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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.

2-3 Nov 2021

& 4-5 Nov 2021

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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

Programme

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

Presenters

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.

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.

Book now

Book now

2-3 Nov 2021
Live webinar
2-3 Nov 2021
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 21 Sep*
Enrol now
to attend
Live webinar
4-5 Nov 2021
Face-to-face, (venue not yet confirmed)
4-5 Nov 2021
Face-to-face
(venue not yet confirmed)
GBP 1,499 1,299
EUR 2,099 1,819
USD 2,338 2,026
Until 23 Sep*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 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

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

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.

Contact us

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Previous customers include...

  • Beckman Coulter
  • Becton Dickinson (Pty) Ltd
  • Becton Dickinson BV
  • BioTop Medical
  • Cepheid
  • DGM Denmark A/S
  • Diagnostic Grifols SA
  • Genomtec SA
  • Gentian AS
  • GlaxoSmithKline
  • Glycobond
  • GSK R&D Unlimited
  • INNOGENETICS
  • International Fund Services (Ireland) Ltd/IFS
  • Kaneka Eurogentec S.A.
  • Medical Lab Science Council of Nigeria
  • Medical Laboratory Science Council of Nigeria
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Medicines and Medical Devices Agency of Serbia
  • NAMSA Medvance
  • Newcastle University
  • Novartis Consumer Health SA
  • Psephos Biomedica
  • R&D Systems Europe Ltd
  • Saudi Food and Drug Authority
  • Sestria Ltd
  • SPD Development Company Limited
  • Systagenix Wound Management
  • Team Consulting Ltd
  • Welsh Blood Service

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

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

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