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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…
How to best protect patients and volunteers during magnetic resonance imaging (MRI) examinations.
The call for applications for phase 2 of the AI Airlock is now closed.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
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.
Report on the service providing sterile, controlled environments for the preparation of injectable medicines into ready-to-administer formats for patients.
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
How to respond to the GCP inspection report findings, increase awareness of the GCP Inspectors’ expectations and aid formulation of an acceptable response.
Requirements and recommendations for sponsors and those conducting trials.
Guidance on how Pharmacy First will help pharmacies support their communities, with information on the new clinical pathways and fee structure.
How the MHRA decides whether to approve a clinical investigation for medical devices.
Types of ingredients permitted in nicotine-containing liquids in electronic cigarettes and refill containers.
Which product type to select when submitting a notification of intent to market e-cigarette and vape products in Great Britain.
Which submission type to select when submitting a notification of intent to market e-cigarette and vape products in Great Britain.
How manufacturers can comply with the regulations when providing instructions for using medical devices in an electronic form.
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 manufacturers in Northern Ireland should undertake a clinical investigation for medical devices to ensure they comply with EU medical device regulations.
The pre-clinical evaluation team at VDEC provides a safe and controlled environment to test new vaccines and therapeutics before they progress to clinical trials
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