EU MDR Medical Device Classification System: Your Guide
EU MDR establishes requirements for the safety, performance, and marketing of medical devices to ensure patient safety. The EU MDR medical device classification system has been developed to simplify the regulatory pathway for medical devices entering Europe. Correct...
CE-marked Medical Devices and IVDs to Remain Accepted Indefinitely in Great Britain
The UK government has confirmed eligible CE-marked medical devices and IVDs will continue to be recognized indefinitely in Great Britain. This removes previous uncertainty around future market access. The decision reduces regulatory duplication for manufacturers,...
Illustrated guide to IEC 62304 & medical device software development
In this guide, we will explain the role of IEC 62304 in safe and compliant medical device software development. IEC 62304 is not merely a documentation standard. It is a risk-based framework for managing the entire software life cycle of medical devices. Notably,...