The Egyptian Center for Studies of Export & Import ‫"!

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The Single European Market

Europe is a prize market, easier to access than ever before. Too many exporters,
especially small and medium sized enterprises, avoid it because the technical
requirements for entry seem too complicated, too difficult, or too expensive. The
manufacturers who have successfully accessed the European market know that the
time to understand the European system is well worth the effort.

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COUNCIL DIRECTIVE 93/68/EEC of 22 July 1993 about CE Mark

The CE Mark System

CE marking participating countries

CE Marking Directives Covered

Testing/Certifying Labs

Technical File Procedures

Declaration of Conformity (Supplier's declarations EC)

The CE Marking affixed

The European Union standard for accreditation developed
• European Committee for Standardization (CEN)
• European Committee for Electrotechnical Standardization (CENELEC)
• European Telecommunications Standards Institute (ETSI)

European Standards Institutions

• British Standards Institution (BSI)
• Deutsches Institut fur Normung (DIN)
• Association Francaise de Normalisation (AFNOR)
• Denmark - Dansk Standard (DS)
• Ente Nazionale Italiano di Unificazione (UNI)

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In Ar<cle (1) this directives was amended the following council
Directives:
1 87/404/EEC of 25 June 1987 Simple pressure vessels
2 88/378/EEC of 3 May 1988 Safety of toys
3 89/106/EEC of 21 December 1988 Construction products
4 89/336/EEC of 3 May 1989 Electromagnetic compatibility
5 89/392/EEC of 14 June 1989 Machinery
6 89/686/EEC of 21 December 1989 Personal protective equipment
7 90/384/EEC of 20 June 1990 Non-automatic weighing instruments
8 90/385/EEC of 20 June 1990 Active implantable medical devices
9 90/396/EEC of 29 June 1990 Appliances burning gaseous fuels
10 91/263/EEC of 29 April 1991 Telecommunications terminal equipment,
including the mutual recognition of their
conformity
11 92/42/EEC of 21 May 1992 Efficiency requirements for new hot-water
boilers fired with liquid or gaseous fuels
12 73/23/EEC of 19 February 1973 Eectrical equipment designed for use within
certain voltage limits

From Ar<cle 2 to Ar<cle 13:

Detailed amendments were given, throughout from Ar<cle 2 to Ar<cle 13, to the 12
Council Direc<ves listed in Ar<cle 1. Amendments varied from Direc<ve to Direc<ve.
But, in general, we can find more important amendments:

1. The Term EC Mark was replaced by CE marking

2. EC verification is the procedure whereby a manufacturer or his authorized
representative established within the Community ensures and declares that
the products are in conformity to the type described in the EC type-
examination certificate or with the design and manufacturing schedule
referred to in Annex II sec<on 3 having received a cer<ficate of adequacy.

3. CE Marking and Inscriptions :

a- The CE Conformity marking shall consist of the initials CE in the following
form:

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• If the CE marking is reduced or enlarged the proportions given in the

above graduated drawing must be respected.
• The Various components of the CE marking must have substantially
the same dimension, which may not be less than 5mm.

b- Inscriptions

4. CE Conformity marking and information

5. Administrative Provisions:
• On request, each notified body shall make available to the other
notified bodies and the competent authority, all relevant information
on EC type-examination certificates and addends issued, refused or
withdrawn.
• The manufacturer or his authorized representative shall keep with the
technical documentation a copy of the Ec type-examination certificate
and the supplements to them for a period of at least five years from
the manufacture of the last appliance .
6- Verification by checking and testing of each appliance.
7- Statistical Verification
8- EC unit Verification
9- CE conformity marking and additional specific markings
10- EC DECLARATION OF CONFORMITY TO TYPE (guarantee of production quality)

10- EC declaration of Conformity

11- Internal production control

From Article 14 to Article 15

Ar<cle 14
1. Member States shall adopt and publish the laws, regulations and administrative
provisions
necessary to comply with this Direc<ve by 1 July 1994.
They shall apply these provisions from 1 January 1995.
2. Un<l 1 January 1997 Member States shall allow the placing on the market and the
bringing into service of products which comply with the marking arrangements in
force before 1 January 1995.
3- Member States shall Communicate to the Commission the Texts of the Provisions of
national law which they adopt in the field covered by this directive.
the commission shall inform the other member states thereof.
Ar<cle 15
This Directive is addressed to the member States
Done at Brussels, 22 July 1993.
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The CE Mark History

1. Since the signing of the Treaty of Rome in 1957, the European community has
continued to pursue the plans for economic development laid out in that document.

