Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (Text with EEA relevance)
Date: 2008-07-09
Institutions: Council of the European Union, European Parliament
Subjects: EC conformity marking, market supervision, marketing, product safety

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DECISIONS ADOPTED JOINTLY BY THE EUROPEAN PARLIAMENT AND THE
COUNCIL

DECISION No 768/2008/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 9 July 2008

on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

(2)

Having regard to the Treaty establishing the European Commu-
nity, and in particular Article 95 thereof,

This Decision lays down common principles and reference
provisions intended to apply across sectoral legislation in
order to provide a coherent basis for revision or recasts of
that
legislation. This Decision therefore constitutes a
future
framework of a horizontal nature for
general
legislation harmonising the conditions for the marketing
of products and a reference text for existing legislation.

Having regard to the proposal from the Commission,

(3)

Having regard to the opinion of the European Economic and
Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251
of the Treaty (2),

Whereas:

acknowledged the

(1) On 7 May 2003 the Commission issued a Communication
to the Council and the European Parliament entitled
the New Approach
‘Enhancing the Implementation of
Directives’. In its Resolution of 10 November 2003 (3), the
Council
the New
Approach as an appropriate and efficient regulatory model
allowing technological
innovation and enhancing the
competitiveness of European industry, and confirmed the
necessity of extending the application of its principles to
new areas, while recognising the need for a clearer
framework for conformity assessment, accreditation and
market surveillance.

importance of

(1) OJ C 120, 16.5.2008, p. 1.
(2) Opinion of the European Parliament of 21 February 2008 (not yet
published in the Official Journal) and Council Decision of 23 June
2008.

(3) OJ C 282, 25.11.2003, p. 3.

for CE marking. Furthermore,

This Decision provides, in the form of reference provisions,
definitions and general obligations for economic operators
and a range of conformity assessment procedures from
which the legislator can select as appropriate. It also lays
down rules
reference
provisions are provided as regards the requirements for
to be notified to the
conformity assessment bodies
Commission as competent
the relevant
conformity assessment procedures and as regards the
notification procedures. In addition, this Decision includes
reference provisions concerning procedures for dealing
with products presenting a risk in order to ensure the safety
of the market place.

to carry out

(4) Whenever legislation is drawn up which concerns a product
already subject to other Community acts, those acts must
be taken into account to ensure the consistency of all
legislation concerning the same product.

is

that

(5) However, the specificities of sectoral needs may provide
grounds for recourse to other regulatory solutions.
In
the case where there are specific,
particular,
comprehensive legal systems already in place in a sector,
as for example in the fields of feed and food, cosmetic and
tobacco products, common market organisations
for
agricultural products, plant health and plant protection,
human blood and tissues, medicinal products for human
and veterinary use and chemicals, or where sectoral needs
require specific adaptation of the common principles and
reference provisions, as for example in the fields of medical
devices, construction products and marine equipment. Such
adaptations may also be related to the modules set out in
Annex II.

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(6) Whenever legislation is drawn up, the legislator may depart,
totally or partially,
from the common principles and
reference provisions laid down in this Decision on account
of
the sector concerned. Any such
departure should be justified.

the specificities of

(7) Although the incorporation of

this
Decision in future legislative acts cannot be required by law,
the co-legislators adopting this Decision have entered into a
clear political commitment which they should respect in
any legislative act falling within the scope of this Decision.

the provisions of

(8)

Specific product
legislation should, wherever possible,
avoid going into technical detail but should limit itself to
the expression of essential requirements. Such legislation
should, where appropriate, have recourse to harmonised
standards adopted in accordance with Directive 98/34/EC
of the European Parliament and of the Council of 22 June
the provision of
1998 laying down a procedure for
information in the field of
standards and
regulations and of rules on Information Society servi-
ces (1)
for the purpose of expressing detailed technical
specifications. This Decision builds on and complements
the standardisation system provided for by that Directive.
However, where health and safety,
the protection of
consumers or of the environment, other aspects of public
interest, or clarity and practicability so require, detailed
technical specifications may be set out in the legislation
concerned.

technical

(9)

The presumption of conformity to a legal provision
conferred by conformity to a harmonised standard should
enhance recourse to compliance with harmonised stan-
dards.

