Medical device regulation and litigation: A comparative analysis of Australia, the United Kingdom and the United States of America

Medical devices (e.g., vascular stents and pacemakers) are commonly used in medical procedures but pose significant risk to patients if they do not function as expected. To protect patients, many countries require that medical devices be registered prior to use. However, regulation can limit innovation and restrict access to new products, creating debate on whether reduced regulation and increased litigation could adequately protect patients. This research uses a comparative methodology to examine the risk/regulatory theory that underpins medical device regulation in Australia, the United Kingdom and the United States of America and the role litigation plays in these systems