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Information for people who wish to apply to release a vaccine or a blood product to market in the UK.
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.
A step-by-step guide on using the MORE Platform for Submissions of device related incidents.
This guidance has been produced in collaboration with the UK Kidney Patient Safety Committee (KPSC), to summarise known safety issues with dialysis and continuous renal replacement therapy (CRRT) and describe what to do to m…
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.
This guideline is to provide developers of biosimilar products with a clear outline of the requirements in Great Britain.
What is considered off-label use of a medical device and examples of it.
Guiding principles for the use of Predetermined Change Control Plans (PCCPs) for managing rapid product changes.
To assist sponsors and those conducting trials on implementing adequate oversight and monitoring processes for trials of investigational medical products.
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
How to distinguish between products that are regulated as medical devices and those regulated as medicinal products.
E-learning modules for healthcare professionals on minimising the risks of using medicines and information on how to access medical device modules.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
Guidelines for communicating clear and relevant information about machine learning-enabled medical devices.
How traditional herbal medicines and homeopathic medicines will be treated by the MHRA.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
How investigators and sponsors should manage clinical trials during COVID-19
Types of ingredients permitted in nicotine-containing liquids in electronic cigarettes and refill containers.
A user guide for understanding and applying the national taxonomy for incident learning in clinical imaging, magnetic resonance imaging and nuclear medicine.
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