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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.

★★★★★ "Excellent course which give a deep insight into the IVDR regulation without overloading with too muc... more"

3-4 Nov 2022 + 3 more dates

Need help?  Enrol or reserve

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

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

Enrol or reserve

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

  • PMS

Key timelines and practical considerations

Discussion: Preparing a roadmap for transition

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Nancy Consterdine

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.

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Stuart Angell

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/Classroom 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

3-4 Nov 2022

Live online

09:00-16:30 UK (London) (UTC+00)
10:00-17:30 Paris (UTC+01)
05:00-12:30 New York (UTC-04)
Course code 11779

  • GBP 1,299
  • EUR 1,859
  • USD 2,098

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Not ready to book yet?

for 7 days, no obligation

9-10 Mar 2023

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 12169

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

Until 02 Feb

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Not ready to book yet?

for 7 days, no obligation

26-27 Jul 2023

Classroom
Rembrandt Hotel
London

09:00-16:45 UK (London)
Course code 12720

  • GBP 1,299 1,499
  • EUR 1,869 2,149
  • USD 2,137 2,449

Until 21 Jun

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • 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 Nov 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

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


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

Nov 2 2021

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

United Kingdom

  • AbbVie
  • AstraZeneca
  • Automata
  • Bespak
  • Bespak Europe Ltd
  • Binding Site Group Ltd
  • Danaher
  • Gentian
  • GlaxoSmithKline
  • GSK R&D Unlimited
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Microvisk Technologies
  • NAMSA Medvance
  • Newcastle University
  • PA Consulting Group
  • Psephos Biomedica
  • R&D Systems Europe Ltd
  • Renishaw plc
  • Sekisui Diagnostics (UK) Ltd
  • Sestria Ltd
  • SPD Development Company Limited
  • Systagenix Wound Management
  • Team Consulting
  • Welsh Blood Service

Belgium

  • FUJIREBIO EUROPE
  • Fujirebio-Europe NV
  • Janssen Pharmaceutica NV
  • Kaneka Eurogentec S.A.
  • Omega

United Arab Emirates

  • BD
  • BD & Company
  • Becton Dickinson
  • Becton Dickinson BV

Norway

  • Gentian AS
  • Lyfstone
  • LYFSTONE AS

Switzerland

  • Beckman Coulter
  • Exact Sciences
  • Novartis Consumer Health SA

Denmark

  • DGM Denmark A/S
  • Radiometer Medical

Italy

  • Alifax SPA
  • Di Renzo SRL

Netherlands

  • BioTop Medical
  • Omron Healthcare Europe BV

Nigeria

  • Medical Lab Science Council of Nigeria
  • Medical Laboratory Science Council of Nigeria

Saudi Arabia

  • Becton Dickinson BV
  • Saudi Food and Drug Authority

Spain

  • Diagnostic Grifols SA
  • Vivia Biotech SL

United States of America

  • Cepheid
  • Siemens Healthineers - Laboratory Diagnostics

France

  • GlaxoWellcome Production

Ireland

  • International Fund Services (Ireland) Ltd/IFS

Kenya

  • Becton Dickinson East Africa Limited

Poland

  • Genomtec SA

Serbia

  • Medicines and Medical Devices Agency of Serbia

South Africa

  • Becton Dickinson (Pty) Ltd

Sweden

  • Glycobond

Ukraine

  • Pharmaceutical Corporation "YURiA-PHARM"

Enrol or reserve

Run Introduction to the In-Vitro Diagnostic Regulation (IVDR) Live online/Classroom for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee
  • Course tailored to your requirements
  • At your choice of location, or online

 

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 expert Aleksandra Beer 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:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy