Q: I’m taking my first steps into product development with a view to exporting within the EU straight away. When talking to a potential distributor, he asked me if my product had the ‘CE’ standard, or if I intended seeking it. He added that, without my product having the standard, he probably wouldn’t stock it.
My problem is that, while I’ve seen the ‘CE’ mark on some products, I’ve no idea what this means, or how I can get it. Is it a long drawn out process?
A: If you make or export products that are subject to EU-wide standards, you can seek the CE marking to certify compliance – this will help open doors for your product across the continent.
It can, unfortunately, be a long process: you will need to identify the standards required, test to ensure that your product meets these requirements, and put together a technical dossier proving that your product fulfils all the EU-wide requirements. As the manufacturer, you are the sole person responsible for declaring conformity.
First, of course, you will need to identify the EU-wide requirements for your product. These are can be accessed through europa.eu. Not all products are required to bear CE marking – only products falling within the scope of at least one of the ‘sectoral directives’ requiring the marking for distribution. However, based on your conversation with this potential distributor, I imagine your product is covered. These directives lay down the essential requirements that products have to fulfil.
These can be complex, so some 20,000 harmonised European standards covering a vast array of product areas have been published. The simplest way to ensure that you’re meeting the essential requirements of European directives is to follow the applicable harmonised. You can find harmonised standards on the the OJEU site, or by visiting the New Approach website established by the European Commission and EFTA with the European Standardisation Organisations.
For some products, independent authorities must verify that your product meets the technical requirements. To find out whether your product needs specialised testing, and identify the authority responsible, you can use the New Approach Notified and Designated Organisations (NANDO) database, available here. If independent testing isn’t required, then you are responsible for checking that it conforms with the technical requirements. This includes documenting and estimating any possible risks entailed in using your product.
Next, it’s time to complete the technical dossier. This should be clear and comprehensive, including all the documents needed to prove that your product conforms with the technical requirements. It will usually include a technical description, drawings, circuit diagrams and photos, a bill of materials, specification of critical components and materials used (which may include declarations of conformity), details of any design calculations, test reports or assessments, instructions, and an EC Declaration of Conformity. Looking ahead, you must also hold this technical documentation for up to ten years after manufacturing the last unit.
Because the CE Marking is a self-declaration system, you will also have to formally declare compliance by writing a Declaration of Conformity. This must include the manufacturer’s details, essential characteristics the product complies, any European standards and performance data, the identification number of any Notified Body which tested it, and a legally binding signature on behalf of your organisation.
Finally, you can put the CE marking on your product. Alongside this marking, you will need to put the identification number of any authority that you needed to involve in testing the product. Once your product bears the marking, you should provide your distributors or importers with copies of all the supporting documentation.
While this sounds like quite a lot of hassle, it is essential if you’re going to export in a serious way within the EU. Moreover, unless your product requires independent testing, the ‘self declaration’ system allows you to work through the process promptly.