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Advice for manufacturers of Class I medical devices for placing products on the UK market
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
Check the tariff classification for smart watches.
Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How to write clear and effective field safety notices (FSNs) for medical devices.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
How to conform with the legal requirements for placing medical devices on the market.
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