GMLP
The article describes in detail the regulatory requirements for certain innovative 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.
AI
The article provides an overview of the regulatory approach to be applied with respect to certain categories of innovative medical devices.
Medical Devices
EUDAMED (European Database on Medical Devices) is an essential information system for the European Union’s regulatory framework for medical devices.
BfArM
The Federal Institute for Drugs and Medical Devices (BfArM), the German regulating authority in the sphere of healthcare products, has published a notice dedicated to notifications of interruptions or terminations of the supply of medical devices the parties responsible should submit in order to communicate the crucial information to all the stakeholders involved.
