Classroom Training Information

The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. The final day may start and finish earlier to accommodate peoples travel arrangements.

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

14 September | 60 mins | 12:00 PM UK

Introduction to the IVDR

• Introduction to the EU Regulations:
  • Structure of the regulation
  • Different types of regulation used by the Commission
  • CE marking
• What will be the impact of the new IVD Regulation?
• Quality Management Requirements
• Who is involved?
  • Competent Authorities / Notified Bodies
  • Economic Operators

Day 1

18 October  2022

Introduction to the IVDR

A risk based approach

• Review of Product Classification
• Risk Management

General safety and performance requirements

• Overview of the sections
• Impacts for manufacturing and software
• The use of Standards

Compiling your technical documentation

• The use of product families
• What is the difference between a Technical File and Design Dossier?
• What is needed for each document?
• How to proceed to CE Marking

Post-Market Surveillance (PMS) and vigilance responsibilities

• What the Regulation says regarding:
  • Incidents
  • Post-market surveillance
  • Post production experience
• How should the quality system interface with vigilance requirements?
• Review of the MEDDEV guidelines
• In depth review of PMS strategies

Practical exercises, group work and case studies

Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.

Day 2

19 October 2022

Documentations, clinical evidence and clinical performance of diagnostics in the EU

• Review of the regulation
• Overview of the standard
• When is a clinical study needed?
• What is needed for the Competent Authority and Ethics Committee submissions?

Product verification and validation

• Conformity testing activities:
  • Product Performance testing
  • Testing strategies
  • Usability Assessment

Labelling of IVDs

• Requirements from GSPR
• Use of language and symbols
• Translations
• Instructions for use
• Symbols
• Electronic labelling
• Examining Unique Device Identification (UDI)

Conformity assessment

• Conformity Assessment routes:
  • Optional routes for each class of device
  • What is required for each Conformity Assessment Annex?
  • An overview of IVD routes
  • Impact of the In Vitro Diagnostics Device Regulation (IVDR)

Practical exercises, group work and case studies

Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.

Richard Young has over 20 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.

Richard has delivered both online and classroom training courses on devices and IVDs. He can provide multiple examples and case studies during training, drawing on his extensive industry experience. This helps delegates understand regulatory and quality concepts.