The UK Government has confirmed that the UKCA mark will come into force on 1 Jan 2021, although CE marking will continue to be recognized in the UK until the end of 2021, as long as the UK and EU regulations remain aligned. However, from the beginning of 2022 only products with UKCA marking will be accepted in Great Britain.
BSI is an approved body (0086) for the UKCA mark and we can work with you on the required conformity assessment procedures that will allow you to affix the UKCA marking under the following areas:
At the time of writing, guidelines and timescales regarding UKCA marking for Medical Devices and IVD’s differ to those for the products listed above.