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." 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.