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Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
Advice for manufacturers of Class I medical devices for placing products on the UK market
How manufacturers should undertake a clinical investigation for a medical device to ensure they comply with medical device regulations.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
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