Label translation requirements for EU (European Union)

[JB0424]

I am seeking clarification on translation requirements for labels.

I am working with a product that has a which has the same language a warning in the IFU. If I provide a symbol such as the caution symbol or consult instructions for use symbol from ISO 15223-1 and EN 980 on the label to direct the user to the IFU, can I provide the label in English only?

 

[GStough]

Re: Label translation requirements for EU

What kind of products are you referring to here? I believe the labeling requirements may differ depending on the product.

 

[RobertvanBoxtel]

Re: Label translation requirements for EU

If you use symbols on labels that are identified in the harmonized standard EN 980, you do not need to explain them on the label or IFU.
Be carefull, ISO 15223 is not harmonized and there are some differences between both standards.

Regarding labels and IFU, any information on the device shall be made available in the local language of any country in the EU where you place it on the market or put it into service.

 

[Ronen E]

Re: Label translation requirements for EU

Regarding labels and IFU, any information on the device shall be made available in the local language of any country in the EU where you place it on the market or put it into service.

This is not automatic - the MDD allows any member state to require it, but not all do (or at least some will suffice with English even though it's not their national language).