Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course (May 19-20, 2022) –

Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course (May 19-20, 2022) –

Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course (May 19-20, 2022) –

DUBLIN–(BUSINESS WIRE)–The “Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course” conference has been added to’s offering.

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

Key Topics Covered:

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

For more information about this conference visit


Laura Wood, Senior Press Manager

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