Frequently asked questions
What does UKCA Marking stand for?
It stands for United Kingdom Conformity Assessed and signifies that essential health and safety requirements of ALL appropriate UK Regulations have been met. It is not a quality mark or a specific statement concerning the test methodology that has been employed
What is UKCA Marking?
The UKCA marking represents the manufacturers (or distributors) claim that the product meets the essential requirements of all relevant UK Regulations are satisfied. If a product requires UKCA Marking, it cannot be legally "taken-into-use" in Great Britain. The term "taken-into-use" applies to a wide range of situations including,
- Sold and delivered to a customer
- Hired out
- Given away!
- On loan
- Demonstration equipment
- Your own in-house equipment
UKCA marking a product is not an option; it is required by law if the product falls under one of the relevant UK Regulations. The UKCA Marking ndicates to the authorities that the product is in compliance with the essential health and safety requirements of all UK regulations that apply to the product.
When considering any new product development or improvement it is essential to consider the regulatory requirements. It is always easier to design in compliance rather than to try and sort things out once the product has been made.
Why have UKCA Marking?
UKCA Marking follows on from the CE Marking that was required when the UK were members of the EU, it is basically the same but references the UK regulations only. CE marking was introduced throughout the EU for the following reasons ,
- To harmonise standards through the European Union
- Create a single European market
- Protect the consumer/custome and the environment
- Simplify the lives of manufacturers!
The last point often comes as a surprise to people involved in the manufacture of products, however before the introduction of these harmonized standards it was not uncommon for a manufacturer involved in export to have to "jump through a variety of compliance hoops" for each European country. In most cases the requirement for UCKA and CE Marking are the effectively same, but processes differ when Notified Bodies/UK Approved bodies need to be involved.
What type of products need to be UKCA marked?
The official answer to this is anything that is covered by the UK regulations that cite the requirement for UKCA Marking!. UKCA marking only applies to products within the scope of these regulations and should not be applied to products if they are outside the scope. We've been doing this for a long time and so can help, often if a product is outside the scope we can tell you pretty quickly, and unless this take a vast amount of time (so borderline products take a lot of work), it will cost you nothing.
Should all products be UKCA Marked?
The simple answer is NO! Only products within the scope of the "UKCA Marking" UK Regulations should bear the UKCA Marking. Increasingly manufacturers were being asked to CE mark "inappropriate" products, it is likely that the same thing will apply to UKCA Marking!
Does my product need to be CE Marked?
A simple question which can take a while to answer! The "UK Regulations" page gives an outline of "scope" of each of the UKCA Marking Regulations so have a quick look. Chances are you'll still be a little confused, so give us a call or email us. We don't charge for initial discussions and a lot of people go away happy without ever paying for our services
I just sell/import , does it affect me?
Any product offered for sale in GB must carry the UKCA Marking after 1st Januatry 2022 (if it is covered by the regulations), prior to that date CE Marking is acceptable (in most cases). If the product has not been put through the process by the manufacturer then it will be your responsibility... so beware.
Is third party testing/involvment required?
In most cases no, ... but some compliance requirements involve the mandatory use of approvals or certification bodies. In some cases the requirement for the involvement of a "UK Apporved body" depends on the route chosen to demonstrate compliance.
What is a UK Approved Body?
These are organizations appointed by the UK Comptent authorities uto conduct third-party conformity assessment procedures to the product in question or its production processes, as required by the Reulations, iin order that it may carry the UKCA Marking. The procedures vary according to the regulatrions and third-party involvement is not compulsory for mostl products. When required Manufacturers must use the services of UK Approved Body rather than an EU Notified Body (but often they are related). UK Approved Bodies are only involved when considering higher risk products or for some regulations when appropriate standards have not be applied or only partly applied. It should be noted that Approved bodies are not "permitted" to provide advice concerning solutions to any problems that are found, although a good one will provide off-the-record guidance.
Is PCL an Approved Body?
No, we are a Consultancy that can help with UKCA Marking, however will ork closely with Approved bodies as required. Being an independent organization we are able to provide detailed assistance concerning solutions to problems and even help to implement those remedial actions. When a project does require the involvement of a Approved body, we can help to define the scope, identify a suitable body and act as liaison throughout the project.
What does the UKCA Marking signify?
UKCA Marking indicates that a declaration has been made by the manufacturer (or distributor/importer) that the product meets all the appropriate provisions of ALL relevant UK Regulations
What is a (UK) Declaration of Conformity?
