European Union
The article provides a general overview of the UK regulatory framework for medical devices.
AI
The article provides an overview of the regulatory approach to be applied with respect to certain categories of innovative 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.
Medical Devices
The European Commission’s Health Technology Assessment Regulation (HTAR) marks a significant step toward harmonizing health technology evaluations across EU member states.
Medical Devices
This article outlines the key steps and practices to ensure effective cybersecurity protocols.
