The regulatory process for medical devices is complex and is to some degree dependent on the nature of the device and its classification. In this assignment, you will consider the regulatory

pathway needed to take a transcatheter heart valve and its delivery device to market in accordance to the Medical Devices Regulation 2017/745. You are required to discuss the steps the manufacturer needs to take in the key stages below to gain CE Marking: 1. Confirm medical device classification and chosen conformity route 2. Identify and meet the General Safety and Performance Requirements, and 3. Summarise Technical File contents covering various aspects of the medical device (10 marks) (10 marks) (10 marks) Your report should be a 5-page document (with references allowed on an additional page) and font size should 12 point. You should use the lectures and notes given throughout the module together with any other sources you may find useful in compiling this report. References must be included within the text and also listed at the end as a bibliography/reference list.