How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
The following devices in Great Britain (England, Wales and Scotland) need to be registered with the MHRA under existing arrangements:
- Class I medical devices
- custom-made devices
All other classes of device placed on the Great Britain market require registration with the MHRA subject to grace periods, depending on the class of devices.
In Great Britain devices must conform to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) as they apply in Great Britain so that they can be registered with the MHRA.
Registration requirements under those regulations differ for Northern Ireland.
The MHRA will only accept registration of devices from manufacturers or UK Responsible Persons that have a place of business in the UK, or from Authorised Representatives based in Northern Ireland (for the purposes of the Northern Ireland market).