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Notify the MHRA about a clinical investigation for a …

    https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device
    A notification to the MHRAwill not be required for medical devices that are UKCA / CE / CE UKNI marked for the purpose that is under investigation. See more

Medicines, medical devices and blood regulation and …

    https://www.gov.uk/topic/medicines-medical-devices-blood/clinical-trials-investigations
    Aug 17, 2020 · Clinical trials for medicines: manage your authorisation, report safety issues Clinical trials for medicines: authorisation assessment performance MHRA phase I …

Clinical trials for medicines: apply for authorisation in the UK

    https://www.gov.uk/guidance/clinical-trials-for-medicines-apply-for-authorisation-in-the-uk
    Dec 18, 2014 · Contact. For information about your submission, including status and tracking enquiries, contact the clinical trials helpline on 020 3080 6456 (Monday to Friday 8:30am …

Regulating medical devices in the UK - GOV.UK

    https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
    Dec 31, 2020 · Overview. The Medicines and Healthcare products Regulatory Agency ( MHRA) is responsible for regulating the UK medical devices market. This guidance …

Medical device trials | Research Support - University of …

    https://researchsupport.admin.ox.ac.uk/clinical-trials-research-governance/preparation/medical-device-trials
    1 day ago · You will need to pay MHRA a standard application fee and a fee for any amendments until trial completion. Protocol registration Journals that follow the guidelines …

Medical devices and in vitro diagnostic medical devices – …

    https://www.ukri.org/councils/mrc/facilities-and-resources/find-an-mrc-facility-or-resource/mrc-regulatory-support-centre/developing-healthcare-products/medical-devices-and-in-vitro-diagnostics/
    A study that validates an in vitro diagnostic for medical use is a performance evaluation. MHRA regulates devices and in vitro diagnostics in the UK; they must be notified of …

Medical Device Clinical Trials: Regulatory Pathways

    https://www.greenlight.guru/blog/medical-device-clinical-trials
    Jan 1, 2023 · Medical Device Clinical Trials: Regulatory Pathways & Study Types Explained. Written by: Jon Bergsteinsson. January 1, 2023. In both the US and the EU, medical …

Clinical trials of medicines and medical devices

    https://www.manchester.ac.uk/research/environment/governance/clinical-trials-medical-devices/
    Oct 24, 2021 · Clinical trials of medicines and medical devices. Clinical studies that look at investigating the effects of drugs or medical devices are subject to UK and EU law. They …

How to submit a clinical -CE marked device or a CE …

    https://www.imperial.ac.uk/media/imperial-college/research-and-innovation/research-office/public/RGIT_SOP_014_Medical-Device_v10.0_07-Jan-2021.pdf
    Sep 14, 2022 · Author: Thomas Lewis, Clinical Trials Facilitator Approved by: Ruth Nicholson, Head of Research Governance and Integrity Date: Version Date Reason for …

Medical devices and software applications - Health …

    https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/medical-devices-and-software-applications/
    Jan 6, 2022 · Under the Medical Devices Regulations 2002, ethical approval is required for a clinical investigation undertaken by, or with the support of, the manufacturer or another …



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