CE Marking for Custom Ordered Products Outside of the EU

D

danch

#1
Hi, our company in UK recently had its products (Class I) CE marked but I have few confusions about it.
1. If we have CE marked products, does that mean we can put CE mark on future Class I products as long as we document everything properly?

2. A company in New Zealand wants us to make a custom surgical knife in a small quantity (10,20) but wants them to be CE marked. They are not intending to sell in EU but just wants to keep surgeons happy by saying "these products are CE marked".
As far as I understand, for the CE mark to be valid, the product will have to be our product with our labels on it, but they want their company name on the product.
Since it's such a small quantity they don't want to apply for CE for that product, rather, they want to pay us a bit for the hassle. (they are not a manufacturing company - merely a distributor trying to see how the markets reacts to new product)
Is it possible to deliver their order with CE mark on it? and regulatory stuff that we have to do to achieve that?

Thanks in advance for any help.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello and welcome to the cove :bigwave:

1. Every new device (i.e. outside the declared scope of an already-compliant product type) that will be placed on the EC market will require full compliance with the MDD. There is no "inheritence" other than with trivial changes (e.g. changing a single dimension) where it's clear that no new risks are introduced.

2. If they're willing to sponsor your effort, you could clear a new version with their labelling. Basically you'd have to repeat the same process as you originally did, and the clearance would relate to the private-label version.

Cheers,
Ronen.
 
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