Legal Manufacturer - MDD Definition of "Legal Manufacturer"

K

Kleppy

#1
Hi, I stumpled to this forum while looking for the standard definition of "Legal Manufacturer" as I can't find it in MDD.
Is there another regulation I should be reading?

Thank you very much!
 
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somashekar

Staff member
Super Moderator
#2
Re: Definition of "Legal Manufacturer"

"manufacturer' means the natural or legal person with responsibility for the design,
manufacture, packaging and labelling of a device before it is placed on the market under
his own name, regardless of whether these operations are carried out by that person
himself or on his behalf by a third parry.

The above is from the MDD.
So if xyz company Ltd, No. 007, Medical street, Healthcare city.
is the name and address on the label of a device then xyz company Ltd. is the legal manufacturer.
 

harry

Super Moderator
#3
Re: Definition of "Legal Manufacturer"

For further reading, check this thread: MDD Definition of Address as it applies to Medical Device Labeling

Further clarification: The legal manufacturer is the Legal entity that is the final approval authority on design changes and assumes Quality Systems responsibility for the development, design and manufacture of the product (e.g. under ISO 13485 or equivalent quality systems).

The Legal Manufacturer may perform all of the activities required to develop, design, manufacture, package, sterilize and place a product on the market OR the legal manufacturer may contract (or by letter of appointment) all or any of these activities to a third party.
 
K

Kleppy

#4
Re: Definition of "Legal Manufacturer"

Thanks for replying, Somashekar.

I guess I'd like to clarify my question a little... that, in MDD it says "manufacturer" is the natural or legal person, but it isn't using the term as "legal manufacturer", am i correct?

I understand that there's an overall usage of the term "legal manufacturer" that means the same thing as "manufacturer" defined by MDD, but the term "legal manufacturer" itself is never a standardized term, right?
 

somashekar

Staff member
Super Moderator
#5
Re: Definition of "Legal Manufacturer"

Thanks for replying, Somashekar.

I guess I'd like to clarify my question a little... that, in MDD it says "manufacturer" is the natural or legal person, but it isn't using the term as "legal manufacturer", am i correct?

I understand that there's an overall usage of the term "legal manufacturer" that means the same thing as "manufacturer" defined by MDD, but the term "legal manufacturer" itself is never a standardized term, right?
Yap ~~~
For the simple reason, Manufacturer (company or organization) is an entity and the MDD and its competent authorities seeks to touch base with the person who in the business sense is responsible for the application of the regulatory. It could be the owner or an appointed person representing on behalf.
Further the 309-1003.A05-EN.doc © ZLG has these definitions, but Legal manufacturer is your word :) within MDD scope.
Private Label: Equivalent to trade name
Private Label Manufacturer: Company that appears as manufacturer in the meaning of the Medical Devices Directives, but does not itself produce (often also called "quasi manufacturer").
The devices are not modified by the Private Label Manufacturer, or only slightly; normally they are only purchased, stored and sold under his own name.
OEM: "Original Equipment Manufacturer"
OEM Producer: Company that produces the finished device for a Private Label
Manufacturer and in this case does not appear as the manufacturer in the meaning of the Medical Devices Directives.
 
R

Roland Cooke

#6
Re: Definition of "Legal Manufacturer"

When clients of mine who have complicated arrangements have struggled with this, I have tried to simplify for them.

"Okay, let's cut to the chase - who is going to jail?"

It's more complicated than that (of course!), but I find that it does help focus the mind! :lol:
 
M

medic61

#7
Re: Definition of "Legal Manufacturer"

I would like to ask a question that sort of relates to this post.

How can you satisfy the MDD and the FDA at the same time with the same label for the following issue?

Our company is revising our labeling and top mgmt feels we should stated "Manufactured for XYZ" because XYZ is not registered as a manufacturer with the FDA (only a repackager/relabeler). However we apply the CE mark so this means the label should stated "Manufactured by XYZ".

Would it resolve everything if I used the Manufacturer symbol from EN 980?

Company XYZ only has a few international customers, most sales are in non EU countries.
I don't think we can please both.
Thanks for the feedback!
Medic
 
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M

MIREGMGR

#8
Re: Definition of "Legal Manufacturer"

How can you satisfy the MDD and the FDA at the same time with the same label for the following issue?

Our company is revising our labeling and top mgmt feels we should stated "Manufactured for XYZ" because XYZ is not registered as a manufacturer with the FDA (only a repackager/relabeler). However we apply the CE mark so this means the label should stated "Manufactured by XYZ".

