Regulation of medical devices in Northern Ireland

Overview:

Under the terms of the Northern Ireland Protocol, the rules for placing medical devices on the Northern Ireland market differ from those applicable to Great Britain (England, Wales and Scotland).

The Government has introduced new legislation to make changes to how the Northern Ireland Protocol will apply.  You should continue to use the guidance below for now.  It will be updated in due course, giving you time to prepare for any new requirements.

There is a requirement, in certain cases, to register devices with the MHRA and to have a UK Responsible Person if the manufacturer is based outside the UK, as set out below.

Summary of key requirements for placing a device on the Northern Ireland market:

The following requirements apply to manufacturers wishing to place medical devices on the Northern Ireland market:

  • Since 26 May 2021, the EU MDR has applied in Northern Ireland. The EU IVDR will apply in Northern Ireland from 26 May 2022
  • CE marking is required for the Northern Ireland market. In addition, the UKNI indication is required if a UK Notified Body undertakes mandatory third-party conformity assessment
  • certain medical devices, including in vitro diagnostic medical devices (IVDs), placed on the Northern Ireland market need to be registered with the MHRA
  • all custom-made devices must be registered with the MHRA within 28 days of being made available on the Northern Ireland market
  • when placing devices on the Northern Ireland market, Great Britain-based manufacturers must appoint an EU or Northern Ireland-based Authorised Representative
  • IVD manufacturers based outside the UK may be required to have a UK Responsible Person in place to act as a regulatory point of contact within the UK and comply with the registration requirements.

The EU MDR and EU IVDR in Northern Ireland:

The EU Medical Devices Regulation (2017/745) has applied in Northern Ireland since 26 May 2021. The in vitro Diagnostic Medical Device Regulation (2017/746) will apply in Northern Ireland from 26 May 2022.

Please see guidance on the application of the MDR and IVDR in Northern Ireland.

CE marking for the Northern Ireland market and implications for UK Approved Bodies:

Although the UKCA marking is available for use in Great Britain, a CE marking is needed for devices placed on the Northern Ireland market and EU rules need to be met.

Where allowed for in the relevant legislation, you can CE mark your device on the basis of self-certification for the purposes of the Northern Ireland market.

To place a CE marking on your device for circulation in both Northern Ireland and the EU, you must use an EU-recognised Notified Body to undertake any mandatory third-party conformity assessment. The results of conformity assessments carried out by UK Notified Bodies are not recognised within the EU.

UKNI indication:

As noted above, for the purposes of the UKCA marking, a UK Approved Body must be used in cases where third party conformity assessment is required. However, for the purposes of the Northern Ireland market, UK-based conformity assessment bodies are referred to as ‘UK Notified Bodies’.

UK Notified Bodies can apply to be designated under the relevant EU legislation for the purposes of conducting conformity assessments for the Northern Ireland market.

Please note that there are currently no UK Notified Bodies designated to undertake such assessments under the EU MDR or the EU IVDR. This section outlines the criteria for affixing a UKNI marking to devices should any UK Notified Bodies be designated in future.

In addition to the CE marking, device manufacturers will also need to apply the UKNI indication if they choose to use a UK Notified Body (should any be designated in future) for mandatory third-party conformity assessment. Device manufacturers must never apply the UKNI indication on its own - it must always accompany a CE marking.

To place goods on the EU market, manufacturers must use an EU-recognised Notified Body and then affix the CE marking on its own. Goods bearing the combined “CE & UKNI” marking will not be accepted on the EU market. If a device manufacturer uses an EU-recognised Notified Body for mandatory third-party conformity assessment, the CE marking on its own is sufficient to place a device on the Northern Ireland market.

In summary, you need to use the UKNI indication if:

  • you are placing medical devices on the Northern Ireland market; and
  • your medical devices require mandatory third-party conformity assessment; and
  • you use a UK Notified Body to carry out those conformity assessments.

You do not need to use the UKNI indication if you have self-certified your medical device or have used an EU-recognised Notified Body for mandatory third-party conformity assessment.

The UKNI indication is sometimes referred to as the UK(NI) mark or the UK(NI) marking. These terms refer to the same marking.

Further guidance on applying the UKNI marking.

Registration and UK Responsible Person requirements for Northern Ireland:

Certain medical devices, IVDs and custom-made devices that are placed on the Northern Ireland market need to be registered with the MHRA. The precise requirements depend on the location of the manufacturer, the location of the Authorised Representative and the device class, as set out below. Please see the MHRA’s guidance on registrations for more information.

If you are a non-UK manufacturer placing a IVD on the Northern Ireland market, you may be required to appoint a single UK Responsible Person within the UK. Non-UK manufacturers are not required to appoint a UK Responsible Person for the purpose of placing other devices on the Northern Ireland market.

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

  • 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.

Great Britain manufacturers are required to appoint an Authorised Representative based in the EU or Northern Ireland in order to place a device on the Northern Ireland market. Where a Northern Ireland-based Authorised Representative is appointed, the Authorised Representative needs to register devices of all classes with the MHRA. Where an EU-based Authorised Representative is appointed, the Great Britain-based manufacturer needs to register all device classes other than Class I devices and general IVDs with the MHRA.

It is possible for a single entity to act as both an Authorised Representative based in Northern Ireland and a UK Responsible Person.

There is currently a requirement to register with the MHRA, certain medical devices (including IVDs, custom-made devices and systems or procedure packs) that are placed on the Northern Ireland market. This requirement does not apply to manufacturers placing Class I medical devices or general IVDs on the Northern Ireland market in cases where:

  • the manufacturer is based in the EU or EEA, OR
  • the manufacturer is based outside Northern Ireland, the EU or EEA and has appointed an EU-based Authorised Representative.

Registration of custom-made devices in Northern Ireland:

We have recently introduced legislation to supplement provisions that were introduced in Northern Ireland on 26 May 2021 when the EU Medical Devices Regulation (2017/745) (EU MDR) took effect. This legislation includes a requirement to register all custom-made devices with the MHRA within 28 days of being made available on the Northern Ireland market.

Unfettered access provisions:

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.

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.

Post-market surveillance and vigilance:

The MHRA is the Competent Authority for post-market surveillance activity for devices placed on the Northern Ireland market. Where incidents occur in Northern Ireland, these need to be reported to the MHRA.


Regulation of medical devices in Northern Ireland:

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