Get Your E.U. Declaration of Conformity — 5 Essential Steps
Needless to say, the E.U. is a vital market for SA businesses, particularly firms that manufacture goods for export here and abroad.
Are your exports EU ready?
Needless to say, the E.U. is a vital market for SA businesses, particularly firms that manufacture goods for export here and abroad. But that doesn’t mean the European Union holds the door wide open for SA-made goods. If you’d like to sell physical merchandise in the E.U., you need to ensure that your products meet the stringent standards set by the European Commission and associated authorities.
Key in this process is the process towards CE marking, a vital self-certification that many goods sold into the E.U. must obtain. The penalties for exporting unauthorized goods into the E.U. are stiff — the E.U. considers such activity akin to smuggling. It’s crucial that you CE mark your product and draw up your declaration of conformity prior to making any arrangements to sell your products in Europe.
Here are the six essential steps to get your CE marking and take full advantage of the vast E.U. market.
Determine the Directives Governing Your Product Type
Once you have a marketable product, the first major step is to determine the E.U. directives that govern your product type. The E.U. has more than 25 such directives.
If you’re unlucky, you’ll need to take your product back to design to ensure that it conforms with its category standards. If you’re luckier, your product will be in market-ready form: for some products you can follow ISO standards to comply with the E.U. directives, which your product may well already meet.
Examine Each Directive’s Requirements
Each directive contains requirements your product should meet. But not all requirements apply to all products. Make sure to examine the relevant European Commission’s directives and determine the requirements that are relevant for your product. An in-house engineering team can likely navigate this process on your behalf; if you’re running a smaller startup, you may need to retain an outside consultant to ensure it’s done properly.
Determine the right strategy towards conformity
The kind of product determines how to obtain conformity. For many products, it is allowed to do the conformity assessment procedure yourself. For other products, it is mandatory to hire a so-called “notified body” to conduct the assessment procedure.
Arrange Conformity Testing, If Necessary
Any product that requires CE Marking also requires evidence of a successful conformity test. If you have adequate testing resources at your disposal, and you are allowed to do the testing yourself, you can complete this process internally. If not, you may need to retain a reputable, certified outside laboratory to conduct it on your behalf.
Compile a Thorough Technical File
Before drawing up your declaration of conformity, you need to confirm that your technical file is complete and secure. Required inclusions may vary, but complete technical files generally must feature thorough product descriptions and specification sheets, schematics, independent testing results, user manuals and other data.
Draw up Your Declaration of Conformity
When the product and its documentation meet all requirements, the last step in the process is to draw up the declaration of conformity. This somewhat understates the magnitude of the task, as even small errors can jeopardize your attempt to enter the EU and force time-consuming revisions.
When in doubt, consult with an expert who has navigated this process before and understands what E.U. trade authorities are looking for. When drawn up, include the declaration of conformity in your technical file.
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