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A taxonomy of different incident types, modalities and outcomes in clinical imaging, MRI and nuclear medicine.
This report reviews data on patient doses and equipment trends in dental X-ray imaging procedures between 2014 and 2017.
Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
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.
Video series explaining the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
The VDEC clinical evaluation team works to support vaccine and therapeutic development by providing expertise in immunological and functional assays used to support clinical trials (Phase I to IV)
We use decades of experience in safe bioagent handling to support partners in research, development and testing of vaccines and therapeutics
MHRA's Improving Patient Information project aims to modernise how medicines product information is delivered, making it more accessible, trusted, and future-ready.
Guidance for manufacturers who source their own-branded products from another company.
How to comply with the regulations when using a medical device differently to the manufacturer's instructions.
An initiative to help drive advancements in healthcare, to ensure patients benefit from innovation and new treatments sooner.
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…
Applying for market authorisation for plasma master files (PMFs) and vaccine antigen master files (VAMFs).
Overview of the different types of MHRA safety communications about medicines, medical devices and other healthcare products, including what they are and who they are aimed at, and information on decision-making around safet…
What 'single-use' means and what symbol is used by manufacturers to show this.
Information for manufacturers of software as a medical device, detailing events that may cause indirect harm and are therefore reportable.
Guidance on how to report suspected adverse incidents and safety concerns with diabetes management equipment to the Yellow Card scheme.
Guidance on registration of certain in vitro diagnostic devices reliant on expired or expiring CE certificates or declarations of conformity.
Further explanatory guidance for Diagnostic Radiopharmaceutical (RP) Investigation Medicinal Products (IMPs) and Good Manufacturing Practice (GMP) requirements.
How manufacturers can comply with the regulations when providing instructions for using medical devices in an electronic form.
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