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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.

3-4 Nov 2022

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Details

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.

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

Presenters

Nancy Consterdine (More...)

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 (More...)

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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NEW higher discounts for booking multiple places - 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
3-4 Nov 2022
Live webinar
09:00-16:45
UK (London)
3-4 Nov 2022
Live webinar
09:00-16:45
UK (London)
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 29 Sep*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

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Previous customers include...

  • AbbVie
  • BD
  • BD & Company
  • Becton Dickinson (Pty) Ltd
  • Becton Dickinson BV
  • Becton Dickinson East Africa Limited
  • Binding Site Group Ltd
  • BioTop Medical
  • Di Renzo SRL
  • Diagnostic Grifols SA
  • Gentian
  • Gentian AS
  • GlaxoSmithKline
  • GlaxoWellcome Production
  • Glycobond
  • GSK R&D Unlimited
  • International Fund Services (Ireland) Ltd/IFS
  • Janssen Pharmaceutica NV
  • Lyfstone
  • Medical Laboratory Science Council of Nigeria
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Microvisk Technologies
  • Renishaw plc
  • Saudi Food and Drug Authority
  • Sekisui Diagnostics (UK) Ltd
  • Sestria Ltd
  • Systagenix Wound Management
  • Team Consulting Ltd
  • Vivia Biotech SL
  • Welsh Blood Service

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 21

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

Jason Reece, CTO, Nov 19

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 19

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 18

This course met all my expectations, money well spent!

Hilde Sofie Larsen Skaug, Regulatory Affairs Specialist, Gentian AS, Nov 18

Very knowledgeable people, focusing on the needs of the trainees.

Marijke De Roeve, Q&C Director, FUJIREBIO EUROPE, Nov 18