The CE Marking a "passport" which allow a Manufacturer to freely circulate products within the European marketplace to access the European Economic Area (EEA)

The CE Marking Process

At Macro ICS, we can determine the route to compliance that is most appropriate to your needs and help you through the CE Marking Process cost effectively and efficiently. There are many Directives require products/ systems to be independently certified; a Notified Body/Competent Body must do this.

The Steps you need to follow:

Step 1: Identify the New Approach Directive(s) that are applicable 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 upon your product and Directive. If you are unsure about which procedure to take please contact Macro ICS for advice.

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. In these cases it is an offence to place a product on the market without CE Marking.

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 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.

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.

Step 9: Check that no other purely national requirements exist in the countries where the product will be sold. These may include national standards, labelling or packaging requirements. Step 10: Apply CE Marking on your product and/or it’s packaging and accompanying literature as stated in the directive.