Article 22 MDR System

#1
Okay, I need some help on this, as I am total lost. Manufacturer A makes a product and Manufacture B makes a product. Neither are a medical device until they are connected together, separate they are just component pieces. How do you go about writing a letter stating that Manufacture A wants Manufacture B to be the one to do the tech file and taking all liability of Manufacture A. (This probably makes zero sense, but I am at a loss.) Any help would be appreciated.
 
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shimonv

Trusted Information Resource
#2
Well, there is no way to "sugar coat" this but to say that you are not setup nor do you have the resources needed to meet the regulatory requirements of MDR. Then ask if they can take the lead on the regulatory activities.

Good luck,
Shimon
 

krm29

Registered
#3
Out of curiosity, are you asking for a (university) spin-off by any chance? Problems like this are common because of funding and/or personnel issues. In any case, asking a supplier to become legal manufacturer is probably met with a "no". Who wants liability for a product they are not the owner of?
 
#4
Nope, funding is no issue. Company A makes one component and Company B makes one component and when put together they are considered a medical device. Company A wants Company B to complete the Tech File on the products. Basically asking how to go about writing an authorization letter for Company B to use Company A's component in their Tech File.
 

shimonv

Trusted Information Resource
#5
Basically asking how to go about writing an authorization letter for Company B to use Company A's component in their Tech File.
For that you need a commercial or quality agreement between company A and company B that also specifies who is the legal manufacturer.

Shimon
 

Billy Milly

Involved In Discussions
#6
In my opinion, you are outsourcing the R&D in the described case. Company B is your service provider - supplier. For starting, see ISO 13485, 7.4. I believe such scenario requires a pretty detalied contract.
 

krm29

Registered
#8
Such a contract needs to specify who is responsible for what, who maintains which files, in what format files are transferred, how often are transfers required, if something goes wrong who is responsible, traceability, etc. etc. Basically as Billy says, it requires a pretty detailed contract.
 
#9
Such a contract needs to specify who is responsible for what, who maintains which files, in what format files are transferred, how often are transfers required, if something goes wrong who is responsible, traceability, etc. etc. Basically as Billy says, it requires a pretty detailed contract.
Thank you! I agree I just wanted to make sure I was on the right track as we have several legal agreements between the two companies already I just wanted to make sure there was nothing I was missing.
 

Raisin picker

Quite Involved in Discussions
#10
I'm not an expert in this area, but I'm missing an important part in the original question:
Manufacturer A makes a product and Manufacture B makes a product. Neither are a medical device until they are connected together ...
WHO does connect these devices, is this manufacturer A, or B, or a new manufacturer C? That one manufacturer holds responsibility for everything (and can outsource it via contracts).
You cannot sell part A (nit MD) and part B (not MD) separately and ask the customer to combine them (suddenly MD), or can you? The entity providing the instructions in that case would hold responsibility, in my eyes.
 
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