Overview

The​ Medicines and Healthcare products Regulatory Agency (MHRA) ​​​is​ the competent authority for medical devices and in vitro diagnostic (IVD) devices in Northern Ireland.

This guidance provides general information about regulatory requirements for placing medical devices and IVD devices on the Northern Ireland market only. For information on the regulation of medical devices on the Great Britain (England, Wales and Scotland) market, see ouryou [guidancecan read our guidance on regulating medical devices in the UK.

The application of EU MDR and IVDR in Northern Ireland

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

The EU Medical Device Regulation (2017/745) (MDR) and the In Vitro Diagnostic Medical Device Regulation (2017/746) (IVDR) have applied in EU member states and in Northern Ireland since 26 May 2021 and 26 May 2022 respectively.

WeYou recommendshould make sure you familiariseare yourselfaware withof the legislation that isapplies applicable to your devices:

• medical devices: The Medical Devices Regulation (2017/745)
• in vitro diagnostic medical devices (IVDs): The In Vitro Diagnostic Medical Devices Regulation (2017/746)
• MDCG endorsed documents and guidance

The Medical Devices In Vitro Diagnostic Devices etc. Amendment Regulations 2024 came into force on 21 March 2024 and introduceintroduced provisions required for implementing the MDR and IVDR in Northern Ireland.

These include:

• penalties (in the form of a criminal offence punishable by imprisonment, a fine or both), powers to impose enforcement notices and an amendment to extend the civil sanctions regime in Schedule 2 to the Medicines and Medical Devices Act 2021 (when that is brought into force) for the infringement of provisions in the IVDR
• appointing the Secretary of State as the authority responsible for notified bodies in relation to the IVDR
• requirement for certain documentation concerning in vitro diagnostic medical devices to be in English
• provisions for fees for the designation and monitoring of UK notified bodies, and fees for certificates of free sale to continue (at the same level as existing fees) and for fee recovery, refund and waiver under IVDR
• an arbitration procedure for refused applications for performance studies
• requirement for performance study sponsors to apply to an ethics committee for an ethical review
• requirement for performance study sponsors to hold sufficient insurance (or equivalent finance resources) to meet any potential financial liability in the event of injury or death attributable to participation in the performance study
• requirementprovision for performance studies of inIVD vitro diagnostic devices and clinical investigations of medical devices taking place in Northern Ireland and Great Britain, to allow forsponsors to appoint only a contact person to be established in Northern Ireland, supported by thea legal representative established in Great Britain
• provision for a Coronavirus test that complies with the EU commonCommon specificationSpecifications for such tests to be placed on the Northern Ireland market without also obtaining a separate approval (CTDA) from the MHRA
• provision for continued unfettered access by ensuring that inIVD vitro diagnostic medical devices that meet the requirements of the IVDR and that are Qualifyingqualifying Northern Ireland Goods,goods, can be placed on the Great Britain market with no additional barriers or burdens to Northern Ireland traders
• requirement in Article 7(2) of the Windsor Framework for the UK(NI) indication to be affixed to inIVD vitro diagnostic medical devices assessed under the IVDR by notified bodies established in the United Kingdom

Manufacturers and authorised representatives

If you are manufacturing or placing a medical device on the Northern Ireland market, you must meet the applicable obligations set out in the respective regulations, including, but not limited to, ensuring that:

• the device has been correctly classified against the risk classification criteria (Annex VIII of the MDR and IVDR)
• general safety and performance requirements are met, including for labelling, and technical documentation and quality management systems (Annex I of the MDR and IVDR)
• requirements for clinical evidence are met (Annex XIV of the MDR and IVDR)
• requirements for person responsible for regulatory compliance are met (Article 15 of the MDR and IVDR)

If you are a Great Britain-based manufacturer supplying to Northern Ireland, you need to designate a sole authorised representative based in the EU or Northern Ireland. To see a list of existing EU or Northern Ireland-based authorised representatives, please visit the EUDAMED database.

