UK MHRA Guidance: Regulation of Medical Devices in Northern Ireland: What You Need to Know in 2025

The post-Brexit regulatory landscape for medical devices in the UK has brought significant changes, particularly in Northern Ireland, where the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) continue to apply. For manufacturers, distributors, healthcare institutions, and clinical trial sponsors, understanding the specific rules governing medical devices in Northern Ireland is essential.

Unlike Great Britain (England, Scotland, and Wales), Northern Ireland continues to align with EU MDR and IVDR due to the Northern Ireland Protocol. This means that medical devices placed on the Northern Ireland market must:

• Comply with EU legislation.

• Bear the CE marking (or CE + UK(NI) if UK Notified Bodies are involved).

• Follow specific importation and distribution rules for EU-aligned markets.

This dual system allows UK-wide companies to operate across both regulatory systems, but it introduces complexities that must be carefully navigated.

Manufacturers outside the EU (including Great Britain) must appoint an EU Authorised Representative (EU AR) if they wish to place devices on the Northern Ireland market.

Key requirements:

• The EU AR must be established in an EU or EEA member state.

• Their responsibilities include device registration, technical documentation maintenance, and acting as the primary point of contact with EU authorities.

• UK-based manufacturers must also register devices with the MHRA.

Failure to appoint a proper EU AR can prevent market access and lead to regulatory non-compliance.

Importers and Distributors: Key Obligations

Any business placing devices into Northern Ireland must understand their role as:

• Importers (if sourcing from outside the EU, including GB).

• Distributors (if supplying within the EU/NI).

Importers must:

• Ensure CE (or CE + UK(NI)) conformity.

• Maintain documentation for 10 years.

• Indicate their name and address on the device or its packaging.

Distributors must:

• Verify that the device is correctly labelled.

• Refuse distribution if the product appears non-compliant or damaged.

• Maintain complaints and withdrawal records.

A clear understanding of these roles is critical to maintaining a compliant supply chain.

Sponsors conducting clinical investigations or performance studies involving devices in Northern Ireland must comply with:

• EU MDR Article 62 for clinical investigations.

• EU IVDR Articles 57–77 for performance studies.

These must be:

• Notified to the MHRA, even though the study is conducted under EU rules.

• Ethically approved, ensuring patient protection.

• Supported by a robust data collection process aligned with GCP and ISO 14155.

This ensures consistency in clinical evidence generation while complying with the unique dual-regulatory landscape. For more details, refer to the official guidance here: Medical devices: EU regulations for MDR and IVDR.