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.

Brochure will be available shortly.

26-27 Nov 2018

& 21-22 May 2019

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course Overview

The new In-Vitro Diagnostic Device Regulation (EU) 2017/746 came into force in May 2017 with a transition period of 5 years. The IVD Regulation is significantly different from the IVD Directive, including changed classification rules and requirements for conformity assessment. It is intended to strengthen the current approval system for in-vitro diagnostics, making substantial changes to the existing IVD Directive (98/79/EC) legislation.

The IVD Regulation introduces a new risk-rule classification system based on the Global Harmonization Task Force (GHTF) rules for classification which, for the first time, takes patient impact into consideration. This change to the classification system will have an impact on all manufacturers of IVDs. The majority of IVDs are currently self-declare devices but under the new regulation about 80% of IVDs require some form of conformity assessment by a Notified Body.

Practical workshops over the two days will help consolidate the information provided.

Why you should attend

By attending this course, you will:

  • Gain a comprehensive overview of the new IVD regulation
  • Be aware of how the role of the Notified Body will change under the IVD regulation
  • Understand the requirements of the Technical Documentation for an IVD
  • Plan your labelling requirements and strategies
  • Know the key changes to ISO13485
  • Learn how IVDSs are classified
  • Understand the requirements for clinical evidence
  • Know the vigilance and Post Market Surveillance (PMS) requirements for IVDS

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 Day one

9.30 Welcome and introduction

9.45 Introduction to IVDs

  • Definition of an IVD
  • Why are IVDs regulated separately?
  • Investigating standards and their use
  • Exploring CE marking

10.30 Historical overview of the current IVD Directive (98/79/EC)

  • Examining the structure and content of the IVD Directive- 98/79/EC

11.00 Refreshments

11.15 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

12.00 Notified Bodies (NB)

  • How has the role of the Notified Bodies changing under the IVD Regulation?
  • Conformity assessment

12.30 Lunch

13.30 Key changes to IVD Regulation

  • Persons responsible for regulatory compliance
  • Economic operators, importers, distributors
  • UDI
  • Software
  • Intended use/intended purpose (including an interactive workshop)
  • Performance evaluation
  • Clinical evidence

15.00 Refreshments

15.15 Compiling the technical documentation for an IVD

  • Structure and content of STED
  • Technical File Vs Design Dossier

15.45 Labelling requirements and strategies

  • Understanding electronic Instructions for Use (e-IFUs)
  • Use of language and symbols
  • Translation requirements
  • Traceability and EUDAMED
  • UDIs

16.45 Day one wrap up and introduction to day two

17.00 Close of day one

Programme Day two

9.00 Welcome and recap on day one

9.15 ISO13485:2016

  • Introduction to ISO13485
  • Key changes from 2012 to 2016
  • Where does it fit to IVDD & IVDR?

9.45 Risk-Based classification

  • How are IVDs classified?

10.15 Workshop – Product classification

  • Discussion: Classification of example IVDs

10.45 Refreshments

11.00 Risk management

  • Regulatory requirements
  • ISO14971
  • Usability

11.45 Workshop – Risk management

12.30 Lunch

13.30 Clinical evidence and common specifications

  • Scientific validity Vs Performance evaluation

14.15 Vigilance and Post Market Surveillance (PMS)

  • Regulatory requirements
  • Incident reporting/FSCA management

15.00 Case studies: Reporting/recalls

  • Post Market Surveillance (PMS)

15.30 Refreshments

15.45 Key timelines and practical considerations

  • Transition period
  • Practical tips of preparing for IVD Regulation

16.30 Discussion: Preparing a roadmap for transition

16.45 Wrap up and close of forum

Presenters

Nancy Consterdine (26-27 Nov 2018)

Nancy Consterdine. This MDTI expert 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 (26-27 Nov 2018)

Stuart Angell, This MDTI expert 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.

Book now

26-27 Nov 2018
26-27 Nov 2018 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
21-22 May 2019
21-22 May 2019 Venue not yet confirmed
+ VAT @ 20.00%
Enrol now

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