Regulatory guidance

1. Digital mental health technology - GOV.UK > Guidance > Digital mental health technology: qualification and classification - This is the primary detailed guidance we would refer people to for determining if something is a medical device and what classification it would be. Appendix 1 is the MHRA DMHT characterisation form which can be filled out and sent to This email address is being protected from spambots. You need JavaScript enabled to view it. if there is uncertainty.
2. Software and artificial intelligence (AI) as a medical device - GOV.UK – This page presents more guidance and features useful links to pages such as Crafting an Intended Use Statement, which is a valuable resource.
   1. Further detailed guidance - Medical devices: software applications - GOV.UK

1. Clinical investigations for medical devices - GOV.UK provides advice on whether an application is required to MHRA for a clinical investigation.
   1. The first paragraph on the page links to a flow chart and accompanying guidance which can be used to determine if an application is required to MHRA.
2. Once you have determined if you think an application is required, you can confirm this by emailing This email address is being protected from spambots. You need JavaScript enabled to view it. as detailed below (copied from page 7 of the accompanying guidance)
   • If you need further assistance in determining the correct regulatory route, please provide an annotated copy of the flow chart showing and explaining your decision pathway to This email address is being protected from spambots. You need JavaScript enabled to view it. with the title ‘[Company Name] – Is a Clinical Investigation required?’.
   • When contacting MHRA, please provide details of:
     • Who has manufactured the device
     • Who is conducting the proposed study
     • What the intended purpose of the device is
     • What the intended purpose of the proposed study is
     • Whether any medical application is foreseen for the device
     • Please provide a copy of the study protocol where possible
   • Once received, the MHRA Clinical Investigations team will reply to you to confirm.
3. If you would prefer, there is also the option of requesting a Regulatory Advice Meeting, following the process below (Copied from Clinical investigations for medical devices - GOV.UK)
   • Regulatory advice meetings
     The MHRA clinical investigations team can offer a comprehensive device regulatory advice meeting.
   • See information on fees regarding the charges for a regulatory advice meeting.

The MHRA cannot review individual documents but they can provide guidance on navigating the regulatory landscape.

For all the above links, please check you are using the most up to date guidance on the MHRA website.