]

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

[bednobs]

well it rather depends what you are using them for really!

[Hustle]

Body piercing. They are clamps to hold the skin and scissors the cut the cannula tube.

[Hustle]

I think I may have found the answer. Either the seller of the manufacturer must have the CE certificate but the product does have to. Can anyone confirm this please?

[DocHH]

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.

[Buenchico]

A useful starting point:
http://www.bis.gov.uk...ation/ce-marking-faqs

[tonywiltshire]

The CE marking means the item conforms to the applicable European directive and it is the responsibility of the manufacturer or importer’s to obtain.