The applicable regulations
The United Kingdom (UK) consists of two markets for in vitro diagnostic (IVD) medical devices: (1) The Great Britain market covering England, Scotland and Wales and (2) the Northern Ireland market. Different rules apply in the two markets.
In Great Britain (GB) IVDs must comply with the UK Medical Device Regulations of 2002. At that time, UK MDR 2002 transposed the EU’s in vitro diagnostic Directive (IVDD) into UK law and continues to be the legislation in force in Great Britain; now with GB specific requirements for UKCA marking, registration with MHRA, a UK responsible person and a UK approved body. Additionally, a 2023 amendment to UK MDR 2002 allows IVD devices which comply with either the original EU IVDD, or with the latest EU IVDR, to also be accepted on the GB market, again with some GB specific requirements.
Click the button below for more details on the regulations that apply to IVDs in Great Britain (England, Scotland, Wales).
In Northern Ireland (NI) medical devices must comply with the EU’s latest IVD regulation (IVDR). Click the button below for more details on the regulations that apply to IVDs in Northern Ireland.
Appointing a UK Responsible Person
To place a device on the Great Britain market, manufacturers based outside of the UK must appoint a UK Responsible Person established in the UK.
Different requirements exist for the Northern Ireland market where EU authorised representatives are also recognised.
Registrations in Great Britain and Northern Ireland
In Great Britain all medical devices, including IVDs, must be registered with the MHRA before they can be placed on the market. In Northern Ireland the registration requirements depend on the location of the manufacturer or the Authorised Representative.
The MHRA only accepts registrations of devices from manufacturers or UK Responsible Persons that are based in the UK, or from Authorised Representatives based in Northern Ireland (for the purposes of the Northern Ireland market).
Click the link below to view the MHRA’s most recent guidance on registering medical devices for the markets in Great Britain and Northern Ireland.
You can view the MHRA's registration database using the link below.
Marking requirements
In vitro diagnostic devices placed on the Great Britain market may have either a UKCA mark or a CE mark on the labelling, depending on which legislation the device has been certified under.
Follow the link below for more information about the UKCA marking.
Ongoing recognition of CE marking in the GB market
In 2023 the UK government extended the acceptance of CE marked IVDs on the Great Britain market. The legislation allows for CE marked IVDs to be placed on the Great Britain market according to the timelines shown below:
