1st August 2023 UK Government announces indefinite extension to CE marking > Read More...
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On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom. The response outlined the intended regulatory reform including the transitional arrangements for CE and UKCA marked devices placed on the Great Britain market. At the time of writing the UK Government aims to bring new medical device regulations into force by July 2024. What follows is a summary of the status of Great British regulatory environment as of January 2023.

Summary

Devices in Great Britain are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) which give effect in UK law to the directives listed below:

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. However, under the Northern Ireland Protocol (correct at the time of writing – February 2023) different rules apply in Northern Ireland to those in the rest of the United Kingdom (Great Britain). The directives listed above together cover all medical equipment being placed on the market in Great Britain (England, Wales & Scotland). For more information on the regulatory system for medical devices outside of Great Britain please see our EU MDR and Northern Ireland pages.

Note that if you are importing OEM devices from outside of the UK to sell under your own brand within the UK, you are classed as a manufacturer and the same obligations apply to your device as to other UK-manufactured devices and you may not be able to rely on the markings associated with an OEM device. See our page for Importing CE marked Medical Devices into the UK. 

 

See our Medical Devices Regulation page for the EU

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