Regulation of devices in Northern Ireland
Information about the EU Regulations and their implementation in Northern Ireland
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, please see our published guidance.
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.
We recommend you familiarise yourself with the legislation that is 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)
- and MDCG endorsed documents and guidance
The Medical Devices In Vitro Diagnostic Devices etc. Amendment Regulations 2024 came into force on 21 March 2024 and introduce provisions required for implementing the 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
- requirement for performance studies of in vitro diagnostic devices and clinical investigations of medical devices taking place in Northern Ireland and Great Britain, to allow for only a contact person to be established in Northern Ireland, supported by the legal representative established in Great Britain
- provision for a Coronavirus test that complies with the EU common specification 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 in vitro diagnostic medical devices that meet the requirements of the IVDR and that are Qualifying Northern Ireland 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 in 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 an Authorised Representative based in Northern Ireland, some of the obligations for manufacturers will apply. Refer to 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).
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 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 – more information is here.
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. Further 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 can be found 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 IVDs 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
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that the EU declaration of conformity of the device has been drawn up
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a manufacturer is identified and, where the manufacturer is not in NI 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, once the relevant Eudamed 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 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 can be found 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.
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 at which 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 the EU, or, if all of the following conditions are met, in Great Britain:
- The investigation or study must be taking place in both Northern Ireland and Great Britain
- The investigation or study must not be taking place in an EU Member State
- The sponsor must be either established in or have 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
- The sponsor must establish a contact person in Northern Ireland for the clinical investigation or performance study, who will be the addressee for all communications with the sponsor provided for in MDR or IVDR. Any communication with that contact person is deemed to be communication with the sponsor
All remaining requirements under the MDR and IVDR apply.
Registration requirements
To register a clinical investigation for medical devices in Northern Ireland, please refer to our guidance about clinical investigation for a medical device.
To register a performance study for IVDs in Northern Ireland, please submit an application through IRAS (Integrated Research Application System). Further guidance on the application process is available on IRAS.
Contact the MHRA
Please direct any queries on these Regulations to info@mhra.gov.uk. Please add Northern Ireland to the subject heading of your email.
Updates to this page
Last updated 25 March 2024 + show all updates
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Updated to reflect the coming into force of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 and to include information on MDCG guidance on the Health Institution Exemption
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Updated to include Medical devices: Clinical investigations and performance studies in Northern Ireland replacing Temporary Disapplication of Sponsors and Legal Representatives in Northern Ireland.
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Information on Temporary Disapplication of Sponsors and Legal Representatives in Northern Ireland added.
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Update to information under section 'Importer requirements'
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A new section on importer requirements has been added.
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This page has been updated due to the end of the Brexit transition period.
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Published a new section following European Parliament and Council decision to delay the full implementation of the Medical Device Regulation by one year to 26 May 2021.
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Added new section on Guidance for Annex XVI manufacturers and added PDF attachment.
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Added a link to our consultation on the Health institution exemption for IVDR/MDR
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contact email address updated.
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Added a one-page guide to outline to key changes in the new MDR IVDR which affect health institutions.
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First published.