Technical File - Own Brand Labeling (OBL) Requirements

R

Rob Udo

#1
Company A manufactures and sells CE marked products. Certified by a Notified Body.
Company B purchases these products from Company A, with only Company B address information. ie. company B is the legal manufacturer under the MDD.

What technical file information should company B have available for the Notified Body?

Any suggestions are welcome.

Rob.
 
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M

MIREGMGR

#2
Re: Technical file Own Brand Labelling requirements

The entire Technical File as it would exist if Company A were compiling it and Company A was the Manufacturer.

Some additional information may be needed to explain that the validated processes, etc., that the TF documents as controlled by you are in fact at someone else's facility, and therefore your control flows through your systems and also their systems.
 
A

Alexisss

#3
Re: Technical file Own Brand Labelling requirements

The entire Technical File as it would exist if Company A were compiling it and Company A was the Manufacturer.

Some additional information may be needed to explain that the validated processes, etc., that the TF documents as controlled by you are in fact at someone else's facility, and therefore your control flows through your systems and also their systems.
I don't agree fully with MIREGMGR...

It depends on the product and the individual NB. I know a notified body that just requires you to perform a detailed risk assessment, have a "quality agreement" with the supplier (I had found one within the forum 2-3 years ago), and also you to be certified for ISO13485.

Another NB requires no quality agreement or risk assessment, but requires you to sample and test each lot imported.

A third NB requires a technical file as if you are the true manufacturer (like MIREGMGR said).

In my opinion, you may have a detailed procedure for the acceptance of a manufacturer within your ISO13485 file, have a quality agreement, have a risk assessment, and test the incoming products from time to time - depending on the type of product... whether it is a consumable or a machine (you may have 3rd party testing of the consumables from time to time).

a
 
M

MIREGMGR

#4
Re: Technical file Own Brand Labelling requirements

A third NB requires a technical file as if you are the true manufacturer (...)
This comment would imply that the "true manufacturer" is the company that actually assembles the product.

Per MDD Article I #2(f), "manufacturer" has a specific regulatory meaning:

'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 party.
By this definition, it is incorrect to describe a contract medical-device-maker as a "manufacturer".

Per various MDD-related requirements, including NB-MED/2.5.1/Rec5, the manufacturer is responsible for the technical file.

Perhaps in the first two NB-relationship examples provided above, the NB had concluded that the medical device company was a distributor rather than a manufacturer.
 
A

Alexisss

#5
Re: Technical file Own Brand Labelling requirements

This comment would imply that the "true manufacturer" is the company that actually assembles the product.

Per MDD Article I #2(f), "manufacturer" has a specific regulatory meaning:



By this definition, it is incorrect to describe a contract medical-device-maker as a "manufacturer".

Per various MDD-related requirements, including NB-MED/2.5.1/Rec5, the manufacturer is responsible for the technical file.

Perhaps in the first two NB-relationship examples provided above, the NB had concluded that the medical device company was a distributor rather than a manufacturer.
Well, when I say "true manufacturer" I mean "have the whole technical file, as if you were performing all the operations"

The key point is that there is already a manufacturer with CE-marked product, and you are just changing the label. Means that a NB has already assessed the design, manufacture processes etc.

So you need the technical file to show that you have the same characteristics on the label, as his own label, and also a quality agreement showing that the product you will be sent is the same with the one that has been CE-certified originally, and finally i find the risk assessment important.

It is a special case for the NB, where they do not inspect the whole design of the product for example.

I am attaching the British MHRA guidelines.
 

Attachments

A

asaglam

#6
can anybody help me to find a sample OBL contract?

I am "company B" and the "company A" informed me that our NB should supply the OBL contract to be signed with "company A". But my NB have no idea about such a contract. So I think that if I can find a sample then we can adopt it to us. So, can anybody help me to find a sample OBL contract? Thanks in advance. :thanks:
 

somashekar

Staff member
Super Moderator
#7
Re: can anybody help me to find a sample OBL contract?

I am "company B" and the "company A" informed me that our NB should supply the OBL contract to be signed with "company A". But my NB have no idea about such a contract. So I think that if I can find a sample then we can adopt it to us. So, can anybody help me to find a sample OBL contract? Thanks in advance. :thanks:
Hii asaglam ~~~
Welcome to the Cove.
You may see This thread and find a typical agreement format. Read it and modify to suit your purpose
 
M

MIREGMGR

#8
Re: Technical file Own Brand Labelling requirements

(...) It is a special case for the NB, where they do not inspect the whole design of the product for example.

I am attaching the British MHRA guidelines.
For future-viewer use, we probably should attach the German guidelines here alongside the British ones, since (at least in my view) they differ significantly:

EK-Med 3.9 B16 Certification of OEM devices
 
S

skoed

#9
Does anybody have document EK MED 3.9 B16 issued on October 2010 in English. On the ZLG website it is only German version.

E
 
M

MIREGMGR

#10
ZLG has a dysfunctional approach to version control, change notification and clarity of language availability.

As far as I can tell, there is no English version of the later-dated version...but since they have the same document identifier, in theory there is no substantive difference between the 2007 and 2010 versions. (Maybe.)
 
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