Brexit guidance: regulating medical devices from 1 January 2021

What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets from 1 January 2021.

From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system.

This guidance provides information on how the UK system will operate, including for:

  • Getting your device certified
  • Conformity marking your device
  • Registering your device with the MHRA

This guidance is divided into sections on the different rules that will apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.

For Northern Ireland, different rules will apply to those in Great Britain after the end of the transition period. For more information on the regulatory system for medical devices in Northern Ireland, please see ‘Regulation of medical devices in Northern Ireland’

Regulating medical devices from 1 January 2021, “medical device” includes in vitro diagnostic medical devices and active implantable medical devices.

This guidance only applies to medical devices and does not cover other CE marked products, which are subject to separate guidance.

The proposals outlined in this guidance notice will take effect through legislative changes that will be introduced later in 2020. They are still therefore subject to parliamentary approval.

This information is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations. Speak to your solicitor or trade association if you are unsure which regulatory framework applies to your goods.

The Gov.UK website has the full details of the legislation that will apply here.

If you require support from our regulatory specialists regarding how this affects you, contact us today.

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