Demonstrating compliance with CE requirements opens up the EU market, as well as countries that have adopted CE standards or equivalent rules. But it’s not enough to demonstrate compliance once—the product manufacturer must maintain the compliance over time.
Here are a few tips to maintain CE compliance
for your product:
Choose the Right Certification
Path
The first key to maintaining CE compliance is to obtain the right certification in the first place. First, decide whether CE Certification applies to the product; the CE mark is only required for products that have applicable, relevant EU specifications.
Products that require CE Certification to be sold in EU (or countries that adopt CE or equivalent standards) may be subject to multiple requirements in different areas. For example, a medical device with electromagnetic capabilities is likely subject to the Medical Device Regulation (MDR), the Electromagnetic Compatibility Directive (EMC), and potentially the Low Voltage Directive (LVD) as well. Other directives, like the Machinery Directive (MD) and Radio Equipment Directive (RED), and other standards come into play based on the purpose and function of the product.
Even when CE Certification is the right path
for the product, there are nuances to consider: Which specific standards apply
to this product? Is self-certification sufficient, or will a Notified Body be
required to test this product (aka Third Party Approval)? Is there an
opportunity to test one sample to represent a family of products? Are there any
product requirements that do not apply under certain conditions? Answer these
questions with the help of an experienced compliance professional to set your product
on the right path.
Maintain Accurate, Up-to-Date
Documentation
Technical documentation is one of the most important parts of demonstrating conformity and maintaining compliance. In the process of designing and testing the product, the manufacturer should compile a technical dossier of the product’s dimensions, functions, and performance in various tests.
Even for self-certified products, a national
authority can request all the information and supporting documentation
concerning CE Certification. The product owners must be prepared to provide
accurate, thorough, and up-to-date documentation of the product, or risk losing
CE compliance.
Apply the CE Mark Correctly
Even if the product perfectly demonstrates conformity, applying the CE mark incorrectly can invalidate CE compliance.
The
CE mark must be applied visibly, legibly, and in a way that it
cannot be removed. There are additional rules regarding size, proportionality,
and applying the mark to packaging when it cannot be affixed to the product
itself. Follow these rules precisely to ensure the product is labeled
appropriately and can remain on the EU common market.
Recertify After Major Product Changes
If the product undergoes significant changes,
make a plan to update the CE certification as well. Changes in functionality
and performance should be documented in the technical information, as well as
any written materials required for self-certification or third-party approval.
Failure to update the certification may result in the modified product being
ineligible for the EU market.
Learn More About Self-Declaration for the CE Mark
The compliance professionals at G&M Compliance can help you determine if your product needs CE certification, and if so, whether or not the self-declaration process will work for you. G&M Compliance can support the entire process, from the strategy for harmonized international standards to the logistics of product testing, and get your product to market.
Contact G&M Compliance today to get a
quote or learn more about the requirements of the CE Mark.