UKCA (UK Conformity Assessment) is the product marking system intended to replace CE marking for the GB market (England, Wales and Scotland). This will be introduced by the UK Government after the end of the EU Exit ‘Implementation Period’ (i.e. after 31/12/20).
Products currently in Stock
Government guidance states that existing stock, i.e. products fully manufactured can be made available on the GB market with no changes after 1st January 2021, even where otherwise a change of Notified Bodies would be required.
UKCA Marking will apply throughout GB and all products will need to have UKCA marking to be traded in England, Wales, or Scotland. At the end of the transition period, the Ireland / Northern Ireland (IE/NI) protocol applies which means that goods placed on the NI market are subject to EU law, so therefore require CE marking.
This means that when necessary products will need to have had their Notified Body conformity Assessments updated by an EU notified Body to maintain the CE Marking.
Products that have been certified by a NI Notified Body will need to mark the product next to the CE mark with UK(NI). This distinct marking allows the identification of products which can be legally placed on the market in NI but not the EU.
Products marked with UK(NI) will be allowed to be sold in the UK with no additional regulatory checks.
An entity who first places the product on the UK market becomes a UK importer.
An entity who first places the product on the EU market becomes an EU importer.
These entities assume the associated responsibilities of an importer.
When selling products into Europe you will need an EU address for the product, so either the importer puts their address on the packaging and therefore assumes responsibility or you can use an EU authorised representative office service.
UKCA requirements will mirror the CE marking rules which means that the manufacturer’s name and address must be on the product, packaging, or associated documentation.
If the manufacturer is NOT established in the UK, then the name and address of the UK importer must also be on the product, packaging, or associated documentation.
The manufacturer may also use a UK authorised representative where their details need to be on the product, packaging, or associated documentation.
This information is the current interpretation as of September 2020 – Changes may take place before the end of December which affect the below guidance especially with regards Northern Ireland.
The information provided in this document applies to all product that fall under the current CE marking regulations, with one exception;
The Medical Devices Directive transitioning to the Medical Device Regulation has differing requirements identified on the following link.
Manufacturers are able to apply the UKCA mark immediately however, in most cases manufacturers are not required to so until 1st January 2023. During 2021 and 2022, CE marking will be accepted in the UK as demonstrating compliance. This is referred to as the ‘standstill period’. Things may change during the ‘standstill period’ and manufacturers are encouraged to be ready to UKCA mark.
CE Marking during the ‘Standstill Period’ applies if;
Note – If a product is subject to mandatory third party conformity assessment AND you use a Notified Body in the UK that has NOT had certifications re-issued by an EU notified Body, the CE marking will not be valid from January 2021
This means that you will be have to place a UKCA mark on the product but the CE mark certification that has been issued by a UK Notified Body will no longer be valid and will need to be updated and re-issued by a EU Notified Body.
Many UK Notified Bodies have been working on getting representation in Europe to enable them to update certificates.
UK Notified Bodies will be automatically become UK Approved Bodies from 1st January 2021.
Products will need to have two certificates - one for the EU and one for UK requirements.
The technical requirements for UKCA marking are expected to mirror those of CE marking as outlined in the ‘Blue Guide’.
Initially, the regulations are expected to remain similar but will change over time as the UK implement changes not adopted by the EU, or the EU makes changes not adopted by the UK.
Changes can take places during the ‘standstill period’, so companies will need to be vigilant and keep abreast of updates.
Products which currently comply with CE Conformity assessment procedures will need to be updated to demonstrate compliance with the UK statutory Instruments. These are the UK laws that are implemented for each of the European Directives.
The declaration of Conformity will need to be updated to reflect the correct UK Statutory Instruments and British Standards. Products that are to be sold in EU and UK will need two separate Declarations of Conformity one for the UK and one for the EU.
The Technical File that has been generated for the CE mark will be adequate as evidence for the UKCA mark. One Technical File is adequate. Regulations will change over time and evidence will be required to demonstrate compliance for both sets of regulations.
Below is a list of the UK Statutory Instruments against the EU directives.