How to CE Mark your product: 7 steps to compliance
Quite often I get asked, “How do I CE Mark my product?.”
My answer is usually the same and uses 7 simple steps that can be followed for any product to help you meet the requirements that are needed.
The 7 steps to compliance
1. Determine which EU Directives apply to your product
Initially, you should determine which directives or regulations may apply to your product and in doing so you should:
- Consider the scope of all directives/regulations that may be relevant
- Consider exclusions given in most directives/regulations
- Take advice and consider what others have done
- Don’t be unnecessarily harsh on yourselves but be reasonable
2. Evaluate and/or test your product to cover the essential requirements of each directive that applies
Once you have determined which directives or regulations apply then you should evaluate your product against the essential requirements of those directives to ensure that your product meets them. This may be through the use of harmonized standards which will give a “presumption of conformity” to the relevant directives.
3. Modify your design as necessary following evaluation and retest if appropriate
If during the evaluation you find that the product doesn’t meet the requirements then at this point you should consider the design of your product and how it can be modified so it meets the requirements.
4. Decide how conformity will be maintained and ensured for volume production
If your product is to be produced in volume then you should also consider how the design that meets the requirements remains in conformity throughout the product process. This is specified in some of the directives and may require third-party inspections from a notified body (for example the Gas Appliances Directive). It may also be beneficial to have a formal quality system in place to help with this continued compliance. There should also be a quality plan that shows what tests and inspections are made throughout the process. This may include all or some of the following:
- Goods inwards checks on suppliers
- Routine production line tests (sub-assembly and final assembly)
- More detailed audit tests on % of products made
5. Write your “EC Declaration of Conformity” for the product
When you are happy that your product complies with all the relevant directives then you should write your “EC Declaration of Conformity” for the product. This should include:
- The name and address of the manufacturer
- Full identification of the product(s) covered
- A list of all directives or regulations that have been applied
- References of all harmonized standards or technical specifications applied
- Notified body certificate references (where relevant)
- Identification of the individual responsible
This declaration is the description of what the CE mark applied to your product means.
6. Produce your technical file for the product
You should then produce a technical file for your product that includes the following information and documentation:
- A complete description of the product
- Details of procedures (standards) used to ensure conformity with each directive
- Test reports giving details of tests and examinations made
- A complete set of product drawings and/or photographs
- All instruction manuals that are supplied with the product
- Details of quality control procedures in place
- A copy of the Declaration of Conformity
This file must be made available to enforcement bodies if it is requested
7. At regular intervals, review the decision to affix the CE Mark to your products
One of the most important steps, and one that is often forgotten, is to review your declaration of conformity at regular intervals. The product or the environment may have changed along with new directives and standards coming into force which may mean your product no longer complies. At the time of placing a product on the market (even if a product has been on the market for many years) you are required to comply with the latest legislation.
Author: Greg Childs, Certification Team Manager
