
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 article outlines the key points associated with the classification rules for medical devices.
The article provides an overview of the regulatory approach to be applied with respect to certain categories of innovative 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 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.