From 1st January 2021 manufacturers of both medical devices and personal protective devices must, thus, regularise their products pursuant to the requirements of the British regulations.
As we have reiterated, from 1 January 2021 UKCA marking is the compliance mark to be used in the GB market for products previously covered by CE marking. However, almost all CE marked products will be covered by a grace period continuing to 31 December 2021, during which CE markings will still be accepted in Great Britain.
To date the technical requirements, assessment standards and essential health and safety standards required to demonstrate UKCA conformity do not differ from the requisites applying in the European Community for CE compliance.
The United Kingdom has, in fact, adopted EU directives and regulations and the harmonised norms which imply EU conformity have become designated standards which will be used for UKCA conformity presumption purposes.