MDD 2007/47/EEC - Medical Device Directive Labeling Changes

E

eshint

#1
Hi,

I would like to know what are the changes that need to be implemented as per 2007/47/EEC requirements to get labels in compliance except single use statement and revision date?

Thanks.
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Re: 2007/47/EEC MDD labeling changes

Can any medical device folks help with this? If so, my appreciation in advance!
 

Michael Malis

Quite Involved in Discussions
#3
Re: 2007/47/EEC MDD Labeling Changes

Hi,

I would like to know what are the changes that need to be implemented as per 2007/47/EEC requirements to get labels in compliance except single use statement and revision date?

Thanks.
Great Question!
The Right Answer - "You need to confirm with your Registrar..."

Today, there is a difference exists between the understanding what is need to be done from one Registrar to another...

However, in general Labeling change is necessary not just for Single Use and Revision Date, but also for identification of Phthalates.

What you need to know that there are a number of widely-used phthalates (DEHP, DIDP, and DINP). DEHP is the mostly plasticizer used in PVC due to low cost.

These chemicals are mainly used as plasticizers to add flexibility and durability to plastics such as PVC(polyvinyl chloride). Unfortunately due to the Health concerns, US and EU are phasing out many products with Phthalates. Because a lot of Medical Products utilized different forms of phthalates, MDD 2007 asked Manufacturers to "identify phthalates present in their products". There is no definition today, what is really needed and the requirements vary widely between the Registrars...

Please contact your Registrar for their identification of this issue and than Draft the Label change for approval.

Hope this helps,
Mike
 
E

eshint

#4
Re: 2007/47/EEC MDD Labeling Changes

thanks MArc,
i know about pthaltaes requirment too....i am more concerned about langauge requirment. Is it madatory to have IFU and box labels in to minimum six langauges? my compnay is currently doing lot of translation and they ahve tranlsated IFUS or PIs in to Dutch if it is not available in to Dutch. i havent find it any MDD.
thanks
 

Michael Malis

Quite Involved in Discussions
#5
Re: 2007/47/EEC MDD Labeling Changes

...i am more concerned about langauge requirment. Is it madatory to have IFU and box labels in to minimum six langauges? my compnay is currently doing lot of translation and they ahve tranlsated IFUS or PIs in to Dutch if it is not available in to Dutch. i havent find it any MDD.
thanks
If we talk about Single Use product, than only the product information that does not gave symbols and is present on your pouch must be translated.

For example, if the "Non-pyrogenic" statement is present on your Blood Collection set, than these phrase must be translated into "langualges of the countries where your product is sold". However, if you have symbols on your product label such as CE or sterility symbol - those you don't need to translate as long as you have this information and Translations in your IFU.
In this example, you will not translate anything in Greek langualge if you have no plans to sell product in Greece.

At minimum, if you plan to sell product in EU, you will need UK English, German, French, Dutch, Portugese, Spanish, Italian.
 
E

eshint

#6
Re: 2007/47/EEC MDD Labeling Changes

thanks for your reply.
but when you say "At minimum, if you plan to sell product in EU, you will need UK English, German, French, Dutch, Portugese, Spanish, Italian."
is it mandatory to have all these languages if your company just sell products in to Italy, France? is it necessay to have these above mentioned langauges? if yes, where it says in MDD?
again, i would really apprecate your help.
 
S

Slayer_ch

#7
Re: 2007/47/EEC MDD Labeling Changes

No you only need the languages for the Countries where you sell the products.
 

Michael Malis

Quite Involved in Discussions
#8
Re: 2007/47/EEC MDD Labeling Changes

thanks for your reply.
but when you say "At minimum, if you plan to sell product in EU, you will need UK English, German, French, Dutch, Portugese, Spanish, Italian."
is it mandatory to have all these languages if your company just sell products in to Italy, France? is it necessay to have these above mentioned langauges? if yes, where it says in MDD?
again, i would really apprecate your help.
No, as I stateted above, translation is only needed in the countries of sale.
However, can you be sure that the product you sell to France will not end up in Austria (thru distribution)? You may have an answer to this question already if you are selling direct, if not - than you should reconsider...
 

chris1price

Trusted Information Resource
#9
Re: 2007/47/EEC MDD Labeling Changes

Hi

Take a look at Article 4, section 4:

Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use.

In practice, almost all countries require labeling and IFUs in their native language(s). However, this is only for those countries where the product is to be sold. If distributors are allowed to sell accross borders, make sure their territories are well defined in their contracts.

Chris
 
A

Alexisss

#10
Re: 2007/47/EEC MDD Labeling Changes

But lets dont forget something fundamental: the European Union is now borderless, there are no exclusive distributionships (al least they cannot stand legally, except very special cases where the lawyers describe things very specifically in contracts), and products can be bought from whoever in the EU and can be sold wherever in the EU.

This means that although you have 5 different languages on your label and/or ifu, you never know where will your product end. Especially now that internet sales are increasing, and people can for example enter the website of your German customer and order a sphygmomanometer to be sent to Italy or Greece.

In this case, you can find your self into trouble with authorities for stupid reasons, especially in countries where you need to put "oil" in the machine in order to work (if you get what I mean....). Of course, dont forget unfair competition practices too, when a competitor can set this up for you to get in trouble, especially if he has good relations with the aforementioned authority. (i am writing from own experiences, with labels and also with competitors who opened sterile pouches, placed mosquitos and resealed them!).

a
 
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