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"
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.
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.
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
7-8 March 2024
09:00-16:30 UK (London) (UTC+00)
10:00-17:30 Paris (UTC+01)
04:00-11:30 New York (UTC-05)
Course code 13537
Until 01 Feb
24-25 July 2024
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 13817
Until 19 Jun
5-8 November 2024
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 14010
Until 01 Oct
* 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.
A really good introduction, well pitched and informative
Mar 9 2023
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.
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.
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.
Nov 19 2019
An enjoyable and insightful course. Good discussions and real-life examples and the exercises were worthwhile and interesting.
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.
Quality Engineer / PMO, Siemens Healthineers - Laboratory Diagnostics
Nov 26 2018
Very knowledgeable people, focusing on the needs of the trainees.
Marijke De Roeve
Q&C Director, FUJIREBIO EUROPE
Nov 26 2018
This course met all my expectations, money well spent!
Hilde Sofie Larsen Skaug
Regulatory Affairs Specialist, Gentian AS
United Arab Emirates
United States of America
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: