MEC432   Regulatory Affairs for Medical Devices   (10 credits)

Description

Medical devices bring great benefit to many patients but it is essential to ensure that devices are fit for purpose; safety is vital. This module explores the underlying principles of medical device regulation and demonstrates how a regulatory framework can be applied to reduce risks and uncertainties with ultimate benefits to the patient, user and the manufacturer. The main objectives of this module are to familiarise students with; i. current regulatory frameworks for Medical Devices, ii. the system of risk classification and how this is applied within the wide range of Medical Devices currently available and the challenges presented by innovative solutions that may become available in the future, and iii. the role of Quality Standards, CE Marking, Notified Bodies, Competent Authorities and other key regulatory agencies in this process. The way in which the system of regulation is managed at national, European and in other areas of the world will be explored highlighting similarities and differences. The students will exploit this information by developing a dossier outlining the path to be followed in seeking approval for a device from the initial design phase, through the process of testing and conformity assessment and, ultimately, leading to pre-market approval for an exemplar, novel, medical device.

Reading List