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Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Information and guidance on a range of medical devices for users and patients.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Information about the EU Regulations and their implementation in Northern Ireland
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Advice on writing clear notices and maximising replies to your FSNs.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
Medicines and Healthcare products Regulatory Agency (MHRA) guidance on using medical devices safely.
Advice for manufacturers of Class I medical devices for placing products on the UK market
Report a problem ('adverse incident') with a medical device or medicine to MHRA using the Yellow Card Scheme
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
Posters and leaflets about using medical devices safely for healthcare professionals.
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