• In The Treaty of Rome, ar<cle 8a

"The community shall adopt measures with the aim of progressively

establishing the internal market ... The internal market shall comprise an area
without internal frontiers in which the free movement of goods, persons,
services and capital is ensured"

2. 1975 The European Court of Jus<ce via "the rule of reason" permits European Union
(then called European Community) members to set national rules so long as trade
between member states is not restricted. However, product restrictions were
permitted for health, safety or environmental reasons.
3. 1979 The European Court of Jus<ce upholds "mutual recognition" permitting
products manufactured (or imported) by a member state which do not present a
health, safety or environmental threat, to travel freely among other states.
4. 198٦ The European Council requests the European Commission to propose revised
legislation for health, safety and environmental product restrictions.
The European Council approves "New Approach" legislation, eliminating national
regulations that restrict trade and establishing community-wide standards, testing
and certification procedures.
5. 1992 The Vice President of the Commission of Brussels along with ministers from the
EU and the EFTA sign an agreement organizing the free movement of goods, persons,
services and capital within the European Economic Area (EEA).

CE Mark (Definitions)

1. The CE marking is a symbol that indicates that a particular product complies with
European product safety, health and environmental requirements. The CE marking
system promotes free trade with Europe by providing a single set of safety and
environmental requirements a product must meet. Products complying with CE
marking are currently accepted in 32 European countries. This is a market of 400
million people with a GNP over $8 trillion. CE marking is accelera<ng as the “globally
accepted system” for ensuring product safety and environmental requirements.
Possible extensions to other areas of the world are being negotiated at this time.

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2. CE marking is a declaration by the manufacturer that the product meets all the
appropriate provisions of the relevant legislation implementing certain European
Directives.
3. CE marking gives companies easier access into the European market to sell their
products without adaptation or rechecking

4. The Implementation of Directives Based on the New Approach

5. Before you Export to EU You Must establish first which, if any, of the New Approach
Directives or older Global Approach Directives applies to your product.
Because CE marking only applies to products within the scope of these Directives.
It should not be applied to products if they are outside the scope of the Directives.
6. The European Commission refers to the CE Marking of products as a "passport" which
can allow a manufacturer to freely circulate their products within the European
marketplace.

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The Market Access Requirements, which are demanded by either EU governments or
private sector parties, are based on:

1. consumer health,
2. product safety,
3. environmental,
4. Social and quality concerns.

Procedures for CE Marking

Before CE marking can be affixed to the product, the manufacturer must follow
certain procedures which may differ for each directive and each product.
A manufacturer must :
1) Identify which New Approach directives apply to the product;
2) prepare the Declaration of Conformity,
3) draw up the Technical Construc<on File (TCF)7
4) compile the CE User Manual.

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i) European Union Countries:

Austria Ireland Cyprus Slovenia Belgium

Italy Czech Republic Denmark Luxembourg Hungary

Finland Netherlands Latvia France Portugal

Lithuania Germany Spain Estonia Greece

Sweden Malta U.K. Poland Slovakia

Bulgaria Romania

ii) EFTA COUNTRIES

Iceland Liechtenstein Norway Switzerland

iii) A candidate for accession

Turkey

CE Marking Directives Covered

The Directives(New Approach)

1. In the period up to 1992, and subsequently, the European Parliament has enacted a
series of measures intended to put the Single Market into practice. Some of these
Directives have been aimed at removing barriers of a purely customs/excise nature,
others have concentrated on transport arrangements to ensure the free movement of
goods, while a series of Directives (produced under the heading of `New Approach
Directives') are intended to provide controls on product design, with the principal
objective being to provide a `level playing field' for product safety requirements
across the European Community.

