Examining the National Regulatory Environment of Medical Devices: Major Issues in the Risk-Benefit Assessment of High-Risk Devices

Ghislaine Mathieu & Bryn Williams-Jones


High-risk medical devices (MDs) are mostly used as last-resort treatment or in surgical procedures. Their approval by national regulatory bodies depends essentially on their quality, safety, and efficacy for a particular clinical indication. In our study, we examine the national regulatory processes of the five founding members of the former Global Harmonization Task Force (replaced by the International Medical Device Regulators Forum in 2012) – Australia, Canada, the European Union, Japan, and the United States – with a view to identifying which uncertainties associated with high-risk devices raise sufficiently serious ethical concerns to warrant more robust regulatory oversight and governance. The assessment of the safety and effectiveness of high-risk medical devices is a challenging issue, during both the premarket and post-market phases of evaluation, because there may be a lack of robust and reliable evidence to demonstrate long-term safety and effectiveness, as seen in the many product recalls in recent years (e.g., hip replacement prostheses). Faulty devices can have a significant negative impact on patients and the broader public. The deployment of unsafe or ineffective medical devices raises questions about the extent to which manufacturers, regulators, and clinicians attend to fundamental ethical principles of medicine, such as informed consent, beneficence, and non-maleficence. Respect for these principles is essential to facilitating optimal decision making by patients and clinicians who are considering recourse to a procedure involving the use of a high-risk device; failure to respect these principles can undermine public confidence in clinicians, manufacturers, and regulators. We therefore suggest some avenues to improve the current regulatory requirements and practices for high-risk devices, specifically with regard to how evidence is assessed at both the premarket and postmarket levels.

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