Overview

A key part of the agreement on the UK withdrawal from the European Union was the implementation of the Northern Ireland Protocol. This means that certain products on the Northern Ireland market, including medical devices, are required to comply with relevant EU legislation as well as with UK law.

Under the Northern Ireland Protocol, any product moving from or through Great Britain (England, Wales and Scotland) to Northern Ireland is considered an import into the EU. A Northern Ireland retailer or wholesaler of medical devices may now be considered an importer for Northern Ireland as opposed to a distributor of products.

Since 1 January 2021, there have been new requirements for placing medical devices on the Great Britain and Northern Ireland markets. These are explained in our guidance on regulating medical devices.

This guidance summarises the key changes that will affect Northern Ireland supermarkets and other retailers after the transition period.

Conformity marking

A CE marking must be affixed to medical devices so that they can be placed on the EU market. The CE marking demonstrates that a device conforms to the relevant EU legislation.

Northern Ireland continues to follow EU rules on medical devices and a CE marking is required for devices placed on the Northern Ireland market.

In Great Britain devices must carry the UKCA product mark. Devices carrying the UKCA mark alone cannot be sold in Northern Ireland. However dual marked devices (CE or CE and UKNI and UKCA) will be accepted on the Northern Ireland market.

In cases where a UK-based notified body has undertaken third party conformity assessment for a device, that device will be marked with both a CE and a UKNI indication. Devices affixed with both the CE and UKNI markings can be sold in Northern Ireland but will not be valid for the Republic of Ireland or other EU Member States.

Additional importer requirements

Previously, when goods moved into Northern Ireland from Great Britain, they were being distributed. A Northern Ireland business is now considered an importer if they are bringing goods into Northern Ireland from either Great Britain or another non-EEA country and placing them on the Northern Ireland market.

This means that Northern Ireland businesses (including supermarkets) may now have additional importer obligations.

The precise requirements will depend on which legislation the manufacturer has certified their devices under, as set out below. The retailer should check with the manufacturer which legislation has been used in order to understand and apply the specific requirements.

For devices that conform to the Medical Devices Directive (Directive 93/42/EEC) (MDD) or the Active Implantable Medical Devices Directive (Directive 90/385/EEC) (AIMDD), which will continue to apply in Northern Ireland until 25 May 2021, or the in vitro Diagnostic Medical Devices Directive (Directive 98/79/EC) (IVDD), which will continue to apply in Northern Ireland until 25 May 2022, existing obligations around storage, transportation and checking device labels for the CE marking, as set out in the Blue Guide, will continue to apply.

Since 26 May 2021 the new EU Medical Device Regulators (MDR) (Regulation 2017/745) will fully apply in Northern Ireland. This covers medical devices, including for example, bandages, plasters and thermometers.

Since 26 May 2022, the new in vitro Diagnostic Medical Devices Regulations (IVDR) (Regulation 2017/746) fully applies in Northern Ireland. This will cover in vitro diagnostic medical devices, including for example pregnancy self-test kits.

The MDR and IVDR place additional obligations on importers. You can read more about these obligations in our guidance on the EU regulations for MDR and IVDR.

The importer is also required to inform the relevant manufacturer (if the manufacturer is based in Great Britain), Northern Ireland-based Authorised Representative or UK Responsible Person of their intention to import a device. The Great Britain-based manufacturer, Northern Ireland-based Authorised Representative or UK Responsible Person is in turn required to provide the MHRA with a list of device importers. Please see our registrations guidance page for more information.

Customs requirements

If you move goods between Great Britain and Northern Ireland the Trader Support Service will guide you through any changes due to the implementation of the Northern Ireland Protocol. You can read more about the Trader Support Service in our guidance.

It may be that your goods will be covered by common or Union transit, in which case importer obligations will not apply to your device. You can read more about this in our guidance on using common or Union transit.

Further information

For further information, you can email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000.

Alternatively, contact your Trade Association by emailing:

Association of British HealthTech Industries (ABHI): enquiries@abhi.org.uk
British In Vitro Diagnostics Association (BIVDA): enquiries@bivda.org.uk
Proprietary Association of Great Britain (PAGB): regulatory@pagb.co.uk

Supplying medical devices to Northern Ireland