If you are an authorised representative based in Northern Ireland, some of the obligations for manufacturers will apply. ReferFind toout more in the MDCG guidance Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

Notification of interruption or discontinuation of the supply of a medical device for manufacturers based in Northern Ireland

In accordance with Article 10a of the MDR and IVDR, manufacturers established in Northern Ireland, or manufacturers with their authorised representative established in Northern Ireland, must inform the MHRA if they anticipate an interruption or discontinuation of the supply of a medical device, where it is reasonably foreseeable that such interruption or discontinuation could result in serious harm, or a risk of serious harm, to patients or public health in Northern Ireland or in one or more EU Member States. Additionally, notification of the anticipated interruption or discontinuation must also be made to ALL economic operators, health institutions and healthcare professionals to whom the manufacturer supplies the device directly.

This requirement does NOT apply to custom-made devices.

Notification must be provided at least 6 months before the anticipated interruption or discontinuation, other than in exceptional circumstances. Manufacturers should complete and submit the Manufacturer Notification Form to the MHRA by email to info@mhra.gov.uk. The MHRA may need to share the information provided with the Department of Health (NI) if the disruption is anticipated to affect Northern Ireland patients or public health.

Further information is provided by the Q&A document on Article 10a published by the European Commission.

Note: Interruption or discontinuation of the supply of a medical device that was anticipated by the manufacturer before 10 January 2025 does not have to be reported, even if the interruption or discontinuation itself occurs after 10 January 2025.

Post-market surveillance

Medical devices placed on the market or put into service in Northern Ireland must follow the post- market surveillance rules set out in relevant EU law. Guidance is available via the Medical Device Coordination Group (MDCG).(MDCG) .   WhereIncidents incidentsthat occurhappen in NI,Northern theseIreland need to be reported to the MHRA in the following ways:  

• patients and public can report a suspected problem with a medicine or medical device using the Yellow Card Scheme

• if you are a healthcare professionalprofessionals working in NI,Northern youIreland can report a problem with a medical device to the Northern Ireland Adverse Incident Centre (NIAIC)

• manufacturers can submit reports relating to adverse incidents for devices to the MHRA via the MORE portal

Conformity assessment and regulatory marking

CE marking is required for the Northern Ireland market, and manufacturers based in Northern Ireland do not require an authorised representative established in the EU.

For the purposes of the CE marking, an EU-recognised notified body, where required, must be used.

Manufacturers of Class I (non-sterile, non-measuring, and non-reusable) medical devices and Class A (non-sterile) IVD devices can continue to self-declare their conformity against the MDR or IVDR respectively. Under transitional arrangements, devices bearing a valid CE marking will be accepted on the Great Britain market until 30 June 2028 and 30 June 2030 depending on the EU legislation it complies with. ForYou can find out more information,in seeour Implementationguidance on the implementation of the future regulations.

UK(NI) marking

Where a UK-based notified body has been used for your conformity assessment, you must place a combined CE and UK(NI) marking on the device. Devices bearing the combined CE and UK(NI) marking can be placed across the whole UK market but will not be accepted on the EU market. Seethe EU market. We Furtherhave more guidance on applying the UK(NI) marking.

Unfettered access of qualifying Northern Ireland goods

Qualifying Northern Ireland goods may continue to be placed on the Great Britain market with a valid CE marking on an indefinite basis. This arrangement is a result of the government’s commitments to Northern Ireland’s unfettered access to the market in the rest of the UK and is underpinned by the UK Internal Market Act 2020.

Health institutions in Northern Ireland

Health institutions wishing to apply the exemption under the MDR and IVDR will need to ensure that:

• products meet the relevant general safety and performance requirements (Annex I of the MDR and IVDR)
• there is an appropriate quality management system in place
• there is a justification for applying the exemption
• technical documentation is in place

The full requirements of implementing the healthcare institution exemption are available in Article 5(5) of the MDR and IVDR.

The Medical Devices Coordination Group (MDCG) has published guidance on implementing the health institution exemption. Northern Ireland-based health institutions wishing to apply the exemption to their medical devices or IVDsIVD devices should refer to the MDCG guidance. See Operation of the health institution exemption for EU IVDR and MDR.

