Course description

Regulation of In Vitro Diagnostic Medical Devices

This Masterclass is also Module 19 of the MSc and is 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. This class is also module 19 of the TOPRA MSc Regulatory Affairs.

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Suitability - Who should attend?

This course is suitable for

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

Outcome / Qualification etc.

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

Training Course Content

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