2023: Northern Ireland Medical Device Requirements

The United Kingdom is made up of four countries: England, Scotland, Wales and Northern Ireland. All four countries left the European Union in the so-called ‘Brexit’. Collectively England, Scotland and Wales make up Great Britain. While Northern Ireland is a UK country, they are not part of Great Britain.

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

This includes all of the requirements needed to meet CE marking, such as: compilation of the technical documentation file compliant to 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 or recognize UKCA marking. Many of the above CE marking requirements differ from UKCA requirements.

Currently manufacturers may place CE marked devices onto the Great Britain market, as long as they have met the requirement to appoint a UK Responsible Person and register their devices with the MHRA. That allowance was originally supposed to end on 30 June 2023; however, the MHRA postponed it by one year, to July 2024. Additionally, the MHRA will provide a further 3-5 transition period.

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

For more information the UKCA marking transition dates, please read: MHRA Officially Postpones UKCA Marking

Why are Northern Ireland’s requirements different from the rest of the UK?

While the UK, as a whole, voted to leave the European Union by a narrow margin, Northern Ireland’s majority vote was to remain in the EU. However, Scotland also voted by a high majority to remain an EU member state. So, why would Northern Ireland opt to keep closer EU ties and continue to require CE Marking, while Scotland will move forward with UKCA marking?

Aside from the political factors, another consideration is location.

England, Scotland and Wales (‘Great Britain’) all share a common landmass. While Northern Ireland is a UK country, they are not part of Great Britain. Further, Northern Ireland is physically separate from Great Britain and instead shares its landmass with Ireland (aka Republic 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. Notably, the Northern Ireland/Ireland border is the UK’s only land border with the EU.

What is the Northern Ireland Protocol?

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:

- Includes Northern Ireland in the EU Single Market for goods and the Customs Union
- Requires that UK goods must undergo checks and controls at Northern Ireland ports of entry
- EU customs duties apply to goods entering Northern Ireland from any other part of the UK (or any other third country)

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. If you have compliance concerns, we recommend reading to the Protocol in full for comprehensive understanding.

Do I need a UK Responsible Person and/or EU Authorized Representative for Northern Ireland?

European Authorized Representative

Any manufacturer not within the European Single Market must appoint a European Authorized Representative (EU AR) in order to place devices onto 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. Because Northern Ireland requires CE Marking and CE Marking requires all ‘third country’ manufacturers appoint an Authorized Representative, Great Britain manufacturers must obtain CE marking and appoint an EU AR to place devices onto Northern Ireland.

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

UK Responsible Person

A UK Responsible Person (UKRP) is only required for non-UK companies placing certain types of IVDs onto Northern Ireland. Specifically, per the MHRA guidance, if:

- you are a manufacturer based in the EU or the EEA; and
- you place an Annex II device or a device for self-testing on the Northern Ireland market or make available such a device for performance evaluation; OR
- you are a manufacturer based outside the UK, the EU and the EEA; and
- you have an Authorised Representative based outside Northern Ireland; and
- you place an Annex II device or a device for self-testing on the Northern Ireland market or make available such a device for performance evaluation.

If you have appointed an EU AR located in Northern Ireland, they may also act as your UKRP.

Read more about the UKRP requirements here: UK Responsible Person

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

Not at this time. While Great Britain 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. Instead, CE Marking is sufficient.

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, Northern Ireland businesses can continue to place most CE and CE UKNI marked devices on the Great Britain market after 30 June 2023*.”

*June 30, 2023 was the original UKCA marking mandatory compliance date for Great Britain. However, the MHRA postponed UKCA Marking until July 2024. Further, the MHRA will extend the CE Marking transition period by another 3-5 years after the new regulation is implemented, depending on the type of device. For more information, please read: UKCA Marking Postponed & CE Marking Transition Period Extended

Do I need to register with the MHRA before placing devices onto Northern Ireland?

In some situations, yes, 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.

The baseline is that Northern Ireland requires CE Marking, and therefore, registration requirements should follow the EU Directives/Regulations, as applicable. However, there are certain cases where devices must be registered with the MHRA. Specifically, those are:

- Annex II List A, Annex II List B, self-test IVDs
- Custom made devices
- Systems or Procedure Packs

Where the manufacturer’s European Authorized Representative (EU AR) is located in Northern Ireland, the EU AR must notify class I devices and IVDs per the Directives/Regulations.

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 as 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 does not apply in the following scenarios:

- If a manufacturer selects a non-UK based Notified Body to issue CE Marking, UKNI marking is not applicable. For example, if you select a Notified Body located in Germany to issue your CE Marking certificate, you cannot obtain, and will not affix, UKNI marking.
- UKNI marking is not recognized in the EU. The UKNI indication is only applicable if you are placing devices onto the Northern Ireland market and have selected a UK Notified Body. The EU only requires CE Marking.
- UKNI marking is not applicable to self-certified devices. It is only applicable for devices which require third-party conformity assessment.

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 Ireland and/or Great Britain?

Generally, no. As mentioned in the above UKNI marking section, UKNI marking is rarely applicable.

What is ultimately needed to place devices onto markets is:

Great Britain

- MDD/AIMDD CE marking for three years after the new UK regulation goes into effect or the certificate expires, whichever is sooner
- IVDD CE marking for five years after the new UK regulation goes into effect or the certificate expires, whichever is sooner
- MDR/IVDR CE marking for five years after the new UK regulation goes into effect or the certificate expires, whichever is sooner
- UKCA marking
- The only exception is if you are a Northern Ireland manufacturer with CE Marked devices, in which case you may continue to place your CE Marked devices onto Great Britain even after UKCA marking becomes mandatory in Great Britain

The new UK regulation is expected to go into effect in July 2024. This means European CE marking will be accepted in Great Britain (if all conditions are met) until July 2027-2029, depending on the type of device. After these dates, companies must have UKCA marking to continue marketing in Great Britain.

Northern Ireland

- CE marking is sufficient.
- The only exception is if you select a UK-based Notified Body to issue your CE marking certificate, instead of an EU-based Notified Body, in which case you also require UKNI Marking.

Who is eligible to use 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.

Table of differences between Northern Ireland and the rest of the UK

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

	Great Britain	Northern Ireland
Conformity Assessment	CE Marking (allowed until transition period ends between July 2027-2029, depending on the type of device) UKCA marking (mandatory as of 2027-2029, depending on the type of device)	CE Marking In some rare cases, UKNI marking
In-country representative	UK Responsible Person (UKRP)	European Authorized Representative (EU AR) UKRP not required for manufacturers located in Northern Ireland UKRP required if placing List A, List B or self-test IVDs onto the Northern Ireland market
Registration	All manufacturers and devices must be registered with the MHRA. Registration conducted by the UKRP if the manufacturer is located outside of the UK.	Per CE Marking requirements. May also include notifying the MHRA of some devices, e.g., custom-made devices, IVDs and systems/procedure packs placed onto the Northern Ireland market
Labeling	CE marking / UKCA marking, as applicable. UKCA marking should not be affixed unless the device has been UKCA marked. UK Responsible Person – only required on labeling if the device is UKCA marked	CE Marking In some rare cases, UKNI marking EU Authorized Representative

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What are the requirements in Northern Ireland?