Ready for UKCA?
Following Brexit, products that currently bear a CE mark will require a new UKCA (UK Conformity Assessed) mark to remain or be introduced on the UK market.
The new UKCA regulation came into effect on January 1, 2021. The use of the CE mark is still possible during a "standstill period" until January 1, 2023 – and for medical devices until July 1, 2023.
The use of the CE mark prior to the deadlines mentioned is only allowed on condition that those EU rules, under which the product has been CE-certified, have not changed after January 1, 2021. If so, the CE mark may no longer be applied on products for the UK. Instead the UKCA mark needs to be applied immediately. For many medical devices this also implies that the product gets certified by a UK approved notified body.
The quality requirements are mainly the same for both CE and UKCA. Therefore, the implementation of the UKCA is an administrative procedure to go through in order to remain on the UK market.
The mark must be at least 5 mm high – unless relevant legislation specifies different dimensions.
The proportions of the letters must be kept according to the original mark.
UKCA is a Great Britain product marking for England, Wales and Scotland.
UKCA is not recognized in the EU/EEA or Northern Ireland. These countries still require CE marking.
Some class I devices can be self-certified. Most medical products must be certified by a UK Approved Body. Manufacturers from outside UK must appoint a UK Responsible Person to register and act on their behalf.
Yes, it is possible to have both marks on one product, as long as they fulfil both CE and UKCA regulations. Wherever possible, marks must be applied directly on the product. They must also be easily visible and legible.
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