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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.
Advice and guidance on the health needs of migrant patients for healthcare practitioners.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
Information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect on 23 July 2025.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
Better and faster access to NHS data for researchers, with gold standard security and privacy measures.
How to conform with the legal requirements for placing medical devices on the market.
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to use a patient-reported outcomes and experiences study to evaluate your digital health product.
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