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Fundamentals of the EU IVD Regulation (IVDR)

18 & 19 October 2022 | Hybrid Course | London

£995.00£1,395.00

The price is for both days | 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 | 2 September to save £400 | 30 September to save £200

Discount is applied to the price above. VAT, if applicable, will be added. The full price for the classroom option is £1,595 and live online is £1,195.

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. If you have any concerns about COVID-19 before registering on to the course,please read our COVID-19 commitment.

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 to 5 weeks after the last session
  • Reinforcement session delivered 4 to 5 week after the course (online) providing you with extra time with the trainer
  • A validated certificate of attendance available for you to download

 

Learn more about how we deliver live online training

What is a Hybrid Training Course?

 

You decide what format is best for you. The course is delivered as a classroom (in-person) course that is also delivered online. You can decide whether you would like to attend in person or online. The price is dependent on the option.

 

We recommend visiting our website to learn more. Click here to learn more about hybrid training at Educo Life Sciences.

Register For Free Online Session

 

There are limited spaces on the introductory session. 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.

What is Included in a Classroom Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Refreshments and lunch provided on each day
  • Reinforcement session delivered 4 to 5 week after the course (online) providing you with extra time with the trainer
  • A validated certificate of attendance available for you to download
  • Access to the Educo Life Sciences Training Portal before and after the course for additional learning materials

 

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

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

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

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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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.

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.

Most of our classroom courses are located at a venue in central London. The city has good transport links and is good place to socialise with fellow attendees. Accommodation is not included in the price. We recommend staying in a hotel within walking distance of the venue. Lunch and refreshments are included on all days where you will be able to interact with fellow peers and the trainers.

The course is held in the following venue:
Hallam Conference Centre, Cavendish Venues, 44 Hallam St, London, W1W 6JJ

Link to the Google Map

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

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

| 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

 

 

 

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

| 90 mins | 12:00 PM 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

| 90 mins | 1:30 PM 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

| 90 mins | 12:00 PM 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

| 90 mins | 1:30 PM 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?
Module 6

| 90 mins | 12:00 PM UK

Product verification and validation

  • Conformity testing activities:
    • Product Performance testing
    • Testing strategies
    • Usability Assessment
Module 7

| 90 mins | 1:30 PM 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

| 90 mins | 12:00 PM 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 Online Module and Pricing

 

  • Module 1 is free to attend and is delivered online and is recorded.
  • To enrol onto module 1, please submit your details in the form.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
  • There are price tiers for this course. The dates of these are at the located above the 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.