New Legal Framework - CE marking

New Legal Framework
Carlo Casati
Milan, 1 April 2016

06.11.2013 NOTIFIED BODY TRAINING 012
• New Legislative Framework
• Market Surveillance
• Conformity Assessment
• CE Marking
Summary

New Legislative Framework (NLF)
01.04.20163 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX

01.04.2016 WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX4
• Primary legislation
• Founding Treaties
• Constitution
• Secondary legislation
• Jurisprudence
• Sentences of the Court
of Justice
• Sentences of the Court
of First Instance
European Union Law (Aquis)

• Regulations: these are binding in their entirety and
directly applicable in all Member States;
• Directives: these bind the Member States as to the
results to be achieved; they have to be transposed into
the national legal framework and thus leave margin for
manoeuvre as to the form and means of implementation;
• Decisions: these are fully binding on those to whom they
are addressed;
• Recommendations and opinions: these are non-
binding, declaratory instruments.
European Union Legal instruments

To improve the internal market for goods and strengthen the
conditions for placing a wide range of products on the EU Market,
the New Legislative Framework was adopted in 2008
• improves market surveillance rules to better protect both
consumers and professionals from unsafe products, including those
imported from outside the EU;
• sets clear and transparent rules for the accreditation of conformity
assessment bodies;
• boosts the quality of and confidence in the conformity
assessment of products through stronger and clearer rules on the
requirements for the notification of conformity assessment bodies;
• clarifies the meaning of CE marking and enhances its credibility;
• establishes a common legal framework for industrial products in
the form of a toolbox of measures for use in future legislation.
New Legislative Framework

• Regulation (EC) 765/2008 setting out the
requirements for accreditation and the
market surveillance of products;
• Decision 768/2008 on a common framework
for the marketing of products, which includes
reference provisions to be incorporated
whenever product legislation is revised. In
effect, it is a template for future product
harmonisation legislation;
• Regulation (EC) 764/2008 laying down
procedures relating to the application of
certain national technical rules to products
lawfully marketed in another EU country.
The package consists of:

• Low Voltage Directive - 2014/35/EU;
• Electromagnetic Compatibility Directive: 2014/30/EU;
• ATEX Directive - 2014/34/EU;
• Lifts Directive - 2014/33/EU;
• Simple Pressure Vessels Directive - 2014/29/EU;
• Measuring Instruments Directive - 2014/32/EU;
• Non-automatic Weighing Instruments Directive -
2014/31/EU;
• Civil Explosives Directive - 2014/28/EU.
Alignment of product legislation

• In addition, aligned legislation has also been adopted in
the areas of Pyrotechnic Articles (Directive 2013/29/EU),
Toy Safety (2009/48/EU), Restriction of Hazardous
Substances in Electrical and Electronic Equipment
(2011/65/EU), Recreational Craft (2013/53/EU), Radio
Equipment (2014/53/EU), Pressure Equipment
(2014/68/EU) and Marine Equipment (2014/90/EU).
Further aligning proposals are pending on Medical
Devices, Gas Appliances, Cableways, and Personal
Protective Equipment.
Alignment of product legislation

Market Surveillance

Market surveillance for products
• Member States have to take appropriate
measures to prevent the placing on the market
and use of non-compliant products.
• Market surveillance activities may be organized
differently depending on the nature of the product
and may range from control of formal
requirements to profound laboratory
examinations.
• All economic operators have a role and
obligations in market surveillance.
• One major task for market surveillance
authorities is to keep the public informed against
potential risks (RAPEX)
• Non-compliant products are subject to corrective
measures, bans withdrawals or recalls.
• The level of the sanctions is determined at
national level

Manufacturer
• The manufacturer is any natural or legal person who manufactures a
product or has a product designed or manufactured, and places it on
the market under his own name or trademark.
• The manufacturer is responsible for the conformity assessment of
the product and is subject to a series of obligations including
traceability requirements.
• When placing a product on the Union market, the responsibilities of a
manufacturer are the same whether he is established outside the
European Union or in a Member State.
• The manufacturer must cooperate with the competent national
authorities in charge of market surveillance in case of a product
presenting a risk or being non-compliant.
Economic Operators

