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Is technical file of device mandatory to put on device on market?
I was reading the full text of MDR, in this regard, if I have correctly understood: the technical file of the device is mandatory to be registered by an EU manufacturer or its representative. Once this is done in the EU country of the manufacturer or representative, the device can be put on the market in ALL EU countries (not only the country where it was registered). Am I right?
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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
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Sep 23, 2022
Sep 23, 2022
Sep 23, 2022