MHRA guidance on registering medical devices for sale in the UK from 1 January 2021

The below highlights how to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland from 1 January 2021.

Update on the requirements

From 1 January 2021 the following devices will need to be registered with the MHRA under existing arrangements:

• Class I medical devices
• IVDs
• Custom-made devices

All other classes of device placed on the Great Britain market will require registration with the MHRA, subject to grace periods, over the following 12 months, depending on the class of devices.