Regulation of In-Vitro Diagnostics Medical Devices

Regulation of In-Vitro Diagnostics Medical Devices
Module 19 of the MSc and Masterclass: Primarily focusing on the In Vitro Diagnostic Regulation, this course will present the latest information covering the new regulation and how this differs from the In Vitro Diagnostic Directive in the EU and other jurisdictions.

18 - 20 April 2023
Where: TOPRA Office, 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE, United Kingdom

Also available as a virtual course, please click here for the virtual registration option.

Course overview

The Masterclass will cover both the current regulatory environment and the new regulations as they come into effect and cover:

  • The current EU regulatory environment and a comparison to the regulatory environments in jurisdictions such as Japan, China and Brazil
  • Definitions and classification of IVD devices
  • Conformity Assessment
  • Quality Management Systems
  • Risk management
  • Technical documentation
  • Performance data and product claims
  • Post market surveillance, vigilance and FSCA
  • Other relevant legislation
  • Companion diagnostics and other emerging technologies

Course benefits

This course will enable you to:

  • Demonstrate a critical understanding of the regulatory environment in the EU and other territories and critically evaluate how these compare
  • Critically evaluate the challenges involved in conducting clinical evidence studies using IVD products, giving consideration to the differences between these products and other medical devices in the design and production of clinical data
  • Demonstrate critical understanding of the quality system requirements associated with the manufacture and supply of IVDs
  • Demonstrate critical understanding of the roles of the different stakeholders involved in the manufacture, supply and regulation of IVDs
  • Be able to recommend development strategies for IVD products that will meet global requirements
  • Explain the regulatory requirements for vigilance and post-market surveillance for IVDs and be able to make recommendations about the implementation of a surveillance strategy
  • Explain the regulatory requirements for the development of an IVD medical device and be able to guide the preparation of the IVD technical documentation needed for CE Marking
  • Critically appraise and evaluate communications from regulatory bodies and research publications regarding IVDs
CPD: This course provides 15 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.


You can view and download an example programme based on previous courses here

Module Leaders


TOPRA Masterclasses are developed and delivered by a faculty of expert speakers from relevant industry, agencies, notified bodies and other stakeholders, and are validated by the University of Hertfordshire. In addition to the module leaders listed above, previous speakers for this course include:

Suitable for

  • Students of the TOPRA MSc programme
  • Delegates from the regulatory affairs industry who wish to develop their knowledge of IVD's
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject



    • TOPRA MSc students: £1,500 + VAT*
    • Delegates: £1,700 + VAT*

    Discounted places

    A limited number of discounted places are available at the rates below. Please email us at for a discount code before making your booking.

    • Those working for regulatory agencies, government agencies or academic institutions: £1,275 + VAT*
    • Those working for charities, patient groups or in full-time education: £1,275 + VAT*
    *VAT, if applicable, is charged at the rate of 20%.

    Terms and conditions

    By booking a place on this course you are agreeing to the training terms and conditions.

    18/04/2023 - 20/04/2023
    TOPRA Office 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
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