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Is technical file of device mandatory to put on device on market?

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Guest user Created:   Sep 23, 2022 Last commented:   Sep 23, 2022

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

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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Sep 23, 2022

Yes, you understand it right. 

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Sep 23, 2022

Sep 23, 2022

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