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Fundamentals of the EU IVD Regulation (IVDR)

16 February 2022 | 2 Week Live Online Course

£590.00

Register for Module 1 | Free

Gain a comprehensive overview of the IVD Regulation (IVDR) to ensure your diagnostics are compliant in the EU.

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Enrol before | 7 January to save £400 | 4 February to save £200

 

 

Course Overview

 

The In-Vitro Diagnostic Regulation (IVDR) was introduced by the EU to replace the In-Vitro Diagnostic Directive (IVDD). Like the MDR, the aim is to improve patient safety with more accurate diagnostics and more stringent post market surveillance procedures. For a sector so used to being self-certified, the IVDR is a huge change for IVD professionals who must now navigate much stricter regulations.

 

This course provides you with a complete overview of the IVDR from economic operators and classification to working with a Notified Body and understanding conformity assessment routes. You will examine the key clauses of the new IVDR and its implementation in Europe. Once completed you will have the knowledge, skills and tools to carve out a transition strategy, ensuring your IVD product(s) remain compliant.

 

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

 

  • Gain a complete overview of the new IVD Regulations (IVDR) to help you formulate a transition strategy from the IVD Directive (IVDD).
  • Examine the key clauses in the IVD Regulation (IVDR) to ensure continued compliance and access to the European market.
  • Fully comprehend the changes to the IVD industry and begin planning for a successful transition.
  • Understand the importance of risk and quality management throughout the lifecycle of your diagnostic product
  • Examine the conformity assessment routes and technical documentation required under the IVDR to ensure compliance
  • Review the requirements for performance evaluation studies and clinical evidence under the IVDR
  • Understand the latest labelling and UDI requirements for your diagnostic to minimise market access delays
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

25 January  | 60 mins | 12pm 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

 

 

 

Register For Module 1 | Free

 

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Module 2

16 February | 60 mins | 12pm UK

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
Module 3

17 February | 60 mins | 12pm UK

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
Module 4

18 February | 60 mins | 12pm UK

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
Module 5 & 6

21 February | 60 mins | 12pm UK

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
Module 7

24 February | 60 mins | 12pm UK

Labelling of IVDs

  • Requirements from GSPR
  • Use of language and symbols
  • Translations
  • Instructions for use
  • Symbols
  • Electronic labelling
  • Examining Unique Device Identification (UDI)
Module 8

24 February | 60 mins | 12pm UK

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)

 

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.

This course is suitable for professionals who work in or are new to the In Vitro Diagnostic (IVD) industry and require a complete overview of the new In Vitro Diagnostic Regulation (IVDR). These include: Regulatory Affairs | Quality | Design & Development | Clinical | Management | Device Manufacturers | Device Distributors | Professionals new to IVD regulations from devices or pharma.

Free module 1 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.

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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.