(10)

It should be possible for Member States or the Commission
to object in cases in which a harmonised standard does not
entirely satisfy the requirements of Community harmonisa-
tion legislation. The Commission should be able to decide
not
the
to publish such a standard. To that end,
Commission should,
in such manner as appropriate,
consult sectoral representatives and Member States before
the Committee set up by Article 5 of Directive 98/34/EC
delivers its opinion.

(11) The essential requirements should be worded precisely
enough to create legally binding obligations. They should
be formulated so as to make it possible to assess conformity
with them even in the absence of harmonised standards or
where the manufacturer chooses not to apply a harmonised
standard. The degree of detail of the wording will depend
on the characteristics of each sector.

(12) The successful accomplishment of the required conformity
to
assessment procedure enables economic operators

demonstrate and the competent authorities to ensure that
products made available on the market conform to the
requirements applicable.

(13) The modules for the conformity assessment procedures to
be used in the Community harmonisation legislation were
initially set out in Council Decision 93/465/EEC of 22 July
1993 concerning the modules for the various phases of the
conformity assessment procedures and the rules for the
affixing and use of the CE conformity marking, which are
intended to be used in the technical harmonisation
directives (2). This Decision replaces that Decision.

(14)

It is necessary to offer a choice of clear, transparent and
coherent conformity assessment procedures, restricting the
possible variants. This Decision provides for a menu of
modules, enabling the legislator to choose a procedure
from the least to the most stringent, in proportion to the
level of risk involved and the level of safety required.

(15) For the purposes of ensuring inter-sectoral coherence and
avoiding ad-hoc variants, it is desirable that the procedures
which are to be used in sectoral legislation be chosen from
among the modules, in accordance with the general criteria
set out.

(16)

In the past, legislation on the free movement of goods has
used a set of terms partly without defining them and
guidelines for explanation and interpretation have conse-
quently been necessary. Where legal definitions have been
introduced they differ to some extent in their wording and
sometimes in their meaning, which gives rise to difficulties
in their interpretation and correct implementation. This
Decision therefore introduces clear definitions of certain
fundamental concepts.

(17) Products that are placed on the Community market should
comply with the relevant applicable Community legislation,
and economic operators should be responsible for the
compliance of products, in relation to their respective roles
in the supply chain, so as to ensure a high level of
protection of public interests, such as health and safety, and
the protection of consumers and of the environment, and
to guarantee fair competition on the Community market.

(18) All economic operators are expected to act responsibly and
in full accordance with the legal requirements applicable
when placing or making products available on the market.

(19) All economic operators intervening in the supply and
distribution chain should take appropriate measures to
they make available on the market only
ensure that
products which are in conformity with the applicable
legislation. This Decision provides a clear and propor-
tionate distribution of obligations which correspond to the
role of each operator in the supply and distribution process.

(1) OJ L 204, 21.7.1998, p. 37. Directive as last amended by Council

Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81).

(2) OJ L 220, 30.8.1993, p. 23.

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(20) As certain tasks can be executed only by the manufacturer,
it is necessary to distinguish clearly between the manu-
facturer and operators further down the distribution chain.
It
is also necessary to distinguish clearly between the
importer and the distributor, as the importer introduces
products from third countries to the Community market.
The importer has thus to make sure that those products
comply with the applicable Community requirements.

(21) The manufacturer, having detailed knowledge of the design
and production process,
is best placed to carry out the
complete conformity assessment procedure. Conformity
assessment should therefore remain the obligation of the
manufacturer alone.

(22)

It is necessary to ensure that products from third countries
entering the Community market comply with all applicable
Community requirements, and in particular that appro-
priate assessment procedures have been carried out by
manufacturers with regard to those products. Provision
should therefore be made for importers to make sure that
the products they place on the market comply with the
applicable requirements and that they do not place on the
market products which do not
comply with such
requirements or present a risk. For the same reason,
provision should also be made for importers to make sure
that conformity assessment procedures have been carried
out and that product marking and documentation drawn
up by manufacturers are available for inspection by the
supervisory authorities.

