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

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

4 June 2024
+ 5 December 2024 »

from £299

Need help?  Enrol or reserve

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.

Enrol or reserve

The Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers course will cover:

Labels and IFUs

  • What is a label?
  • Regulatory requirements for product labels in the UK, EU and USA
  • Managing labelling with an ISO 13485 quality management system
  • Use of symbols on labels and IFUs
  • Requirements for translation of label information
  • Electronic labelling
  • Marketing literature
  • When do you need an IFU?

Labels and IFUs (continued)

  • Information to be provided with a medical device
  • Validation of labelling systems
  • Chemical indicators and the ISO 11140 standard

UDIs and Barcodes

  • Regulatory requirements for barcoding in the UK, EU and USA
  • Basic UDIs, GMNs and GTINs
  • UDI carriers, Human Readable Information and UDI databases
  • Eudamed and its use within the EU

Enrol or reserve

Annette Callaghan
Sterile Management Systems

A quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

4 June 2024

Live online

13:30-17:00 UK (London) (UTC+01)
14:30-18:00 Paris (UTC+02)
08:30-12:00 New York (UTC-04)
Course code 14313

  • GBP 299 349
  • EUR 429 499
  • USD 501 579

Until 30 Apr

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Not ready to book yet?

for 7 days, no obligation

5 December 2024

Live online

13:30-17:00 UK (London) (UTC+00)
14:30-18:00 Paris (UTC+01)
08:30-12:00 New York (UTC-05)
Course code 14314

  • GBP 299 349
  • EUR 429 499
  • USD 501 579

Until 31 Oct

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Iceland

  • Nox Medical

United States of America

  • West Pharmaceutical Services

Enrol or reserve

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy