Site search

This article is the second of two on the EU Artificial Intelligence Act (EU AI Act) and its interaction with the EU Medical Devices Regulation (EU MDR) for AI‑enabled medical devices. The first article focuses on risk classification and the points of convergence and divergence between the two frameworks. Building on that foundation, this article identifies key implementation gaps and proposes ways manufacturers can operationalize EU AI Act obligations using existing EU MDR processes and international standards, including risk management, data governance, transparency, and postmarket monitoring, until CEN-CENELEC harmonized standards and common specifications become available. The article also provides a decision tree to help readers prepare for the phased rollout of EU AI Act implementation.

This article provides a detailed examination of the evolution of the framework for predetermined change control plans (PCCPs) in the US from concept to implementation and its emergence as a potential global standard. Building on perspectives shared by regulatory, legal, and technical experts, it analyzes key elements of two recent US Food and Drug Administration (FDA) guidance documents for PCCPs for artificial intelligence-enabled device software functions and for all medical devices. The article further explores best practices for drafting and maintaining PCCPs across the total product lifecycle and considers their strategic implications for manufacturers and regulators.

Global regulatory harmonization in the medical device sector is essential for ensuring timely patient access to safe and effective technologies while reducing redundant regulatory burdens. This article explores the evolving landscape of harmonization efforts, focusing on the convergence of regulatory frameworks across key markets such as the EU, US, and Asia-Pacific region. It highlights the role of international initiatives such as the International Medical Device Regulators Forum (IMDRF), reliance models, and mutual recognition agreements in shaping a more unified global approach. Furthermore, the article examines how regulatory reliance, streamlined documentation, and shared clinical evidence are being leveraged to accelerate approvals and maintain compliance. It also addresses the challenges of aligning diverse regulatory expectations, particularly in postmarket surveillance (PMS), labeling, and quality system requirements. The discussion underscores the importance of cross-functional collaboration, digital transformation, and proactive engagement with notified bodies and competent authorities, emphasizing the importance of a strategic, risk-based approach to global regulatory operations that balances innovation, patient safety, and market agility.

While FDA experience is highly valued in the private industry, transitioning from the agency to private-sector employment requires new skills and a shift in mindset. This article provides resources for regulatory professionals with FDA experience seeking careers in the private sector. The article explores common career pathways in the medical device space, addresses key differences between the FDA and industry roles, and provides strategies for leveraging FDA experience outside the agency. The insights are based on the authors' experiences after departing from the FDA. The article is divided into two sections – the first outlining career pathways and the second offering advice on job hunting.