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MDR submission

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Guest user Created:   Nov 25, 2021 Last commented:   Nov 29, 2021

MDR submission

Hi we are a new medical device manufacturer, preparing for our MDR submission. For our samples, do the sample need to be like how it would be i.e. with design, brand name, labels, product description with translation of different languages, and EC Rep?
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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Nov 29, 2021

Samples that are sent for performance testing and biocompatibility must have a final design because there is no point in testing a product that you will then change.

Brand name, labels, and any instructions for use are not necessary for this kind of testings. But, if you are going for usability testings, then all those elements (brand name, labels, and product descriptions) must be in the final stage. 

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Nov 29, 2021