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.
To enable you to decide if you are required to submit a formal clinical investigation please use this flow chart
Medical devices clinical investigations during the coronavirus (COVID-19) outbreak
How to notify the MHRA of your clinical investigation
A notification to the MHRA will not be required for medical devices that are UKCA / CE / CE UKNI marked for the purpose that is under investigation.
Payment of fees
Fees payable in relation to clinical investigation and amendments to clinical investigations
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, MHRA will invoice the applicant upon receipt of an application for a clinical investigation or amendment to a clinical investigation.
A review of the application or amendment will not begin until payment has been received.
Once you have made the payment please provide evidence of payment by email to the relevant email address:
- Clinical investigations - CI-applications@mhra.gov.uk
- Amendments - CI-amendments@mhra.gov.uk
Validation Checklist
When MHRA receive your application for a clinical investigation of a medical device our regulatory handers will validate your application against this checklist we hope that in providing this checklist it will support you in submitting a valid application.
MHRA guidance
Follow the and guidance for manufacturers when preparing your notification application.
Applications are submitted electronically using the Integrated Research Application System (IRAS)
See for what is required by clinicians involved in the investigation.
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.
Fees
The Medical Devices (Fees Amendment) Regulations 2017 came into force on 1 April 2017. These regulations include the introduction of new fees for amendments to clinical investigations.
You do not need to attach proof of payment to applications. You will receive an invoice to allow you to make payment for the correct amount once your application has been validated.
Information on how to notify the MHRA about an amendment for a clinical investigation can be found below under Amendments. Information on the applicable fees are available using the link below.
Please note: The fee rate is based on a single investigational device being used in a study. Where two or more investigational devices are being used and there is no functional relationship between them, the fee will be increased to reflect the additional workload to the MHRA. For further clarification, contact info@mhra.gov.uk
See fees for clinical investigationsand make a payment to the MHRA for your notification before submitting it if you havent already.
Assessment
This section concerns clinical investigations being conducted in Great Britain only. Please see the separate section below for studies involving Northern Ireland.
When the MHRA has received your documents and validated them, we will write to you within 5 working days to confirm that the 60-day assessment has started or we will let you know if there are any issues. If there are any issues raised, the 60-day assessment 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 Notification. For example, If an application is received on 24th August and the assessor validates the submission on 28th August, the clock starts on 29th 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. The MHRA will write to you if we require further information. It is essential that you contact the MHRA as soon as possible if you require clarification. Where possible we will arrange a teleconference for a better understanding a