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Guidance for healthcare professionals on managing specific medicines and medical devices and using them safely.
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
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
How to conform with the legal requirements for placing medical devices on the market.
Medicines and Healthcare products Regulatory Agency (MHRA) guidance on using medical devices safely.
Advice on writing clear notices and maximising replies to your FSNs.
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).
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).
Information on when software applications are considered to be a medical device and how they are regulated.
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