Single Registration Number for MDR

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:

• EU MDR Article 31 – Registration of manufacturers, authorized representatives and importers - https://advisera.com/13485academy/mdr/registration-of-manufacturers-authorised-representatives-and-importers/

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:

• European Medical Device Nomenclature (EMDN) https://webgate.ec.europa.eu/dyna2/emdn/A

• MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN) - https://ec.europa.eu/health/system/files/2021-06/md_2021-12_en_0.pdf
• EU MDR Article 26 – Medical devices nomenclature - https://advisera.com/13485academy/mdr/medical-devices-nomenclature/