December 7, 2016
While the US and China boast some of the best country-wide economies in the world, the European Union is a powerhouse of countries that is not to be trifled with. It’s no wonder startups salivate over the chance to sell products in the EU.
According to the European Commission, the EU contains more than 500 million consumers and boasts an average GDP of 25,000 euros per head. Its 28 member countries account for 16 percent of global exports. It’s the world’s largest unified export market — larger than China, which most laypeople assume is the planet’s export king — and is the biggest trading partner for some 80 countries around the world.
For startups and small businesses seeking new markets for their products, the EU is a tantalizing opportunity. Unfortunately, it’s also famous for strict regulations and onerous red tape. Before your startup can legally sell goods in Europe, those goods need to pass muster with regulators. That involves an arduous, multi-step process that culminates in a CE Marking, the official stamp of approval. “CE” is short for “Conformite Europeenne,” or “European Conformity.”
If you are interested in pursuing this conformity in hopes of selling your product in this lucrative market, start at the beginning by asking yourself these five questions:
Which directives and standards apply to my product?
First, determine which European directives and standards apply to your product. Visit the European Commission’s website and scan its 25 product groups. Most groups have EU-specific directives with EU-specific requirements. In those cases, you need to follow those to the letter. In some cases, you’ll need to rework your product to conform.
Some groups lack EU-specific directives. Those groups have harmonized standards that generally follow ISO specifications. In such cases, you need to obtain and maintain the appropriate ISO certification.
What are the requirements for my product?
Next, dive deeper and determine the specific requirements for your directives and standards. You’ll need to closely examine the text of the applicable directives and standards to determine how they fit in with your product.
If you lack internal technical expertise, you may need to bring in an outside consultant to help with this process or spend a significant amount of your own downtime wading through the literature.
Do I need conformity testing?
Most of the time, the answer is going to be “yes.” Depending on your product, you may be able to test it internally without having to hire an outside testing lab.
Your group directive should clearly state whether the product type requires a declaration of conformity, which then necessitates conformity testing. The directive should also list all the applicable conformity requirements. Your conformity test must address all of these requirements in full.
What should be included in my technical file?
Products seeking declarations of conformity must be accompanied by comprehensive technical files that outline the product’s design with regards to the applicable standards and its conformity to applicable European Commission standards.
Complete technical files contain any and all data relevant to product design and conformity: source code, schematic files, technical images, independent testing results, written reviews and descriptions, and more. Like all important documentation, your technical file needs to be preserved and secured such that it’s impervious to tampering.
How does my declaration of conformity look?
Finally, you need to make sure your product’s declaration of conformity is properly formatted and includes all required information. European regulators are serious about keeping nonconforming products out, so they’re sticklers for details. Given the already lengthy processing period and ample red tape, it’s in your company’s interest, and the interest of your own personal sanity, to get your declaration of conformity right the first time.
If you lack internal technical staff or regulatory experts, as most startups and small businesses do, the most cost-effective and reliable way to properly draft your declaration of conformity is to populate a ready-made template with the relevant information. Note that a declaration of conformity is not the same as a Certificate of Conformity (CoC). You can’t simply populate your declaration of conformity template with CoC information.
Photo: Flickr / Thomas Quine
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