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2. The directives cover a very wide range of product areas. One of the first to be
implemented concerned the safety of children's toys. Subsequent directives have
included provisions for machinery, electromagnetic compatibility (EMC), personal
protective equipment, medical devices, gas appliances and commercial explosives,
among others. Also relevant is the Low Voltage Directive. Strictly speaking the LVD,
which was first enacted in 1973, pre-dates the New Approach directives, but
subsequent amendments have given it a very similar function and legal structure, and
the amendment which introduced the requirement to CE mark products recognised
that the LVD should broadly be treated as if it were a New Approach directive

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The General Product Safety Directive (GPSD) covers all products not specifically
covered by CE marking directives but which do require some level of safety regulation.
These products may also be regulated at the national level by member states.
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The Directives Lists of references of harmonized standards and general

information
2006/95/EC Low Voltage
Ar<cle 1
For the purposes of this Directive, "electrical equipment" means any
equipment designed for use with a voltage ra<ng of between 50 and 1000
V for alterna<ng current and between 75 and 1500 V for direct current,
other than the equipment and phenomena listed in Annex II.
Ar<cle 2
1. The Member States shall take all appropriate measures to ensure that
electrical equipment may be placed on the market only if, having been
constructed in accordance with good engineering practice in safety
matters in force in the Community, it does not endanger the safety of
persons, domestic animals or property when properly installed and
maintained and used in applications for which it was made…
Ar<cle 4
In relation to electrical equipment, the Member States shall ensure that
stricter safety requirements than those laid down in Ar<cle 2 are not
imposed by electricity supply bodies for connection to the grid, or for the
supply of electricity to users of electrical equipment.
Ar<cle 12
This Directive shall not apply to electrical equipment intended for export
to third countries.
Ar<cle 15
This Directive shall enter into force on the twentieth day following that of
its publication in the Official Journal of the European Union.
Ar<cle 16

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This Directive is addressed to the Member States.

Done at Strasbourg, 12 December 2006.

87/404/EEC Simple Pressure Vessels

90/488/EEC Ar<cle 1
93/68/EEC
1.This Directive applies to simple pressure vessels manufactured in
series.
2. For the purposes of this Direc<ve, ‘simple pressure vessel’ means any welded
vessel subjected to an internal gauge pressure greater than 0,5 bar which is
intended to contain air or nitrogen and which is not intended to be fired.
Moreover,
— The parts and assemblies contributing to the strength of the vessel under
pressure shall be made either of non-alloy quality steel or of non-alloy
aluminium or non-age hardening aluminium alloys,
— The vessel shall be made of:
— Either a cylindrical part of circular cross-section closed by outwardly
dished and/or flat ends which revolve around the same axis as the
cylindrical part,
— or two dished ends revolving around the same axis,
— The maximum working pressure of the vessel shall not exceed 30 bar
and the product of that pressure and the capacity of the vessel (PS.V) shall not
exceed 10 000 bar/liter,
— The minimum working temperature must be no lower than − 50 ‫؛‬C
and the maximum working temperature shall not be higher than 300 ‫؛‬C for
steel and 100 ‫؛‬C for aluminums or aluminum alloy vessels.
3. The following vessels shall be excluded from the scope of the Directive:
— Vessels specifically designed for nuclear use, failure of which may cause
an emission of radioactivity,
— Vessels specifically intended for installation in or the propulsion of ships
and aircraft,
— fire extinguishers.

Safety of toys
88/378/EEC
93/68/EEC Ar<cle 1
1. This Direc*ve shall apply to toys. A ‘toy' shall mean any product or
material designed or clearly intended for use in play by children of
less than 14 years of age.
2. The products listed in Annex I shall not be regarded as toys for the
purposes of this Directive.
Ar<cle 3
Member States shall take all steps necessary to ensure that toys cannot
be placed on the market unless they meet the essential safety
requirements set out in Annex II.

