How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland.
All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in Great Britain (England, Wales and Scotland).
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 placed on the market and registered with the MHRA.
Registration requirements differ for Northern Ireland.
The MHRA will only accept registration 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).
You must ensure all information registered with the MHRA is accurate and up to date.
Registration of your devices with the MHRA (the UK Competent Authority) does not represent any form of accreditation, certification, approval or endorsement by the MHRA.
Therefore, you are not permitted to make any claims to this effect, including the use of any MHRA logos in any marketing materials, on device packaging, in the instructions for use, on laboratory tickets/dockets, or in any other documentation.