This is the third in a series of blogs we’ve been posting about CE Marking. It’s obviously a subject that’s important to us at IES, but for a very good reason. A large number of importers and manufacturers do not fully understand the application of, or the implications behind, CE Marking legislation as it is increasingly being implemented. This is not something that can be ignored or easily got over when and if you’re caught!
So, to be clear, the products affected can be found under the Directives listed in our April 2015 blog at http://www.ies.co.uk/news/. The countries CE Marking applies to are all those in the European Economic Area (EEA), comprising the EU and EFTA countries plus Switzerland and Turkey.
Responsibility for securing CE Marking and then for placing it on the product is entirely that of the manufacturer or, if applicable, the importer or distributor into those countries involved. This responsibility involves the initial carrying out of the conformity assessment, the setting up of the technical file, the issue of the EC Declaration of Conformity (DoC) and the placement of CE Marking on the product concerned.
The process will depend on your product, so:
Step One: Identify the Directive that applies to your product. As mentioned above these Directives can be found on our April 2015 blog. There are 20 of them, and each gives details of the essential requirements that each product needs to meet. These are mostly to do with safety.
Step Two: Make sure your product complies with the essential requirements of the Directive. The responsibility for ensuring compliance rests with you. In essence how you do this is your decision, the easier option is to follow a standard.
Step Three: Check whether you need to have an independent conformity assessment for you product. This depends on the directive you are adhering to, so it’s important to check. If you need what is known as a Notified Body you can find a list of these on the NANDO (New Approach Notified and Designated Organisations) database.
Step Four: Test your product for conformity. This will usually include a risk assessment. By meeting the harmonised European Standard you’ll be fulfilling the essential legal requirements.
Step Five: Prepare and have available all the technical documentation required by the Directive. These should prove the product’s conformity to the technical demands of the Directive, and the risk assessment. This documentation could be demanded at any time by the national authorities of any country the product is being marketed to (not necessarily sold to).
Step Six: CE Marking your product. This is a complicated procedure in itself. Only you or your authorised agent may place the CE Mark on a product. It must be visible, legible, impossible to remove and have the right information printed on it. If a Notified Body was involved at any stage then its reference number must be displayed.
Easy? No, not at all. And whilst it’s possible to undertake this procedure for yourself our experience would strongly advise against it. You’re far better working with experts who will guide you through the entire process, ultimately saving you both time and money.