CE Mark "piggybacking" on suppliers technical files - Looking for contract example

[Bridget]

One of our EU customers is working on ISO 13485 and the MDD to obtain his own CE mark so he can have his company name on the products we sell to him. Currently he sells product with our labeling and CE mark.

He advised me it was possible for him to obtain his CE mark without technical files if we can get our notified body to sign an agreement that allowed the him to refer to ours. I imagine if an event occured I would be required to send the file within the time allotted but this is a way to help a good customer and keep the files confidential.

I checked and our notified body who stated this is possible!!! I am looking for examples of a contract that would be used between both companies or any advice.
Has anyone gone through this before?
Thanks,
Bridget

[johnquinn]

Bridget,

Hope this helps you, I had to cross this bridge a short while ago and my memory on it is the following: The main issue was confidentiality of the technical file. The agreement you mention between NB's is more about them maintaining the confidentiallity they are bound by.

If my memory serves me well, I remember that the TF and the "other" NB could interact directly (once NB's agree), there was no requirement for the technical file to go to the middle person (your EU customer) and hence any agreement was of a commercial nature only.

The NB is bound by confidentiallity so your TF is safe and shouldn't be released or discussed with your EU customer. (This in itself is a contradiction in terms and involves you in several process of the MDD that you shouldn't need to do)

If you have no issue with giving this customer your TF, then I would let them create their own using all the technical info that you have created (ISO 11607, 10997, etc, etc), then you become a defacto supplier with no obligations under the MDD (with this customer only of course) as the EU customer now CE's the product and places it on the EU market. It is now his problem to manage their own CE/TF, etc.

If you link your TF, then you would be obliged to keep your EU customer in the loop regarding material changes and all that, not sure if the admin makes it attractive.

In my case, at the end of the day, we decided that it was all too messy and we built a technical file for a product and just used the relevent information from the supplier technical file to make our own and (with this particular product - Class III), we got it over the line with the NB in just 2 weeks, nice and clean and we are paddling our own canoe.

If you wish to control confidentiallity of your TF with your supplier if you hand it over, then I think you could include it in the commercial arrangement.

The only disclaimer I will make with everything I have written above is that christmas starts in 2.5 hours for me and my brain is already is shutdown mode but it summarises my own experience of the same situation as I remember it as it related to a product we were importing into the EU.

Slán,
John.

Hope this helps...

[Al Rosen]

Bridget:

Don't you employ an independent Authorized Representative in accordance with article 14 of the MDD? This entity would maintain your TF and confidentiality. No matter what, I would advise you not to disclose any proprietary information in your TF to your customer under any circumstances. If for any reason the relationship dissolves, your customer will be free to find another supplier using the information in your TF. It's difficult enough fighting these things in domestic courts, more so internationally.

I know of a US company that had an agreement, with a European company, to market and service the european company's products (electronics) in the US. The European company could not keep up with the US demand, so the US company used the engineering data to develop their own products. Some products the US company assembled, others were sub-contracted to another US company with the special process capabilities required for them. The US parts appeared and performed the same as the European parts. This happened over 25 years ago and both companies are still competing in the US and internationally. BTW, they are not in the medical device industry.

[Bridget]

John:
Thanks for sharing your experience. I agree that it might be easier to make non confidential file and leave the customer to their own but there are several reasons we may allow this for this particular customer:
1. I have over 30 technical files and it would be a lot of work to create sanitized versions and keep the customers versions in mind. It is hard enough to keep the copy with the EU rep up to date, much less another set.
2. My boss seems to like this idea.
3. Regarding your statement about notifying them for changes--our raw materials don't change, even if we change suppliers we can obtain the same grade, size, or color of materials.
4. Our customer has agreed to use the same notified body as us, he hopes it will make things go easier.
5. He will format his labeling (except with their language) the same so I can be assured the product is identified correctly.
FYI-Our notified body does not keep copies on file, they will audit them at our facility.
What it comes down to for me is that I would rather be in charge, even if they created their own files they would constantly be asking for further information from me.

I already have had two different agreements sent to me by other contacts so I will be reviewing them closely and perhaps sending them to the lawyer.

Al:
Our European Rep was the first one I asked about this and they have no problem with it. 85% of our business is exported and so far our customers have been loyal as far as regulatory issues are concerned. I agree with you, a technical file should be confidential. Our largest supplier had provided us with Part A of their technical file which stated that Part B was confidential. But when we purchased their company 5 years later I found Part B had no more information in it than Part A!

Thanks to you both for some great feedback,
Merry Christmas
Bridget

[rthompson]

Bridget,
Would you mind sharing one of the sample contracts you received from your other contacts? Thanks in advance for your assistance.....you can send it to me via private messge if you prefer.
Regards,
Rob

[ScottK]

My experience is with the Pressure Equipment Directive, not medical devices but here's what went down:

Our customer took one of our parts that we make under Sound Engineering Practice (no CE mark) to a notified Body and got certification to apply their own mark and NOBO number based on basic drawings and performance testing. We could never have given them the TF because you don't need a full TF for SEP.

We found out about this and asked our NOBO about it. He flipped out totally and seriously considered filing a complaint against the other NOBO but we got them to stop.
It could have caused a tremendous mess.

Just my 2 cents in hoping to avoid a pitfall.

Oh - and the customer still hasn't gotten back to us about whether they are willing to pay the upcharge for us to get the full certification. Cheapskates.

[Roland Cooke]

Do a search under Own Brand Labelling and/or Private Labelling. This topic (piggybacking) has been discussed before, can't remember if anyone posted a template agreement.