Enrol before | 25 August to save £400 | 20 September to save £200
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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.
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.
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.
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.
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
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
8 September 2023 | 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
9 October 2023 | 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
9 October 2023 | 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
10 October 2023 | 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
10 October 2023 | 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
11 October 2023 | 90 mins | 12:00 PM UK
Product verification and validation
Conformity testing activities:
Product Performance testing
Testing strategies
Usability Assessment
Module 7
11 October 2023 | 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
12 October 2023 | 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.
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.
