Looking for a template SOP for UDI implementation for EU Medical Devices

[JanviChokshi]

Hey,

I am looking for a template for SOP for implementing UDI for EU Medical Device regulations.

Your help will be really appreciated.

Thanks in advance,

Janvi

 

[regina_q]

Hey,

I am looking for a template for SOP for implementing UDI for EU Medical Device regulations.

Your help will be really appreciated.

Thanks in advance,

Janvi

Just wondering if you came across a template yet or if someone had responded to your inquiry?? I'm looking for something similar

 

[Parul Chansoria]

Just wondering if you came across a template yet or if someone had responded to your inquiry?? I'm looking for something similar

Hi Regina,

Please find our response to the question below.

Based on the requirements laid out in the EU MDR, the following is the basic information to be covered in an SOP for UDI implementation:

1. UDI requirements on the following to be included but are not limited to

• requirements to affix UDI numbers such as which type/class of devices would require UDI to be permanently affixed to the device before placing a device on the market, etc.,
• valid and applicable characters to be used in UDI number as per ISO/IEC 646 character set etc. should be covered
• UDI registration
  • steps to enter certain data elements into the GUDID and EUDAMED
  • coding standards provided by issuing entities - UDI FDA-approved issuing agencies, etc.
  • UDI change process
    • steps to be followed for the UDI change process if the device undergoes changes that lead to the request for a new UDI number. The changes might include a new model number, name, trade name, etc.