Presented by
Management Forum
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"
5-6 February 2025
+ 16-17 July 2025, 4-5 November 2025 »
from £1099
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.
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
5-6 February 2025
Live online
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 14559
Until 01 Jan
Not ready to book yet?
for 7 days, no obligation
16-17 July 2025
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)
Timings may be different for each day
Course code 14870
Until 11 Jun
Not ready to book yet?
for 7 days, no obligation
4-5 November 2025
Live online
Course code 15036
Until 30 Sep
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; and apply only when booking multiple delegates on the same date.
A really good introduction, well pitched and informative
Mar 9 2023
Katherine Kouwenberg
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
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
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
CTO,
Nov 19 2019
An enjoyable and insightful course. Good discussions and real-life examples and the exercises were worthwhile and interesting.
Tracey Jacob
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
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
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2 days
Typical duration
Pricing from:
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: