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Guidance on how to report suspected adverse incidents and safety concerns with diabetes management equipment to the Yellow Card scheme.
The MHRA has published advice for patients and healthcare professionals
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
This report reviews data on patient doses and equipment trends in dental X-ray imaging procedures between 2014 and 2017.
How to comply with the regulations when using a medical device differently to the manufacturer's instructions.
A taxonomy of different incident types, modalities and outcomes in clinical imaging, MRI and nuclear medicine.
Types of ingredients permitted in nicotine-containing liquids in electronic cigarettes and refill containers.
Information for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
The EU has published guidance on exemptions for medical devices manufactured and used within EU health institutions, which applies to Northern Ireland-based health institutions, replacing interim guidance from the MHRA.
What 'single-use' means and what symbol is used by manufacturers to show this.
Checklists providing a practical guide to using medical devices in a range of healthcare settings.
Guidance for medical device manufacturers on when to use electronic instructions and how to comply with the regulations.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
The types of emissions a manufacturer or importer of e-cigarettes should notify us about.
Ten guiding principles that can inform the development of Good Machine Learning Practice (GMLP).
Background information for MHRA AI Airlock launched in Spring 2024 and is the MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products.
Key insights of three simulation workshops from the AI Airlock pilot testing programme. Please note that these documents are not formal guidance.
Acceptable naming, presentation and packaging of nicotine-containing electronic cigarettes and refill containers.
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
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