A (UK) declaration of conformity (UK-DoC) is a document (usually a single page) that is produced by the Manufacturer (or distributor/importer) that provides addition details in support of the UKCA Marking. The detailed requirements for a UK-DoC depend on the individual regulations but a typical UK-DoC will include the following i) of UK contact details for the manufacturer (or distributor/importer) ii) information concerning which UK regulations have been covered and any standards that have been used and iii) details of the designated signatory and iv) details of any UK Approved body that might have been involved. It is common for customers or prospective customers to ask for copies of the Declaration, the must be supplied on request.
Is a Certificate of Conformity the same thing?
No definitely not!, A "Declaration of Conformity" has a specific legal status, a CoC is something that someone might issue in relation to quality control saying that it complies with specification.
Do you issue a "Declaration of Conformity"?
A "Declaration of Conformity" cannot be issued by a third party, it must be signed by the manufacturer, authorised representative or importer. But we can help you put one together.
What is the Process?
The process that you need to go through to be able to UKCA-mark your products vary widely and depends on a number of things including,
- The applicable UK Regulations
- The product itself
- The target user/customer
- The market requirements
- The manufacturers choice (in most cases)
In a majority of situations, the regulations allow self-declaration in place of third party involvement; but the right to self-declare compliance with the law means that a manufacturer must be responsible for completing all the procedures required by the law and must be able to prove it. This is done by the production of technical documentation (generally referred to as a Technical File).
The Technical File is the written justification that all aspects of a product are safe and should be prepared before the product is placed on the market. The Technical File includes information that demonstrates the technical basis for conformity of the product to the applicable requirements of the regulations. The manufacturer must keep the Technical File for ten years after the last unit is placed on the market, unless the directive provides for a different duration.
What is a Technical File?
The UKCA marking process revolves around the construction of technical documentation (usually referred to as a technical file) for the product. This is intended to cover all of the essential details that shows that the product complies. It supports the UK-DoC but is a company confidential document and need only be produced in the event of a legal challenge, or in some instances when requested by government bodies.
How long do we need to keep the file?
Normally the technical file must be kept for a defined period (usually 10 years) after the product is withdrawn from the market
Who enforces the process and what would happen if I don't UKCA Mark a product?
Enforcement varies according to the regulations. Some are enforced by local Trading Standards Departments, others by HSE and yet others by the Medical and Healthcare Products Regulatory Agency and the Vehicle Certification Agency and OFCOM. Except where safety is at risk, the relevant enforcement authority will usually provide you with an opportunity to ensure that your product is correctly UKCA-marked. If you fail to comply then you will be obliged to take your product off the market, and you may also be liable to a fine and/or imprisonment
Who can help?
Depending on the product, We can! , give us a call
What is your approach?
Understanding the requirements for UKCA/CE Marking can be complex and time consuming and is something of a diversion from most the mainstream of most businesses. Our assumption is that you do not want to become an expert on UKCA/CE-marking; you just want the problem solved quickly and with the minimum disruption to your business, That’s what we do!
Over the years we have found that the most effective way of establishing a sustaining UKCA/CE –marking process within a business is for us to lead the process and assemble the technical files etc for the first product. We use this time to transfer the knowledge to people within the business so that when we leave the process is sustainable and can be applied to subsequent products. In these circumstances we can provide assistance to your in-house team in the following areas,
- Determining the relevant directives
- Review of product and process
- Practical advice and assistance with problems
- Preparation of the Technical File
- Assistance with 3rd party testing if required
- Provision of Declaration of Conformity (or Incorporation) formats
- Assistance with modification of user documentation
- General advice and assistance
Our approach differs from many other “Compliance organizations”, as a result of our personnel’s many years of experience in the product development and manufacture. We will never just accept that a product fails a particular test; we will delve into the reasons and try practical solutions to remove the issues. Ultimately a problem may be too serious and require redesign or remanufacture but you can rest assured that Petts Consulting Limited will have made it best effort to ensure that the product legitimately passes the assessments.
What will it cost?
Costs vary greatly depending on the product, the directives and the requirement for the involvement of notified bodies. We can usually provide a fairly good estimate of the likely costs once we have information concerning the product. The more information you can give, the better service we can give you. All information is kept in strictest confidence.
How long does it take?
Again this is highly product dependent, we have done the process in less that a week but typically a elapse time of 2-3 months is more normal.
Statement: Petts Consulting Ltd will provide an Organization with the knowledge of the Directives and an appropriate process which, when applied correctly will demonstrate due-diligence. However, the CE-marking is the manufacturers claim that the product meets the essential requirements of all relevant European Directives. In many cases the process to be carried out is a self-declaration process and the responsibility for any decisions lie with the management of the Company. During the course of the project Petts Consulting Limited will provide guidance and advice but ultimately it cannot be held responsible for such decisions.