n Low Voltage Directive
73/23/EEC (amended 93/68/EEC)
n Simple Pressure Vessels
87/404/EEC (amended 90/488/EEC, 93/68/EEC)
n Toys 88/378/EEC (amended
n Construction Products
89/106/EEC (amended 93/68/EEC)
n Electromagnetic Compatibility
89/336/EEC (amended 92/31/EEC, 93/68/EEC, 98/13/EC)
n Machinery 98/37/EC
n Personal Protective
Equipment 89/686/EEC (amended 93/68/EEC, 93/95/EEC,
n Nonautomatic Weighing
Instruments 90/384/EEC (amended 93/68/EEC)
n Active Implantable
Medical Devices 90/385/EEC (amended 93/68/EEC, 93/42/EEC,
n Gas Appliances 90/396/EEC
n Hot Water Boilers
92/42/EEC (amended 93/68/EEC)
n Civil Explosives
n Medical Devices 93/42/EEC
(amended 93/68/EEC, 98/79/EC)
n Potentially Explosive
n Recreational Craft
n Lifts 95/16/EC
n Refrigeration Appliances
n Pressure Equipment
Terminal Equipment 98/13/EC (now replaced by the Radio
and Telecommunications Terminal Equipment)
n In Vitro Diagnostics
n Radio and Telecommunications
Terminal Equipment 99/5/EC
n Cableway Installations
n Noise Emission in
the Environment by Equipment for Use Outdoors 2000/14/EC
n Transportable pressure
n Fluorescent Lighting
Directives based on the principles of new approach
n Packaging and Packaging
n High-Speed Rail Systems
n Marine Equipment
n Conventional Rail
To compete in today's global
marketplace, U.S. manufacturers are beginning to export
more goods to Europe. Before doing so, however, many companies
must obtain CE marking, which allows them to move their
products freely throughout the European Economic Area. CE
marking is required on products that fall within the scope
of any of the European Union's 29 New Approach Directives.
"CE" is an abbreviation of the French phrase
"Conformité Européenne." CE marking
on a product is the manufacturer's assertion that the product
complies with the essential/safety requirements of relevant
In 1985 the European Union changed its approach toward
certification and standards compliance by introducing the
New Approach Directives. These established essential requirements
and performance levels for specific products. The directives
also established "harmonized standards" to which
a product must comply and set procedures for assessing products'
conformity to relevant essential requirements. The following
overview of CE marking covers these requirements in more
With the European Union's consolidation, and to allow
for a single approach toward standardization, all member
countries are now following the New Approach Directives.
Many of the older national regulations, specific to one
country, are being replaced by these directives. Currently,
manufacturers may place CE marking only on products that
comply with the New Approach Directives. Furthermore, all
products intended for sale in the European marketplace must
comply with any relevant directives once they're voted into
The directives cover a wide and growing range of products.
As mentioned, CE marking on a particular product is a claim
of compliance with a specific directive and any New Approach
Directive that might relate to the product. For example,
an electromechanical device that incorporates a pressurized
vessel might have to comply with the Pressure Equipment
Directive, the Machinery Directive and the Low Voltage Directive.
Given the diversity of subjects covered by the New Approach
Directives, it's not possible to outline specific actions
that will lead to CE marking for your product. These marks
mean different things for different products under different
directives. However, there are commonalities across most
Essential/safety requirements are key components of CE
marking and the New Approach Directives. The requirements'
complexity varies from directive to directive. For example,
the essential requirements of the Medical Devices Directive
cover devices' safety, risk assessment, physical properties,
sterilization, biocompatibility, measuring functions, electrical
safety, labeling and instructions for use. The Medical Devices
Directive is currently under review.
In order to meet the directives' essential requirements,
compliance with harmonized standards is helpful and, in
some cases, may be required. Harmonized standards are technical
specifications written under a mandate from the European
Commission. Once they're accepted as being harmonized, these
standards are listed in the Official Journal of the European
Union. A harmonized standard offers a presumption of conformity
with relevant essential requirements. In other words, when
a manufacturer declares that its product meets a harmonized
standard, it's presumed that the product meets relevant
It's manufacturers' responsibility to understand how the
essential requirements relate to their products and to identify
all relevant and appropriate standards.
The manufacturer decides which standards are appropriate
for demonstrating conformity with essential requirements.
The manufacturer also determines how to demonstrate conformity.
To assist in determining applicable standards and how they
apply, it's often helpful to perform in-house testing or
hire an independent third-party testing group.
For many products, and for some essential requirements,
there may be no established standards. In these cases, the
manufacturers' own specifications may become the basis for
compliance. When using nonharmonized standards, a manufacturer
must demonstrate that they effectively address the European
Union's essential requirements.
Having established compliance with essential requirements,
the manufacturer must next take steps to ensure the objective
evidence is available. Although the content, format and
quantity of this documentation will vary from directive
to directive, within directives and between product families,
technical documentation is critical. For some, the technical
documentation's required format is purposely vague to allow
manufacturers some flexibility in how they compile and maintain
the documentation. For other directives, there are more
Typically, technical documentation includes descriptions
of the product and its intended use, product specifications,
details of materials, test results and reports, essential
requirements checklists, data addressing the directives'
requirements, design and manufacturing information, supporting
documentation and labels.
Under all directives, notified bodies play a role in the
CE marking process. The notified body is a third-party organization--normally
an ISO 9000 registrar, testing body or certification body.
