MDD Requirement - SOP for on how to translate from one language to another

For MDD requirement, we have been requested by TUV auditors that we have had to have a SOP for on how if we have to translate from one language to another. Any help out there?

But we told the auditors that we only export to UK and used only English and do not require any translation into other EU languages.....

Where is the shall?

SilverHawk said:

For MDD requirement, we have been requested by TUV auditors that we have had to have a SOP for on how if we have to translate from one language to another. Any help out there?

But we told the auditors that we only export to UK and used only English and do not require any translation into other EU languages.....

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Where in the MDD does it state that you need an SOP? As far as I know the language requirements are stated in two places,

Article 4, Free Movement, Devices intended for special purposes, point # 4

Member States may require the information, which must be made available to the user and the patient in accordance with Annex 1, 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.

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and

Article 11, Conformity assessment procedures, point 12

The records and correspondence relating to the procedures referred to in paragraphs 1 to 6 shall be in an official language of the Member State in which the procedures are carried out and/or in another Community language acceptable to the notified body

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Language translations

We have not been asked to have an SOP but we have a statement in our CE procedure that we will comply with the language requirements according to the chart. This chart is updated to reflect any additional language requirements or changes.

It is very difficult to get regulatory and mandatory language requirements.


Is there a matrix available to relect language requirements for Europe or for that matter internationally?

Thanks

amjadrana said:

We have not been asked to have an SOP but we have a statement in our CE procedure that we will comply with the language requirements according to the chart. This chart is updated to reflect any additional language requirements or changes.

It is very difficult to get regulatory and mandatory language requirements.


Is there a matrix available to relect language requirements for Europe or for that matter internationally?

Thanks

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You can find something attached in the first post of the thread CE Language Requirements on labeling (both device and packaging).

Translation

Hi,
we are a german mdd manufactorer und our notified body never ask us or recommended that we have an SOP for translation.
Our SOP are in German. However, because we have costumer around the world, it is more an support to have the also SOP in english availible.

TUV PS auditors insisted that we have to have a SOP on how the translation is to be carried out if the labelling required or needed to be in other languages.... beside English even though we have insisted that our products are supplied to UK market.