Hello - We modify one of our devices to sell exclusively to a another company to connect with their software. It is branded with our company name but will only work with their software. They import, sell and place, lets call it "the system" on the EU market. They are responsible for initial triage of all complaints with "the system" and let us know when our peice of "the system" caused a failure. My interpretation is that the company that places "the system" on the market would be considered the "manufacturer" in the eyes of the EU, however this company insists that we register the device that we modify for them as a finsihed device under our name. Has anyone else run into this type of issue?
Who is the "manufacturer" in the eyes of EU?
- Thread starter wrensch
- Start date
The manufacturer is the entity that designs, manufactures, packs, and labels a device before placing it on the market under its own name or trademark, regardless of whether these operations are carried out by that person themselves or on their behalf by a third party.
The manufacturer would have authority over design changes and documentation. Even if the other company handles initial complaints that doesn't make them the Manufacturer of Record.
Just to clarify, as this concept may not be clear to the original poster. The manufacturer has to be identified on the label per the MDR. If your organization is identified as the manufacturer on the label, then your organization is the legal manufacturer. This is what is meant by "placing it on the market under its own name...".
Thank you for the response. Would this change if we were to private label the device for them?
We have private labeled devices for another company but on the device it still had the factory symbol with our name on it. You can't escape that responsibility
Hypothetical - Our company private labels the same product for 3 other companies. There is a serious harmful event using this device. Regulators want to control the problem at the source, not the private labelers but the company that made the device originally.
Maybe an analogy to Boeing is helpful. The 737 Max was private labeled for United, Delta, Southwest etc. When United Airlines had an issue with the 737 Max they (Regulators) went to Boeing not United to find the party responsible. I think this is correct - Covers please correct me if Im wrong.
Hypothetical - Our company private labels the same product for 3 other companies. There is a serious harmful event using this device. Regulators want to control the problem at the source, not the private labelers but the company that made the device originally.
Maybe an analogy to Boeing is helpful. The 737 Max was private labeled for United, Delta, Southwest etc. When United Airlines had an issue with the 737 Max they (Regulators) went to Boeing not United to find the party responsible. I think this is correct - Covers please correct me if Im wrong.
Billy Milly
Quite Involved in Discussions
In general, there are two options:
1. You are labelled as manufactuer and hold full responsibility
2. The other company is labeled as a manufacturer and holds full responsibility. To allow them "being responsible", you need to provide them with complete technical documentation ("tech file").
This only concerns the product(s), QMS requirements not included - e.g. in second case, you would be their critical supplier...
hth
1. You are labelled as manufactuer and hold full responsibility
2. The other company is labeled as a manufacturer and holds full responsibility. To allow them "being responsible", you need to provide them with complete technical documentation ("tech file").
This only concerns the product(s), QMS requirements not included - e.g. in second case, you would be their critical supplier...
hth
Thank you Billy Milly. After some deliberation I think I may be asking the wrong question. I understand that we can't escapte being responsible for the device in the case of an adverse event caused by our part of "the system". However, when it comes to local registration of the device that they will exclusively be placing on the market for use with their software, it seems that it would be their responsibilty for registration. They are okay with this if they have a physical presence in the target country or a distributor willing to take on the registration responsibilities. Where they don't have a presence or a willing distributor, they want us to sign agreements with local AR's of their choice to work with them to register. Our standpoint is that we can provide them all the technical documentation they need to work with whatever local representative they choose but the relationship should be between them and local rep.
Thank you. We
The name of the legal manufacturer on the label must match the name on the EC certificate. If your organization is identified as the manufacturer on the label, then your organization will have to lodge an application with a notified body for conformity assessment. I'm assuming the device is not class 1 self-declared. Who markets the "system" has nothing to do with it. It is all about the label. The notified body will only accept an application from the legal manufacturer. They will verify labeling as part of the conformity assessment to confirm identify of the legal manufacturer. The only way to change this is if the customer agrees to be identified as the manufacturer on the label.
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Thats an interesting read if you want to see what the MDR was designed to do for patients. Traceability.
Key sentence is
If it means "the device is useless without the software" (and not "both companies intend it to be used with that particular software, but technically it could also work with other SW") then this is not a finished device, but rather just a component (the finished device is what's referred to as "the system"). As such the requirement to "register it" (actually CE mark it) under your name is baseless from a regulatory perspective. They could, of course, make all sorts of demands (that make less or more sense), from a business aspect...
I agree with this interpretation, provided that
means that their name (and address) appears on the labeling in a way that makes "the system" look as their product - not yours.