Notified bodies receive designation based on demonstrated
expertise, experience and competence in assessing product
and/or quality systems, as required by the directives. Notified
bodies may be obliged to review technical documentation,
examine products and/or assess quality management systems'
implementation. Under some directives there's very little,
if any, notified body involvement; other directives require
A manufacturer must follow a conformity assessment procedure
in order to place CE-marked products on the market. The
company may select from a number of conformity assessment
modules, depending on the modules that are permitted or
required by the particular directive and the product's perceived
risk level. Some products may require a combination of modules,
A. Internal Control of Production--This encompasses internal
production control. For most directives, this module doesn't
require notified body involvement. However, for directives
such as the Pressure Equipment Directive and noise directives,
a derivative called Module A1 does require notified body
B. EC Type Examination--This includes an examination of
the technical documentation and of the product by a notified
body and will normally be followed by a module that assesses
the production phase. The notified body then issues the
EC Type Examination certificate. A similar and related module
is B1. EC Design Examination. The processes are the same,
but with Module B1, the product's design is evaluated rather
than the product itself.
C. Conformity to Type--This covers the production phase
and follows Module B. It provides for conformity to type
as described in the EC Type Examination certificate issued
according to Module B. The notified body is normally required
to audit this process.
D. Production Quality Assurance--This details the production
phase and may follow Module B. Derived from the quality
assurance standard EN ISO 9002, Module D requires the intervention
of a notified body, which is responsible for approving and
verifying the quality system for production and final product
inspection and testing.
E. Product Quality Assurance--This covers the production
phase and may follow Module B. It derives from quality assurance
standard EN ISO 9003 and requires the intervention of a
notified body, which is responsible for approving and verifying
the quality system for final product inspection and testing.
F. Product Verification--This occurs at the production
phase and may follow Module B. The notified body controls
conformity to type (as described in the EC Type Examination
certificate or according to the manufacturer's technical
documentation) and issues a certificate of conformity.
G. Unit Verification--This concerns the design and production
phases. The notified body issues a certificate of conformity
for each individual product examined.
H. Full Quality Assurance--Originating from quality assurance
standard EN ISO 9001, Module H concerns the design and production
phases. A notified body is again responsible for approving
and verifying the quality system for design, manufacture,
final product inspection and testing as set up by the manufacturer.
Many directives, such as the Toy Directive, rely heavily
on Module A, which doesn't require notified body involvement
except for products that don't comply wholly with the harmonized
standard, which require undergoing a type examination. Other
directives, such as the Medical Devices Directive, use the
full range of modules, depending on the class of the product.
Because the modules are intended to provide templates for
conformity assessment, there may be variations in exactly
how the individual directives implement them.
To review, the manufacturer is responsible for identifying
which, if any, directives are applicable to its product.
If relevant directives are in force, then compliance with
the directives' requirements and affixing CE marking for
the product will most likely be mandatory.
Under the directives, the manufacturer needs to identify
all available conformity assessments required for its product.
The manufacturer can then select and choose to follow the
most appropriate conformity assessment module, or modules,
that fit with its business model.
The manufacturer must also address the directive's essential
requirements, identifying and using appropriate standards
throughout the process. And the manufacturer's technical
documentation must demonstrate compliance with the directive's
If the directive stipulates that notified body involvement
is required, the manufacturer must submit, as appropriate,
the quality system, technical documentation and product
sample to the notified body for conformity assessment. If
the directive indicates that no notified body involvement
is required, the manufacturer proceeds using the guidelines
given in Module A.
Once a satisfactory conformity assessment is completed,
the manufacturer signs a declaration of conformity. This
declaration asserts that the product:
n Meets the appropriate directive's
n Has technical documentation
n Has satisfactorily passed
a conformity assessment
The declaration of conformity allows the manufacturer
to affix CE marking on the product and prepare to place
the product on the market. Careful attention to the declaration
must be made because it's considered a crime to falsely
prepare a declaration of conformity.
Although the New Approach Directives are intended to open
European markets to the free movement of goods, national
deviations and interpretations may exist, and manufacturers
must be aware of them. Therefore, make careful reference
to the individual directives that apply to your product(s).
Additionally, when CE marking is applied, the manufacturer
essentially is claiming that its product complies with national
variations of the European directives in countries in which
it intends to market the product. Because European countries
pass the directives into national laws, attention to these
individual variations is critical. For example, if a medical
device manufacturer wants to place products on the UK market,
it must comply with the UK national regulations, which incorporate
the Medical Devices Directive into the UK Consumer Protection
CE marking is still a somewhat daunting and confusing
procedure to the uninitiated, but the more you're involved,
the clearer it gets. In reality, the directives are incredibly
efficient and empower manufacturers to take responsibility
for demonstrating their products' and manufacturing systems'
compliance, based on the declaration of conformity. If in
doubt, always check with your notified body or your consultant.
With concerted effort, diligence and time, your product
will bear CE marking, and the European marketplace will
be open to you.
Paul Brooks, an expert on CE marking under the Medical
Devices Directive, is the head of BSI's Medical Devices
Group, a Notified Body. He joined BSI in 1981 and has been
working with the company's U.S. subsidiary, BSI Inc., since
1993. Today, he's responsible for BSI's Conformity Assessment
Body and IVD Notified Body activities. Letters to the editor
regarding this article should be e-mailed to email@example.com.