Amendment: Exempted implantable and class III devices (Reg 2017/745)

This regulation updates the list of high-risk medical devices, specifically implantable and Class III devices, that are exempt from the requirement to conduct full clinical investigations. It aims to streamline the certification process for well-established devices while maintaining patient safety standards.

This affects medical device manufacturers and healthcare providers. It reduces the regulatory burden for producing specific high-risk devices by allowing alternative evidence of safety and performance instead of new clinical trials.