CE Marking Issue- this seems illegal to me...

[ScottK]

A customer took one of our parts that is not CE marked.
It needs to be CE marked to be used in their device.

They then somehow got a type approval for the part without us knowing... even using our address and part number on the certificate.
They then came back and asked us for our QMS certification...

Seems to me you just can't do that.
I don't know what the NoBo based their approval on as we never submitted technical documentation.
I'm dying to see the technical file they "approved".

I think this is actually illegal. Or it it possible to "pass through" a part?
The part is a safety device.

[Jennifer Kirley]

They should be asked to stop at once. I would go further and ask for a recall of the parts marked improperly.

If they refuse, I would report them.

[ScottK]

Originally Posted by Jennifer Kirley

They should be asked to stop at once. I would go further and ask for a recall of the parts marked improperly.

If they refuse, I would report them.

Oh yeah - the customer stopped. They hadn't actually marked any, luckily.
I think from the customer view they were looking for a way to get around us charging a premium for CE marking and the Ops Manager is not very sharp with this stuff.

It's the NoBo that really has me scratching my head. They should really have known better.
And they're not a small NoBo/registrar.

[Al Rosen]

Originally Posted by ScottK

A customer took one of our parts that is not CE marked.
It needs to be CE marked to be used in their device.

They then somehow got a type approval for the part without us knowing... even using our address and part number on the certificate.
They then came back and asked us for our QMS certification...

Seems to me you just can't do that.
I don't know what the NoBo based their approval on as we never submitted technical documentation.
I'm dying to see the technical file they "approved".

I think this is actually illegal. Or it it possible to "pass through" a part?
The part is a safety device.

Your device can be used by having it evaluated as part of theirs without you first having it marked.

[db]

I worked with a company that needed the get the CE mark. A major component of their product was a product they purchased from a supplier (the supplier sells this product stand-alone as well). We required the supplier to submit a risk analysis of the product, so we could include that in our risk analysis. We made it clear to our supplier that our product would have a CE mark. Our CE mark is for our product, but the supplier component does not carry its own mark.

[ScottK]

Originally Posted by Al Rosen

Your device can be used by having it evaluated as part of theirs without you first having it marked.

right...
which brings up another question. This customer doesn't sell parts. They make assemblies...

unless they want to re-sell as a repair kit.
In which case the component probably needs to be individually marked?

[Paul Simpson]

Originally Posted by ScottK

A customer took one of our parts that is not CE marked.
It needs to be CE marked to be used in their device.

What directive is it covered by, Scott?

Originally Posted by ScottK

They then somehow got a type approval for the part without us knowing... even using our address and part number on the certificate.
They then came back and asked us for our QMS certification...

Again depending on the directive module they may be entitled to apply CE Marking without a "formal" type approval.

Originally Posted by ScottK

Seems to me you just can't do that.
I don't know what the NoBo based their approval on as we never submitted technical documentation.
I'm dying to see the technical file they "approved".

Agreed - if one is needed.

Originally Posted by ScottK

I think this is actually illegal. Or it it possible to "pass through" a part?
The part is a safety device.

Again it may be - depends on the directive / part.

[ScottK]

Originally Posted by Paul Simpson

What directive is it covered by, Scott?

PED.
97/23/EC

I'm not sure about them just including it in an assembly without a CE mark.
If they can that's great.

But the issue here is really, whether it needs CE marking or not, they were wanting to CE mark our part. Even with self assessment I don't think they can do that becuase you still need an abbreviated technical file.