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. However Conformance, and a small number of other consultancies, exists because the CE marking process can be extremely complicated and time consuming. It also 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.
Our CE Marking Specialists can advise you at any or all of the following stages should you require our help.
Decide which CE marking Directives apply to your product
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.
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.
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
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.
Rectify any areas of non-compliance
This may involve:
- Redesigning your product
- Adding protective measures and equipment
- Changing marking and instruction manuals
Affix the CE logo to the product
In order to affix the 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.
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.
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
Copies of any markings and labels
Copy of instructions (user, maintenance, installation)
Quality control & commissioning procedures
Declaration of Conformity