Authorised rep question

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.

 

The first question I have is if the medical device has a CE mark , they must have an Authorised Representative. If you are outside of the EU you cannot have a CE mark without this in place. This is one of the areas that the NB will be looking. This is a requirement in Article 14 paragraph 2 of 93/42/EEC.

With regard to your question for medical device system/procedural packs you need to meet the Article 12 requirements of 93/42/EEC. I am not sure of the exact requirements for IVD's

 

Thanks for your reply. When the original Chinese manufacturer approached us, they had CE certification for all the IVD components of the system and an Authorised Representative in Ireland, but were under the impression that we as a distributor had to register with the MHRA in the UK to market our products here. As they had no office in the UK, I recommended that they registered with HPRA in Ireland, which they did. They have told us that they don't think the lancet manufacturer has an EC rep or has registered in the EU but are finding out the situation from them.

When my company have manufactured IVD kits for self test use containing lancets, we have just had a separate pouch within the kit bearing the lancet manufacturers details, appropriate symbols,NB number etc and registered the kit with MHRA as one IVD entity. I'm just not sure what the position is when the kit comprises two different manufacturers who are not from the EU.

To complicate things further, the EC rep in Ireland appears to have registered all the IVD components separately (meter, test strips and control solution), not as one kit. So there is no mention of the lancets as an accessory to the test, although they would be sold as such within the kit.