|by Kevin J. Quinn and Paul Brooks
Sufficiently testing a product to overseas requirements and proving
conformity in the new global trade environment can be daunting.
Authors Kevin Quinn and Paul Brooks offer a simple overview of
the CE Mark and New Approach Directives, and the role they play
in introducing your product into the European marketplace.
In 1985 the European Community changed its approach to certification
and compliance with standards, by introducing the concept of New
Approach Directives. These directives establish essential safety
or other requirements for specific products or product types and
prepared a set of ground rules or procedures for assessing the
conformity of products with the relevant essential requirements.
The New Approach Directives
These New Approach Directives cover a wide and growing range of
products. The presence of CE Marking on a particular product is
not only a claim of compliance with a specific directive, but
of compliance with 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
Simple Pressure Vessels Directive, the Machinery Directive and
the Low Voltage Directive. Incidentally, CE Marking may only be
used to indicate compliance with New Approach Directives, and
not with the older technical directives, many of which remain
Because of the diversity of subjects covered by the New Approach
Directives, it is not possible to state, simply, that such-and-such
an approach will lead to the right to apply CE Marking. In each
case, reference must be made to the directive in question for
the specific requirements that apply.
Free Movement of Goods
The CE Marking of products is intended to support the free movement
of goods within the European Economic Area. All products that
bear CE Marking must comply with all provisions of the applicable
directives. Where a product carries appropriate CE Marking, the
member countries of the European Economic Area must allow the
product to be placed on the market.
CE Marking directives now cover many product areas. The current
CE Marking directives are:
Low Voltage Directive 73/23/EEC (amended 93/68/EEC)
Simple Pressure Vessels 87/404/EEC (amended 90/488/EEC, 93/68/EEC)
Toys 88/378/EEC (amended 93/68/EEC)
Construction Products 89/106/EEC (amended 93/68/EEC)
Electromagnetic Compatibility 89/336/EEC (amended 92/31/EEC,
Machinery 98/37/EC (amended 98/79/EC)
Personal Protective Equipment 89/686/EEC (amended 93/68/EEC,
Non-Automatic Weighing Instruments 90/384/EEC (amended 93/68/EEC)
Active Implantable Medical Devices 90/385/EEC (amended 93/68/EEC,
Gas Appliances 90/396/EEC (amended 93/68/EEC)
Hot Water Boilers 92/42/EEC (amended 93/68/EEC)
Civil Explosives 93/15/EEC
Medical Devices 93/42/EEC (amended 93/68/EEC, 98/79/EC)
Potentially Explosive Atmospheres 94/9/EC
Recreational Craft 94/25/EC
Refrigeration Appliances 96/57/EC
Pressure Equipment 97/23/EC
Telecommunications Terminal Equipment 98/13/EC
In Vitro Diagnostics 98/79/EC
Radio and Telecommunications Terminal Equipment 99/5/EC
Those new Approach Directives that do not require CE Marking are:
Packaging and Packaging Waste 94/62/EC
High Speed Rail Systems 96/48/EC
Marine Equipment 96/98/EC
Where a new approach directive is relevant and in full force then
compliance with the directive is normally mandatory for all relevant
products destined to be placed on the European Market.
The bottom line is that CE Marking means different things to different
products under different directives. There are, however, fundamentals
that are common across most directives.
Essential Requirements and Standards
One of the key components of new approach CE Marking directives
are essential requirements. Meeting these requirements is fundamental
to meeting the relevant directive and being able to place the
product on the European market with CE Marking. The extensiveness
of the requirements will vary from directive to directive. For
the Medical Devices Directive, debatably one of the most comprehensive
new directives, the essential requirements cover, for example,
safety of the device, risk assessment, physical properties, sterilization,
bio-compatibility, measuring functions, electrical safety, labeling,
and instructions for use.
Key to meeting essential requirements are the standards, compliance
with which demonstrates how the essential requirements have been
met. Harmonized standards are standards that have been written
normally under a mandate from the European Commission, which specifically
address essential requirements. A standard that has been accepted
as being harmonized will have been listed in the Official Journal
(OJ) of the European Union.
Manufacturers have a responsibility to understand how the essential
requirements relate to their products and identify all relevant
and appropriate standards. Once the standards have been identified,
the manufacturer decides which ones will be used to demonstrate
conformity with essential requirements and how this will be achieved;
perhaps commissioning independent third party testing or in-house
testing would be practical.
For many products, and for some essential requirements, there
may not be established standards and in this case the manufacturers
own specifications may become the basis of compliance. In all
cases, and particularly when utilizing non-harmonized standards,
the manufacturer must be able to demonstrate that selected standards
effectively address the essential requirements. The benefit of
utilizing harmonized standards is that there is a presumption
of conformity with the relevant essential requirements; this means
that where a product satisfies the harmonized standard it is also
presumed to meet the essential requirements that have been identified,
normally within the standard.
Having established the compliance with essential requirements,
the manufacturer needs to take steps to ensure that the objective
evidence is available. The need for technical documentation is
core to the directives, although the content, format and quantity
of this documentation will vary enormously from directive to directive
and, within directives, from product family to product family.
The format of technical documentation was deliberately left vague
in some directives to allow manufacturers some flexibility in
how they compiled and maintained documentation to demonstrate
conformity. For other directives there are more prescriptive requirements.
