MHRA Updates Guidance on Regulation of Medical Devices in Northern Ireland

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the regulation of medical devices in Northern Ireland, clarifying the continued application of the EU MDR and IVDR under the Windsor Framework. The updated version was published on 20 February 2026 .

For manufacturers placing devices on the Northern Ireland (NI) market, the regulatory framework remains distinct from Great Britain and continues to follow EU legislation.

EU MDR and IVDR Continue to Apply in Northern Ireland

Under the Windsor Framework, EU Regulation (EU) 2017/745 (MDR) and EU Regulation (EU) 2017/746 (IVDR) apply in Northern Ireland.

The Medical Devices In Vitro Diagnostic Devices etc. Amendment Regulations 2024 (in force since 21 March 2024) introduced additional provisions necessary to implement MDR and IVDR in NI . These include:

• Criminal penalties and enforcement powers for non-compliance

• Appointment of the Secretary of State as the authority responsible for IVDR notified bodies

• English language requirements for certain IVD documentation

• Fee provisions for UK notified bodies and free sale certificates

• Requirements for performance study sponsors (including ethics review and insurance obligations)

• Specific provisions regarding coronavirus tests compliant with EU Common Specifications

• Continued unfettered access for qualifying Northern Ireland IVD goods to the Great Britain market

Impact for manufacturers: Companies supplying Northern Ireland must ensure full compliance with EU MDR/IVDR — not the standalone Great Britain regime.

New Supply Interruption Notification Obligations (Article 10a)

Manufacturers established in Northern Ireland — or those with an authorised representative in NI — must notify the MHRA of any anticipated interruption or discontinuation of supply that could result in serious harm or risk to patients or public health .

Key points:

• Notification must be made at least six months in advance, except in exceptional circumstances

• All directly supplied economic operators, health institutions and healthcare professionals must also be informed

• Custom-made devices are excluded

• The requirement does not apply to interruptions anticipated before 10 January 2025

Why this matters: Manufacturers must integrate this obligation into their PMS and supply chain risk management processes to avoid regulatory exposure.

CE Marking and UK(NI) Marking Requirements

For Northern Ireland:

• CE marking is mandatory

• An EU-recognised notified body must be used where required

• Northern Ireland-based manufacturers do not require an EU authorised representative

If conformity assessment is performed by a UK-based notified body, devices must bear the combined CE + UK(NI) marking. These devices may be placed on the UK market but cannot be placed on the EU market .

Under transitional arrangements:

• CE-marked devices remain accepted on the Great Britain market until 30 June 2028 or 30 June 2030, depending on applicable EU legislation .

Strategic consideration: Manufacturers using UK notified bodies must carefully assess market access implications for EU distribution.

EUDAMED Mandatory Use from May 2026

Economic operators supplying devices to Northern Ireland must register in EUDAMED (except distributors).

From 28 May 2026, four modules will become mandatory:

• Actor Registration

• UDI/Device Registration

• Notified Bodies and Certificates

• Market Surveillance

Manufacturers remain responsible for device registration in EUDAMED.

Operational impact: Companies not yet registered must accelerate preparation for mandatory EUDAMED compliance.

Post-Market Surveillance and Vigilance

Devices placed on the Northern Ireland market must comply with EU post-market surveillance requirements.

Incidents occurring in Northern Ireland must be reported to the MHRA:

• Via the Yellow Card Scheme (patients and healthcare professionals)

• Via the MORE portal (manufacturers)

Important: EU vigilance principles apply in NI, reinforcing the need for aligned PMS systems across EU and NI markets.

Clinical Investigations and Performance Studies

Sponsors conducting clinical investigations or performance studies in Northern Ireland must generally be established in Northern Ireland or an EU Member State .

Where studies take place in both NI and Great Britain (and not in the EU), a contact person in Northern Ireland may suffice, provided specific conditions are met.

Applications must be submitted to MHRA prior to commencement.

What Manufacturers Should Do Now

Manufacturers placing devices on the Northern Ireland market should:

• Confirm correct classification under MDR/IVDR

• Verify CE marking and notified body strategy

• Ensure EUDAMED actor and device registration readiness

• Review Article 10a supply interruption procedures

• Align PMS and vigilance reporting processes with EU requirements

• Reassess labelling and importer obligations

Northern Ireland remains legally aligned with EU device legislation, creating a dual regulatory landscape within the UK. Manufacturers operating across EU, NI and GB markets must maintain clear regulatory strategies to avoid compliance gaps.

Read the full document below.