ANNEX I

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PRODUCTS NOT REGARDED AS TOYS FOR THE PURPOSE OF THIS DIRECTIVE

1.Christmas decorations
2. Detailed scale models for adult collectors
3. Equipment intended to be used collec<vely in playgrounds
4. Sports equipment
5. Aquatic equipment intended to be used in deep water
6. Folk dolls and decora<ve dolls and other similar ar<cles for adult collectors
7. ‘Professional' toys installed in public places (shopping centres, sta<ons, etc.)
8. Puzzles with more than 500 pieces or without picture, intended for specialists
9. Air guns and air pistols
10. Fireworks, including percussion caps (1)
11. Slings and catapults
12. Sets of darts with metallic points
13. Electric ovens, irons or other func<onal products operated at a nominal
voltage exceeding 24 volts
14. Products containing hea<ng elements intended for use under the supervision
of an adult in a teaching context
15. Vehicles with combus<on engines
16. Toy steam engines
17. Bicycles designed for sport or for travel on the public highway
18. Video toys that can be connected to a video screen, operated at a nominal
voltage exceeding 24 volts
19. Babies’ dummies
20. Faithful reproduc<ons of real fire arms
21. Fashion jewellery for children

89/106/EEC Construction products

93/68/EEC (Safety and performance of building products including requirements for
Regulation (EC) mechanical stability, fire resistance, hygiene, noise and energy efficiency.)
No 1882/2003 Ar<cle 1
1. This Direc<ve shall apply to construc<on products in so far as the
essen<al requirements in respect of construc<on works under Ar<cle 3
(1) relate to them.
2. For the purposes of this Direc<ve, ‘construction product’ means :
Any product which is produced for incorporation in a permanent manner in
construction works, including both buildings and civil engineering works.

‘Construction Products’ are hereinafter referred to as ‘products’;

Construction works including both buildings and civil engineering
works are hereinafter referred to as ‘works’.

ANNEX I
ESSENTIAL REQUIREMENTS
The products must be suitable for construction works which (as a whole and in
their separate parts) are fit for their intended use, account being taken of
economy, and in this connection satisfy the following essential requirements
where the works are subject to regulations containing such requirements. Such
requirements must, subject to normal maintenance, be satisfied for an
economically reasonable working life.
The requirements generally concern actions which are forseeable.
1. Mechanical resistance and stability

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The construction works must be designed and built in such a way that the
loadings that are liable to act on it during its constructions and use will not
lead to any of the following:
(a) collapse of the whole or part of the work;
(b) major deformations to an inadmissible degree;
(c) damage to other parts of the works or to fittings or installed equipment as
a result of major deformation of the load- bearing construction;
(d) damage by an event to an extent disproportionate to the original cause.
2. Safety in case of fire
The construction works must be designed and built in such a way that in the
event of an outbreak of fire:
— the load-bearing capacity of the construction can be assumed for a
specific period of time,
— the generation and spread of fire and smoke within the works are limited,
— the spread of the fire to neighbouring construction works is limited,
— occupants can leave the works or be rescued by other means,
— the safety of rescue teams is taken into consideration.
3. Hygiene, health and the environment
The construction work must be designed and built in such a way that it will
not be a threat to the hygiene or health of the occupants or neighbours, in
particular as a result of any of the following:
— the giving-off of toxic gas,
— the presence of dangerous particles or gases in the air,
— the emission of dangerous radiation,
— pollution or poisoning of the water or soil,
— faulty elimination of waste water, smoke, solid or liquid wastes,
— the presence of damp in parts of the works or on surfaces within the works.
4. Safety in use
The construction work must be designed and built in such a way that it does
not present unacceptable risks of accidents in service or in operation suchas
slipping, falling, collision, burns, electrocution, injury from explosion.
5. Protection against noise
The construction works must be designed and built in such a way that noise
perceived by the occupants or people nearby is kept down to a level that will
not threaten their health and will allow them to sleep, rest and work in
satisfactory conditions.
6. Energy economy and heat retention
The construction works and its heating, cooling and ventilation installations
must be designed and built in such a way that the amount of energy required
in use shall be low, having regard to the climatic conditions of the location
and the occupants.

