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Guidance on whether or not your product is a medical device.
Guidance for healthcare professionals covers the use, management and safety of in vitro diagnostic (IVD) devices, including blood glucose meters.
Guidance on managing and using bed rails safely.
Government outlines action to make UK a world leader in tackling ethnic and other biases in medical devices.
How to distinguish between products that are regulated as medical devices and those regulated as medicinal products.
Notices of publication and a consolidated list for designated standards for medical devices.
Guidance for healthcare and social services organisations on managing medical devices in practice.
How to use a cost utility analysis to evaluate your digital health product.
UK guidance on re-manufacturing of Single-use medical devices.
The Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new UK Approved Bodies, almost doubling the UK’s capacity to certify medical devices, supporting faster certification of safe and effective medical devices for healthcare professionals and the public.
Guidance on the procurement of in vitro diagnostic (IVD) medical devices, their safety, quality and performance.
Guidance for manufacturers, importers and distributors.
The Medicines and Healthcare products Regulatory Agency (MHRA) have embarked upon an ambitious programme of reform to ensure that medical device regulation is fit for purpose for software, including artificial intelligence (AI).
Notices of publication and a consolidated list for designated standards for active implantable medical devices.
Report on all regulations in force during the first reporting period made using the powers in specific sections of the act, including stakeholder feedback and the department’s response.
E-learning modules for healthcare professionals on minimising the risks of using medicines and information on how to access medical device modules.
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