Register Medical Devices to Place on the Market

On 12 March 2021 the MHRA updated the guidance on how to register medical devices with the 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
IVDs (including all IVDs undergoing performance evaluation)
Custom-made devices
Systems and procedure packs

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.

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 Authorized Representatives based in Northern Ireland (for the purposes of the Northern Ireland market).