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UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
Device-specific guidance for manufacturers on reporting adverse incidents under the vigilance system
MHRA sets out new plans to protect patient safety and enable access without delay for UK patients to innovative medical technologies
The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics.
Information on road traffic devices, such as breath-testing, speed cameras and immobilisation devices.
Community diagnostic centre (CDC) sites have already delivered over 7 million tests, checks and scans to patients across England.
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
This guidance is designed to help UKHSA customers and partners to navigate engaging and working with us and to signpost upcoming events and opportunities.
Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).
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