Labelling and UDI for Medical Devices and IVDs

20 May 2024 | 1 Week Live Online Course


(6 customer reviews)

The price is for all 8 ModulesRegister for Module 1 – Free

Fully understand medical device and IVD labelling and UDI requirements to ensure your product is MDR/IVDR compliant.

Register For Module 1 | Free-To-Attend


Module 1 of this course is free to attend and delivered online. Register to receive joining instructions for the live event, recording and presentation slides.

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Enrol before | 5 April to save £400 | 3 May to save £200

Discount has been applied to the price above. VAT, if applicable, will be added.

Course Overview


Medical Device and IVD labelling are areas that have been significantly impacted by the MDR and IVDR. To improve patient safety labelling requirements have been revamped with the introduction of Unique Device Identification (UDI), EDAMED database and expanded content requirements.


This Medical Device and IVD labelling training course will develop your knowledge and skills so you have the confidence to navigate the latest requirements. You will examine major new elements such as UDI requirements, label requirements and how the label is related to the EUDAMED database, PMS and risk management. Once completed you will have the ability to develop strategies to transition smoothly to the new requirements under the MDR and IVDR.


With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

Course Dates


Find out when this course is running so you can plan your training.

20 May 2024

1 Week Live Online Training
Register at the top of the page.


25 November 2024

1 Week Live Online Training

Get in touch to register for these dates. The largest price saving of £400 will be applied.

Key Learning Objectives


  • Examine the labelling requirements under the MDR and IVDR to ensure your label follows regulatory guidelines
  • Learn what information must go on the label at each stage of packaging to ensure your device/diagnostic is compliant
  • Assess differences in labelling requirements between the new Regulations (MDR / IVDR) and previous Directives
  • Understand the Instructions For Use (IFU) and eIFU to ensure your label is compliant.
  • Gain an awareness of the US labelling requirements and the implications of Brexit for manufacturers
  • Analyse specific case study examples including single-use devices, sterilisation labels, implantable devices and hazard warnings
  • Gain a comprehensive understanding of Unique Device Identification (UDI) in order to implement effectively
  • Discover how labelling requirements impact other major regulatory areas such as risk management and PMS
  • Understand the quality and regulatory implications of making labelling and Instructions For Use available on the manufacturer’s website

What is Included in a Live Online Course?


  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Bitesize learning
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 4 weeks after the last session
  • Full access to the Educo Post Learning Implementation Plan (PLIP)
  • A validated certificate of attendance available for you to download

Learn more about how we deliver live online training

Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)

Post Learning Implementation Plan (PLIP)


  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Introductory Module 1
FREE to Attend | Live & Recorded

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11 April 2024 | 60 mins | 1:00 PM UK 

Introduction and overview

  • Examine the labelling requirements under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
  • Highlight the main differences between the directive and the new Regulations.



Register For Module 1 | Free

There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

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Module 2

20 May 2024 | 90 mins | 12:00 PM UK 

Examine specific changes in labelling requirements for Devices and IVDs

  • Examine and review
    • Level of information instruction going on the label
    • What information is required for these changes?
    • Harmonised symbols
    • The challenges with symbols and translation
  • Learn the requirements for each stage of packaging
    • Review of labelling and packaging requirements at each stage of packaging
    • Stages include: Instructions for Use (IFU), primary packaging, secondary packaging, tertiary packaging and pallet
  • Review and discuss
    • Examine electronic labelling
    • Publishing labelling on your website
    • Label printing
  • Examine the requirements in the US, highlighting key differences
Module 3

20 May 2024 | 90 mins | 1:30 PM UK 

Applications of labelling in the product life cycle

This session is designed to review examples of labelling for specific products including:

  • Single-use devices
  • Sterilisation
  • Implantable devices
  • Clinical investigation
  • Hazard warnings
  • Storage temperature
  • Economic operators
Module 4

21 May 2024 | 90 mins | 12:00 PM UK 

Usability assessment and instructions for use (IFU)

  • Review of the usability requirements compared with those from the Medical Device Directive (MDD)
  • Assess Instructions For Use (IFU) and how to ensure they meet usability requirements
  • Understand the electronic Instructions For Use eIFU
Module 5

21 May 2024 | 90 mins | 1:30 PM UK 

Labelling development and maintenance interfaces

In this session you will examine how labelling is impacts other process functions such as post market surveillance, risk management and design development.

