Before being sold in the United Kingdom, all medical devices, IVDs, and custom-made devices must be registered with the MHRA so-called MHRA Registration. This is mandatory for all types of devices. To be registered with the MHRA in the United Kingdom (England, Wales, and Scotland), devices must comply with the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023).
Where the manufacturer or their UK Responsible Person has a registered place of business in the UK, the MHRA registration is feasible. If the manufacturer is located outside of the United Kingdom, they must nominate a UK Responsible Person with a registered business address in the United Kingdom.