MSc in Regulatory Affairs: Module 12 – Medical Device Regulatory Affairs

Aim

To provide students with a good appreciation of the regulatory control of medical devices particularly within the European Union. After participation in the Module, students should be able to provide strategic advice on the application of the medical device directives to enable products to be CE-Marked and on key international legislation.

Learning outcomes

• Students will distinguish the routes to Conformity Assessment in the EU.
• Students will assess the role of the Competent Authorities and the Notified Bodies.
• Students will define the requirements of post-market surveillance and vigilance, and the role that risk management plays throughout the lifecycle of a device.
• Students will identify the documentation requirements for CE-Marking and the application of Harmonised Standards.
• Students will compare how medical devices are regulated in other markets and examine related international activities such as the Global Harmonisation Task Force.
• Students will interpret the requirements of clinical evaluation, how to initiate a clinical study and the ever increasing impact of Health Technology Assessment.

Outline of Module topics

• The New Approach legislative environment in the European Union and the medical devices directives
• Conformity Assessment procedures
• Clinical evaluation
• Essential Requirements and Standards
• Risk-based classification system
• Post-market surveillance including vigilance
• Risk analysis and risk management
• The role of the Competent Authority and the Notified Body
• Medical device legislation in other markets and the Global Harmonisation Task Force
• Labelling for medical devices
• Devices containing drugs and borderline products
• In-vitro diagnostics

Links with other modules

• Module 1 covers global regulatory strategy.
• Module 4 and 5 cover the global clinical development programme.
• Module 7 and 8 cover regulatory strategies and data requirements for abridged applications.
• Module 9 covers global strategies for biotechnology products.

ECTS credits

"Whilst the TOPRA MSc in Regulatory Affairs is based in the UK it has students globally, and covers regulations globally, too. It is also part of the "European Credit Transfer and Accumulation System"(ECTS). This means that if you attend its modules then you can get credits against other degree courses across Europe should you wish to transfer the learning which you have accumulated, and vice versa where you have done studies of part of an MSC course in another EC country. This has great advantages of mobility and flexibility.

For more information contact the TOPRA office or go to www.topra.org/msc/ects.