Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers Training Course

Course Overview

The information supplied with medical devices, both on their labels and in any accompanying Instructions for Use form part of the device itself and are critical to the safety and performance of the device and to compliance with regulatory requirements. Regulations for medical devices include particular requirements for labelling and the provision of Instructions for Use. These regulatory requirements relate to general safety and performance aspects of the products, and the requirements for clear and unambiguous information to be supplied to clinicians, patients and other users. Evidence of labelling which includes all required information is important and expected when demonstrating conformity with the regulations. 

These requirements have been supported by a portfolio of standards, regulations and guidance documents on:

• Information to be supplied by the manufacturer;
• Symbols to be used with information to be supplied by the manufacturer;
• Unique Device Identifiers (UDIs); and
• Use of electronic labelling

This course provides an introduction to these regulatory requirements as they relate to the labelling of medical devices and how manufacturers may demonstrate compliance.

This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

Benefits of Attending

• Gain an overview of the information that needs to be supplied with medical devices
• Understand how the use of symbols can overcome language and translation barriers
• Learn the regulatory requirements for use of UDIs in the UK, EU and USA
• Gain an awareness of the ways in which information can be provided to customers

Who Should Attend

• Regulatory Compliance specialists
• Quality Management System (QMS) specialists
• Internal Auditors
• Regulatory and Quality professionals

Please note that access to copies of ISO 15223-1 and ISO 20417 would be beneficial to delegates attending this training. If you do not already have access to these through your organisation, please see below the ways to acquire them:

ISO 15223-1 - https://www.iso.org/standard/77326.html

ISO 20417 - https://www.iso.org/standard/67943.html  

These standards are also available from national standards organizations such as BSI, DIN, AFNOR, AAMI, NSAI, etc.

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