Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems

This guidance aims to assist sponsors of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 medical devices intended to be used in direct contact with the heart, CCS or the CNS will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.

Download the guidance