On 20 February 2026, the Medicines & Healthcare products Regulatory Agency published an update to its guidance on registering medical devices for placement on the market in Great Britain and Northern Ireland under the UK Medical Devices Regulations 2002. The update affects manufacturers and authorised representatives placing medical devices and in vitro diagnostic devices on the UK and Northern Ireland markets, with implications for Northern Ireland registration pathways, annual registration fees, and public register transparency.
Details of the Update
The updated guidance clarifies revised Northern Ireland registration requirements ahead of 28 May 2026. From that date, most non-custom-made medical devices must be registered in the European Database on Medical Devices before being placed on the EU or Northern Ireland markets, and MHRA registration will no longer be required for those devices for the Northern Ireland market. Custom-made devices remain outside the scope of EUDAMED and must continue to be registered with MHRA for Northern Ireland.
The guidance introduces a detailed framework for the annual MHRA registration fee regime taking effect from 1 April 2026. Fees will be calculated based on Level 2 Global Medical Device Nomenclature (GMDN) categories registered with MHRA, requiring manufacturers to review how their device portfolios are structured for registration purposes.
Further clarification is provided for in vitro diagnostic devices (IVDs) undergoing performance evaluation studies, confirming that registration must be completed before studies begin in the UK. The update also reiterates that COVID-19 antigen and molecular (PCR) test devices must obtain Coronavirus Test Device Approval (CTDA) validation, or be listed on the relevant protocol, before an MHRA registration application will be accepted.
In addition, the guidance confirms enhancements to the Public Access Registration Database (PARD). From 23 February 2026, medical device brand or trade names will be displayed publicly, increasing transparency around registered products.
Regulatory Implementation Timeline
- 23 February 2026: Medical device brand and trade names will begin to be displayed on the Public Access Registration Database (PARD), increasing public visibility of registered products.
- 1 April 2026: Annual registration fees for medical devices registered with the Medicines & Healthcare products Regulatory Agency will take effect, with fees calculated per Level 2 Global Medical Device Nomenclature (GMDN) category.
- 28 May 2026: EUDAMED registration will become mandatory for most non-custom-made medical devices placed on the EU or Northern Ireland markets. From this date, MHRA registration will no longer be required for those devices for the Northern Ireland market.
Why It Matters
This update provides greater regulatory clarity on post-transition arrangements for Northern Ireland, aligns UK processes with EU digital infrastructure through EUDAMED, and establishes a structured fee framework to support regulatory oversight. The changes aim to improve efficiency and transparency while keeping additional administrative burden focused on defined registration and data maintenance activities.
Who This Is Relevant For
The guidance is relevant for medical device and IVD manufacturers, authorised representatives, and regulatory, quality, and compliance teams responsible for UK and Northern Ireland market access, as well as IT and data teams managing regulatory submissions and public product information.
Next Steps
Stakeholders should review their current MHRA registrations to identify devices that will require EUDAMED registration by late May 2026, assess the impact of annual fees ahead of April 2026, and update internal processes accordingly. Manufacturers placing devices on the Northern Ireland market should also confirm authorised representative arrangements, ensure CTDA validation where applicable, and prepare for increased public visibility of product details on PARD.
As organizations adjust to these evolving UK and Northern Ireland registration requirements, RegASK supports regulatory and compliance teams by monitoring implementation timelines, tracking jurisdiction-specific obligations, and streamlining registration and data management workflows. RegASK is a leading agentic AI regulatory intelligence and workflow orchestration platform that empowers global organizations in highly regulated sectors, including consumer products and life sciences, to proactively navigate complex regulatory landscapes. By combining advanced Agentic AI with experts in the loop, RegASK delivers timely predictive actionable insights and end-to-end automation, streamlining compliance processes, mitigating risks, and accelerating market access across more than 160 countries. Learn more or book a demo now.
FAQs
What changes did MHRA introduce for Northern Ireland medical device registration?
From 28 May 2026, most non-custom-made devices must be registered in EUDAMED for the EU and Northern Ireland markets, and MHRA registration will no longer be required for those devices in Northern Ireland.
When do annual MHRA medical device registration fees take effect?
Annual registration fees take effect from 1 April 2026 and are calculated per Level 2 GMDN category registered with MHRA.
Are custom-made medical devices required to register in EUDAMED?
No. Custom-made devices do not require EUDAMED registration and must continue to be registered with MHRA for the Northern Ireland market.
How can RegASK help teams manage these MHRA registration changes?
RegASK helps regulatory and compliance teams track upcoming deadlines, assess the impact of new fee structures, and manage registration obligations across the UK, Northern Ireland, and EU through centralized regulatory intelligence and automated workflows.
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