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UK approved bodies for medical devices - GOV.UK

    https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices
    Under Part II of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002) See the Approved Body’s full designated scope SGS United Kingdom...

Regulating medical devices in the UK - GOV.UK

    https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

    Medical devices: UK approved bodies - GOV.UK

      https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies
      UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). From: Medicines and Healthcare products …

    Approved bodies for medical devices - GOV.UK

      https://www.gov.uk/government/publications/approved-bodies-for-medical-devices/approved-bodies-for-medical-devices
      Approved bodies for medical devices Medicines & Healthcare products Regulatory Agency Guidance Approved bodies for medical devices Published 31 …

    Factsheet: medical devices overview

      https://www.gov.uk/government/publications/medicines-and-medical-devices-bill-overarching-documents/factsheet-medical-devices-overview
      There are approximately 600,000 medical devices available on the UK market. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring …

    Medical devices: how to comply with the legal …

      https://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirements
      A UK Approved Body ensures manufacturers comply with the regulations including reviewing clinical and scientific data, manufacturing processes and the quality …

    Medical devices: conformity assessment and the UKCA …

      https://www.gov.uk/guidance/medical-devices-conformity-assessment-and-the-ukca-mark
      UKCA mark requirements for medical devices are based on the 3 main types of medical devices and their associated Part in the Medical Devices Regulations …

    ukmdr.com – home of the uk's medical device regulations

      https://ukmdr.com/
      UK approved bodies Regulations Latest guidance from MHRA The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices in the UK. …

    UKCA marking for medical devices …

      https://www.bsigroup.com/en-GB/medical-devices/market-access/ukca/
      Download UKCA timeline Why choose BSI for your UKCA marking? BSI UK is the only UK Approved Body (0086) designated for Medical Devices and IVDs and the only …

    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 reusable : , Medical table clamp : , Mobile medical equipment stand non-powered : , Patient positioning sensor : , …



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