The CE marking procedure is one of self-certification. Generally, you can do everything yourself and the steps below will guide you through the process.
The UKCA and CE marking process requires a detailed knowledge of the directives and standards relevant to your product. The only cases where it is not possible for the manufacturer/importer to do everything themselves are when the relevant directives specifically state that a Notified Body must be involved in the assessment of the products.
However, because the CE marking process can be extremely complicated and time consuming, we’re here to help. Our CE Marking Specialists can advise you at any or all of the stages involved in certification, should you require our help.
How UKCA & CE Self Certification Works
There are various stages that are involved in the UKCA and CE Marking processes, and our product compliance specialists are able to provide help and advice at any of them. The stages involved with certification are:
1. Decide which directives apply to your product
Under the New Legislative Framework the revised directives are now in force. The UK government has an obligation to enact these directives into UK law however this process was delayed but is currently on-going.
Guidance from The Department for Business, Innovation and Skills (BIS) advises that economic operators should comply with the requirements of the new directives from 20th April 2016 and products placed on the market after this date should be compliant with, and consequently have a declaration of conformity against, the new Directives.
Here you can find a summary of each of the principle European Directives and Regulations with links to the full text of the directives themselves as well as sources of further information relating to the directives. The directive will define which products need Notified body involvement.
2. Search for appropriate standards
You must identify which standards apply to your product. The safety requirements relate to the design of the product and can be demonstrated by meeting the requirements of the relevant harmonised standards.
There are a number of on-line resources where you can purchase the relevant standards, the cheapest place we have found to purchase these standards is on the EVS.EE website.
3. Check your equipment/product complies with the standards
Once you have identified the relevant standards you will need to create checklists and apply them to your product. This will require carrying out assessments and where necessary commissioning external testing.
4. Rectify any areas of non-compliance
This may involve:
- Redesigning your product
- Adding protective measures and equipment
- Changing marking and instruction manuals
5. Affix the UKCA and/or CE logo(s) to the product
In order to affix the UKCA or CE logo you must be confident that you have completed the process accurately and effectively because it is illegal to apply the mark to a non-compliant product.
6. Prepare a declaration of conformity
The Declaration of Conformity is a legal Document which must be applied to all CE Marked products sold in the European Union. It is a one page certificate which you must complete that guarantees your product meets the requirements of the directives.
Someone within your company must take responsibility for this document and sign it.
Often customers contact us to ask for a Declaration of Conformity without realising they must first complete the previous steps.
7. Compile a technical file
All CE marking directives require the manufacturer of the product to create a technical file which should contain the information required to show that the product properly complies with the requirements of the directives which apply to it.
The directives contain clauses, which give some general details of the kind of information which will be required in the technical file, but this is couched in the most general of terms. As a general guide, the following items should be included:
- Description of the apparatus, usually accompanied by block diagram
- Wiring and circuit diagrams
- General Arrangement drawing
- List of standards applied
- Records of risk assessments and assessments to standards
- Description of control philosophy/logic
- Datasheets for critical sub-assemblies
- Part list
- Copies of any markings and labels
- Copy of instructions (user, maintenance, installation)
- Test reports
- Quality control & commissioning procedures
- Declaration of Conformity
Why Choose Conformance?
Conformance is the UK's leading independent specialist in Product Safety, CE Marking and UKCA Marking. For more than 30 years, we have specialised in helping companies, small and large, to meet the regulations that their products are required to comply with in their markets and industries.
Get in touch with us today to find out more about our UKCA and CE Marking assessments.
Product Safety FAQs
What is CE Marking?
"CE marking" is a process that applies to a wide variety of products and one which manufacturer located in the EU or importers of goods into the EU must complete.
Learn more here.
What is UKCA Marking?
The UK Conformity Assessed mark is a mandatory mark on a product to indicate that it conforms to GB legislation. The manufacturer or, if mandated, their authorised representative will be responsible for affixing the UKCA mark to the product, which is the same principle as CE marking but for the GB market.
Is UKCA & CE Marking Compulsory?
Yes, if the product falls under at least one of the directives then having the appropriate mark (whether UKCA or CE) is mandatory.
The penalties for not correctly marking a product, falsely marking a product or failing to mark a product for which it is required are generally a maximum of 3 months in jail and a £5000 fine (for the director of the offending company).
What’s the difference between UKCA & CE Marking?
In technical terms, the differences between the requirements for CE marking and for UKCA marking are slight. Products which meet the technical requirements for one will mostly meet the requirements for the other for the foreseeable future. Most of the differences between the two systems are administrative in nature and reflect the fact that the UKCA mark only applies in Great Britain.
Other differences relate to the separation of UK conformity assessment bodies from the EU Notified Body system
Learn more here.