Importers and distributors in Northern Ireland

If you are an importer in Northern Ireland, you will need to make sure: 

• the device has been CE marked
• that the EU declaration of conformity of the device has been drawn up
• a manufacturer is identified and, where the manufacturer is not in NINorthern Ireland or the EU, an authorised representative has been designated by the manufacturer
• the device is labelled in accordance with MDR or IVDR and accompanied by the required instructions for use
• where applicable, a UDI has been assigned by the manufacturer
• the device has been registered in Eudamed,EUDAMED, once the relevant EudamedEUDAMED module is fully functional and instated as mandatory
• you comply with the manufacturer’s transport and storage requirements
• you keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them
• you inform the manufacturer and their authorised representative if you have reason to believe a device does not conform to the requirements
• you must keep a copy of the EU declaration of conformity and relevant certificates for 10 years (and(15 15 years for implantable devices)
• you cooperate with the MHRA and provide samples or grant access to the devices when requested

If you are a distributor in Northern Ireland, you will need to make sure: 

• the device has been CE marked
• that the EU declaration of conformity of the device has been drawn up
• for imported devices, to ensure that the importer has complied with their requirements as per above
• the device is labelled in accordance with MDR or IVDR and accompanied by the required instructions for use
• where applicable, a UDI has been assigned by the manufacturer
• you comply with the manufacturer’s transport and storage requirements
• you keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and importers with any information requested by them
• you inform the manufacturer, their authorised representative or importer if you have reason to believe a device does not conform to the requirements
• you cooperate with the MHRA and provide samples or grant access to the devices when requested

Full importer obligations are available in Article 13 of the MDR and IVDR. You may also wish to refer to the MDCG guidance on Articles 13 and 14 of the MDR and IVDR.

Notification of interruption or discontinuation of the supply of a medical device for importers and distributors based in Northern Ireland

Northern Ireland-based importers and distributors who have been notified in accordance with Article 10a of the MDR and IVDR must inform any other economic operators, health institutions and healthcare professionals to whom they directly supply the device of the anticipated interruption or discontinuation, without undue delay.

Further information is provided by the Q&A document on Article 10a published by the European Commission.

Labelling requirements

Importers will also need to provide the following details along with the device:

• importer name, registered trade name or registered trademark
• your place of business
• the address where you can be contacted

These details can appear on the device, the packaging, instructions for use or in a document accompanying the device, such as an invoice.

Clinical investigations and performance studies in Northern Ireland

Sponsors of clinical investigations and performance studies in Northern Ireland

Clinical investigations and performance studies that take place in Northern Ireland require the sponsor or their legal representative to be established in Northern Ireland or in an EU member state. The sponsor is any individual, company, institution or organisation which takes responsibility for the EU,initiation, or,for the management and setting up of the financing of the clinical investigation or performance study.

This requirement does not apply if all of the following conditions are met, in Great Britain:    met:   

• the clinical investigation or performance study mustis bebeing takingconducted place in both Northern Ireland and Great Britain 

  Britain

• the investigation or study mustis not bebeing takingconducted place in an EU member state 

  state

• the sponsor mustis be either established in Great Britain or havehas a written agreement with a legal representative established in Great Britain, who is responsible for ensuring compliance with the sponsor’s obligations in the MDR or IVDR 

  IVDR

When the sponsorabove mustconditions establishare met, only a contact person is required to be established in Northern Ireland for the clinical investigation or performance study,study. The contact person is any individual, company, institution or organisation who will be the addressee for all communications with the sponsor provided for in MDR or IVDRIVDR. –Any we will consider any communication with that contact person is deemed to be communication with the sponsor sponsor of the investigation or study.

The sponsor or its legal representative must have a written agreement with the contact person to provide for:

• the contact person to immediately inform the sponsor or legal representative of all communications received in its capacity as the contact person
• the sponsor or legal representative to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under the MDR or IVDR

All remaining requirements under the MDR and IVDR apply.

RegistrationApplication and notification requirements

Clinical Investigations of medical devices with study sites in Northern Ireland require aan application to MHRA,MHRA prior to commencement.  ToYou can find out how to submit a clinical investigation application,application seein our our guidance about clinical investigation for a medical device.

ToPerformance registerstudies aof performanceIVD studydevices forwith IVDsstudy sites in Northern Ireland,Ireland submitrequire an application throughor IRASnotification (Integratedto ResearchMHRA, Applicationif System).the Furtherstudy falls under IVDR Article 58 (1&2) and Article 70(1). You can read guidance on the application process on isIRAS available(Integrated onResearch IRAS.Application System).

Contact the MHRA

For any queries on these regulations, contact info@mhra.gov.uk. Add Northern Ireland to the subject heading of your email.