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Labelling and UDI for Medical Devices and IVDs

22 March 2022 | 2 week live online course

£800.00

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

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Enrol before | 16 February to save £400 | 11 March to save £200

 

 

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.

 

 

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 and file

Learn more about how we deliver live online training

 

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
Post Learning Implementation Plan (PLIP)

Pre-course

  • 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

22 March | 60 mins | 10am 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.

 

Module 2

22 March | 60 mins | 11am 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

22 March | 60 mins | 11am 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

24 March | 60 mins | 10am 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

25 March | 60 mins | 10am 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

28 March | 60 mins | 10am 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

28 March | 60 mins | 11am 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

29 March | 60 mins | 10am 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.

Pricing

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.

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• 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.