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Guidance: Notify the MHRA about a clinical investigation for a medical device

Medicines Healthcare Products Regulatory Agency

January 20
16:29 2023

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.

MHRA guidance

Follow the guidance on compiling a submission (PDF, 211 KB, 16 pages) 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 (PDF, 144 KB, 10 pages) for what is required by clinicians involved in the investigation.

Check the information on the biological safety assessment (PDF, 150 KB, 8 pages) for the scientific data you must submit.

Check statistical considerations (PDF, 163 KB, 14 pages) for presenting statistical information for your clinical investigation.

Check guidance on applying human factors and usability engineering to medical devices including drug-device combination products.

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 and to find a resolution within the 60-day assessment time, if there are possible grounds for objection.

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.

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. If you have not yet registered for the MORE portal, details on how to do so can be found here: MORE Registrations - user reference guide - GOV.UK (www.gov.uk)

Quarterly Summary Reports

In addition to the reporting of individual serious adverse events as detailed above, please provide quarterly summary reports of all serious adverse events.
When providing these summaries please include in tabular format the following information broken down by event type:

  • number of serious adverse events
  • number of participants affected by those events
  • percentage of the total number of enrolled participants affected by those events

When providing this table, please ensure it contains information on SAEs for the entire duration of the trial, not just those which have occurred during this quarter.

Event type Number of events Number of participants affected % of participants affected Expected % rate of SAE - (based upon literature of similar devices or alternative treatments)
e.g. Stroke

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