Would it resolve everything if I used the Manufacturer symbol from EN 980?
Not a good idea for four reasons:

1. I assume your product is not an IVD. Some elements of FDA recognize that symbol's EN 980 meaning for applications other than IVDs, even though the applicable FDA guidance states that that's the extent of its recognition. So, such a use would have the potential to cause confusion within FDA.

2. I gather that you want to use a single label for all markets. Clearly the presence of the EN 980 "Manufactured By" symbol would have the potential to cause confusion among your US customers, at least some of whom probably are familiar with European labeling approaches. More importantly, an English-text "Manufactured For" on the same label statement will be a nonstarter in Euro markets for multiple reasons.

3. The FDA is moving toward harmonization, most particularly in regard to this Fall's scheduled Voluntary Audit Submission Program startup, which will recognize ISO 13485 QMS conformance as sufficient evidence of no need for QSIT 1 inspection exposure. That change in particular is likely to initiate quicker moves toward integration on the labeling side. There's no margin in setting a path now that will be inadequate again in just a few months.

4. Maybe this applies, maybe not: will the actual maker List your product as its Manufacturer if you declare yourself to not be the Manufacturer? Every medical device must have a Manufacturer. If you label as if you're not the Manufacturer, but the actual maker can convincingly show that they should not be regarded as the regulatorily responsible Manufacturer, the FDA can come back to you and determine that the product is adulterated because your labeling illegally disclaims responsibility for a device for which they regard you as responsible.

Why don't you just List the product as its Manufacturer with US FDA, and be done with it? Your cost won't change, your legal exposure won't change, and it takes ten minutes. What's the reason why that's not the obvious course?
 
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M

medic61

#9
Re: Definition of "Legal Manufacturer"

Not a good idea for four reasons:

1. I assume your product is not an IVD. Some elements of FDA recognize that symbol's EN 980 meaning for applications other than IVDs, even though the applicable FDA guidance states that that's the extent of its recognition. So, such a use would have the potential to cause confusion within FDA.
No, Class I and IIa medical devices

2. I gather that you want to use a single label for all markets. Clearly the presence of the EN 980 "Manufactured By" symbol would have the potential to cause confusion among your US customers, at least some of whom probably are familiar with European labeling approaches. More importantly, an English-text "Manufactured For" on the same label statement will be a nonstarter in Euro markets for multiple reasons.

Since most of the sales for this company will be in the US we will go the "Manufactured for" route.

3. The FDA is moving toward harmonization, most particularly in regard to this Fall's scheduled Voluntary Audit Submission Program startup, which will recognize ISO 13485 QMS conformance as sufficient evidence of no need for QSIT 1 inspection exposure. That change in particular is likely to initiate quicker moves toward integration on the labeling side. There's no margin in setting a path now that will be inadequate again in just a few months.
Thank you for the info, I will monitor this.

4. Maybe this applies, maybe not: will the actual maker List your product as its Manufacturer if you declare yourself to not be the Manufacturer? Every medical device must have a Manufacturer. If you label as if you're not the Manufacturer, but the actual maker can convincingly show that they should not be regarded as the regulatorily responsible Manufacturer, the FDA can come back to you and determine that the product is adulterated because your labeling illegally disclaims responsibility for a device for which they regard you as responsible.

Actually one of our other companies in the same complex manufactures the products.

Why don't you just List the product as its Manufacturer with US FDA, and be done with it? Your cost won't change, your legal exposure won't change, and it takes ten minutes. What's the reason why that's not the obvious course?
The FDA charges several thousand dollars a year if you register as a manufactuer but nothing for a repackager/relabeler. I am responsible for several companies, one being the manufacturer and the others just sell different brand names plus a few other product lines we purchase.

I did not do the "quote" thing accurately but I placed my reply in the section above.
I appreciate your help, it has cleared up a few things.
Medic
 
M

MIREGMGR

#10
Re: Definition of "Legal Manufacturer"

Why don't you just List the product as its Manufacturer with US FDA, and be done with it? Your cost won't change, your legal exposure won't change, and it takes ten minutes. What's the reason why that's not the obvious course?
The FDA charges several thousand dollars a year if you register as a manufactuer but nothing for a repackager/relabeler. I am responsible for several companies, one being the manufacturer and the others just sell different brand names plus a few other product lines we purchase.
I'd think your total cost for all your companies would be equal.

In one scenario, the maker is a contract manufacturer, the seller is the Manufacturer, and you pay one registration fee.

In the other scenario, the maker is the Manufacturer, the seller is a distributor, and you pay one registration fee.

As I noted, all products must have a Manufacturer. And, you're going to have a tough time making everyone happy with a single label if the CE Mark belongs to the US distributor.

But I'll butt out now. :D
 
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