Постановление № 185 от 31 юли 2007 г. за приемане на Наредба за съществените изисквания и процедурите за оценяване на съответствието със съществените изисквания на активни имплантируеми медицински изделия

This regulation establishes the essential safety and performance requirements for active implantable medical devices. It also outlines the specific procedures required to assess whether these devices comply with these standards, ensuring they are safe for long-term use inside the human body. Manufacturers of active implantable medical devices and healthcare regulatory bodies are affected. The rules ensure that patients receiving implants, such as pacemakers, are protected by strict quality and safety assessments.