EU
The article describes in detail the approach to be followed in order to determine the regulatory status and applicable regulatory requirements.
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.
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.
EU
The article provides a general overview of the EU vigilance regulatory framework.
MDCG
The article provides a general overview of the regulatory approach to be applied with respect to corrective actions.
MDCG
The new article further elaborates on the most crucial aspects related to corrective and preventative actions to be taken by the parties responsible for medical devices in order to ensure continued safety and proper performance.
