This guidance provides information on the EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).
From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will continue to act as the Competent Authority for medical devices in Northern Ireland. For more information about placing a device on the Northern Ireland market from 1 January 2021, please read our guidance on regulating medical devices.
This guidance is only relevant for medical devices on the Northern Ireland market. For information on the regulation of medical devices on the Great Britain (England, Wales and Scotland) market, please see our published guidance…
