MHRA Updated Guidance on Regulating Medical Devices from 1 January 2021

On 7 December 2020 the MHRA Updated the Medical Devices Guidance.

From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will be responsible for the UK medical devices market that are currently managed 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.

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