  • Labelling and Post Market Surveillance (PMS)
  • Labelling and design development
  • Labelling and risk management
Module 6

22 May 2024 | 90 mins | 12:00 PM UK 

Examining Unique Device Identification (UDI) and EUDAMED requirements

  • Definition of UDI
  • Why was UDI introduced?
  • Gain a complete regulatory understanding of UDI
  • Examine strategies for achieving UDI success
  • Identify the differences between existing US system and the new EU system
  • Global UDI and database insights (GUDID)
  • Learn how to register your UDI
  • EUDAMED considerations:
    • Learn how UDI is linked to the new EUDAMED database
    • Examine the requirements in the US
Module 7

22 May 2024 | 90 mins | 1:30 PM UK 

Global labelling requirements

  • Strategies to get your labelling globally accepted
  • Implementation of a label strategy
  • Best practice working with an overseas supply chain/ manufacturer
Module 8

23 May 2024 | 90 mins | 12:00 PM UK 

Brexit and the impact on labelling requirements

This session will examine how Brexit impacts labelling for both UK ad EU countries looking access both markets.

  • Brexit and labelling and the UKCA marking
  • Is the UK following same rules as the EU?
  • Will the CE mark need to be on the label?

Richard Young has over 25 years’ experience in the medical device and IVD industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.


Richard has been an independent consultant for over 6 years, supporting companies with regulatory and quality advice on a range of different products. He has extensive experience of European regulations including the MDD, IVDD and more recently the MDR and IVDR. In addition, Richard understands the US FDA requirements for devices and diagnostics. He also has a comprehensive working knowledge of device ISO standards such as 13485 and 14971.


In a changing regulatory environment, communication with customers and end users is a critical element for all manufacturers in the life sciences sector. The content of labelling and internet communications is a vitally important part of the development and maintenance of compliance of all medical products. Richard has extensive experience in regulatory and quality roles for all classes of medical products and offers you a unique insight into the practicalities and requirements of labelling in todays markets.

This training course is designed for regulatory professionals who are involved in labelling of devices and diagnostics. These include:

  • Regulatory Affairs
  • Quality
  • Project managers
  • Product Launch Team
  • Design and Development Team
  • Manufacturers
  • Distributors
Free First Module and Pricing
  • Module 1 is free to attend for this live online course and is delivered a few weeks before the start date.
  • To enrol onto module 1, please submit your email at the top of the page.
  • All sessions are recorded. If you are unable to attend module 1, you can catch up ahead of the course start date.
  • There are two price tiers for this course:
    • Super Early Bird Discount – Enrol approximately 3 to 5 weeks before the course starts.
    • Early Bird Discount – Enrol 7 to 10 days before the course starts.
    • The early bird dates for this course are at the top of the page, above Course Overview.

Frequently asked questions (FAQs)

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.


Complete our contact form by following the link. Get in touch.


• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.

6 reviews for

Labelling and UDI for Medical Devices and IVDs

20 May 2024 | 1 Week Live Online Course

  1. Individual Booking


  2. Certification Company

    The trainer is a strong communicator, with experience shining through his every word. He shared information at a high level, in a comprehensible and practical way. I am very pleased with the content of this course, and am ever-grateful to the trainer for sharing his expertise, and for the passion, drive and ethics he displays. An inspiration to listen to and learn from. Thank you!

  3. Hologic

    Great overview of the labeling related requirements

  4. Hologic

    The course provided me with a broader idea of what is involved in the subject of labels on medical equipment & devices. How important they are as a key point in the next step of the device manufacturing process when it gets into the hands of the healthcare professionals.

  5. Cantel

    I very much appreciated that the course deals with Labeling in a transversal way not only from Regulatory side but also from a broader point of view.

  6. Holland & Barrett


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