The new European medical device regulations, EU MDR 2017/745, have introduced the Unique Device Identification (UDI) system as a requirement for medical device products that are to be sold in the European markets. Medical devices will need to be assigned a UDI number which will be linked to a UDI database.
The aim of this template is to illustrate the UDI system to manufacturers of medical devices and define its obligations regarding the UDI system and UDI number on their products.
A preview of the UDI Template (MDR) is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.