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Management Forum

Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

★★★★★ "A really good introduction, well pitched and informative"

26-27 July 2023
+ 7-10 November 2023
from £1099

Need help? Enrol or reserve

Format: Live online
CPD: 12 hours for your records
Certificate of completion

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Course Overview

The In-Vitro Diagnostic Regulation (EU) 2017/746, which came into force in May 2017 with a transition period of five years, is intended to strengthen the current approval system for in-vitro diagnostics and makes substantial changes to the existing IVD Directive (98/79/EC) legislation.

The Regulation introduces a new risk-rule classification system based on the Global Harmonization Task Force (GHTF) rules which, for the first time, takes patient impact into consideration. This will have a significant impact on all manufacturers of IVDs as about 80 per cent of all devices will now require some form of conformity assessment by a Notified Body.

This seminar will clarify the requirements applicable to in-vitro diagnostic devices under the new Regulation, highlight the major changes to responsibility and product data expectations and provide a thorough understanding of the impact on the industry.

Practical workshops over the two days will help consolidate the information provided.

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

Who should attend

Regulatory affairs personnel
Persons responsible for regulatory compliance
Quality assurance professionals
Those responsible for OEM/subcontractor control of IVDs
Economic operators, importers, distributors

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The Introduction to the In-Vitro Diagnostic Regulation (IVDR) course will cover:

Introduction to IVDs

Definition of an IVD
Why are IVDs regulated separately?
Investigating standards and their use
Exploring CE marking

Historical overview of the current IVD Directive (98/79/EC)

Examining the structure and content of the IVD Directive

Introduction to IVD Regulation (EU) 2017/746

How did we come from the Directive to the Regulation?
Main drivers for change
Scale of change
Structure and Annex

Notified Bodies

How has the role of the Notified Bodies changed under the IVD Regulation?
Conformity assessment

IVD Regulation – key changes

Persons responsible for regulatory compliance
Economic operators, importers, distributors
UDI
Software
Intended use/intended purpose
(including an interactive workshop)
Performance evaluation
Clinical evidence

Compiling the technical documentation for an IVD

Structure and content of STED
Technical file vs design dossier

Labelling requirements and strategies

Understanding electronic instructions for use (e-IFUs)
Use of language and symbols
Translation requirements
Traceability and EUDAMED
UDIs

ISO 13485:2016

Introduction to ISO 13485
Key changes from 2012 to 2016
Where does it fit with IVDD & IVDR?

Risk-based classification

How are IVDs classified?

Workshop: Product classification

Discussion on the classification of example IVDs

Risk management

Regulatory requirements
ISO14971
Usability

Workshop: Risk management

Clinical evidence and common specifications

Scientific validity vs performance evaluation

Vigilance and PMS

Regulatory requirements
Incident reporting/FSCA management

Case studies: Reporting/recalls

Key timelines and practical considerations

Discussion: Preparing a roadmap for transition

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Nancy Consterdine
Ivdeology

Nancy Consterdine is a joint director in her own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices, focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016.

She has over 30 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex II list products. Also identifying regulatory strategies around global submissions (EU, FDA, Health Canada, TGA, Russia, Latin America and China). She has a special interest in labelling and UDI requirements.

More details

Stuart Angell
Ivdeology

Stuart Angell is a joint director in his own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016.

He has over 15 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex list II products including technical documentation for EU and global submissions (FDA, Health Canada, TGA, Russia, Latin America). He has an excellent understanding of risk management, Post Market Surveillance (PMS) and vigilance.

More details

Book Introduction to the In-Vitro Diagnostic Regulation (IVDR) Live online training

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

26-27 July 2023

Live online

09:30-16:45 UK (London) (UTC+01)
10:30-17:45 Paris (UTC+02)
04:30-11:45 New York (UTC-04)
Course code 12720

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 21 Jun

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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Not ready to book yet?

for 7 days, no obligation

7-10 November 2023

Live online

13:30-17:00 UK (London) (UTC+00)
14:30-18:00 Paris (UTC+01)
08:30-12:00 New York (UTC-05)
Course code 12400

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 03 Oct

4 sessions of live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Reviews of IPI's Introduction to the In-Vitro Diagnostic Regulation (IVDR) training course

A really good introduction, well pitched and informative

Mar 9 2023

Katherine Kouwenberg United Kingdom
Marketing Associate, SPD Development Company

Mar 9 2023

Both speakers were nothing short of impressive. Also, I am thankful they directed us to the IVDeology app, it will be most useful, particularly in team discussions and again highlights the level of service the speakers and company offer. Also, I am thankful they directed us to the IVDeology app, it will be most useful, particularly in team discussions and again highlights the level of service the speakers and company offer.

Charlotte Briggs United Kingdom
RA and QA Consultant, Insight Regulatory

Nov 2 2021

Lived up to my expectations with respect to content. Nice presentation, and the speakers really knew everything about the IVDR.

Lena Vang Denmark
R&D Senior Specialist, Design Verification, Radiometer Medical

Nov 19 2019

Excellent course which give a deep insight into the IVDR regulation without overloading with too much detail.

Jason Reece United Kingdom
CTO,

Nov 19 2019

An enjoyable and insightful course. Good discussions and real-life examples and the exercises were worthwhile and interesting.

Tracey Jacob United Kingdom
Project Manager, Team Consulting

Nov 26 2018

The course was at the perfect level for an IVD industry professional who needed the basics of the new IDV Regulation as well as detailed information on the major areas of change. The speakers were extremely knowledgeable and were able to clearly and concisely answer our questions and guide the discussions until we understood the topic. Their vast experience in our industry gave me confidence that the information and guidance they provided was accurate and reliable. I hope to be able to bring them to one of our Siemens facilities in the US for my other colleagues.

Kathy Roberts United States of America
Quality Engineer / PMO, Siemens Healthineers - Laboratory Diagnostics