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Language requirements on medical device class 1 products

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Guest user Created:   Jun 10, 2021 Last commented:   Jun 11, 2021

Language requirements on medical device class 1 products

1. What language requirements are there on the following in countries within EU?

  • Labels of main product
  • Labels of product boxes
  • Labels of outer boxes
  • Manuals/IFU

2. Do you have a list on specific language requirements PER country on the above?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jun 11, 2021
1. What language requirements are there on the following in countries within EU? Labels of main product Labels of product boxes Labels of outer boxes Manuals/IFU

According to Article 10 _ General obligations of manufacturers, Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of General Safety and performance requirements in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible, and clearly comprehensible to the intended user or patient.  

So, this means that if you put your medical device only on one market, then it is enough to have it in only one official language of the EU.

For more information, see:

2. Do you have a list on specific language requirements PER country on the above?

No. We do not have a list of specific language requirements per country.

 

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Jun 10, 2021

Jun 11, 2021