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

FREE to Attend | Live & Recorded

Sign up

18 October  | 60 mins | 12:00 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.

 

Module 2

14 November | 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

14 November | 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

15 November | 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

15 November | 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

16 November | 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

16 November | 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

17 November | 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.