New MHRA Northern Ireland inbox launched

New MHRA inbox for Northern Ireland medical device queries

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a dedicated Northern Ireland support inbox to help businesses and individuals with medical device regulation queries.

You can email your questions to NI-support@mhra.gov.uk. MHRA’s Northern Ireland regulatory experts will review your query and aim to reply within 14 days.

Medical device regulation in Northern Ireland

The MHRA is the regulatory authority for medical devices and in vitro diagnostic (IVD) devices in Northern Ireland. Under the Windsor Framework, Northern Ireland follows a different regulatory system from Great Britain, and devices placed on the Northern Ireland market must comply with applicable EU regulations. The MHRA oversees market safety and enforcement. This unique regulatory position gives Northern Ireland companies access to both UK and EU markets, supporting growth in the life and health sciences sector.

One-to-one regulatory support sessions

The MHRA, with Invest Northern Ireland, is hosting regular one-to-one sessions for local life and health sciences organisations. These sessions are designed to help businesses, researchers and clinicians understand regulatory requirements and engage with the MHRA earlier in their development journey. If you wish to be added to the MHRA mailing list for future sessions, email NI-support@mhra.gov.uk.

Further guidance

Read MHRA guidance on medical devices and EU regulations for Northern Ireland.

First published 10 September 2026