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.

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. :mad:

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. :mad:

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.

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.

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.

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?

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?

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.

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.

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.

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.

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. You are right but they may be using the type examination route.
Module B (EC type-examination)
1. This module describes the part of the procedure by which a notified body ascertains and attests that a representative example of the production in question meets the provisions of the Directive which apply to it.

2. The application for EC type-examination must be lodged by the manufacturer or by his authorised representative established within the Community with a single notified body of his choice.

The application must include:


- the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
- a written declaration that the same application has not been lodged with any other notified body,
- the technical documentation described in section 3.

The applicant must place at the disposal of the notified body a representative example of the production envisaged, hereinafter called `type'. The notified body may request further examples should the test programme so require.

A type may cover several versions of pressure equipment provided that the differences between the versions do not affect the level of safety.
Having had it type examined they get an agreement in principle then go about putting together the technical documentation mentioned.

You are right but they may be using the type examination route.

Having had it type examined they get an agreement in principle then go about putting together the technical documentation mentioned.

I'm still very dubious.

Wouldn't we have to agree for them to be our "authorized representative in the community" for them to file this on their own? And even so, they need a whole lot of technical documentation that only we have.

And then they were asking for our Module D certificate. But our Mod D cert doesn't list this particular part becuase we don't CE mark it!

(We ran this by our NoBo auditor, BTW. He had a fit and was ready to report the other NoBo himself.)