![]() ![]() Please see the separate section below for studies involving Northern Ireland. This section concerns clinical investigations being conducted in Great Britain only. For further clarification, contact fees for clinical investigationsĪnd make a payment to the MHRA for your notification before submitting it if you haven’t already. 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. Please note: The fee rate is based on a single investigational device being used in a study. Information on the applicable fees are available using the link below. #NOTIFYR ALTERNATIVE HOW TO#Information on how to notify the MHRA about an amendment for a clinical investigation can be found below under Amendments. You will receive an invoice to allow you to make payment for the correct amount once your application has been validated. You do not need to attach proof of payment to applications. These regulations include the introduction of new fees for amendments to clinical investigations. The Medical Devices (Fees Amendment) Regulations 2017 came into force on 1 April 2017. See information for clinical investigators ( PDF, 144 KB, 10 pages) for what is required by clinicians involved in the investigation.Ĭheck the information on the biological safety assessment ( PDF, 150 KB, 8 pages) for the scientific data you must submit.Ĭheck statistical considerations ( PDF, 163 KB, 14 pages) for presenting statistical information for your clinical investigation.Ĭheck guidance on applying human factors and usability engineering to medical devices including drug-device combination products. MHRA guidanceįollow the guidance on compiling a submission ( PDF, 211 KB, 16 pages) and guidance for manufacturers when preparing your notification application.Īpplications are submitted electronically using the Integrated Research Application System ( IRAS) We will resume processing of new applications received during this period on Monday 29 November 2022.Ī 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. From Monday 7 November - Friday 26 November, no new applications will be processed. ![]()
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