Where can I find the MDD definition of Labeling?

Q

QA_RA_Lady

Hi all,

I am looking for the exact definiton of labeling as stated by 93/42/eec. Does anyone know what or where this is, I'm getting ready to engage in a "discussion" with my marketing department and I'd really like to be able to site the reg when asked (and I will be asked)

Also I'm hearing a lot of rumble about no longer being able to provide IFUs and product in english in the EU... even when the device is for professional use... can anyone comment on that point?

Thanks,

QA_RA Lady
 
R

Reiko Shiratori

Hi QA_RA Lady,

Requirements for labeling and IFU is in Annex I, 13 (13.1 to 13.6) of MDD (of course the amended one).

Regarding to IFU, I don't have enough information, so please wait other Covers opinions.

Reiko
 
B

blewispunk

Attached is an export form a database I created with various regulations and then have classified by things like labeling. This is filtered on the MDD and Labeling so should have what you're looking for. Note that the entire reg may not be present as the field length may be exceeded but it gives the idea and will point you to the correct clauses.
 

Attachments

  • Labeling MDD Regs.pdf
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P

Persson - 2010

Hi QA_RA Lady,

Requirements for labeling and IFU is in Annex I, 13 (13.1 to 13.6) of MDD (of course the amended one).

Regarding to IFU, I don't have enough information, so please wait other Covers opinions.

Reiko

Labeling means usually "Label + Instruction For Use."
 
R

Rolande Hall

:notme::thanks:
Hi all,

I am looking for the exact definiton of labeling as stated by 93/42/eec. Does anyone know what or where this is, I'm getting ready to engage in a "discussion" with my marketing department and I'd really like to be able to site the reg when asked (and I will be asked)

Also I'm hearing a lot of rumble about no longer being able to provide IFUs and product in english in the EU... even when the device is for professional use... can anyone comment on that point?

Thanks,

QA_RA Lady
:thanx:

I must thank you and those replying for giving me the chance to say that the problem with this question is that it is not answered in the EU Medical Device Directives.
This is because the word "labeling" is an American word not used in UK English documentation. The Medical Device Directives refer to "label", "labels" and "labelling" but not "labeling". There is also a language compatibility issue in the German language text on this point.
I note that 'Persson' has correctly posted that Labeling means usually "Label + Instruction For Use.":thanks: Persson is clearly familiar with the American use of the word.
Relevent Terminology Definitions are as follows:
Labelling: information on the immediate or outer packaging (Ref: EU Council Directive 92/27/EEC of March 1992).
Label [1]: the USA Federal Food, Drug and Cosmetic Act in Section 201(k) defines "label" as a "display of written, printed, or graphic matter upon the immediate container of any article..."
Label [2]: ASTM, D 996 defines label as a piece of paper or other material to be affixed to a container or article, on which is printed a legend, information concerning the product, or addresses. It may also be printed directly on the container.
Labeling (1): the USA Federal Food, Drug and Cosmetic Act in Section 201(m) defines "labeling" as "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article" at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.
Labeling (2): written, printed, electronic or graphic matter affixed to a medical device or its packaging; or accompanying a medical device (ref: ISO 11607-1:2006 and ISO 11607-2: 2006).

Regarding the use of ENGLISH as the only language for Information Supplied by the manufacturer of medical devices, Council Directive 93/42/EEC states as follows:
" 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."
To date, almost all Members States have demanded that the product label and IFU should be in one or more of their National languages.

The translators will never be made redundant.:nopity:
 
P

Persson - 2010

:notme::thanks:

:thanx:

I must thank you and those replying for giving me the chance to say that the problem with this question is that it is not answered in the EU Medical Device Directives.
This is because the word "labeling" is an American word not used in UK English documentation. The Medical Device Directives refer to "label", "labels" and "labelling" but not "labeling". There is also a language compatibility issue in the German language text on this point.
I note that 'Persson' has correctly posted that Labeling means usually "Label + Instruction For Use.":thanks: Persson is clearly familiar with the American use of the word.
Relevent Terminology Definitions are as follows:
Labelling: information on the immediate or outer packaging (Ref: EU Council Directive 92/27/EEC of March 1992).
Label [1]: the USA Federal Food, Drug and Cosmetic Act in Section 201(k) defines "label" as a "display of written, printed, or graphic matter upon the immediate container of any article..."
Label [2]: ASTM, D 996 defines label as a piece of paper or other material to be affixed to a container or article, on which is printed a legend, information concerning the product, or addresses. It may also be printed directly on the container.
Labeling (1): the USA Federal Food, Drug and Cosmetic Act in Section 201(m) defines "labeling" as "all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article" at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.
Labeling (2): written, printed, electronic or graphic matter affixed to a medical device or its packaging; or accompanying a medical device (ref: ISO 11607-1:2006 and ISO 11607-2: 2006).

Regarding the use of ENGLISH as the only language for Information Supplied by the manufacturer of medical devices, Council Directive 93/42/EEC states as follows:
" 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."
To date, almost all Members States have demanded that the product label and IFU should be in one or more of their National languages.

The translators will never be made redundant.:nopity:

Thanks Rolande Hall!

As a matter of fact, the information I posted before was derived from an internal document supplied to us by our EC Rep, Wellkang Tech Consulting in London. The original wording from Wellkang is "Labelling means usually the Label plus the Instruction For Use except for the cases when Instruction For Use is not a compulsory requirement..."

I could not upload and share with you guys the document because it is copyrighted materials written by Wellkang consultants.
 
R

Reiko Shiratori

Thank you Persson and Rolande,

Now I see, I should have used "label and IFU" in the thread.

Definitions are helpful. :thanx:

Reiko
 
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