CE Marking a product for a company (customer) based in America

[GLW79]

I've recently been asked to CE mark a product for a company (customer) based in America, who are the manufacturer of the product in question and also want to retain the term "manufacturer" in line with the CE mark. They need the CE mark approval in order to get TGA registration as their current FDA approval on it's own isn't good enough from what I can gather??? Is this right?

They have no NB in the EU, which is why they've come to us, hoping that they can piggy-back on our NB. Is there a legal way this can be achieved e.g. we obtain the CE mark and they carry out an OBL approach?

Any help on this subject would be much appreciated.

 

[pkost]

Re: CE Marking for another company

I don't understand why they don't CE mark it themselves. You say it is because they don't have a NB and are not registered in the EU, but then you go on to say that they will carry out an OBL - this will require them to register and get a notified body (assuming it's not a class I). If they already have US clearance then they have the necessary documentation to register over here, if they didn't they would still have to generate it for you!

I don't know the in's and out's of registration with the TGA however I do believe they are correct in saying that it is easier to get approval for a product with CE as opposed to FDA clearance.

I would also have to assume that they wouldn't be able to enter the Aus market off the back of your CE mark if they wanted to claim it as their own - again they would have to have their own CE mark to do that

 

[GLW79]

Re: CE Marking for another company

Thank you for the response. I think I'm going to have to speak to my NB and ask them what they suggest as a quick route to market.

THe technical file is almost complete, so all the documentation is in place for our NB to review, but maybe instead of my company submitting they submit the file.

 

[Ronen E]

I've recently been asked to CE mark a product for a company (customer) based in America, who are the manufacturer of the product in question and also want to retain the term "manufacturer" in line with the CE mark. They need the CE mark approval in order to get TGA registration as their current FDA approval on it's own isn't good enough from what I can gather??? Is this right?

They have no NB in the EU, which is why they've come to us, hoping that they can piggy-back on our NB. Is there a legal way this can be achieved e.g. we obtain the CE mark and they carry out an OBL approach?

Any help on this subject would be much appreciated.

Hi there,

A few quick notes, if the final goal is clearance in Australia:

1. Why not go straight to TGA clearance?
2. If they intend to lever their future CE mark for TGA clearance through the MRA, they should note that (as far as I understand) the MRA applies to manufacturers located inside the EC and Australia.
3. Even with a CE mark, they would still need an Australian Sponsor or an own Australian establishment (branch etc.).

And yes, it matters a great deal whether the subject device is class 1 (non m/s) or not.

Cheers,
Ronen.

 

[GLW79]

Thank you for your help.

Going straight through to the TGA was an option discussed, but the customer stated that they've had difficulty before due to the fact the product didn't have a CE mark, which is why they asked us to get the CE mark for them, but unless there is something I'm missing here, surely this can't be acheived as they want to be the manufacturer?

 

[pkost]

Ronen is right - they could just go direct through TGA instead of the EU, it seems I had tunnel vision when you asked your question and didn't think of this.

From your posts it seems to me that the company wants to dodge the work which is required to introduce a product into different markets....This is a little short sited of them and would have me a little concerned!

If they want to be the "manufacturer" i.e. the one with the name on the box, then they have to jump through the hoops, there are no loopholes to avoid this. Certainly they can get you to CE mark it, but it will be your name on the box and you will be responsible and liable. The could OBL off the back of your CE mark, but why? they would have to help you CE mark it in the first place and then they would still have to do some work to apply their own CE mark.

 

[GLW79]

With the technical file nearly complete, could I not just hand this over to them, for them to register it in the EU? Is there a loop hole that allows a company outside the EU who aren't ISO13485 and MDD accredited to do this?

 

[pkost]

Any company in the world can register a product for sale in the EU, all they have to do is hire an EC-rep to act as a liaison (you could perform this function if necessary and you have an appropriate contract in place)

It is also possible to receive an approval for a device without ISO13485, however the MDD requires a quality management system and if you haven't got 13485 the notified body will tear through it to check that it meets the requirements, therefore it isn't recommended. 13485 is a harmonised standard and so if you have a certificate, it is assumed during the technical file review that you have an appropriate system in place which is compliant with the MDD. To put it into perspective, I spoke to an very experienced auditor once and they said that they had only ever come across one company without 13485 but there was a very good reason for this (they wouldn't go into any more detail because it's confidential)

There is no such thing as MDD accredited.


You say that you have almost completed the technical file...how have you done this? it suggests that you have done it without the help of the manufacturer? Have you validated the design? Have you demonstrated compliance with all the essential requirements? How did you do this without the manufacturer giving you all the necessary information? Why didn't they just do it themselves!

If you were to submit this technical file, what is the next step? You will have a product, but it will be your name on the box, which you have already said is not what the company wants. In order for them to get their own name on the product they will have to own brand it...this will require them to register with a notified body and obtain ISO 13485

 

[Ronen E]

With the technical file nearly complete, could I not just hand this over to them, for them to register it in the EU? Is there a loop hole that allows a company outside the EU who aren't ISO13485 and MDD accredited to do this?

What class is the device?

 

[GLW79]

Your point regarding an EC-rep looks to be a good one. Potentially I could just pass on the file I've created to the customer and they get the approval.

THe company I work for is acc. ISO 9001:2008, ISO 13485:2003, so we have no problem there. To clarify, when I mentioned MDD accredited, I just meant that we work to MDD.

The file has nearly been completed with the help of the customer i.e. product information, validation work, process details, basically everything I need for the file. One thing I think I should add here is that we could be manufacturing this product on site in the near future and while I've been asked to do the file there is a lot of things going on that I don't have a full picture of as yet. The reason they didn't do it themselves I'm unsure of but I think it was due to the fact that they have little knowledge of the process and wanted a company with better knowledge to carry this through for them. Looking back, they should've probably gone to a consultancy firm.

THe nest step would be to OBL the product and from various conversations I've had before the requirements to do this is:

1. DOC needs to signed by the OBL
2. Customer concerns procedure needs to be in place
3. PMS procedure needs to be in place

There may have been 1 more thing, but I'd ahve to check, but basically you piggy back on the company that has all the relevant systems etc in place.