
SAHPRA Guidance on Medical Device Classification
The article outlines the key points associated with the classification rules for medical devices.
The article outlines the key points associated with the classification rules for 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.
EUDAMED (European Database on Medical Devices) is an essential information system for the European Union’s regulatory framework for 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.
The European Commission’s Health Technology Assessment Regulation (HTAR) marks a significant step toward harmonizing health technology evaluations across EU member states.