Page Last Updated: 4 October 2023

What are the requirements in Northern Ireland?

From a regulatory standpoint, the UK is made up of two territories:

All four UK countries left the European Union in the so-called ‘Brexit’. However, the two territories are subject to differing regulatory requirements.

Great Britain

Medical devices and IVDs in Great Britain, fall under the requirements of the UK Medical Device Regulation 2002 (UK MDR 2002). Currently the UK MDR 2002 allows manufacturers to market based on either their European CE Marking, or UKCA Marking. Further, they are required to appoint a UK Responsible Person (if located outside of the UK) and register their devices with the MHRA.

The CE Marking grace period was originally supposed to end on 30 June 2023; however, the MHRA extended it.

After the transition period ends, devices must be UKCA marked to be placed on the Great Britain market. Once this occurs, the requirements between Great Britain and Northern Ireland will more fully diverge.

For more information on the UKCA marking transition dates, please read: UK MHRA Announces New Dates for UK Regulation & CE Marking

Northern Ireland

Northern Ireland requires, and will continue to require, European CE marking. The MDR and IVDR dates of application were mandatory in Northern Ireland, just as they were throughout the European Union.

This includes all of the requirements needed to meet CE marking, such as: compilation of the technical documentation file compliant with the EU Directives/Regulations, as applicable; appointment of a European Authorized Representative; registration of Economic Operators and devices; appointment of Person Responsible for Regulatory Compliance; market surveillance; post-market surveillance; vigilance monitoring and reporting.

Unlike the rest of the UK, Northern Ireland will not implement, nor recognize, UKCA marking.

Why are Northern Ireland’s requirements different?

To ensure that a hard border was not implemented between Northern Ireland and Ireland (aka Republic of Ireland), the Northern Ireland Protocol was put into place. This was to safeguard the 1998 Good Friday (Belfast) Agreement.

England, Scotland, and Wales (‘Great Britain’) all share a common landmass. While Northern Ireland is a UK country, it is not part of Great Britain.

Further, Northern Ireland is physically separate from Great Britain and instead shares its landmass with Ireland (“the island of Ireland”), which is a European Union member state. There are up to 30,000 estimated cross-border workers/students between Northern Ireland and Ireland.

What is the Northern Ireland Protocol / Windsor Framework?

Prior to Brexit, Northern Ireland and the Republic of Ireland followed the same EU trade requirements, making it easy to move goods between the two countries. However, after Brexit, suddenly trade restrictions exist under the EU-UK Trade and Cooperation Agreement, which entered into force on 1 May 2021.

Considering the historical movement of goods between Northern Ireland and Ireland, the Protocol on Ireland and Northern Ireland* was put into place.

The Protocol:

Northern Ireland is not intended as a way to avoid customs duties or circumvent UKCA marking requirements. Please see the MHRA’s guidance on moving qualifying goods from Northern Ireland to the rest of the UK for more details.

*The above is a general overview of the Protocol; there are nuances and caveats in the 181-page document not addressed here.

Windsor Framework

The Northern Ireland Protocol was replaced with the Windsor Framework, effective as of 1 October 2023. The Windsor Framework does not change the medical device regulatory requirements in Northern Ireland. It is focused on:

“…providing a fundamentally new set of arrangements to restore the smooth flow of trade within the UK internal market; safeguard Northern Ireland’s place in the Union; and address the democratic deficit that was otherwise at the heart of the original Northern Ireland Protocol.”

For more information, please read:

Do I need a UKRP and/or EU AR for Northern Ireland?

EU Authorized Representative (EU AR)

Any manufacturer not within the European Single Market must appoint a European Authorized Representative (EU AR) in order to place devices onto the market in Northern Ireland. The EU AR can be, but is not required to be, located in Northern Ireland.

The above requirement to appoint an EU AR for Northern Ireland also applies to manufacturers located in Great Britain. Northern Ireland requires CE Marking and CE Marking requires all ‘third country’ manufacturers to appoint an Authorized Representative. Therefore, Great Britain manufacturers must obtain CE marking and appoint an EU AR to place devices onto the market in Northern Ireland.

