Distinction between a critical supplier and a Virtual manufacturer

Sullen-gent

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#1
Hello,

Editing a supplier agreement template that looks like it covers some aspects related to virtual manufacturing including holding registrations. but is termed a supplier agreement.

We have a number of suppliers who manufacture (inc. packing non-sterile) and will hold the original formulation or design. Leaving us with the job of label creation distribution etc. However they are not a virtual manufacturer as they don't hold certification and do not sell the product themselves. Therefore the relationship here is a critical supplier one.

So first question can anyone help me with the specifics of a critical supplier relationship, what are the obligations here?

Is it a case of ensuring that their procedures that cover the manufacture of our device and their QMS documentation is in line with the standard?

Are we obligated to make them virtual manufacturers?

For Virtual manufacturers, they will be selling the product themselves so have their own regulatory registrations and guidance from MHRA is clear about what should be in the agreement: Virtual manufacturing of medical devices

However, would the same provisions that you require for a critical supplier be applicable as well? For example VM agreement clauses + Critical Supplier arrangements?
 
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indubioush

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#2
So first question can anyone help me with the specifics of a critical supplier relationship, what are the obligations here?
You are the manufacturer of the medical device even though you are using a contract manufacturer to produce it. You as the manufacturer are responsible for all regulatory compliance even though you are using a contract manufacturer. This means that you need to have control of the quality and compliance of the device. This usually entails a detailed supplier quality agreement, routine audits of the supplier, some sort of review for the products they produce, clear processes for how to handle changes, ensuring you have access to the medical device file, etc.


Are we obligated to make them virtual manufacturers?
Why would you be obligated to do this?
 

Sullen-gent

Involved In Discussions
#3
You are the manufacturer of the medical device even though you are using a contract manufacturer to produce it. You as the manufacturer are responsible for all regulatory compliance even though you are using a contract manufacturer. This means that you need to have control of the quality and compliance of the device. This usually entails a detailed supplier quality agreement, routine audits of the supplier, some sort of review for the products they produce, clear processes for how to handle changes, ensuring you have access to the medical device file, etc.

Yes that's good seems we have detailed tech agreements in place with suppliers.

Why would you be obligated to do this?
I think with this one I was just making sure that MDR didn't trip us over. I was concerned because I know VM and MDR make more demands on having the whole tech file. However nothing seems to have changed from a critical supplier perspective and MDR, so this relationship can continue and I just wanted to confirm that really.
 
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