UDI Template (MDR)

UDI Template (MDR)

£60.00

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.

Description

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.

Our templates are developed with consultants who have over 20 years’ experience in the Medical Device industry and documentation that has been through successful audits.

Our consultants are available, should you need further assistance in completing the documentation.