Module 13: Principles of Medical Device Regulatory Affairs - 7FHH1151

Principles of Medical Device Regulatory Affairs

Next course: May/June/July 2022

Provides an overview of the legislative framework for the regulation of devices in Europe and beyond. It enables students to understand the practical aspects of regulatory strategy for medical devices and answer questions that arise.

Overview

Students will develop an appreciation of the overall regulatory pathway and key requirements to market for a medical device product in the EU. They will deepen their understanding of all aspects of the regulations and strategic issues to be considered in relation to medical devices, including the application of the EU medical device legislation to enable products to be CE-marked.

An excellent course and would highly recommend."

Learning outcomes

Knowledge and understanding

Successful students will typically:

• Demonstrate a conceptual understanding of the strategies for development and marketing of medical device products so they can be critiqued and alternative hypotheses developed
• Demonstrate a critical knowledge of the legal and other aspects of the regulatory strategy for medical device products
• Possess a systematic understanding and critical awareness of the regulatory requirements of directives, regulations and associated documentation relating to medical device products, with particular emphasis on EU regulatory procedures.

Skills and attributes

Successful students will typically:

• Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences
• Demonstrate the ability to critically analyse the legal documentation and regulatory considerations of medical devices
• Critically appraise and evaluate communications from regulatory bodies and research publications regarding medical devices.

Developing a multispecialty overview? Consider:

• Module 0: Overview of EU Regulatory Affairs  
• 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     

Expanding your options? Consider:

• Module 1: Strategic Planning in Regulatory Affairs
• Module 18: Drug-device Combinations and Other Technologies
• Module 22: Regulatory Requirements for Cell, Tissue and Gene Therapies

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.