
Health Canada Pre-market Guidance for ML-enabled Medical Devices
The article describes in detail the regulatory requirements for certain innovative medical devices.
The article describes in detail the regulatory requirements for certain innovative medical devices.
Clinical evaluation is the cornerstone of the European Union Medical Device Regulation (MDR).
The introduction of the European Union Medical Device Regulation (MDR) represents one of the most significant changes in the history of medical device regulation in Europe.
The article provides an overview of the regulatory approach to be applied with respect to certain categories of innovative medical devices.
EUDAMED (European Database on Medical Devices) is an essential information system for the European Union’s regulatory framework for medical devices.