Regulation of medical devices in Northern Ireland

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, you can 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.

You should make sure you are aware of the legislation that applies to your devices:

The Medical Devices In Vitro Diagnostic Devices etc. Amendment Regulations 2024 came into force on 21 March 2024 and introduced 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

- provision for performance studies of IVD devices and clinical investigations of medical devices taking place in Northern Ireland and Great Britain, to allow sponsors to appoint only a contact person in Northern Ireland, supported by a legal representative in Great Britain

- provision for a Coronavirus test that complies with the EU Common Specifications to be placed on the Northern Ireland market without also obtaining a separate approval (CTDA) from the MHRA