UDI procedure that covers the EU MDR requerment

Unfortunately, the UDI procedure is not part of our ISO 13485:2016 and MDR Documentation toolkit. According to the MDR Article 27 – Unique Device Identification system and MDR Annex 6 – Information to be submitted upon the registration of devices and economic operators in accordance with Articles 29(4) and 31, core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 28 and 29; and the UDI system, there is no need to have documented procedure for UDI. The requirement is for the List of UDI which you have in your toolkit.  

For more information, please read the following:

• EU MDR Article 27 – Unique Device Identification system https://advisera.com/13485academy/mdr/unique-device-identification-system/
• EU MDR Annex 6 – Information to be submitted upon the registration of devices and economic operators in accordance with Articles 29(4) and 31; core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 28 and 29; and the UDI system  https://advisera.com/13485academy/mdr/information-to-be-submitted-upon-the-registration-of-devices-and-economic-operators-in-accordance-with-articles-294-and-31-core-data-elements-to-be-provided-to-the-udi-database-together-with-the-ud/ 

For more information on the mandatory documents in the MDR, please see the following material:

• EU MDR Checklist of Mandatory Documents https://info.advisera.com/13485academy/free-download/eu-mdr-checklist-of-mandatory-documents