Regulation of In Vitro Diagnostic Medical Devices

Regulation of In Vitro Diagnostic Medical Devices
This Masterclass primarily focused 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 such as the US, Japan, China and Brazil. This is also module 19 of the TOPRA MSc Regulatory Affairs.

: 20-22 February 2019
Where: TOPRA. 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE
Start time Day 1: 14.00
End time Day 3: 16.00

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 including: the regulatory environment in other jurisdictions such as Japan, China and Brazil
  • Definitions, classification and notified body involvement
  • Quality management systems
  • Technical documentation and requirements for performance data
  • Risk management
  • Labelling and product information
  • Post market surveillance and vigilance
  • Registration requirements
  • Other relevant legislation
  • Classification, standards and conformity assessment
  • Clinical evaluation and post market management
  • Traceability and strategic issues
  • Developing technologies

Benefits to delegates

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 19 CPD hours upon successful completion

To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Module Leader

Aaron Cousins
Aaron Cousins


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.  

This course is suitable for

  • Students of the TOPRA MSc programme
  • Delegates from the regulatory affairs industry who wish to develop their knowledge of the requirements for a new active substance
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject


    Course fees:
    Type Student Delegate
    Standard    £1500+VAT £1700+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 
    Those working for charities, patient groups or in full-time education

    • VAT, if applicable, is charged at the rate of 20% 
    • The registration fee does not include accommodation 
    • Refreshments and lunch are included in the registration fee

    Related courses:

    MSc Module 13: Principals of Medial Device Regulatory Affairs

    Next steps

    Module 10: Leadership and Strategic Management in Regulatory Affairs
    Module 12: Data Management and Digitalisation of Medical Devices
    Module 21: US Regulation of Medical Devices

    Terms and conditions

    By booking a place on this course you are agreeing to the training terms and conditions
    20/02/2019 14:00 - 22/02/2019 16:00
    TOPRA 6th Floor 3 Harbour Exchange London E14 9GE UNITED KINGDOM
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