CE Certification is required for certain categories of products to enter the European market. Like many product certification processes, the CE Mark process requires time, money, and a strategy for all international markets you want to enter—but does it require a local representative?
CE Certification
During the CE Certification process, the product(s) will be evaluated according to the relevant standards for quality, safety, electromagnetic capabilities, and environmental impact. The standards represented by the CE Mark are used by all European Union (EU) member countries, as well as several countries that also use the framework or equivalent standards (e.g. Iceland, Norway, and Switzerland).
Many, but not all, products must obtain CE
Certification before entering the European market. Chemical substances,
construction equipment, electrical equipment, electronics, gas-burning
appliances, medical devices, and machinery are among the categories of products
that must successfully complete the CE Certification process. Depending on the
type of product, a variety of standards and tests may apply: safety,
electromagnetic function, wireless, hazardous substances, energy use,
recycling, and more.
Authorized Representation in the
CE Mark Process
For certain specialized products,
manufacturers located outside of the European Union must have an Authorized
Representative in the EU to assist with the CE Certification process. However,
this is not the case for all products that require the CE Mark.
The Authorized Representative is a legal entity that serves as a point of contact for the relevant compliance and market surveillance authorities in the EU. When an Authorized Representative is required, their contact information is listed alongside the manufacturer’s in the documentation submitted, and they will be the primary point of contact if there are questions or concerns about the product. The manufacturer and representative will stay in contact throughout the process to respond to requests for documentation or other materials.
An experienced compliance agency can help
find, vet, and coordinate with the Authorized Representative to ensure the
process is as quick and simple as possible.
Keep in mind: the product certification
process can follow two different paths, and the responsibilities of the
Authorized Representative can vary depending on the path and the product:
●
Independent assessment by notified
body - Certain types of products must be evaluated by a notified body, which
will evaluate the product and the documentation to ensure conformity to the
applicable standard
● Self-certification - Some product categories can use the self-evaluation process, in which the manufacturer evaluates and documents the product’s conformity to applicable standards and affixes the CE Mark if all requirements are met
Learn More About the CE Mark From G&M Compliance
The compliance professionals at G&M
Compliance can help you determine if your product needs CE Certification, choose
the right path for CE Marking, and identify a qualified EU representative for
your product(s). G&M Compliance will 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 learn more
about the CE Mark process and the role of an Authorized Representative.