Guidance for Unique Device Identifier (UDI)

Guidance for Unique Device Identifier (UDI)

£100.00

This template gives guidelines to the manufacturer in order to assign correctly the UDI on the device and the UDI database and hence successfully place the device on the market.

A preview of the Unique Device Identifier (UDI) Plan and Report is available here:

You may purchase the full document in convenient Microsoft Word format including instructions for use below.

Description

Unique Device Identifier (UDI) is a unique number that identifies the medical devices and is assigned to the UDI database. The manufacturer is responsible to register the device in the UDI system, label and update regularly the UDI on the device. This template gives guidelines to the manufacturer in order to assign correctly the UDI on the device and the UDI database and hence successfully place the device on the market.

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.