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

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:

• EU MDR Article 10 _ General obligations of manufacturers - https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/

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.