Relabelling a component that will be sold as a spare part - Do I become legal manufacturer?

#1
Hi, as the title asks, if I buy an off the shelf product to use as part of my medical device, which I will then sell as a spare part also, do I become the legal manufacturer for that part? Does it matter if that part is CE marked by the OEM? Does the situation change if the device is classified as an acessory rather than a spare part?

The MHRA guidance on this states that "A virtual manufacturer is an organisation that fully sources its own named product from another company (sometimes known as the ‘original equipment manufacturer’), which has designed and manufactured an identical CE marked product", so I'm unsure if the legal manufacturer obligations apply only to a final device rather than a spare part or component? Thanks
 
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#2
I read the first paragraph and thought of the VM guidance instantly. I can see you refer to that later.
Your role depends on two things:
- which legislation is the CE mark on the component in conformity with (is it medical device or electrical safety for example)?
- whether you're assigning the same medical intended purpose.
If it is a medical device/medical device accessory that has the same intended purpose as the OEM, then you're acting as the VM by relabelling. If you're assigning a different intended purpose for the device/accessory then you're the manufacturer of that new device (and will need Conformity Assessment etc in line with the new intended purpose).
Hope that helps.
 
#3
Thanks for the reply, the component is CE marked for medical use. So even if I'm not changing the intended purpose of the component, you're understanding is that I would become the VM(and would take on all the responsibilities of the legal manufacturer) once I relabel it?

I've been unsure because the MHRA guidance states "A virtual manufacturer is an organisation that fully sources its own named product from another company", and in this situation I'm only sourcing a component/spare part, not a fully sourced named product.
 
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