Typically technical documentation includes a description of the
product and its intended use, product specifications, materials
details, test results and reports, essential requirements check-lists,
data addressing the directives requirements, design and manufacturing
information, supporting documentation, and labels.
Under some directives there is a role for a notified body in the
CE Marking process. The notified body is a third party organization,
normally an ISO 9000 registrar, i.e., BSI (British Standards Institution)
or certification body, which has been formally designated under
the directive as a Notified Body. The Notified Body will have
received designation based on expertise, experience and competence
that can be demonstrated to assess product and/or quality systems
as required by the directives. Notified Bodies may be required
to review technical documentation, examine products and or assess
the implementation of quality management systems.
Under some directives there is very little, if any, Notified Body
involvement; other directives require intense Notified Body involvement.
Conformity assessment is the procedure the manufacturer follows
to place CE Marked products on the market. A select number of
conformity assessment modules exist that the manufacturer may
select from depending on the modules permitted or required by
the particular directive and the classification or level of risk
that is perceived with the product. Some products may require
a combination of modules.
The modules are:
A: Internal Control of Production Covers internal design and
production control. This module does not require Notified Body
B: EC Type ExaminationCovers the design phase, and must be followed
up by a module providing for the assessment of the production
phase. A Notified Body issues the EC Type Examination certificate.
C: Conformity to TypeCovers the production phase and follows
module B. Provides for conformity with type as described in the
EC Type Examination certificate issued according to module B.
This module does not require a Notified Body to take action.
D: Production Quality Assurance Covers the production phase and
follows module B. Derives from quality assurance standard EN ISO
9002, with the intervention of a Notified Body responsible for
approving and controlling the quality system for production, final
product inspection, and testing set up by the manufacturer.
E: Product Quality AssuranceCovers the production phase and follows
module B. Derives from quality assurance standard EN ISO 9003,
with the intervention of a Notified Body responsible for approving
and controlling the quality system for final product inspection
and testing set up by the manufacturer.
F: Product VerificationCovers the production phase and follows
module B. The Notified Body controls conformity to type as described
in the EC Type Examination certificate issued according to module
B, and issues a Certificate of Conformity.
G: Unit VerificationCovers the design and production phases.
Each individual product is examined by a Notified Body, which
issues a Certificate of Conformity.
H: Full Quality AssuranceCovers the design and production phases,
originating from quality assurance standard EN ISO 9001, with
the intervention of a Notified Body responsible for approving
and controlling the quality system for design, manufacture, final
product inspection, and testing set up by the manufacturer.
Many directives, such as the Toy Directive, rely heavily on Module
A, which requires no Notified Body involvement. Other directives,
such as the Medical Devices Directive, utilize the full range
of modules depending on the class of the medical devices in question.
The modules are intended to provide the model for conformity assessment,
but there may be variations in exactly how the individual directives
The Route to CE Marking
The manufacturer must identify which, if any, directives are applicable
to the product. If there are relevant directives and they are
in force, then compliance with the requirements of the directive
and the CE Marking of the product is likely to be mandatory.
If a directive instructs the manufacturer to identify whether
a different conformity assessment module to the product in question
is available, does the directive have any classification requirements
that affect the conformity assessment modules which are applicable?
An appropriate conformity assessment module (or combination of
modules) must be selected and followed.
The manufacturer will need to address the essential requirements
of the directive, identifying and utilizing appropriate standards
throughout the process. Compliance with the requirements of the
directive must be verified in the manufacturers technical documentation.
If the directive identifies that Notified Body involvement is
required, the manufacturer must submit as appropriate: the quality
system, technical documentation, and some product to the Notified
Body for conformity assessment. If the directive indicates no
Notified Body involvement is required, the manufacturer proceeds
under Module A.
Once a satisfactory conformity assessment is completed, the manufacturer
signs a declaration of conformity, which is the manufacturers
claim that the product meets the directives requirements, that
the technical documentation is available and that a conformity
assessment has been satisfactorily completed. This declaration
of conformity allows the manufacturer to affix CE Marking on the
product and prepare to place the product on the market. Careful
with this oneit is considered a crime to falsely prepare a Declaration
of Conformity. In the United Kingdom, the Queen still reigns over
most laws; it is believed that she can order you to be beheaded
for such a crime!
This article has attempted to simplify CE Marking, and while the
concepts and procedures identified are generally accurate, the
directives are implemented with deviations that need to be understood,
therefore, it is important that reference be made to the individual
directives. It is also important to understand that when CE Marking
is applied, the manufacturer is claiming compliance not with the
European directive, but with individual interpretations of the
directives that have been passed into the national laws within
the individual European countries. Better stated, if a medical
device manufacturer wants to place products on the U.K. market
then they must comply with the U.K. national regulations, which
have transposed the Medical Devices Directives into U.K. law.
The new CE Marking New Approach Directives were intended to open
European markets to the free movement of goods, but manufacturers
must still be aware of national deviations and interpretations
that may exist. CE Marking is still a somewhat daunting and confusing
procedure to the uninitiated, but the more you are involved the
clearer it gets. In reality the directives are incredibly efficient
and empower manufacturers to take responsibility for demonstrating
the compliance of their products and manufacturing systems, based
on the declaration of conformity. If in doubt always be sure to
check with your Notified Body or your Consultant.
Eventually it all makes sense, we promise! //
Copyright 2000, ASTM
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