
MHRA Guidance on MD Regulations
The article provides a general overview of the UK regulatory framework for medical devices.
The article provides a general overview of the UK regulatory framework for medical devices.
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.
The new article provides an overview of certain aspects of the regulatory framework pertaining to contact lenses, namely, the matters associated with device identification.
The article provides a general overview of the EU vigilance regulatory framework.
The article highlights the key points related to the regulatory status of legacy devices.
The new article provides additional clarifications regarding specific aspects of the regulatory approach to be followed.