Policy Updates

Management of Medical Devices Policy and Procedure #6

Clinical Governance Practice Management Region: | Reference: GCP19

This policy has been reviewed and updated to include a new procedure at 5.20 about regulating medical devices in the UK. Since the UK left the European Union (EU) on 1 January 2021, CE marking will continue to be recognised in Great Britain until 30 June 2023 but, from 1 July 2023, a UKCA mark will be required in order to place a device in the Great British market. The CE Marking definition has been updated and a new UKCA Mark definition has been added. A new reference has been added about the regulation of medical devices and existing references have been reviewed and updated.