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How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
Millions invested in eight innovative companies behind lifesaving new medical technology which could destroy liver cancer tumours, detect Alzheimer’s and quickly spot those at risk of stroke
How to apply for repayment of import duty and VAT on protective equipment or medical supplies brought into the UK from non-EU countries from 30 January 2020 up to 31 December 2020.
What is considered off-label use of a medical device and examples of it.
Guidance for manufacturers who don’t design or manufacture devices but place their names on the product.
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
Guidance on what approved bodies are, what they do and how you can become one.
Guidance for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
MHRA has published guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
Advice for manufacturers, members of the public and professional users of software or apps being used during the COVID-19 pandemic.
Information on MHRA's enforcement duties and how to report a non-compliant medical device.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Guidance for healthcare professionals covers the use, management and safety of in vitro diagnostic (IVD) devices, including blood glucose meters.
Leicester business Unimed Procurement Services secured government-backed financing to help it deliver life-saving medical equipment around the world.
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
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