CE marking: why and how?
06 October 2010
What does CE marking mean, why should manufacturers and suppliers bother about CE marking their products and how does the CE marking process work? Paul Laidler supplies the answers to these important and frequently asked questions
The idea behind CE marking is very simple. By applying the CE mark and providing the associated EU Declaration of Conformity, the supplier – usually the manufacturer or importer – of a product confirms that the product meets the requirements of all applicable EU Directives. The product can then be freely and legally sold in, and passed between, all of the Eurozone countries.
A product without a CE mark cannot be imported into, or traded between, EU countries and could be seized by customs if any attempt is made to do so. In addition, many products cannot even be legally sold in their EU country of manufacture unless they carry the CE mark. These factors should be incentive enough for all suppliers to put their products through the CE marking process, but that’s not quite the whole story.
It is also necessary to consider how the CE marking scheme is monitored and policed. Essentially, all that has to happen for the CE mark to be applied in relation to most directives is that someone representing the supplier has to sign a Declaration of Conformity for the product. It is very unlikely that anyone will check, at this stage at least, whether the declaration is based on fact or fiction!
So why bother with all the work and expense involved in doing things properly? Why not just draw up a convincing looking Declaration of Conformity and sign it without bothering with the proper procedures? Of course, there may be some rogue suppliers that deliberately adopt this approach and there are certainly many more that make a genuine effort to get things right but fail to do so, usually because they have not fully understood what is required of them.
For suppliers that fall into these categories, there are big risks. If their product is implicated in an accident, for example, the basis of the CE marking will be investigated and, if it is found to be inadequate, large financial penalties may well result and the product could be removed from the market. In addition, if the failings result in someone being seriously injured or even killed, other legal consequences – including imprisonment – may ensue.
In fact, it doesn’t necessarily take an accident to trigger an investigation into CE marking. A user or potential user may find and report failings in the product, or a competitor may bring to the attention of the national enforcement authority any false claims that are being made.
The conclusion has to be that, when it comes to CE marking, it’s important to do the job properly and not to be tempted to cut corners. But what exactly does the CE marking process involve? To answer this, we have to start with a brief overview of the way directives and standards are structured.
One of the functions of the EU is to issue directives that govern, for example, the design, construction and performance of products. There are many of these directives, which are primarily intended to ensure safety, but two of the best known are the Machinery Directive and the Low Voltage Directive.
The directives are binding on all member states of the EU, but it is up to individual states to determine how they are brought into law. The normal method of doing this is for the states to issue legally binding regulations. In the UK, examples are The Supply of Machinery (Safety) Regulations 2008 and The Electromagnetic Compatibility Regulations 1992. Non-compliance with the appropriate regulations can be a criminal offence.
So how do you show compliance? This is where standards come into the picture. Most of the time products that conform to the relevant harmonised European Standards will be presumed to comply with the Essential Health and Safety Requirements (EHSRs) of the associated regulations. In simple terms, build and test your products in line with the requirements of the appropriate standards and, if you are ever challenged, you have a very strong case for claiming that you’ve done all that’s needed to satisfy the regulations.
Note that although the regulations are legally enforceable, the standards are not. Suppliers can, if they wish, choose an alternative method of showing that their products meet the requirements of the regulations. If they go down this route, however, they will need to be very sure of their ground.
At this point, let’s recap. The first step toward CE marking is to design and test your products so that they comply with the appropriate directives. This can be achieved by referring to the associated standards.
When you’ve done all this and you’re sure that the product complies with ALL of the applicable directives, and you’ve produced documentation to provide evidence of what you’ve done, you’re ready to prepare a Declaration of Conformity and get it signed. Then, at last, you can apply the CE mark – well, possibly. Because there’s yet another condition that must be satisfied.
The Declaration of Conformity must include the name and address of the person who is authorised (by the product manufacturer) to compile the technical file, which is the evidence supporting the declaration. And this person must be established in the European Community.
All of this may make it appear that getting a product CE marked is a difficult task fraught with problems. But, it’s not nearly as bad as it sounds. Reputable companies will already be ensuring that their products meet the appropriate directives, so clearing this hurdle is unlikely to be onerous. And the rest is mainly a matter of reviewing procedures and standards to ensure that they are comprehensive and up to date, and then producing the required documentation.
Nevertheless, expert guidance in completing the CE marking process can be invaluable, if only to ensure that nothing is missed, and that any changes needed either to the product itself or to procedures are implemented efficiently and with a minimum of cost and disruption.
Paul Laidler is principal of safety and compliance consultant Laidler Associates
Drawing on its many years of experience in the field of directives and standards, working with companies in all sectors, Laidler Associates offers expert advice to clients of all sizes, from start-ups to established multinationals. The company’s services are modestly priced, and clients almost invariably find that, by calling on the company’s expertise, they save a lot more than they spend.
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