Real Decreto 1616/2009, de 26 de octubre, por el que se regulan los productos sanitarios implantables activos

This Spanish Royal Decree establishes the regulatory framework for active implantable medical devices. These are specialized medical products intended to be placed inside the human body to perform specific functions, such as pacemakers or neurostimulators. Manufacturers, distributors, and healthcare providers must comply with these rules to ensure the safety and performance of these devices. The regulation aims to protect patients receiving implantable technology by setting strict standards for these medical products.