UK – Regulation of devices in Northern Ireland

Information about the EU Regulations and their implementation in Northern Ireland

The​ Medicines and Healthcare products Regulatory Agency (MHRA) ​​​is​ the Competent Authority for medical devices and in vitro diagnostic (IVD) devices in Northern Ireland.

This guidance provides general information about regulatory requirements for placing medical devices and IVD devices on the Northern Ireland market only. For information on the regulation of medical devices on the Great Britain (England, Wales and Scotland) market, please see our published guidance