When the United Kingdom left the European Union, regulatory changes followed. For manufacturer selling products on the United Kingdom market this means you must now comply with UK Legislation and UK Designed Standards. A new UKCA marking will replace CE marking for most categories of products as a ticket to trade in the UK.
The UKCA (UK Conformity Assessed) scheme has been active since 1 January 2021; however, in most cases there is a transition period where CE marking continues to be accepted exists until 31 December 2021 to allow businesses time to adjust. In the case of Medical Devices, this transition is longer, i.e. 30 June 2023.
“We recommend manufacturers start their preparation for transition to UKCA now. While the technical requirements remain largely similar to those of CE marking, an assessment must be performed by a UKCA Approved Body. DNV is already an Approved Body for pressure equipment and in the advanced stages of application for other types of products. Pre-registration is available now to ensure no disruption to market access whether you are importing to or exporting from the UK,” says Otto Hughes, Global Product Assurance Manager in DNV.
For products intended to be sold to both EU, EEA and UK markets, it is possible to combine conformity assessments for both UKCA and CE in a single project.
DNV has 250 product assurance specialists in 20 countries with competence on the new UK regulatory changes as well as schemes on access to other major global markets.