Is SRN required for a contract manufacturer (CE-Marking product)?

#1
Hi all,

Our company is a contract manufacturer of a CE-Marking product. It's been noticed for a while that MDR requires all legal manufacturers to have their SRN. I used to believe, as a contract manufacturer, we don't need to register ourselves on EUDAMED. However, from a recent symposium, I heard a NB said the contract manufacturer needs to fulfill all the necessary requirements of a MFR listed in MDR including obtaining an SRN. I was wondering if it is an interpretation made by the specific NB or it's me who actually misinterpreted the definition of a MFR in MDR? We're not a legal MFR thus won't apply for product registration under MDR. Thus, there's no appropriate channels for me to ask around. Please kindly share your thoughts and experiences to communicate with your NB. Thanks.
 
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#2
Hello,

The Legal Manufacturer needs to get a SRN and register on EUDAMED.

The Legal Manufacturer will have to give your details to their NB, and you may have an (unannounced) audit from the NB, but I have never heard of a requirement for subcontractors to register on EUDAMED.

Surely if you are purely a subcontractor (and don't put devices on the market under your own name), you are not an economic operator under the sense of the MDR, so therefore, do not need to register.

I'd be interested to see if other people have heard this too...

Kind regards,
Tom
 
#3
Hello,

The Legal Manufacturer needs to get a SRN and register on EUDAMED.

The Legal Manufacturer will have to give your details to their NB, and you may have an (unannounced) audit from the NB, but I have never heard of a requirement for subcontractors to register on EUDAMED.

Surely if you are purely a subcontractor (and don't put devices on the market under your own name), you are not an economic operator under the sense of the MDR, so therefore, do not need to register.

I'd be interested to see if other people have heard this too...

Kind regards,
Tom
Hello Tommy, do you know if we change the legal manufacture address from A(America) to B(Europe), but same brand, same company, same product, same OEM(From Asia), do we need to obtain a new manufacturer SRN and a new basic UDI?
 
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