Read more about the Authorized Representative requirements here: European Authorized Representative

UK Responsible Person (UKRP)

A UK Responsible Person (UKRP) is not required to place devices onto the market in Northern Ireland. While the MHRA’s 1 January 2022 version guidance ‘Regulating medical devices in the UK’ did state it was required for certain types of devices, the 27 April 2023 update removed this requirement.

Read more about the UKRP requirements here: UK Responsible Person

Do Northern Ireland manufacturers need UKCA marking to sell in Great Britain?

No, Northern Ireland manufacturers do not need UKCA marking to place their devices onto the Great Britain market – CE marking is sufficient.

While Great Britain (England, Scotland, Wales) manufacturers require CE Marking (and an EU Authorized Representative) to place devices onto the Northern Ireland market, Northern Ireland manufacturers are not required to obtain UKCA marking to place devices onto Great Britain.

This is per the MHRA’s guidance document, which states:

“The UK Government has guaranteed unfettered access for Northern Ireland’s businesses to the rest of the UK internal market.

For medical devices, this means that any CE marked device held by a Northern Ireland business is valid for the whole of the UK market provided it falls within the definition of a qualifying “Northern Ireland good”. Therefore, CE and CE UKNI marked devices that can be placed on the Northern Ireland market and are qualifying Northern Ireland goods, can also be placed on the Great Britain market.

In addition, if you are a Northern Ireland-based manufacturer and have already registered your device with the MHRA for the purposes of Northern Ireland, it can be placed on the Great Britain market and will not need to undergo any further registration in Great Britain.“

Is MHRA registration required for Northern Ireland?

In some situations, yes, medical devices must be registered with the MHRA even if they’re only being placed onto the Northern Ireland market and not onto the rest of the UK.

Northern Ireland requires CE Marking, and therefore, registration requirements should follow the EU Directives/Regulations, as applicable. However, there are certain cases where devices being placed on the Northern Ireland market must be registered with the MHRA.

Please see the table below for more details.

What is UKNI Marking?

UKNI Marking is only required in the following situation:

A manufacturer placing devices onto the Northern Ireland market chooses a UK-based conformity assessment body (aka ‘UK Notified Body’) to issue CE Marking. In this situation, manufacturers would apply both the CE marking and UKNI marking to the device. UKNI Marking is never issued on its own, without CE marking.

The reason for UKNI Marking, is that there are still some UK-based conformity assessment bodies accredited to issue CE Marking, from when the UK was still an EU member state. However, while they could apply to do so in the future, no UK Notified Bodies are currently accredited to issue CE Marking to the MDR/IVDR. Currently, they are all only able to issue CE marking under the Directives .

UKNI Marking does not apply in the following scenarios:

In Short

If you do not use a UK Notified Body for CE Marking, then UKNI Marking does not apply to you. Considering none of the UK Notified Bodies are designated under the MDR/IVDR, the likelihood of needing UNKI Marking is low. 

Do I need UKNI Marking to sell in Northern Ireland?

Generally, no, UKNI Marking is not required to sell medical devices in Northern Ireland. As mentioned in the above UKNI Marking section, UKNI Marking is rarely needed.

What is ultimately needed to place devices onto the UK markets is:

Great Britain

Northern Ireland

What is the Northern Ireland MHRA Authorized Route (NIMAR)?

You may have seen or read updates regarding this route, which became operational as of January 1, 2022.

The Northern Ireland MHRA Authorised Route (NIMAR) is a special access route for medicines, not medical devices. It is to help ensure that people in Northern Ireland continue to have access to prescription-only medicines, if their clinical needs cannot be met through other authorized products or existing regulatory routes. i.e., it provides access to medicines that are unlicensed in Northern Ireland, but which are licensed in Great Britain.

This process is tightly controlled and, as mentioned above, is an option available for medicines and not medical devices.

Differences between Northern Ireland & Great Britain

The below is a brief overview of differences. Please read the above sections for more details.