Harmonized standards are technical
specifications set by European agencies that, when aligned with a product
directive, set compliance standards for a given product. Harmonized standards
are voluntary, but following the right harmonized standard is the best way to
obtain the CE Mark.
Meeting the requirements of an applicable
harmonized standard gives your product a “presumption of conformity” to the
essential requirements for the CE Mark. In other words, if you can prove your
product meets the harmonized standard, you can demonstrate compliance with the
relevant product directive.
Harmonized standards are developed and managed
by three European standards organizations:
●
European Committee for Standardization (CEN) -
consolidates national standardization bodies for 34 European countries and
creates European Standards (ENs) and other technical documents for a wide range
of products
●
European Committee for Electrotechnical Standardization (CENELEC) -
produces ENs and Harmonization Documents (HDs) for electrical engineering
products
●
European Telecommunications Standards Institute (ETSI) - produces global standards for information and telecom technologies,
including internet, mobile, radio, fixes, and broadcast technology.
How Do Harmonized Standards
Affect CE Marking?
The CE Mark is required for certain types of
products to enter any country in the
European Economic Area (EAA), which includes European
Union (EU) countries, as well as Iceland, Norway, and Liechtenstein. CE Marking
is part of the New Approach
legislation that holds all companies accountable for the
same product standards; the CE Mark signifies the product meets safety, health,
and environmental protection standards.
As companies develop products that will be
sold in the EU or the larger EAA, they look to the relevant CE standards for
specific technical requirements. These requirements, which are often altered
and refined through legislation, are best summarized by harmonized standards.
There are harmonized standards for each
product directive associated with the CE Mark, including:
●
Low Voltage Directive (LVD) —
2014/35/EU
●
Machinery Directive (MD) —
2006/42/EC
●
EMC Directive (EMC) — 2014/30/EU
●
Medical Device Directive (MDD) —
93/42/EEC
●
Radio Equipment Directive (RED) —
2014/53/EU
●
Restriction of Hazardous
Substances Directive (RoHS) — 2011/65/EU
The requirements for each product
type—including radio equipment, machinery, medical devices, and more—are only
legally binding once they’re entered into the European
Commission’s Official Journal. However, harmonized standards are an easy
way to see how regulations have changed over time and what standards were
replaced by new versions.
Depending on what the product is and how it
will be used, standards and processes will vary among directives. This
includes:
●
The method of demonstrating
conformity
●
The “essential requirements” for
design and manufacturing
●
The applicable Conformity
Assessment Procedure modules
●
The number of applicable
harmonized standards
The level of risk may also affect the CE
Marking process. Products with minimal risk can be self-certified by preparing
a Declaration of Conformity and affixing the CE Marking to the product.
Products with greater risk need to be independently certified by a “Notified
Body,” a.k.a. an independent test lab in a member state of the European Union.
Consult a compliance professional if you have questions about the level of risk
associated with your product.
Learn More About the CE Mark From
G&M Compliance
One of the most challenging parts of obtaining
the CE Mark is choosing the right standard for your product out of thousands of
choices. A professional compliance organization like G&M Compliance can
help you choose the right standard, ensure compliance, and start selling your
product around the world today.
Contact
G&M Compliance today to get a quote or
learn more about the requirements of the CE Mark.