Introduction
This article is intended to give manufacturers that do not have a base in the UK, that place their products on the UK market or that intend to export to the UK in the future a simple guide to complying with the regulations and the best options for their sales strategy.
Before moving on to the new UKCA mark, which replaces the existing CE mark, the manufacturer must first decide who will be their legal representative, registered in the UK that will be responsible for the product´s documentation and contact with the authorities when necessary.
The options available to the manufacturer include dealing directly with their importer, who was previously referred to as the distributor, or end-user client, or using the services of a UK-authorised representative. For manufacturers that want to maintain commercial flexibility, the best option is to work with an authorised representative. This will allow them to sell and ship the products to any customer in the UK without having to transfer to them the new responsibilities of the importers.
If the manufacturer chooses to use their importer, they must ensure that the importer is aware of their responsibilities and fully comply with the requirements. It is not recommended that the manufacturer simply labels the products with the UKCA mark and then takes the view that once the goods are shipped that it is the importer´s responsibility to comply with the regulations. Non-compliance may lead to complications for the manufacturer as well as the importer.
In cases where the manufacturer works with a number of customers, they can either choose one importer to be responsible for all the products, which may or may not be appropriate depending on the sales strategy, or alternatively work with each importer separately. In the last case, this clearly adds layers of difficulty for the manufacturer.
An alternative to the above is simply to appoint an authorised representative as the one point of contact for the authorities responsible for all the documentation and who can provide the information necessary to comply with the regulations and UKCA mark.
Does my product need the UKCA mark?
The are two basic categories of products that require the UKCA mark; products that can be self-certified, and products that require third-party certification by a Conformity Assessment Body (CAB).
For a list of the individual regulations and sectors visit the government web page: ukca-marking-conformity-assessment-and-documentation
With regards to self-certified products, the rules for doing this are in line with the current CE certification which means that if your product is CE certified you can self-declare for the UKCA marking. However, you should check the specific requirements as there may be some differences you need to be aware of, and remember what was discussed earlier; before self-certifying your product as UKCA compliant, you must ensure that the importer’s details or those of your UK-authorised representative are on the product or documentation for the authorities. If this is not done by the manufacturer, it must be done by the importer before placing the goods on the market.
For products that require third-party conformity assessment, your current CE certificate and test reports are valid to declare your product UKCA-compliant until the end of 2027, as long as the certificate does not expire before this date. Following this date, the certificate must be issued by a UK-CAB. There are a limited number of UK-CABs and there is already a waiting list for some of these, so we recommend you begin preparing for the change as soon as possible.
Technical documentation
You, or your authorised representative (where allowed for in the relevant legislation), must keep documentation to demonstrate that your product conforms with the regulatory requirements.
This must generally be kept for 10 years after the product is placed on the market.
This information can be requested at any time by market surveillance or enforcement authorities to check that your product conforms with the regulatory requirements.
The information manufacturers must keep will vary depending on the specific legislation relevant to your product.
You must keep general records of:
· how the product is designed and manufactured
· how the product has been shown to conform to the relevant requirements
· the address of the manufacturer and any storage facilities
You should keep the information in the form of a technical file which can be supplied if requested by a market surveillance authority.
UK Declaration of Conformity
The UK Declaration of Conformity is a document that must be drawn up for most products lawfully bearing a UKCA marking before they are placed on the market. We recommend that manufacturers have their UK Declaration of Conformity and their EU Declaration of Conformity in separate documents.
In the document you as the manufacturer, or your authorised representative (where allowed for in the relevant legislation), should (among other things):
declare that the product conforms with the relevant regulatory requirements
make sure the document has the name and address of the manufacturer (or your authorised representative) together with information about the product and the conformity assessment body (where relevant)
The UK Declaration of Conformity should be available to market surveillance authorities on request.
The information required in the UK Declaration of Conformity is largely the same as what was required in the EU Declaration of Conformity. This can vary depending on the applicable legislation but generally should include:
your (the manufacturer’s) name and full business address and that of your authorised representative (if applicable)
the product’s serial number, model or type identification
a statement, stating you take full responsibility for the product’s compliance
the details of the approved body which carried out the conformity assessment procedure (if applicable)
the relevant legislation with which the product complies
the name and signature of the person authorised to sign on behalf of the manufacturer or their authorised representative
the date the declaration was issued
supplementary information (if applicable)
Contact us for further information or a consultation.
Article name: The Beginner’s guide to the UKCA Declaration of Conformity