Register medical devices to place on the market

All medical devices, including in vitro diagnostic devices (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.

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.

As part of our data validation and scrutiny of applications to register medical devices and products with the MHRA, we may request further technical documentation from you to demonstrate that your products conform to the requirements of the Medical Device Regulations.

Registration for the Great Britain Market

The following requirements apply to place your device on the Great Britain market.

It is a requirement of the UK MDR 2002 that you inform the MHRA before you place your device on the market in Great Britain.

You must register if you or your company sells, leases, lends or gifts:

If the manufacturer is based outside the UK, they must appoint a single UK Responsible Person to take responsibility for all of their medical devices.