Applying for CE Marking Services

The Steps Every Manufacturer Needs to Follow are:

Step 1: Identify the New Approach Directive(s) that are applicable to your product. Your product may be covered by one Directive or several; however you must identify and comply with all applicable Directives before you can apply the CE marking to your product.

Step 2: Identify the conformity assessment procedure that must be taken. This could be self-certification or involve testing from a Notified Body. The conformity assessment procedure will differ depending on your product and the Directive to which you are CE Marking.

Step 3: Determine the dates by which you must take action. This will be the date that the Directive comes into force. The majority of directives are already in force, which means you must complete all steps to compliance before you can place the product onto the European market.

Step 4: Identify if there are any Harmonized European Standards applicable to your product. These are not always mandatory for manufacturers although there is a presumption of conformity to these standards. The European Directives require that whenever possible or appropriate, manufacturers should follow harmonized standards

Step 5: Ensure the product complies with the essential requirements of the Directive(s). Take appropriate measures to comply or identify existing data and test reports.

Step 6: Identify whether independent assessment of your conformity to the Directive, or some aspects of it, is required from a Notified Body. This will be stated in the directive and is dependent upon the type of product you are CE Marking.

Step 7: Maintain Technical Documentation required by the Directive(s). Your technical documentation should support your compliance with the requirements of the Directive. Some Directives are very specific about how this technical documentation is to be maintained.

Step 8: Prepare the Declaration of Conformity and the required supporting evidence. The Declaration of Conformity along with the Technical Documentation should be available to Competent Authorities (EU Members) upon request. View a sample Declaration of Conformity.

Step 9: Check that no other purely national requirements exist in the countries where the product will be sold. These may include national standards, labeling or packaging requirements.

Step 10: Apply CE marking on your product and/or its packaging and accompanying literature as stated in the directive.

For complete information regarding the CE Marking of your product, contact us.