WHO Medical Device Policy Guidance: A Systemic Approach to Medical Device Ecosystems
The World Health Organisation (WHO) released the second edition of its policy guidance on the deployment of medical devices. This update represents a significant evolution from the first edition, moving away from a narrow focus on regulation and procurement toward a comprehensive medical device ecosystem framework. The guidance reflects changes in global health priorities, technological […]
FDA Investigational Device Exemption IDE: A Practical Guide to US Clinical Studies
An Investigational Device Exemption, commonly referred to as an IDE, is a critical regulatory mechanism that allows medical devices that are not yet cleared or approved to be used in clinical studies in the United States. The IDE framework enables manufacturers and sponsors to collect safety and effectiveness data while protecting study participants and maintaining […]
ISO 10993-1:2025 Explained, What Has Changed and What It Means for Manufacturers
ISO 10993-1 has long served as the foundational standard for the biological evaluation of medical devices. The 2025 revision represents a significant evolution in how biological safety is assessed, documented and integrated into overall device risk management. Rather than focusing on a checklist of biological tests, the updated standard formalises a lifecycle based, risk driven […]
MDCG 2025-9 Breakthrough Devices Guidance Under MDR and IVDR
The publication of MDCG 2025-9 marks a significant development in the European regulatory landscape for medical devices and in vitro diagnostic devices. The guidance introduces a structured framework for qualifying, assessing and certifying breakthrough medical devices and IVDs under the MDR and IVDR. It clarifies how innovation that delivers meaningful clinical impact should be evaluated […]
FDA Premarket Notifications 510(k): A Practical Guide for Medical Device Manufacturers
The FDA Premarket Notification pathway, commonly known as the 510(k), is the most widely used route to market for medical devices in the United States. Primarily applying to moderate risk devices, it requires manufacturers to demonstrate that a new device is at-least-as-safe and effective as a legally marketed predicate device. Crucially, a 510(k) is not […]
FDA Premarket Approval PMA, A Practical Guide for High Risk Medical Devices
The FDA Premarket Approval process, commonly referred to as PMA, is the most rigorous regulatory pathway for medical devices in the United States. It applies to high-risk, Class III devices, which are those that support or sustain human life, are of substantial importance in preventing impairment of human health or present a potential unreasonable risk […]