89/336/EEC Electromagnetic compatibility (EMC)

92/31/EC
93/68/EEC (Noise immunity and emissions performance of electrical equipment.)
2004/108/EC Ar<cle 1
For the purposes of this Directive:
1. ‘Apparatus' means all electrical and electronic appliances together with
equipment and installations containing electrical and/or electronic
components.
2. ‘Electromagnetic disturbance' means any electromagnetic phenomenon
which may degrade the performance of a device, unit of equipment or system.

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An electromagnetic disturbance may be electromagnetic noise, an unwanted

signal or a change in the propagation medium itself.
3. ‘Immunity' means the ability of a device, unit of equipment or
system to perform without degradation of quality in the presence of an
electromagnetic disturbance.
4. ‘Electromagnetic compatibility' means the ability of a device, unit of
equipment or system to function satisfactorily in its electromagnetic
environment without introducing intolerable electromagnetic disturbances
to anything in that environment.
5. ‘competent body' means any body which meets the criteria listed in
Annex II and is recognized as such.
6. ‘EC type-examination certificate' is a document in which a notified body
referred to in Ar<cle 10 (6) cer<fies that the type of equipment examined
complies with the provisions of this Directive which concern it.

ANNEX III
Illustrative list of the principal protection requirements
The maximum electromagnetic disturbance generated by the apparatus shall be
such as not to hinder the use of in particular the following apparatus:
(a) Domestic radio and television receivers
(b) Industrial manufacturing equipment
(c) Mobile radio equipment
(d) Mobile radio and commercial radiotelephone equipment
(e) Medical and scientific apparatus
(f) Information technology equipment
(g) Domestic appliances and household electronic equipment
(h) Aeronautical and marine radio apparatus
(i) Educational electronic equipment
(j) Telecommunications networks and apparatus
(k) Radio and television broadcast transmitters
(l) Lights and fluorescent lamps.
Apparatus, and especially the apparatus referred toin (a) to(l), should be
constructed in such a way that it has an adequate level of electromagnetic
immunity in the usual electromagnetic compatibility environment where the
apparatus is intended to work so as to allow its unhindered operation taking into
account the levels of disturbance generated by apparatus complying with the
standards laid down in Ar<cle 7.
The information required to enable use in accordance with the intended purpose
of the apparatus must be contained in the instructions accompanying the
apparatus.

98/37/EC Machinery
98/79/EC (Safety of all machines with moving parts.)
2006/42/EC Ar<cle 1
Scope
1. This Direc<ve applies to the following products:
(a) machinery;
(b) interchangeable equipment;
(c) safety components;
(d) lifting accessories;
(e) chains, ropes and webbing;
(f) removable mechanical transmission devices;

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(g) partly completed machinery.

2. The following are excluded from the scope of this Direc<ve:

(a) safety components intended to be used as spare parts to replace identical
components and supplied by the manufacturer of the original machinery;
(b) specific equipment for use in fairgrounds and/or amusement parks;
(c) machinery specially designed or put into service for nuclear purposes which,
in the event of failure, may result in an emission of radioactivity;
(d) weapons, including firearms;
(e) the following means of transport:
— agricultural and forestry tractors for the risks covered by Direc<ve 003/37/EC,
with the exclusion of machinery mounted on these vehicles,
— motor vehicles and their trailers covered by Council Direc<ve 70/156/EEC of 6
February 1970 on the approximation of the laws of the Member States relating to
the type-approval of motor vehicles and their trailers (1), with the exclusion of
machinery mounted on these vehicles,
— vehicles covered by Direc<ve 2002/24/EC of the European Parliament and of
the Council of 18 March 2002 relating to the type-approval of two or three-wheel
motor vehicles (2), with the exclusion of machinery mounted on these vehicles,
— motor vehicles exclusively intended for competition, and
— means of transport by air, on water and and on rail networks with the
exclusion of machinery mounted on these means of transport;
(f) seagoing vessels and mobile offshore units and machinery installed on board
such vessels and/or units;
(g) machinery specially designed and constructed for military or police purposes;
(h) machinery specially designed and constructed for research purposes for
temporary use in laboratories;
(i) mine winding gear;
(j) machinery intended to move performers during artistic performances;

