GovWire

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 seeour published guidance.

The application of EU MDRandIVDRin 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 inEUMember 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 theMDRandIVDR)
• general safety and performance requirements are met, including for labelling, and technical documentation and quality management systems (Annex I of theMDRandIVDR)
• requirements for clinical evidence are met (Annex XIV of theMDRandIVDR)
• requirements for person responsible for regulatory compliance are met (Article 15 of theMDRandIVDR)

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 theEU.

For the purposes of the CE marking, anEU-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 theMDR 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 theEUmarket.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 Governments commitments to Northern Irelands 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 theMDRandIVDR)
• 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 theMDRandIVDR.

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

• that the?EU?declaration of conformity of the device has been drawn up

• 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 requi
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