IRAS Help - Preparing & submitting applications

Help - Preparing & submitting applications - MHRA Devices

Help

Using IRAS
- New Users
- Iras E-Learning
- Electronic authorisation
- Verification tool
- Minimal Dataset
- Document Storage and Documents Electronic Submission Guidance
Preparing & submitting applications
- HRA and HCRW Approval
- NHS/HSC R&D Permissions
- NHS staff as research participants
- Ethical review (REC)
- Confidentiality Advisory Group (CAG)
- ARSAC
- HMPPS
- MHRA Medicines
- Site specific information
- MHRA Devices
- Templates for supporting documents
- HR Good Practice Resource Pack
- Radiation Assurance
- Radiation - defining research exposures
- Radiation - MPE and CRE review procedures
- Pharmacy Assurance
- Public Involvement
- IRAS ID
- Interventional Research
- Combined review applications
- IVD Research
- Participant Identification Centres (PICs)
Maintaining your approvals
- Modification guidance -all review bodies
- Modifications for projects conducted in NHS/HSC
- Confidentiality Advisory Group (CAG)
- HMPPS
- Radiation Assurance
- Pharmacy Assurance
- Examples of modification types
End of research
- General guidance about end of research
- Confidentiality Advisory Group (CAG)
- HRA and HCRW Approval - end of research
- HMPPS
- Research Ethics Committee (REC) - end of research
FAQs
- Frequently Asked Questions
Documentation
- User Manual
- Content Index
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- Example Application Forms
- Updates to IRAS
- Supported Browsers
- History of IRAS
Reference
- Collated Guidance
  - Project Filter
  - IRAS Form
  - MHRA Devices
  - MHRA Medicines (EudraCT application)
  - NHS R&D
  - NHS REC
  - NHS REC Research Database
  - NHS REC Research Tissue Bank (RTB)
  - CAG (Research Database)
  - CAG (research project)
  - CAG (Research Tissue Bank)
  - HMPPS
  - Social Care REC
  - Social Care REC Research Database
- Other Guidance
  - Students
  - Submissions

MHRA Devices

Clinical investigation of a medical device

Information about applying to MHRA to conduct a clinical investigation of a medical device is provided on the MHRA's dedicated webpage.

Trials involving a clinical trial of an investigational medicinal product and an investigational medical device (IMP+Device trials)

It is not possible for IMP+Device review applications to be made using this part of IRAS. Guidance on submitting an IMP+Device review application is available on the MHRA website.

Research involving an in vitro diagnostic device (IVD): Currently, different EU regulation applies to studies that involve a performance evaluation of an IVD taking place in Northern Ireland compared to the rest of the UK. To find out more about these regulations and what it means for your research application we have produced some guidance to help.

Information about applying to MHRA to conduct a clinical investigation of a medical device is provided on the MHRA's dedicated webpage.

Page last updated:28 April 2026