Module 19: Regulation of In Vitro Diagnostic Medical Devices - 7FHH1157

Regulation of In Vitro Diagnostic Medical Devices

Next course: September/October 2023

Provides students with a clear understanding of the regulatory framework and requirements relating to the placing of in vitro diagnostic medical device products (IVDs) on the market in the EU. In addition to the EU regulatory environment, this module covers other jurisdictions, such as Japan, China and Brazil.

Overview

This module includes definitions, classification, standards and conformity assessment; clinical evaluation and notified body involvement; quality management systems; technical documentation and requirements for performance data; risk management; labelling and product information; traceability, post-market surveillance and vigilance; registration requirements; and other relevant legislation. Strategic issues and developing technologies are also considered.

Thoroughly enjoyed this module and found it very informative."

Learning outcomes

Knowledge and understanding

Successful students will typically:

• Demonstrate a critical understanding of the regulatory environment and framework in the EU and other territories and critically evaluate how these compare with each other
• Critically evaluate the challenges involved in conducting clinical evidence studies using IVD products, by considering the differences between these products and other medical devices in the design and production of clinical data
• Demonstrate a critical understanding of quality system requirements associated with the manufacture and supply of IVDs
• Demonstrate a critical understanding of the different stakeholder roles involved in manufacturing, supply and regulation of IVDs.

Skills and attributes

Successful students will typically:

• Be able to recommend development strategies for IVD products to 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.

Developing expertise in cutting edge medical technologies? Consider:

• Module 12: Data Management and Digitalisation in Regulatory Affairs
• Module 18: Drug-device Combinations and Other Technologies
• Module 20: Regulation of Electrical, Electronic and Software Devices      
• Module 22: Regulatory Requirements for Cell, Tissue and Gene Therapies

Expanding your options? Consider:

• Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products
• Module 14: Design, Development and Certification of Medical Devices
• Module 15: Clinical Evaluation of Medical Devices
• Module 16: Post-Market Surveillance and Vigilance for Medical Devices
• Module 21: US Regulation of Medical Devices

See the table below for the next planned dates for these modules.

Module schedule

The following table outlines the scheduling for all MSc modules through 2025.

Visit our Masterclasses page to see which modules are currently open for registration.