Ready for UKCA?

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.

What's the required size of the UKCA ?

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.

Which countries require UKCA?

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.

Who is responsible for issuing UKCA certification?

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.

Can products bear both CE and UKCA?

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.