Racing Towards UKCA Compliance: Expert Ed Ball, Senior Associate, RQM+ – A Professionals View

The UK will continue with the UK Medical Devices Regulations 2002 (S.I. 2002/618) (UK MDR), as amended, and by the 30th of June 2023, manufacturers will need to follow the UK Conformity Assessment process and place the UKCA mark on their medical devices, as CE marked medical devices will stop being recognised in Great Britain (England, Scotland and Wales).