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Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
Information to support vessel owners and licence holders of under-12 metre English vessels.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
An overview of the future requirements for rapid COVID-19 diagnostic assays for antigen lateral flow devices.
This page details the government's work to improve the cyber security of enterprise connected devices (or 'IoT' devices.)
Patients in the UK and Singapore could gain faster access to cutting-edge healthcare innovations under a new partnership bringing two globally respected regulators together with one of the world’s leading biotech creators.
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