Are you ready to sell your products into the European Union?
As the world’s largest single-market economy, the E.U. is an enticing prospect for businesses based in North America and elsewhere.
Unfortunately, exporting to the E.U. isn’t as simple as hanging out a shingle in Brussels or Paris, finding a distributor with a good retailer network, and taking out some ads in your target market. Before you can legally sell your products to European consumers or businesses, you need to jump through some important hoops.
For many companies, one key hoop is CE marking. According to the European Commission, the CE mark “signif[ies] that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements.” If your company is ready to sell into the E.U. market, it’ll need to obtain a CE mark when your product falls within the scope of CE marking.
Hundreds of companies need to obtain the CE marking and declare that their products meet the European safety and health requirements. The process is not rocket science. However, it’s relatively easy to make mistakes along the way. In particular, you’ll want to avoid these five common, costly CE marking mistakes.
The declaration of conformity is the linchpin of a proper CE designation. It affirms that your product complies with all relevant E.U. directives and legislation. Without it, you can’t obtain a CE marking for your product, and thus can’t legally sell the product in the European Union. You need to draw up your declaration of conformity as soon you are sure that your product meets all requirements from the relevant Directives.
2. Drawing Up the Declaration of Conformity Without Being Sure About Compliance
Drawing up the declaration of conformity is just the last step in the process of CE marking. When you sign the declaration, you as a manufacturer declare that your product meets all relevant directives. So, before signing the document, you need to make sure that your product complies with these directives by following the full process toward CE marking:
Identify the CE directive(s) that apply to your product
Identify the requirements that apply to your product
Determine if third-party certification is mandatory
Assess product conformity
Create and maintain the technical file
Sign the Declaration of Conformity & affix the CE mark
3. Erroneously Obtaining a CE Mark
The CE mark isn’t a universal standard. Not all products sold into the European market need bear it — only products covered by the E.U.’s New Approach Directives (NAD). Check the European Commission’s website for more detailed information about exactly which products are covered by NAD.
4. Leaving Key Directives and Details Out of Your Declaration of Conformity
As noted, the declaration of conformity is the most important aspect of the process of obtaining a CE marking. Among other elements, your declaration of conformity must include:
The product’s unique identification number
Your organization’s official correspondence address
A detailed description and schematics (if applicable) of the product
A thorough list of the E.U. standards to which the product conforms
Leave any of this information out of your declaration of conformity and your CE marking application is not likely to be approved. Although there are many similarities, each directive has its own requirements on the contents of the declaration.
5. Improperly Designating Your “Responsible Person”
A proper declaration of conformity must be signed off by a “responsible person” of suitable authority within the manufacturer’s organization. This is most often the product’s process owner, the head of the department that manufactures the product, or the organization’s chief executive.
The “responsible person” takes full responsibility for the product’s conformity, meaning that any subsequently discovered deficiencies are on them. It’s common for organizations to mistakenly designate relatively junior employees as responsible. If they lack the standing to remove the product from the market or initiate design changes at the request of E.U. authorities, this mistake can cause serious problems down the line.
Set Yourself Up for Success
Obtaining a CE mark is a celebration-worthy milestone in your organization’s road to global growth.
Then again, the process of obtaining a CE mark is a long and arduous one. You’ll have to deal with plenty of other fires as you work toward your mark. Some will demand your full attention, even as your team works in the background to keep your CE marking initiative on track.
Do yourself and your organization a favor and start you CE mark certification process before you export your products into the European Union. Once you’re in position, connect with peers who’ve successfully completed the process and pick their brains. They’ll be only too happy to help a fellow entrepreneur grow their business.