RegDesk News/Info
The article outlines the key points associated with the classification rules for medical devices.
Medical Devices
Clinical evaluation is the cornerstone of the European Union Medical Device Regulation (MDR).
Medical Devices
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.
Medical Devices
EUDAMED (European Database on Medical Devices) is an essential information system for the European Union’s regulatory framework for medical devices.
Medical Devices
In the highly regulated world of medical devices and in vitro diagnostics (IVDs), ensuring compliance with international standards is critical for market access and patient safety.
Medical Devices
The European Commission’s Health Technology Assessment Regulation (HTAR) marks a significant step toward harmonizing health technology evaluations across EU member states.
