Hi, I work for a UK company that are negotiating with a Chinese company to import and sell a blood glucose monitoring system. This is an IVD in a box comprising a meter, test strips, control solution, a lancing device and lancets. The lancing device and lancets are obviously medical devices, and are manufactured by a separate Chinese company. Everything is CE marked with appropriate documentation, and the IVD maunufacturers have an EC Rep for their products. However the medical device manufacturer does not appear to have an EC rep and their products have not been registered in the EU. Would they be covered by the kit registration, or would they need to be registered separately? The lancets are supplied inside the kit in a small plastic bag with a label containing appropriate information that says "distributed by company A" and identifies the manufacturer as the second Chinese company. Both manufacturers have used the same NB so that number is the same. It's the first time I've dealt with companies outside the EU and would appreciate some guidance please. Thank you.