Professional Documents
Culture Documents
A programme implemented by
Economic Co-operation Programme on
The European Committee for Standardisation
Standards, Quality and Conformity
Assessment
1
European Commission
EC Delegations in
ASEAN countries
Technical Assistance
Food Electricity-Electronic-Telecom Pharmacy
2
Regional workshop on
EU Directives and implication of
Regulatory bodies
EET Sector
3
Contents
17 May 2004
Part 1 :
EU Directives based on the New approach and
the global approach
Part 2 :
The Low Voltage Directive (LVD)
18 May 2004
Part 3 :
The EMC Directive
Part 4 :
The R & TTE Directive
Essential requirements :
Essential requirements lay down the necessary
elements for protecting the public interest.
Essential requirements are mandatory.
Only products complying with essential requirements
may be placed on the market and put into service (15).
Essential requirements must be applied as a function
of the hazards inherent to a given product.
Harmonized standards :
Harmonized standards are European
standards, which are adopted by European
standards organizations, prepared in
accordance with the General Guidelines
agreed between the Commission and the
European standards organizations, and follow
a mandate issued by the Commission after
consultation with the Member States (16).
Harmonized standards :
Harmonized standards in the meaning of the
New Approach are deemed to exist when the
European standards organizations formally
present to the Commission the European
standards elaborated or identified in
conformity with the mandate (17) .
Harmonized standards :
Standardization procedure under the New
Approach:
1. A mandate is drawn up, following
consultation with the Member States.
2. The mandate is transmitted to
European standards organizations.
3. European standards organizations
accept the mandate (18) .
Presumption of conformity :
Conformity with a national standard that
transposes a harmonized standard, whose
reference has been published, confers a
presumption of conformity with the essential
requirements of the applicable New Approach
directive that is covered by such a standard 19).
Presumption of conformity :
Member States must publish the reference of
the national standard that transposes a
harmonized standard.
Presumption of conformity :
The application of harmonized standards,
which give a presumption of conformity,
remains voluntary in the field of New
Approach directives. Thus, the product may
be manufactured directly on the basis of the
essential requirements (19) .
Withdrawal of conformity :
The Commission withdraws the presumption
of conformity, if it has been established that
the harmonized standard does not fully meet
the essential requirements
The modules :
As a general rule, a product is subject to
conformity assessment according to a module
during the design as well as the production
phase.
Technical documentation :
The manufacturer must draw up a technical
file (technical documentation).
The technical documentation is intended to
provide information on the design,
manufacture and operation of the product.
EC declaration of conformity :
The manufacturer or the authorized
representative established within the
Community must draw up an EC declaration
of conformity as part of the conformity
assessment procedure provided for in the
New Approach directives.
Principles of CE marking:
The CE marking symbolizes the
conformity of the product with the
applicable Community requirements
imposed on the manufacturer.
Principles of CE marking:
The CE marking affixed to products is a
declaration by the person responsible that :
the product conforms to all applicable
Community provisions,
the appropriate conformity assessment
procedures have been completed.
Products to be CE marked :
The CE marking is mandatory and must be
affixed before any product subject to it is
placed on the market, save where specific
directives require otherwise.
Products to be CE marked :
Where products are subject to several
directives, which all provide for the affixing of
the CE marking, the marking indicates that the
products are presumed to conform to the
provisions of all these directives.
Products to be CE marked :
A product may not be CE marked, unless it is
covered by a directive providing for its
affixing.
CCA
HAR LCIE