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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.
Anyone in Northern Ireland selling medicines to the public via a website must still comply with the requirement to apply the EU common logo.
How to distinguish between products that are regulated as medical devices and those regulated as medicinal products.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
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.
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
Guidance on whether or not your product is a medical device.
Some of the different symbols used on medical devices.
A user guide for understanding and applying the national taxonomy for incident learning in clinical imaging, magnetic resonance imaging and nuclear medicine.
A taxonomy of different incident types, modalities and outcomes in clinical imaging, MRI and nuclear medicine.
Guidance for medical device manufacturers on when electronic instructions for use can be used.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
A flyer to circulate to customers alongside a field safety notice covering what it is and why it's important to take action.
How to get fast-track approval of medical devices during COVID-19.
How to comply with the regulatory requirements for manufacturing custom-made medical devices.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Helps manufacturers and healthcare professionals understand the definition of assistive technology and the difference between medical devices and aids to daily living.
How the supply of medical devices from Great Britain into Northern Ireland works.
Checklists providing a practical guide to using medical devices.
Information about suspected side effects of e-cigarettes and how to report side effects.
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