Theme | Basic UDI-DI |
Target Audience | UDI Issuing entities |
Products Concerned | MD, IVD |
Regulatory reference | MDR (EU) 2017/745
IVDR (EU) 2017/746 |
Documents mentioned |
This guide provides some clarification on the format of the basic UDI-DI. The basic UDI-DI should be a maximum of 25 characters long, so as not to deviate too much from the maximum length of the UDI-DI. One of these characters must be a number or control character generated by an algorithm of the issuing entity. This algorithm shall be communicated to the Commission and the manufacturers.