Presented by
Management Forum

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

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.

2-3 Nov 2021 + 2 more dates

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  • Format: Live online
  • 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

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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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2-3 Nov 2021
19-20 May 2022
3-4 Nov 2022

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

19-20 May 2022
3-4 Nov 2022

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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Book Introduction to the In-Vitro Diagnostic Regulation (IVDR) Live online training

2-3 Nov 2021

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 11007

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

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19-20 May 2022

Live online

09:00-16:30 UK (London) (UTC+01)
10:00-17:30 Paris (UTC+02)
04:00-11:30 New York (UTC-04)
Course code 11621

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 14 Apr

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3-4 Nov 2022

Live online

09:00-16:45 UK (London) (UTC+00)
10:00-17:45 Paris (UTC+01)
05:00-12:45 New York (UTC-04)
Course code 11779

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 29 Sep

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Reviews of IPI's Introduction to the In-Vitro Diagnostic Regulation (IVDR) training course


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

Nov 19 2019

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

UK

  • AbbVie
  • 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"

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Multiple colleagues?
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