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

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"

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Format: Live online
CPD: 12 hours for your records
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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 of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

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

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.

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Stuart Angell
Ivdeology

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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 Co.

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