Ar<cle 13
Procedure for partly completed machinery
1. The manufacturer of partly completed machinery or his authorised
representative shall, before placing it on the market, ensure that:
(a) the relevant technical documentation described in Annex VII, part B is
prepared;
(b) assembly instructions described in Annex VI are prepared;
(c) a declaration of incorpora<on described in Annex II, part 1, Section B has been
drawn up.
2. The assembly instruc<ons and the declara<on of incorpora<on shall ccompany
the partly completed machinery until it is incorporated into the final machinery
and shall then form part of the technical file for that machinery.

89/686/EEC Personal protective equipment (PPE)

93/68/EEC (Performance of equipment designed to protect the user from injury)
93/95/EEC
96/58/EC
90/384/EEC Non-automatic weighing instruments
93/68/EEC (Performance and calibration procedures for commercial weigh-scales)

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90/385/EEC Active implantable medical devices

93/42/EEC (Active Implantable Medical Devices Directive 90/385/EEC.)
93/68/EEC
90/396/EEC Appliances burning gaseous fuels
93/68/EEC (Article 1)
1. This Directive shall apply to:
- appliances burning gaseous fuels used for cooking, heating, hot water
production, refrigeration, lighting or washing and having, where applicable, a
normal water temperature not exceeding 105 gC, hereinaTer referred to as
'appliances'. Forced draught burners and heating bodies to be equipped with
such burners will also be considered as appliances,
- safety devices, controlling devices or regulating decives and sub-assemblies,
other than forced draught burners and heating bodies to be equipped with such
burners separately marketed for trade use and designed to be incorporated into
an appliance burning gaseous fuel or assembled to constitute such an appliance,
hereinafter referred to as 'fittings'.
2. Appliances specifically designed for use in industrial processes carried out on
industrial premises are excluded from the scope defined in paragraph 1.
3. For the purposes of this Direc<ve, 'gaseous fuel' means any fuel which is in a
gaseous state at a temperature of 15 gC under a pressure of 1 bar.
4. For the purposes of this Direc<ve, an appliance is said to be 'normally used'
when it is:
- correctly installed and regularly serviced in accordance with the manufacturer's
instructions,
- used with a normal variation in the gas quality and a normal fluctuation in the
supply pressure, and
- used in accordance with its intended purpose or in a way which can be
reasonably foreseen.

92/42/EEC Efficiency requirements for new hot-water boilers fired with liquid
93/68/EEC or gaseous fuels
2004/8/EC (Requirements for testing to ensure the mutual recognition of type
2005/32/EC approval of telecoms apparatus)
93/15/EEC Explosives for civil uses
(Performance and safety of commercial explosives excluding
ammunition and pyrotechnics)
93/42/EEC
98/79/EC Medical devices
2000/70/EC (Safety of all medical equipment not covered by directives on In-Vitro
2001/104/EC fertilization or active implantable devices )

94/9/EC Equipment explosive atmospheres (ATEX)

(Safety requirements for control systems and equipment for use in
explosive atmospheres (e.g. coal mines).
94/25/EC Recreational craft
2003/44/EC (Design and construction of boats of 2.5 to 24m, plus specified
components, excluding hydrofoils and hover craft, and craft for
charter.)

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95/16/EC Lifts
(Safety of Lifts provide an essential means of comfortable and safe
access to modern buildings)
97/23/EC Pressure equipment
(Pressure equipment, accessories and assemblies with a maximum
allowable pressure greater than 0.5 bar above atmospheric pressure.)

