UDI Template (MDR)
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.
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.
(Your Company Logo) Document ID: # Revision No.: # Effective Date: Table of Contents 1.0 Introduction ..................................................................................................................................... 3 2.0 Key Objectives ............................................................................................................................... 3 3.0 Responsibilities .............................................................................................................................. 3 4.0 Definitions ....................................................................................................................................... 4 5.0 General requirements of the UDI ................................................................................................ 5 6.0 Specific requirements of the UDI ................................................................................................ 6 7.0 UDI Database ................................................................................................................................. 8 8.0 Specific Rules................................................................................................................................. 8 Red text = needs to be changed and write the information of the product Page 2 of 9
(Your Company Logo) Document ID: # Revision No.: # Effective Date: 1.0 Introduction Unique Device Identifier (UDI) is defined as a series of characters which are created for a device in order to be identified. According to EU MDR 2017/745, a device can only be released on the market if the device is assigned to the UDI system. It is the manufacturer's obligation to assign the device to the UDI system and comply with the GSPRs. The aim of this template is to illustrate the UDI system to the manufacturer and define its obligations with regards to the UDI system. The purpose of this document is to define the Unique Device Identifier (UDI) activities of product XXXX. The range of products is listed below (if necessary). Range of Product (add and remove columns ) Medical Device Family/Category Device Name(s) XXXX XXXX Defined Use In this section give a brief summary of the function of the device (usage of the device), a summary of the warnings, the identification of product labelling, etc. 2.0 Key Objectives This document is aiming to establish the requirements of the UDI system and database of product XXXX. 3.0 Responsibilities The manufacturer of device XXX shall register the device to the UDI system and implant the UDI on the device and package of the device. The economic operators of the device XXX must have records of the UDIs of the devices that they supply or have supplied. Page 3 of 9
(Your Company Logo)<br />
Document ID: #<br />
Revision No.: #<br />
Effective Date:<br />
<br />
Table of Contents<br />
1.0 Introduction ..................................................................................................................................... 3<br />
2.0 Key Objectives ............................................................................................................................... 3<br />
3.0 Responsibilities .............................................................................................................................. 3<br />
4.0 Definitions ....................................................................................................................................... 4<br />
5.0 General requirements of the <strong>UDI</strong> ................................................................................................ 5<br />
6.0 Specific requirements of the <strong>UDI</strong> ................................................................................................ 6<br />
7.0 <strong>UDI</strong> Database ................................................................................................................................. 8<br />
8.0 Specific Rules................................................................................................................................. 8<br />
Red text = needs to be changed and write the information of the product<br />
Page 2 of 9
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