Ce Marking Ho

The document provides an overview of CE marking requirements for medical devices in Europe. It discusses regulations that require medical devices to be safely and effectively designed and developed. Regulations are in place to ensure devices placed on the market do not compromise patient safety or health. Manufacturers must implement a risk management system and conduct clinical evaluations or reviews of scientific literature to demonstrate a device's safety and performance. Notified bodies assess and provide approval for higher risk devices. Manufacturers must maintain technical files and address post-market surveillance requirements. Standards can be used to demonstrate compliance with regulatory requirements.