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UK MHRA: Guidance on Register Medical Devices to place on the Market

Earlier today (27 March 2023) UK's Medicines and Healthcare products Regulatory Agency (MHRA) released updated guidance on "Register medical devices to place on the market" that provides detailed instructions on How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.

For a medical device to go on sale in Great Britain (England, Wales, and Scotland), it must be registered with the MHRA.

The Medical Devices Regulations 2002 must be followed in Great Britain so that devices can be placed on the market and registered with the MHRA, and the requirements for Northern Ireland differ.

Devices can only be registered by UK Responsible Persons or Authorised Representatives based in Northern Ireland (for the Northern Ireland market) or manufacturers based in the UK.

MHRA (the UK Competent Authority) registration does not indicate that your device has been accredited, certified, approved, or endorsed by the MHRA. Therefore, you may not use any of the MHRA logos in marketing materials, device packaging, instructions for use, laboratory tickets or receipts, or in any other document to claim this effect.

In order to start registering your devices, You need to create an account on the MHRADORS.

Click this LINK to know more about details such as Who must register, When you must register, Fees and Review registration, etc.

Also, check out this New updated guidance on "Export medical devices" that details you about ordering a certificate of free sale to export medical devices outside the UK.


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