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Single Registration Number for MDR

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Guest user Created:   May 17, 2022 Last commented:   May 18, 2022

Single Registration Number for MDR

What is considered a Single Registration Number for MDR? How do you acquire it? I have a UDI for each product and Device Nomenclature Codes(GMDN)
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Kristina Zvonar Brkić May 18, 2022

Single registration number is a number that each business entity has to get from the EUDAMED or local competent authority. A single registration number has to be asked for a manufacturer, importer, and EU representative. Distributors do not need to be registered in the EUDAMED. It is covered in Article 31 of the MDR 2017/745. 

For more information, see:

Considering the codes, there are specified codes for medical devices. MDR has a code that is called European medical device nomenclature covered in Article 26 of the MDR. More details regarding this nomenclature you can find on the following links:

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