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Public Access Database for Medical Device Registration

    https://aic.mhra.gov.uk/era/pdr.nsf/name?openpage&start=1&count=200
    Electrical-only medical device connection cable single-use : , Cannula clamp : , Intracardiac ...

Approved bodies for medical devices - GOV.UK

    https://www.gov.uk/government/publications/approved-bodies-for-medical-devices/approved-bodies-for-medical-devices
    The UK MDR 2002 covers the following: active implantable medical devices, covering all powered implants (Part III of the UK MDR 2002) medical devices, …

Factsheet: medical devices overview

    https://www.gov.uk/government/publications/medicines-and-medical-devices-bill-overarching-documents/factsheet-medical-devices-overview
    A medical device is any apparatus, appliance, software, material or other article, whether used alone or in combination, intended by the manufacturer to be used by …

List of medical devices given exceptional use authorisations

    https://www.gov.uk/government/publications/medical-devices-given-exceptional-use-authorisations-during-the-covid-19-pandemic/list-of-medical-devices-given-exceptional-use-authorisations
    MHRA reference number: DEU/003/2022/001 Manufacturer: STERIS Solutions/Medivators Inc. Device/model name: Rapicide PA High-Level Disinfectant …

Register medical devices to place on the market - GOV.UK

    https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
    Medical devices regulation and safety Guidance Register medical devices to place on the market How to register your medical devices with the Medicines and …

Medical device safety information produced by the MHRA

    https://www.gov.uk/drug-device-alerts/medical-device-safety-information-produced-by-the-mhra
    The MHRA is accredited to publish National Patient Safety Alerts (NatPSA) for medical devices and medicines. These alerts are sent to the NHS in England. The …

Medical devices: information for users and patients

    https://www.gov.uk/guidance/medical-devices-information-for-users-and-patients
    Medical devices can diagnose, monitor or treat disease and help people with physical impairments become more independent. Medical devices that people buy for …

Medical devices: guidance for manufacturers on vigilance

    https://www.gov.uk/government/collections/medical-devices-guidance-for-manufacturers-on-vigilance
    The MHRA is responsible for the UK medical device market. Once a medical device has been placed on the UK market, the manufacturer must submit …

Borderline products: how to tell if your product is a …

    https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medical-device
    Under Part II of the UK Medical Devices Regulations 2002 as amended (“UK MDR 2002”), ‘general’ medical devices are grouped into four classes as follows: Class I …



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