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Regulating medical devices in the UK - GOV.UK

    https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
    UKCA markingThe UKCA (UK Conformity Assessed) marking is a UK product marking used fo…UK Approved BodiesThe MHRA can designate UK Approved Bodies to conduct conformity a… See more

Brexit: How You Can Still Sell Your Medical Devices in …

    https://www.johner-institute.com/articles/regulatory-affairs/and-more/brexit-how-you-can-still-sell-your-medical-devices-in-the-uk/
    After June 30, 2023, all medical device manufacturers who want to place their devices on the market in the UK will have work with a UK approved body, at least if their devices are …

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

    https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
    It is a requirement of the UK MDR 2002 that you inform the MHRA before you place your device on the market in Great Britain. You must register if you or your …

Medical devices: how to comply with the legal …

    https://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirements
    Examples of active implantable medical devices include: implantable cardiac pacemakers implantable defibrillators leads, electrodes, adaptors for the above …

UK MHRA Medical Device Registration & UKCA …

    https://www.orielstat.com/blog/uk-mhra-medical-device-registration/
    Medical device manufacturers must apply a new UK Conformity Assessed (UKCA) Mark to their device labeling for products sold in England, Wales, and Scotland. This means that if …

Making your CE-marked device legal to …

    https://www.medicalplasticsnews.com/medical-plastics-industry-insights/medical-plastics-regulatory-insights/making-your-ce-marked-device-legal-to-sell-in-the-uk/
    From 1 July 2023, all medical devices and IVDs to be sold in Great Britain will need a UKCA mark. There is one exception to the UKCA requirement for medical devices produced by …

Export medical devices - GOV.UK

    https://www.gov.uk/guidance/export-medical-devices-special-rules
    Certificates of Free Sale for Medical Devices (PDF, 1.3 MB, 29 pages) Video tutorial How to order and reorder Certificates of Free Sale Contact the Medicines and …

Selling to the NHS: a how to guide

    https://www.tussell.com/insights/selling-to-the-nhs-how-to
    Tussell's market intelligence platform shows that NHS bodies won approximately £5.5 billion worth of contracts from NHS authorities in 2021. In this example, Essex Partnership University …

United Kingdom Medical Device Regulation

    https://www.trade.gov/market-intelligence/united-kingdom-medical-device-regulation
    A new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from January 1, …

Partnering with the NHS to sell goods and services

    https://www.gov.uk/guidance/partnering-with-the-nhs-to-sell-goods-and-services
    Selling through NHS collaborative purchasing arrangements in England Some local NHS organisations may choose to work together in a regional purchasing …



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