MHRA Registration

Before being placed on the UK market, all medical devices and in vitro diagnostic medical devices must be registered with the MHRA. Devices in the United Kingdom must comply with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) in order to be placed on the market and registered with the MHRA.

Only devices registered by manufacturers or UK Responsible Persons based in the UK, or Authorized Representatives based in Northern Ireland, will be accepted by the MHRA.

MHRA registration must be renewed one year following your registration application or confirmation, and every two years after that. If you do not renew your registration, your records will be removed from our database.

After that, you must submit a fresh registration application or your device will no longer be able to be sold in the UK.

The UK MDR 2002 requires you to notify the MHRA before placing your device on the market in the United Kingdom. If you or your business sells, rents, or lends, you must register.

• Class I, IIa, IIb, or III devices you have manufactured
• Class I, IIa, IIb, or III devices you have refurbished or re-labeled
• Any system or procedure pack containing at least one medical device
• Custom-made devices
• IVDs you have manufactured
• IVDs undergoing performance evaluation

Non-UK manufacturers will need a UK Responsible Person to register items placed on the UK market from January 1, 2022. If you do not register your devices, you will be unable to legally sell them in the United Kingdom.