98/79/EC In vitro diagnostic medical devices

(Design and manufacture of In-Vitro medical devices and their
accessories).
1999/5/EC Radio Equipment and Telecommunications Terminal Equipment
and the Mutual Recognition of their Conformity
(Encompasses all products using the radio frequency spectrum (e.g. car
door openers, mobile communications equipment like cellular
telephones, CB radio, broadcast transmitters, etc.) and all equipment
attached to public telecommunications networks (e.g. ADSL modems,
telephones, telephone switches).)
2000/9/EC Cableway installations designed to carry persons
(They mainly Consists of funicular railways, cable cars, gondolas, chairlifts
and drag lifts designed, manufactured, put into service and operated with
the object of carrying persons in safe conditions.)

2004/22/EC Measuring instruments

(Measuring instruments are an essential tool of Ensuring accuracy of
measurement).
Ar<cle 1
Scope
This Directive applies to the devices and systems with a measuring function
defined in the instrument-specific annexes concerning water meters (MI-001),
gas meters and volume conversion devices (MI-002), ac<ve electrical energy
meters (MI-003), heat meters (MI-004), measuring systems for continuous and
dynamic measurement of quantities of liquids other then water (MI-005),
automatic weighing instruments (MI-006), taximeters (MI-007), material
measures (MI-008), dimensional measuring instruments (MI-009) and exhaust
gas analysers (MI-010).

Article 3
Object
This Directive establishes the requirements that the devices and systems referred
to in Ar<cle 1 have to sa<sfy with a view to their being placed on the market
and/or put into use for those tasks men<oned in Ar<cle 2(1).
This Directive is a specific Directive in respect of requirements for
electromagne<c immunity in the sense of Ar<cle 2(2) of Direc<ve 89/336/EEC.
Direc<ve 89/336/EEC con<nues to
apply with regard to emission requirements.
Article 4
Definitions
For the purposes of this Directive:
(a) ‘measuring instrument’ means any device or system with a measurement

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func<on that is covered by Ar<cles 1 and 3;

(b) ‘sub-assembly’ means a hardware device, mentioned as such in the specific
annexes, that functions independently and makes up a measuring instrument
together
— with other sub-assemblies with which it is compatible,
— with a measuring instrument with which it is compatible;
(c) ‘legal metrological control’ means the control of the measurement tasks
intended for the field of application of a measuring instrument, for reasons of
public interest,public health, public safety, public order, protection of the
environment, levying of taxes and duties, protection of the consumers and fair
trading;
(d) ‘manufacturer’ means a natural or legal person responsible for the conformity
of the measuring instrument with this Directive with a view to either placing it on
the market under his own name and/or putting it into use for his own purposes;
(e) ‘placing on the market’ means making available for the first time in the
Community an instrument intended for an end user, whether for reward or free
of charge;
(f) ‘putting into use’ means the first use of an instrument intended for the end
user for the purposes for which it was intended;
(g) ‘authorised representative’ means a natural or legal person who is established
within the Community and authorized by a manufacturer, in writing, to act on his
behalf for specified tasks within the meaning of this Directive;
(h) ‘harmonised standard’ means a technical specification adopted by CEN,
CENELEC or ETSI or jointly by two or all of these organisations, at the request of
the Commission pursuant to Direc<ve 98/34/EC of the European Parliament
and of the Council of 22 June 1998 laying down a procedure for the provision of
information in the field of technical standards and regulations and of rules on
Informa<on Society services (1) and prepared in accordance with the General
Guidelines agreed between the Commission and the European standards
organisations;
(i) ‘normative document’ means a document containing technical specifications
adopted by the Organisation Internationale

Testing/Certifying Labs

Technical File Procedures

Declaration of Conformity (Supplier's declarations EC)

The CE Marking affixed

The European Union standard for accreditation developed
• European Committee for Standardization (CEN)
• European Committee for Electrotechnical Standardization (CENELEC)
• European Telecommunications Standards Institute (ETSI)

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European Standards Institutions

• British Standards Institution (BSI)
• Deutsches Institut fur Normung (DIN)
• Association Francaise de Normalisation (AFNOR)
• Denmark - Dansk Standard (DS)
• Ente Nazionale Italiano di Unificazione (UNI)

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