UKCA – Impact of UK Legislation on Market Access

Yes, the importer address should also be placed on the product. The legislation specific to your product may make allowances for the importer details to be placed elsewhere if it is not practical to place them on the product.

From January 1st 2023, the UKCA mark will be required to be displayed on products (except for medical devices - CE marking will continue to be recognized until June 31st 2023). To reduce the impact on businesses, the UKCA mark can be affixed optionally to the product or an enclosed document using a label. This will be accepted until December 31st 2022 only. After this time, the UKCA mark must be affixed directly to the product (unless the applicable regulations make other allowances).

Existing stocks that were fully manufactured and conformity marked prior to January 1st 2023 can still be placed on the British market after January 1st 2023 with a CE-marking and, where appropriate, the number of the Notified Body.

An EU representative must be located in the EU, UK based representatives will no longer be recognised as an EU representative after 31st December 2020.

Any EU Notified Bodies located within the UK will automatically become UK Approved Bodies on 1st January 2021 so we can be confident that the vast majority of the total scope will be covered by a UK Approved Body. That said there is a risk that for a few products no UK Approved Body will have them on their scope before the end of the transition period, in which case the relevant authority should be contacted for advice.

Under European Union product legislation, Notified Bodies must be established in an EU Member State and must be designated by a competent authority of a Member State in order to perform activities as part of a conformity assessment.

With the loss of “EU status” for many Notified Bodies, as of January 1st 2021, British Notified Bodies based in Great Britain are no longer able to perform conformity assessment activities under European legislation, and as a result, certificates issued by such a Notified Body will not be valid going forward.

At this point, advice to companies is to switch to a Notified Body or type-approval authority located in the EU single market if they wish to continue to market their products and vehicles in the European Union.

Where third party conformity assessment is required by the applicable legislation, test reports issued outside of the UK may be accepted by a UK Approved Body at their discretion for certification. This is only possible if the testing laboratory holds suitable accreditation and the correct test standards were applied.

For many Directives/Legislation no Notified Body/Approved Body involvement is required, however some Directives/ Legislation do require the involvement of a Notified Body. The UKCA requirements very closely mirror the CE requirements, so if you do not require the involvement of a Notified Body for your CE you will not need a UK Approved Body for UKCA.

There is no gap analysis as such but the linked document below shows many of the changes that were made to the directives to make them UK legislation as a result of Brexit: https://www.legislation.gov.uk/uksi/2019/696/made