Virtual Manufacturer and CE Marking

J

jesupesu

#1
Hi,

Does an OEM need a CE mark on their product in order for a virtual manufacturer to gain one?

For clarity - the OEM has a FDA 510k on it, but the OEM has no intentions of selling in Europe themselves. However, the virtual manufacturer wishes to do so. Is it necessary for the OEM to gain a CE mark before the virtual manufacturer can? This is a Class I Non-Sterile product.

Thanks!
 
Elsmar Forum Sponsor
#2
Hello Jesupesu,

From the regulatory perspective, the OEM is essentially selling into Europe themselves if they proceed with sending products to the EU, even under the legal manufacturer model. While the legal manufacturer has ultimate responsibility for the products they put on the EC markets, one responsibility is making sure the OEM is in-line and produces a conforming product. For the OEM, this responsibility of the legal manufacturer primarily manifests in the compilation of the EU Technical File and everything required for that to be accepted by the notified body (e.g. TUV SUD).

Hope this helps and I'm sure some of the experts here can provide better information.
 
J

jesupesu

#3
Hello Jesupesu,

From the regulatory perspective, the OEM is essentially selling into Europe themselves if they proceed with sending products to the EU, even under the legal manufacturer model. While the legal manufacturer has ultimate responsibility for the products they put on the EC markets, one responsibility is making sure the OEM is in-line and produces a conforming product. For the OEM, this responsibility of the legal manufacturer primarily manifests in the compilation of the EU Technical File and everything required for that to be accepted by the notified body (e.g. TUV SUD).

Hope this helps and I'm sure some of the experts here can provide better information.
I guess that's the part that's ambiguous to me still. It seems to me as long as the virtual manufacturer is ensuring that the product meets the EU standards and that the OEM is in line and produces a conforming product, then the OEM does not need a CE mark. Unless you are saying that the OEM is essentially selling into Europe themselves and therefore needs a CE mark.
 

moounir

Involved In Discussions
#4
Hi Jesupesu,

I had created an article on that as I've seen this question a lot of time. The Model Virtual Manufacturer (OBL, PLM) / OEM is under question now with the MDR. But with the MDD in Europe, the OEM should have a CE Certificate.
The reason is the fact that the OEM is currently not providing all the information to the virtual manufacturer. So the virtual manufacturer is showing to its notified body that the OEM is clear with the EU regulation.
If you want more detail you can read my notes here.

Let me know if this answers your question. What is important for you is the fact that by May 26th 2020, all this model can be forbidden. Some solutions to keep it alive are under investigation.
 
J

jesupesu

#5
Hi Jesupesu,

I had created an article on that as I've seen this question a lot of time. The Model Virtual Manufacturer (OBL, PLM) / OEM is under question now with the MDR. But with the MDD in Europe, the OEM should have a CE Certificate.
The reason is the fact that the OEM is currently not providing all the information to the virtual manufacturer. So the virtual manufacturer is showing to its notified body that the OEM is clear with the EU regulation.
If you want more detail you can read my notes here.

Let me know if this answers your question. What is important for you is the fact that by May 26th 2020, all this model can be forbidden. Some solutions to keep it alive are under investigation.
Thank you for the article! It was very helpful. Additionally, in regards to the MDD, it seems like there is no issue as long as the OEM is willing to share their entire technical file to the OBL.
 

moounir

Involved In Discussions
#6
Thank you for the article! It was very helpful. Additionally, in regards to the MDD, it seems like there is no issue as long as the OEM is willing to share their entire technical file to the OBL.
Yes you are right. But it's also the case with MDR.
The situation with MDD is that the OEM is usually sending its CE Certificate to the OBL to prove that they are compliant with the Medical Device Directive.
Now the only way in future is that the OEM is disclosing the full technical file to the OBL to be able to continue to sell its products.

Thanks for this interesting question.
 

DMLqms

Starting to get Involved
#7
Hello All - something that I think is important and relates to this - I am now in the situation that as a 'virtual manufacturer' some of the people we considered OEMs/ODMs are actually virtual manufacturers themselves - they do not physically manufacture the devices. A small paragraph (aren't they all!) in the MHRA guidance for Virtual manufacturers explicitly forbids a virtual manufacturer dealing with another virtual manufacturer I believe? Are we in effect now forced to second-source?
 

DMLqms

Starting to get Involved
#8
Hello all - coming back on this - my notified body has confirmed my opinion that whilst being assessed as a virtual manufacturer, any OEM/ODM EC certificates are essentially irrelevant as it is me who is 'the manufacturer' and has to show that the devices are suitable for the market. The assumption is that this would be made much harder using companies without any certification but let me tell you that I am aware of a number of OEMs that supposedly have full EC certification but will not (cannot?) provide any information.
 
#9
Hello all - coming back on this - my notified body has confirmed my opinion that whilst being assessed as a virtual manufacturer, any OEM/ODM EC certificates are essentially irrelevant as it is me who is 'the manufacturer' and has to show that the devices are suitable for the market. The assumption is that this would be made much harder using companies without any certification but let me tell you that I am aware of a number of OEMs that supposedly have full EC certification but will not (cannot?) provide any information.
Hi, I have the exact same query. Is it now forbiden for a virtual manufacturer to deal with another virtual manufacturer? Could you please let me know which part Of MDR or MHRA guidance refers to it? I would be very grateful.
 
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