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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).

Registering your devices with the MHRA does not mean that we give you any form of:

• accreditation
• certification
• approval for the device

You should not claim this in any marketing materials, on the packaging or in the instructions for use.

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 that demonstrates your products conform to the requirements of the Medical Device Regulations.

Who must register

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

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 single UK Responsible Person to take responsibility for all of their medical devices.

Please note that the accounts of any former Great Britain-based Authorised Representatives that have not updated their role to UK Responsible Person on the MHRA registration system, as well as the accounts of any represented manufacturers, will be suspended from 1 January 2022 until the UK Responsible Person has updated their role.

The UK Responsible Person will then assume the responsibilities of the manufacturer in terms of registering the device with the MHRA.

See guidance for more information about the role of the UK Responsible Person.

Where any changes to registrations are made, a 100 statutory fee will apply per application.

Distributors and suppliers are not required to register with the MHRA.

In cases where the Great Britain importer is not the UK Responsible Person, the importer must inform the relevant manufacturer or UK Responsible Person of their intention to import a device.

In such cases, the UK Responsible Person or the manufacturer must provide the MHRA with the importer details, including their place of business in Great Britain.

Placing a device on the Northern Ireland market

In some circumstances, it is a requirement of the UK MDR 2002 that you inform the MHRA when you first place your device on the Northern Ireland market. The precise requirements depend on the location of the manufacturer, the location of the Authorised Representative and the device class. Please see below for further information.

Register your device to place on the Northern Ireland market

Requirements for non-UK manufacturers

If you are a non-UK manufacturer, you may be required to appoint a single UK Responsible Person within the UK for IVD List A products, IVD List B products and self-test IVDs that are placed on the Northern Ireland market. A UK Responsible Person is not required on order to place IVDs that do not fall within these device classifications on the Northern Ireland market.

Non-UK manufacturers are not required to appoint a UK Responsible Person for the purpose of placing general medical devices and active implantable medical devices on the Northern Ireland market.

The requirement to appoint a UK Responsible Person for the purposes of placing an IVD on the Northern Ireland market applies in cases where:

• you are a manufacturer based in the EU or the EEA; and

• place IVDs on the Northern Ireland market that have not already been registered with an EU Competent Authority.

• you are a manufacturer based outside the UK, the EU and the EEA; and
• have an Authorised Representative based outside Northern Ireland; and
• place IVDs on the Northern Ireland market that have not already been registered with an EU Competent Authority.

The UK Responsible Person will then assume the responsibilities of the manufacturer in terms of registering the device with the MHRA.

See guidance for more information about the role of the UK Responsible Person.

Requirements for Great Britain-based manufacturers placing devices on the Northern Ireland market

Great Britain manufacturers must designate an Authorised Representative based in the EU or Northern Ireland in order to place a device on the Northern Ireland market.

Where an EU-based Authorised Representative is appointed, the Great Britain-based manufacturer must register all device classes other than Class I devices and general IVDs with the MHRA.

Where a Northern Ireland-based Authorised Representative is appointed, the Authorised Representative must register all devices with the MHRA.

Please note that new requirements have recently been introduced regarding the registration of custom-made devices in Northern Ireland. Please see below for further information.

Distributors and suppliers are not required to register with the MHRA.

Registration of importers

The Northern Ireland-based Authorised Representative or UK Responsible Person must provide the MHRA with details of the person placing the product on the Northern Ireland market if the perso

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