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.
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
Document ID: #<br />
(Your Company Logo)<br />
Revision No.: #<br />
Effective Date:<br />
<br />
Written By:<br />
Other references<br />
Version:<br />
Date:<br />
Unique Device Identification (<strong>UDI</strong>)<br />
(Your company logo)<br />
Document Number:<br />
REPORT APPROVAL<br />
Print name Position Signature Date<br />
DOCUMENT REVISION HISTORY<br />
Revision # Author Description of Change Date<br />
Page 1 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
(Your Company Logo)<br />
Document ID: #<br />
Revision No.: #<br />
Effective Date:<br />
<br />
1.0 Introduction<br />
Unique Device Identifier (<strong>UDI</strong>) is defined as a series of characters which are created<br />
for a device in order to be identified. According to EU <strong>MDR</strong> 2017/745, a device can<br />
only be released on the market if the device is assigned to the <strong>UDI</strong> system. It is the<br />
manufacturer's obligation to assign the device to the <strong>UDI</strong> system and comply with<br />
the GSPRs. The aim of this template is to illustrate the <strong>UDI</strong> system to the<br />
manufacturer and define its obligations with regards to the <strong>UDI</strong> system.<br />
The purpose of this document is to define the Unique Device Identifier (<strong>UDI</strong>)<br />
activities of product XXXX. The range of products is listed below (if necessary).<br />
Range of Product (add and remove<br />
columns )<br />
Medical Device Family/Category<br />
Device Name(s)<br />
XXXX<br />
XXXX<br />
Defined Use<br />
In this section give a brief summary of the function of the device (usage of the<br />
device), a summary of the warnings, the identification of product labelling, etc.<br />
2.0 Key Objectives<br />
This document is aiming to establish the requirements of the <strong>UDI</strong> system and<br />
database of product XXXX.<br />
3.0 Responsibilities<br />
The manufacturer of device XXX shall register the device to the <strong>UDI</strong> system and<br />
implant the <strong>UDI</strong> on the device and package of the device. The economic operators of<br />
the device XXX must have records of the <strong>UDI</strong>s of the devices that they supply or<br />
have supplied.<br />
Page 3 of 9
Change language