MDR labelling
Is it mandatory under MDR that labels and instructions of use to be translated in the languages accepted by the Member States of the Union where the medical device is going to be used by a patient? ( Article 10, subparagraph 11)
Would a company be compliant under MDR if the label attached onto the medical device is only provided in English and has a list with the flags representing the EU countries for customer to refer to the applicable language in the IOUs?
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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Yes, the company will be compliant under MDR if the label attached to the medical device is only provided in English
In MDR Annex II – Technical documents, in subparagraph 2. Information supplied by the manufacturer is stated that the manufacturer needs to set the label and Instruction of use in the languages accepted in the Member States where the device is envisaged to be sold. Of course, you can provide information on English as a universal language. However, as part of your Quality management system, you need to provide a procedure for translation where you will describe how you will manage to provide labels and instruction of use if somebody will ask for it.
For more information, see:
- Annex II – Technical documentation - https://advisera.com/13485academy/mdr/technical-documentation/
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Nov 20, 2020