Medicines Healthcare Products Regulatory Agency
You may need to carry out a clinical investigation as part of the process to obtain a UKCA / CE / CE UKNI marking for your medical device. You must inform the MHRA if you are planning to do this at least 60 days before starting your investigation.
Use this flow chart to decide if you are required to submit a formal clinical investigation
Please note: applications under Annex XVI of the Medical Device Regulation (EU) 2017/745 (MDR) for devices with no intended medical purpose cannot be accepted in GB.
How to notify the MHRA of your clinical investigation
Start your application via IRAS.
Note - A notification to theMHRAwill not be required for medical devices that are UKCA / CE / CE UKNI marked for the purpose that is under investigation.
Fees
New fees for clinical investigations and amendments were introduced in April 2023 please see section 9 of our fees page.
Medical Devices Regulations 2002
A fee under this regulation
(a) shall be payable when the notice to which it relates is given to the Secretary of State;
and
(b) shall accompany that notice when it is given
In applying the regulation and to avoid delays,MHRArequire payment to be made upon confirmation of a valid application for a clinical investigation or amendment to a clinical investigation.
A final regulatory decision (approval or objection letter) on the application or amendment will not be provided until payment has been received.
For more information on how to make a payment, please see the relevant sections on payments below.
Validation Checklist
When we receive your application for a clinical investigation of a medical device our regulatory handers will validate your application against the Clinical investigation application check list. We hope that in providing this checklist it will support you in submitting a valid application.
MHRA guidance
Follow the guidance on compiling a submission and guidance for manufacturers when preparing your notification application.
Applications are submitted electronically using the Integrated Research Application System (IRAS).
See information for clinical investigators for what is required by clinicians involved in the investigation.
Check the electrical guidance for clinical investigations.
Check the information on the for the scientific data you must submit.
Check for presenting statistical information for your clinical investigation.
See the guidance on UKCA markings.
Assessment
This section concerns clinical investigations being conducted in Great Britain only. Please see the separate section below for studies involving Northern Ireland.
When theMHRAhas received your documents and validated them, we will contact to you within 5 working days to confirm that the 60-day assessment period has started, or we will let you know if there are any issues. If there are any issues raised, the 60-day assessment period will start when we receive a valid response.
Day 1 of the 60 days is taken as being the first day that follows the date of acceptance of a valid application. For example, if an application is received on 24 August and the assessor validates the submission on 28 August, the clock starts on 29 August.
During the assessment, experts will assess the safety and performance of your device as well as the design of the clinical investigation to be carried out. TheMHRAwill write to you if we require further information. It is essential that you contact theMHRAas soon as possible if you require clarification. If there are possible grounds for objection, where possible we will arrange a teleconference for a better understanding and to find a resolution within the 60-day assessment time.
A letter will be sent to you by the 60th day with a decision (objection or no objection) as to whether or not you can carry out the proposed clinical investigation.
Payment for a Clinical Investigation
You will need to pay a fee for your clinical investigation (seeFeesabove).
Please provide the following information when applying for your clinical investigation, this will enable accurate and timely invoicing:
- Company name and full address
- Contact name and email address of the individual responsible for paying the fee
- If applicable a company invoice or transaction number
Once you have received your invoice and made the payment, please provide evidence of payment by email, quoting the MHRA reference (CI/XXXX/XXX).
Please send to: CI-applications@mhra.gov.uk
Serious adverse event (SAE) reporting
This section concerns clinical investigations being conducted in Great Britain only. Please see the separate section below for studies involving Northern Ireland.
All serious adverse events, whether initially considered to be device/procedure related or not, involving a device under clinical investigation within Great Britain should be reported to the MHRA.
These can be provided using either the MEDDEV 2.7/3 SAE reporting table, or the MDCG 2020-10/2 SAE reporting table, as long as all SAEs are included.
Please submit an SAE reporting form in the new MORE portal with your completed table attached.
See details on how to register for the MORE portal.
Quarterly summary reports
As per the conditions ofMHRA