Firstly you should determine which EU Directives or regulations apply to your product. 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.
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.
You should then produce a technical file for your product that includes the following information and documentation:
- Complete description of the product
- Details of procedures (standards) used to ensure conformity with each directive
- Test reports giving details of tests – Safety / EMC test report
- 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.
When you are happy that your product complies with ALL the relevant directives then you should write you “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 you product means. A copy of the Declaration of Conformity should be held in the product technical files.
One of the most important steps, and one that is often forgotten, is to review your DoC at regular intervals. The product or the environment may have changed along with new directives and standards coming into force. This 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. This may be only a DoC update but it should be checked.