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Information for manufacturers of medical devices about 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.
Tax and reporting rules for employers providing medical or dental treatment and insurance
As an employer providing medical or dental treatment or insurance to your…
You don’t have to report anything to HMRC or pay tax and National…
If the medical or dental treatment or insurance you provide isn’t exempt,…
The value to use is the cost to you of providing the treatment or…
The following guides contain more detailed information: employment income:…
Information and guidance on a range of medical devices for users and patients.
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.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
The Medical Research Council (MRC) is a national funding agency dedicated to improving human health by supporting research across the entire spectrum of medical sciences, in universities and hospitals, in MRC units, centres and institutes in the UK, and in...
Order a certificate of free sale to export medical devices outside the UK.
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.
Government outlines action to make UK a world leader in tackling ethnic and other biases in medical devices.
How to conform with the legal requirements for placing medical devices on the market.
Information about the EU Regulations and their implementation in Northern Ireland
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Information on when software applications are considered to be a medical device and how they are regulated.
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
This collection brings together directions for the National Health Service primary medical services, setting out part of the legal framework under which GP practices operate and are paid.
How to get medical help for emergencies, issues that can't wait until you can see your GP and dental emergencies.
Lists of English-speaking doctors, medical facilities and practitioners around the world to help British people abroad access healthcare.
The Medicines and Healthcare products Regulatory Agency (MHRA) have embarked upon an ambitious programme of reform to ensure that medical device regulation is fit for purpose for software, including artificial intelligence (AI).
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