What needs to be on the label? Medical Device Labelling Requirements

N

Nancy Allen

#1
Hi All,
We are a device manufacturer who does some private labeling. In this case, the company we are working with would like to avoid having our company information on the product. According to 21CFR Part 801(A) (c), the label would only need to say "manufactured for" or "distributed by".
I am less clear on the requirements for selling into the EU. We do hold the CE mark, and therefore our authorized EU Representative and their EU address is on the Instructions for Use. Is it also necessary to have the actual manufacturer name and address (i.e., our US address) with the product?
Thanks so much for any advice!
Nancy
 
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somashekar

Staff member
Super Moderator
#2
Re: What needs to be on the label?

Hi All,
We are a device manufacturer who does some private labeling. In this case, the company we are working with would like to avoid having our company information on the product. According to 21CFR Part 801(A) (c), the label would only need to say "manufactured for" or "distributed by".
I am less clear on the requirements for selling into the EU. We do hold the CE mark, and therefore our authorized EU Representative and their EU address is on the Instructions for Use. Is it also necessary to have the actual manufacturer name and address (i.e., our US address) with the product?
Thanks so much for any advice!
Nancy
You need to have the CE mark with your NB number, your product reference number as in the CE certificate, the date of manufacture, your EU rep name and address next to the EU rep symbol.
Other Symbols as governed by the harmonized standard that your medical device conforms to.
Is it also necessary to have the actual manufacturer name and address (i.e., our US address) with the product?
Yes, you are the legal manufacturer.
the company we are working with would like to avoid having our company information on the product.
Sorry. Unless that company has an OBL (own brand label) CE, which is based on your CE, your company information is a requirement.
Along with this you can have a whole lot of the other company details including their re-order number and label color style and design. Maintain this new label details within your technical file.
 
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N

Nancy Allen

#3
Re: What needs to be on the label?

Hi Somashekar,
Thanks so much for your response. One thing that I failed to mention in my initial post is that out devices are Class I, and we self certify. Therefore, our CE mark does not require a NB number, etc. DOes this make a differnce?
Best,
Nancy
 

somashekar

Staff member
Super Moderator
#4
Re: What needs to be on the label?

Hi Somashekar,
Thanks so much for your response. One thing that I failed to mention in my initial post is that out devices are Class I, and we self certify. Therefore, our CE mark does not require a NB number, etc. DOes this make a differnce?
Best,
Nancy
The EU rep who appeares on your device information is contracted with you. If he appeares on the device information and you do not, then it is a breach of the agreement.
The other company would have no details about the safety and effectiveness of the product as much as you know, as you are the design owner, owner of the technical file and the legal manufacturer.
If your agreement with the other company covers all the requirements as laid out for an OBL regulatory relationship, and this other company also contracts with your EU rep separately then you can agree to your other company requirements. (I assume that the other company is also out of the EU)
 
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N

Nancy Allen

#5
Re: What needs to be on the label?

We are a small division of a much larger comapny (both based in the US). Our parent company does have facilities in the EU, and our authorized rep is "our" employee. The company for whom we are providing the private label is also based in the US. Does this make a difference?
Thanks again!
 

pkost

Trusted Information Resource
#6
Re: What needs to be on the label?

Oh the joys of multinationals!

In essence, the manufacturer MUST be on the label, there is no avoiding this detail. The manufacturer is the entity which is responsible for placing the device on the market, it must demonstrate the devices safety and efficacy, carry out post market surveillance and do all the other things that are the responsibility of the manufacturer.

If your parent company is willing to take on these responsibilities, by all means you can hand over the technical file, relevant regulatory information and merely "sub contract" manufacture for them. This gets your name off the label. If they are not willing to take on these responsibilities your name stays on the label.

With regards to the EC rep, this is necessary if the manufacturer is based outside of the EU. An EC rep should not be confused with the manufacturer and cannot be used as a mask for the manufacturer. The EC rep is only a point of contact for the EU authorities to exercise a measure of control over the manufacturer. This is done by having a contract in place between the EC-rep and manufacturer.
 
S

SilkTie

#7
Re: What needs to be on the label?

We are a small division of a much larger comapny (both based in the US). Our parent company does have facilities in the EU, and our authorized rep is "our" employee. The company for whom we are providing the private label is also based in the US. Does this make a difference?
Thanks again!
What your customer sells in the US can bear the label "manufactured for ..." and your details do not have to appear.

However, if he wants to sell in the EU, the label has to comply with the European labelling requirements: i.e. legal manufacturer (holder of CE) and European Authorized Representative.
If he wants to be the legal manufacturer for your Class I device, there should be an OBL agreement between the two companies, regulating responsibilities between the parties (complaint handling, PMS, auditing of quality, etc.) and informing the customer's EAR.

The customer has to realise that for the European Authorities he will be considered the manufacturer, not you. So he will not be able to claim that 'it's not me but him'.
 
N

Nancy Allen

#8
Re: What needs to be on the label?

Thanks, silk tie,
Your answer is very helpful. You are confirming what I thought, but have not been able to specifically find in the regulations. Any chance you could point me in the right direction (refernce to the correct standard)?
 

c.mitch

Quite Involved in Discussions
#9
Hello Nancy,

I didn't read everything on the thread, so maybe I may say things twice.
If you are class I, you have no NB number, of course.
But you shall add the year of CE marking, whatever your class. This is a regulation of a subset of countries in EU (no matter which ones).
So, you put the CE logo, plus the sentence "year of CE mark: 20XX" under the logo.

You should respect the EN 980:2008 standard to meet some essential requirements of the EU/93/42 directive. This is was our NB told us to do. The standard tells which information shall be present on the packaging about the manufacturer and the authiorized representative. Of source, this standard is copyrighted and you'll have to buy it.

More general, you shall respect the "harmonized standards" published in the EU official journal. See http://eur-lex.europa.eu/JOHtml.do?...bmit=Rechercher&_submit=Rechercher&ihmlang=en , download the pdf 2011/C 16/02 and pick up the applicable standards for your device.


Regards,

Mitch.
 
S

SilkTie

#10
Re: What needs to be on the label?

Thanks, silk tie,
Your answer is very helpful. You are confirming what I thought, but have not been able to specifically find in the regulations. Any chance you could point me in the right direction (refernce to the correct standard)?
You're welcome.

You can find it in MDD Annex I Essential Requirements, Art. 13.3.:
The label must bear the following particulars:
(a) the name or trade name and address of the manufacturer. For
devices imported into the Community, in view of their distribution
in the Community, the label, or the outer packaging, or
instructions for use, shall contain in addition the name and
address of the authorised representative where the manufacturer
does not have a registered place of business in the Community;
[..]
 
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