UK Med Dev Guidance: How to Register Medical Devices with the MHRA and Digital Mental Health Technology Regulation
- Sharan Murugan
- Jul 5
- 3 min read
The regulatory landscape for medical devices and digital health technologies in the UK is evolving rapidly, reflecting the growing complexity and innovation within the pharmaceutical and healthcare sectors. Understanding the requirements for registering medical devices and the classification of digital mental health technologies (DMHTs) is crucial for manufacturers, developers, and stakeholders aiming to bring safe and effective products to market.
Digital Mental Health Technologies encompass software and hardware products designed to support mental health and wellbeing.
Regulatory requirements depend on two main factors:
the intended purpose (e.g., supporting wellbeing versus treating a mental health condition) and
the functionality (e.g., educational modules, AI algorithms, chatbots). If a DMHT is intended for a medical purpose and has complex functionality, it is regulated as Software as a Medical Device (SaMD).
How to Apply: The DORS Platform
Registration must be completed via the Device Online Registration System (DORS). This is a secure online platform managed by the MHRA where you:
Create an account
Upload device and organization information
Pay applicable fees
Monitor or update existing registrations
The MHRA has also provided helpful video tutorials and reference guides to assist applicants throughout the process. Registration incurs a fee, depending on the device type and the number of products listed. Manufacturers should consult the MHRA fees guidance for the latest rates. Payment is typically required before the MHRA processes any registration.
Registrants must keep their entries up to date. Any significant changes—such as manufacturer name, device classification, or labeling—must be reported to the MHRA promptly. The MHRA provides provisions for registering:
Devices with expiring EU CE certificates
Class I devices reclassified under UK MDR or EU MDR rules
Reusable surgical instruments under stricter controls
Certain IVDs with updated classifications
These transitional allowances help businesses maintain continuity while aligning with updated regulations.
Who Must Register?
Any manufacturer, UK Responsible Person, or importer wishing to place medical devices, in vitro diagnostic devices (IVDs), or custom-made devices on the UK market must register with the MHRA. This includes entities based in Great Britain (England, Scotland, Wales) as well as those supplying to Northern Ireland under certain conditions.
Notably, overseas manufacturers must appoint a UK Responsible Person to handle registration and compliance on their behalf.
Registration is a pre-market requirement. You must register your devices before they are placed on the UK market, unless an exemption applies. Certain transitional periods existed following Brexit, but these have largely expired, making timely registration mandatory for almost all device categories.
Additional registration requirements apply to:
IVDs undergoing performance evaluation
Devices with expired or expiring CE certificates
EU MDD Class I devices being reclassified
Digital technologies or AI-based medical software
What Information Is Needed?
To register, you must provide detailed information via the Device Online Registration System (DORS), including:
Manufacturer and UK Responsible Person details
Device details (name, model, GMDN code, classification)
CE or UKCA certificate information (if applicable)
Declaration of Conformity and technical documentation
The accuracy of this data is essential, as it directly impacts the ability of the MHRA to monitor devices in the market.
For a complete and up-to-date guide on registering medical devices in the UK, readers are encouraged to consult the official MHRA guidance on the UK government website:
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