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Medical Devices - Legal Manufacturer and Real Manufacturer

O

Olgamargarita

Involved In Discussions
#1
#1
Hello!!

Please someone who help me with this doubt:

When it considers legal manufacturer and real manufacturer? Below I detail the following cases:

1. A company "Z" has a main factory and a branch or branchs.

2. A company "D" has more than one factory (all factories has the name "D")in its country and also, has one or more factories over the world keeping the name "D"

3. A company "G" is compound by 4 companies, each of them with different names.


Which is the legal manufacturer and real manufacturer?

4. Please, correct if this statement is wrong:
Legal manufacturer involves legal name and/or trading name (busine name)

Thank you very much in advance.:)

Olga
 
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Sarah Stec

#2
#2
According to the MDD, a legal manufacturer is one who has the responsibility for the device before it is placed on the market under his own name, regardless of whether the operations are carried out by the entity or someone else. So it might help to think of it more in terms of who is doing what with respect to the device itself in terms of being the legal manufacturer, as opposed to what they're called and where they're located.

:)
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#3
#3
Hi Olga,

Answers to questions like those have to be in a specific regulatory domain context, because different rules and practices apply. "Regulatory domain" relates to where in the world the devices are marketed for use.

"Legal manufacturer" typically means the entity under whose name the devices are placed on the market, who is also the entity who has the ultimate responsibility for compliance with medical devices regulations. In the EC the name and address of that entity must appear on the label. In the USA there are exceptions.

Cheers,
Ronen.
 
O

Olgamargarita

Involved In Discussions
#4
#4
Thanks Ronen E,

I detail the 3 cases before because I don`t understand why a Ingland company that has 2 factories in its country and one in other country, the three factories have the same name "Intermedic", the factories in its countrie call "Intermedic LTD" and the factory abroad "Intermedic UAB".

It consider the factory located abroad "Intermedic UAB"as a real manufacturer and the legal manufacturer "Intermedic LTD".


1. If the three companies belong to the same group why applies legal and real manufactuer? why one of the factories is located abroad?

2. when the CE certificate mention "holder", it is refer legal manufacturer and "facilities" are other factories (belong the same group / by agreement)

Please explain me.
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#5
#5
Hi,

I'm not sure I understand all your questions or what you're trying to find out.

As I stated earlier, the legal manufacturer is the one under whose name the devices are placed on the EC market (which I understand is the regulatory domain of interest in your case). This is the name which should appear on the labelling, as well as on the EC certificate.

The actual place of manufacture or the business name of the entity actually manufacturing the device are less relevant in that regard. It becomes relevant mostly when being audited by the NB. If you are enquiring about a company you work in/for, then I can ask further questions to try and get a better understanding of the situation, and maybe address some of your concerns.

If, on the other hand, your questions are general or relate to some other company for which you don't work, then probably most of the relevant details are hidden from the public (known only to the company itself and the NB) and therefore my ability to address them is much more limited.

If you could please clarify then I might be able to provide further insights.

Cheers,
Ronen.
 
somashekar

somashekar

Staff member
Super Moderator
#6
#6
Olgamargarita said:
Thanks Ronen E,

I detail the 3 cases before because I don`t understand why a Ingland company that has 2 factories in its country and one in other country, the three factories have the same name "Intermedic", the factories in its countrie call "Intermedic LTD" and the factory abroad "Intermedic UAB".

It consider the factory located abroad "Intermedic UAB"as a real manufacturer and the legal manufacturer "Intermedic LTD".


1. If the three companies belong to the same group why applies legal and real manufactuer? why one of the factories is located abroad?

2. when the CE certificate mention "holder", it is refer legal manufacturer and "facilities" are other factories (belong the same group / by agreement)

Please explain me.
Click to expand...
Intermedic LTD, in England is the legal manufacturer because the company in England (Europe) is within the EU and hence they do not need to appoint and manage a EU representative.
Intermedic UAB located outside of the EU perhaps has the necessary infrastructure and economic conducive policies to manufacture at lower costs as the Intemedic corporation analyses. It is the corporate decision.
Intermedic LTD will be exercising all due controls necessary (agreements as you say) over Intermedic UAB for the manufacturing processes.
 
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