MSc MTRA: Module 1 - Principles of European Medical Technology Regulatory Affairs

Aim

To provide regulatory affairs professionals with a clear understanding of the regulatory path for placing and maintaining medical technology on the market in the European Union (EU) and associated territories.

Course Content

The course addresses European institutions involvement in medical technology regulatory affairs in the EU and the roles they play in relation to current EU legislation, its history and on-going development. The course also outlines the criteria for classifying different types of medical technology and conformity assessment route options for the different classes of technology. It provides an understanding of what is required in a technical file and a design dossier and outlines the detailed activities leading to a CE-Mark.

Lectures

Lectures will be delivered by a number of speakers from industry.
Topics covered include:

• Context and structure of directives within the EU legislative framework
• Role of European Commission, competent authorities and notified bodies
• Definitions / classification of technology and devices including drug / device borderline products
• Conformity assessment routes and the role of quality management systems (ISO 13485) in the CE marking process
• Technical documentation – compilation, content and assessment of compliance with requirements of the directives
• Demonstration of conformity through pre-clinical bench testing and clinical evaluation
• Introduction to the central role of risk assessment and management in regulatory affairs
• Introduction to other applicable regulations
• Summary of post-market regulatory activities

Learning outcomes

Upon completion of the course candidates will be able to:

• Demonstrate a thorough understanding of legislation in Europe, its history and on-going development
• Outline the legislation applicable to specific medical technologies to be marketed within the EU and associated territories
• List the European institutions involved in medical technology regulatory affairs in the EU and demonstrate knowledge of the roles they play
• Describe the criteria for classifying different types of medical technology and be able to determine the conformity assessment route options for the different classes of technology
• Describe and understand what is required in a technical file and a design dossier and outline the detailed activities leading to a CE-Mark
• Demonstrate an ability to apply all of the core components of the module within a group setting, where consensus and team leadership skills will be required.

Medical Technology Regulatory Affairs MSc

In collaboration with TOPRA, the Cranfield MSc provides for the first time a recognised way for professionals working within healthcare regulatory affairs or related areas to formalise their skills in the field of medical technology. Available on a part-time basis only, the MSc is designed to be flexible to fit around your current job and responsibilities. For even greater flexibility, and for professionals with a specific interest, individual modules can be attended as standalone three-day short courses.

For more information about our MSc please contact our Enquiries Office Tel: +44 (0) 1234 758008 Email: enquiries.health@cranfield.ac.uk Website: www.cranfield.ac.uk/health/mod1

In order to access comprehensive information about this particular MSc, please click on the following link - Enquiry Form