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 […]
In Vitro Diagnostic Devices (IVDs), FDA Classification and Regulatory Pathways Explained
In vitro diagnostic devices, commonly referred to as IVDs, play a critical role in modern healthcare by enabling the detection, diagnosis and monitoring of disease. These products inform clinical decision making across a wide range of settings, from central laboratories to point of care environments and, increasingly, the home. In the United States, IVDs are […]
Unique Device Identification in the USA, FDA UDI Requirements Explained
Unique Device Identification, commonly referred to as UDI, is a foundational element of the FDA regulatory framework for medical devices in the United States. The system was established to improve traceability, strengthen post market surveillance, support recall efficiency and enhance patient safety. UDI also enables standardised identification of medical devices across electronic health records, clinical […]
Hazard and Harm in Medical Device Risk Management: What Manufacturers Need to Know
Understanding hazard, harm, and the hazardous situation is fundamental to effective risk management for medical devices. Yet these concepts are often confused, particularly when teams map risks into an ISO 14971 compliant Risk Management File. Getting them right matters. These definitions shape every part of the risk-management lifecycle, from design and development through to production, […]