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MHRA Guidance: Registration & Regulating Medical Devices in UK

Yesterday (28 April 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Regulating medical devices in the UK" that provides detailed instructions on what you need to do to place a medical device in Great Britain, Northern Ireland and European Union (EU) markets.

Medical devices in the UK are regulated by the MHRA, and this guide includes information on the UK medical device regulatory system, such as:

  • getting your device certified

  • conformity marking your device

  • registering your device with the MHRA

This guidance pertains solely to in vitro diagnostic medical devices and active implantable medical devices and is limited to medical devices only. It does not encompass other CE or UKCA-marked products, as these are subject to distinct guidance.

The main purpose of updating this guidance was to incorporate a planned expansion of the acceptance of CE-marked medical devices on the Great Britain market, beyond the deadline of 30 June 2023.

At present, CE-marked medical devices with a valid CE marking can be placed on the Great Britain market until 30 June 2023, and the government intends to extend CE-marking acceptance beyond 30 June 2023.

Manufacturers wishing to sell medical devices in Great Britain now have access to a new route to market and product marking (the UKCA marking) starting on 1 January 2021. UKCA (UK Conformity Assessed) markings are used for certain goods, including medical devices, to appear on the Great Britain market (England, Wales, and Scotland). The UK Market Conformity Assessment Bodies (UKMCAB) database serves as the UK’s database of conformity assessment bodies.

Similarly, there were 2 more guidances that were related to Medical devices on 27th April, 2023


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