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What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
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.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
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
Advice for manufacturers of Class I medical devices for placing products on the UK market
Check the legal requirements you need to meet before you can place a medical device on the market and see how MHRA monitors compliance.
Guidance for local authorities, trusts, schools, colleges and FE institutions about who owns DfE loaned devices, asset management and loan agreements.
How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
How the supply of medical devices from Great Britain into Northern Ireland works.
How to conform with the legal requirements for placing medical devices on the market.
How to get fast-track approval of medical devices during COVID-19.
Information to support commercial fishers on under 12 metre English vessels.
Order a certificate of free sale to export medical devices outside the UK.
Checklists providing a practical guide to using medical devices.
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.
Information on content filtering and mobile device management to ensure devices are safe to use by young people and families
List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.
Advice on writing clear notices and maximising replies to your FSNs.
Don’t include personal or financial information like your National Insurance number or credit card details.
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