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.
Malaysia
The article provides a general overview of the regulatory framework for medical devices no longer supported by their manufacturers, emphasizing the key points to be taken into consideration in order to ensure the continued safety of patients.
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.
EU
The new article provides an overview of certain aspects of the regulatory framework pertaining to contact lenses, namely, the matters associated with device identification.