Authorised representative
• Irrespectively of whether he is established in the EU or not, the
manufacturer may appoint an authorised representative in the Union
to act on his behalf in carrying out certain tasks.
Importer
• The importer is a natural or legal person established in the Union
who places a product from a third country on the EU market.
• His obligations build on the obligation of the manufacturer.
Distributor
• The distributor is a natural or a legal person in the supply chain,
other than the manufacturer or the importer, who makes a product
available on the market.
• Distributors are subject to specific obligations and have a key role to
play in the context of market surveillance.
Economic Operators

Conformity Assessment

Single Market and European Standardisation
Single Market
Technical
Harmonization
CEN European Committee for
Standardization
CENELEC European Committee for
Electro-technical Standardization
ETSI European Telecommunication
Standard Institute

Conformity Assessment and Global Approach
Global Approach
Technical
Requirements
Module Conformity
Assessment
• Not only rules
(technical
harmonisation)
must be shared
but also how to
assess them
• Global Approach:
• Module Conformity
Assessment
• Notified Bodies
• CE marking

Conformity Assessment Modules
There are eight modules. Some of them have variants.

Technical Innovation and New Approach
New Approach
Essential
Requirements
Module Conformity
Assessment
• Innovative products
can not be subjected
by technical
standards, as they
have long
development times.
• The new approach
completes the global
approach keeping the
rules for conformity
assessment but
replacing technical
regulation with
essential
requirement.

Presumption of Conformity
Conformity
Presumption
of Conformity
Essential Requirements
(must)
Harmonised standards
(possibility)
Ceases if:
The harmonised standard expires
The contrary is proved
• The conformity of a product may be
demonstrated not only by
harmonised standards but also by
other technical specifications.
• Other technical specifications
however do not benefit from the
presumption of conformity.

Why standards are used or not used ?
WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX01.04.201620
Used
• Presumption of
conformity through
standards requires often
less resources (time,
money, competence, …)
than proving essential
requirements.
• Standards are worldwide
recognised, may be used
commercially.
NotUsed
• By means of technical
documentation the
conformity of a product
family can be derived
(this is not possible for
global approach and
standard based product
certification).
• No specific standards are
available

Why standards are not used ?
Regulation 765/2008 promotes a uniformly
rigorous approach to accreditation across EU
countries. The main principles of accreditation
are:
• one accreditation body per EU country (it is
possible however to use another country’s
national accreditation body);
• accreditation is a public sector activity and a
not-for-profit activity;
• there is no competition between national
accreditation bodies;
• stakeholders are represented;
• accreditation is the preferred means of
demonstrating technical capacity of notified
bodies in the regulated area.
Nando
(New Approach Notified
and Designated
Organisations)
Information System

CE Marking

CE Marking
What does the CE marking on a product indicate?
By affixing the CE marking to a product, the manufacturer declares on his sole
responsibility that the product is in conformity with the essential requirements of
the applicable Union harmonisation legislation providing for its affixing and that
the relevant conformity assessment procedures have been fulfilled. Products
bearing the CE marking are presumed to be in compliance with the applicable
Union harmonisation legislation and hence benefit from free circulation in the
European Market.
What is a manufacturer’s Declaration of Conformity?
The EU Declaration of Conformity (EU DoC) is a document in which the
manufacturer, or his authorised representative within the European Economic
Area (EEA), indicates that the product meets all the necessary requirements of
the Union harmonisation legislation applicable to the specific product. The EU
DoC must be signed by an individual working for the manufacturer or his
authorised representative, and the employee’s function shall also be indicated.
Whether a Notified Body has been involved or not, the manufacturer must draw
up and sign the EE Declaration of Conformity.

CE marking
• Legal tool
• Mainly based on new legislative
framework directives
• Fulfilment of essential requirements
• Presumption of conformity if
compliance to harmonised standards
• Application of conformity
assessment procedures
• Asserted by technical
documentation & UE declaration of
conformity.
WORKSHOP NUOVE DIRETTIVE LVD - EMC - RED - ATEX01.04.201624

New Legal Framework - CE marking

Recomendados

Recomendados

Mais conteúdo relacionado

Mais procurados

Mais procurados (10)

Destaque

Destaque (12)

Semelhante a New Legal Framework - CE marking

Semelhante a New Legal Framework - CE marking (20)

Mais de Nemko Italy

Mais de Nemko Italy (20)

Último

Último (20)

New Legal Framework - CE marking