Regulatory oversight of patient safety in medical devices

Abstract

The increasing reliance on medical devices and in vitro diagnostic technologies has improved healthcare outcomes but also raised the need for robust regulatory oversight to ensure patient safety. The aims of this study were to identify weaknesses in medical device patient-centred regulatory sciences, and to develop a post-market surveillance regulatory framework focused on providing a strategic oversight approach to ensure long-term patient safety. The methodology consisted of three phases. Phase I identified procedures across EU and non-EU countries related to the oversight of post-market surveillance and vigilance, coupled with a review of global standards and guidelines. Insights were captured in a data collection tool disseminated to European surveillance and vigilance regulatory experts. Findings from this phase informed the design of a regulatory framework in Phase II. Phase III included pilot testing of the framework on a sample of incident reports from the Malta Medicines Authority medical device vigilance database, and a SWOT analysis to refine the framework. Data from each incident report was collated using a developed evaluation template. An adapted CASP-based tool was used to assess application of the developed framework to incident reports to evaluate regulatory performance in real-world scenarios for pilot testing. Phase I revealed five key areas of patient-centric regulatory weaknesses. These areas formed the main domains of the data collection tool: (a) resources in regulatory authorities, (b) incident reporting, (c) legal requirements of legacy and custom-made devices, (d) the recall process, and (e) integration of artificial intelligence (AI) in surveillance and vigilance regulation. The twelve respondents of the data collection tool emphasised the need for training of economic operators on post-market surveillance responsibilities and highlighted the lack of harmonisation and challenges with AI integration. The framework developed in Phase II mapped regulatory processes involved in ensuring safety and performance of medical devices across risk classes, including specific niches such as custom-made devices. It outlines the responsibilities of stakeholders to enhance collaboration and inform training modules, and provides guidelines on integrating the requirements of the newly-adopted AI legislation into regulatory processes. In Phase III, the SWOT analysis revealed opportunities, namely developing guidelines to align AI and medical devices regulations, and implementing training strategies to address threats like the outpacing of regulation by rapidly-evolving technologies. The developed regulatory framework is intended to enhance post-market surveillance and vigilance oversight in medical device regulatory sciences. By addressing key weaknesses and supporting integration of AI-driven solutions, the framework aims to provide a proactive structured approach to mitigate risks while still fostering innovation, to maintain patient safety.