Who must register

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 registered with the MHRA.

Placing a 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:

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

Register your device to place on the Great Britain market

If the manufacturer is based outside of the UK, they must appoint a UK Responsible Person who has a registered place of business in the UK.

When to register a device on the Great Britain market

Where the manufacturer is in the UK or the Authorised Representative is in Northern Ireland, the following devices should be registered with the MHRA presently (no grace period):

• Class I devices
• Custom-made devices
• general IVDs

The following devices must be registered with the MHRA from 1 May 2021:

• Active implantable medical devices
• Class III medical devices
• Class IIb implantable medical devices
• IVD List A products

The following devices must be registered with the MHRA from 1 September 2021:

• Class IIb non-implantable medical devices
• Class IIa medical devices
• IVD List B products
• Self-test IVDs

The following devices must be registered with the MHRA from 1 January 2022 where they have not previously been required to register with the MHRA (manufacturer or Authorised Representative is not based in the UK):

• Class I medical devices
• General IVDs

Further requirements for manufacturers and importers

Manufacturers not established in the UK who need to designate a UK Responsible Person do not need to change the labelling of their products placed on the UK market. It is not mandatory to reflect the UK Responsible Person for a medical device on the labelling.

Importers who import medical devices to the UK market need to proof if a UK Responsible Person is established for the imported product and if the medical device is registered with the MHRA.

For more details, please refer to https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency