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Detailed guide: Notify MHRA about a clinical investigation for a medical device

Medicines Healthcare Products Regulatory Agency

November 26
09:58 2020

You may need to carry out a clinical investigation as part of the process to obtain a CE marking for your medical device. You must inform MHRA if you are planning to do this at least 60 days before starting your investigation.

How to notify MHRA of your clinical investigation

A notification to MHRA will not be required for medical devices that are CE marked for the purpose under investigation.

If possible, please provide MHRA with advanced notice of your intention to submit a clinical investigation by emailing devices.regulatory@mhra.gov.uk with some basic details about the investigational device, the intended population, the type of study, and estimated application date. Please provide as much notice as possible. An advanced notice is helpful to MHRA, however is not a substitute for the formal clinical investigation notification.

You need to prepare your documents before you notify MHRA of a proposed clinical investigation.

Follow the guidance on compiling a submission (PDF, 253KB, 13 pages) and guidance for manufacturers (PDF, 418KB, 18 pages) when preparing your notification application.

Applications are submitted electronically using the Integrated Research Application System (IRAS)

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. Please note that the IRAS forms still have questions relating to payment to MHRA, however you no longer need to pay in advance of making your application.

Information on how to notify 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 devices.regulatory@mhra.gov.uk

See fees for clinical investigationsand make a payment to MHRA for your notification before submitting it if you havent already.

Assessment

When 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 working day that follows the date of receipt of a valid Notification.

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. MHRA will write to you if we require further information. It is essential that you contact 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 or before with a decision (objection or no objection) as to whether or not you can carry out the proposed clinical investigation.

Amendments

Once youve received a letter of no objection from us, you must notify MHRA of all proposed amendments to the investigation. You must wait until we send you another letter of no objection before you implement the changes.

You must tell us about any changes made to:

  • the device under investigation
  • study documentation, including the clinical investigation plan
  • investigators or investigating institutions
  • changes requested by an ethics committee

If you dont tell us about proposed amendments you could be liable to prosecution.

When you notify us of amendments, we need the following information:

  • covering letter with:
    • the MHRA reference number for the clinical investigation
    • a table with a summary of each proposed change with the reason for each change
  • red lined (showing changes being made) and clean copies of all amended study documentation

  • a signed statement by, or on behalf of, the manufacturer that the proposed change(s) do not predictably increase the risk to the patient, user or third party

  • details of who to invoice (full company name, address and registered tax/VAT number)

You can send us the amendments by email unless the files are too big, in which case send them on CDs (3 copies, each copy on a separate CD).

As of 1 April 2017, you will need to pay a fee for amendments to clinical investigations.

In Vitro Diagnostic Medical Devices (IVDs)

Unless an exemption applies, all IVDs being placed on the market or put into service in the EU are required to be CE marked.

This includes devices used in clinical trials of medicines to stratify patients for inclusion/exclusion in the trial or stratified to a cohort within a trial.

At the time of the clinical trial application, the CE mark need only be for the analytical performance of the IVD (eg detection of a biomarker) and will include reagents, equipment, calibrators, controls and software.

These are likely to be self-certified IVDs under the current medical device regulations.

Trials which determine the clinical performance of the assay (biomarker validity) will need to be registered as IVD performance evaluation studies.

The question of whether clinical performance studies involving non-CE marked IVDs can take place on a voluntary basis under the IVDR between now and 2022 is subject to further interpretation.

See guidance on in vitro diagnostic investigations for medical devices (PDF, 133KB, 15 pages).

Special circumstances for healthcare establishments

You dont need to notify

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