(23) The distributor makes a product available on the market
after it has been placed on the market by the manufacturer
or the importer and must act with due care to ensure that
its handling of the product does not adversely affect the
compliance of the product. Both importers and distributors
are expected to act with due care in relation to the
requirements applicable when placing or making products
available on the market.

(24) Council Directive 85/374/EEC of 25 July 1985 on the
approximation of the laws, regulations and administrative
provisions of the Member States concerning liability for
defective products (1) applies, inter alia, to products not in
conformity with Community harmonisation legislation.
Manufacturers and importers who have placed non-
compliant products on the Community market are liable
for damages under that Directive.

for in cases where the size or nature of the product does
not allow it. This includes cases where the importer would
have to open the packaging to put his name and address on
the product.

(26) Any economic operator that either places a product on the
market under his own name or trademark or modifies a
product in such a way that compliance with applicable
requirements may be affected should be considered to be
the manufacturer and should assume the obligations of the
manufacturer.

(27) Distributors and importers, being close to the market place,
should be involved in market surveillance tasks carried out
by national authorities, and should be prepared to
participate actively, providing the competent authorities
with all necessary information relating to the product
concerned.

(28) Ensuring traceability of a product throughout the whole
supply chain helps to make market surveillance simpler and
more efficient. An efficient traceability system facilitates
market surveillance authorities' task of tracing economic
operators who made non-compliant products available on
the market.

(29) The CE marking, indicating the conformity of a product, is
the visible consequence of a whole process comprising
conformity assessment in a broad sense. General principles
governing the CE marking are set out in Regulation (EC) No
765/2008 of the European Parliament and the Council of
9 July 2008 setting out the requirements for accreditation
and market surveillance relating to the marketing of
products (2). Rules governing the affixing of
the CE
marking,
to be applied in Community harmonisation
legislation providing for the use of that marking, should be
laid down in this Decision.

(30) The CE marking should be the only marking of conformity
indicating that a product is in conformity with Community
harmonisation legislation. However, other markings may be
used as long as they contribute to the improvement of
consumer protection and are not covered by Community
harmonisation legislation.

(31)

It is crucial to make clear to both manufacturers and users
that by affixing the CE marking to a product
the
manufacturer declares that the product is in conformity
with all applicable requirements and that he takes full
responsibility therefor.

(25) When placing a product on the market, every importer
should indicate on the product his name and the address at
which he can be contacted. Exceptions should be provided

(1) OJ L 210, 7.8.1985, p. 29. Directive as amended by Directive 1999/
34/EC of the European Parliament and of the Council (OJ L 141,
4.6.1999, p. 20).

(32)

In order better to evaluate the effectiveness of the CE
marking and to define strategies aimed at preventing abuse,
the Commission should monitor its implementation and
report thereon to the European Parliament.

(2) See page 30 of this Official Journal.

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(33) The CE marking can be of value only if its affixing respects
the conditions laid down in Community law. Member
States should,
therefore, ensure proper enforcement of
those conditions and pursue violations and abuse of the CE
marking by legal or other appropriate means.

(34) Member States are responsible for ensuring strong and
efficient market surveillance on their territories and should
allocate sufficient powers and resources to their market
surveillance authorities.

(35) For the purpose of raising awareness regarding the CE
marking, the Commission should launch an information
campaign targeted primarily at
economic operators,
consumer and sectoral organisations and sales personnel,
which are the most appropriate channels for conveying
information to consumers.

(36)

In certain circumstances
conformity assessment
procedures prescribed by the applicable legislation require
the intervention of conformity assessment bodies, which
are notified by the Member States to the Commission.

the

(37) Experience has shown that the criteria set out in sectoral
legislation which conformity assessment bodies have to
fulfil to be notified to the Commission are not sufficient to
ensure a uniformly high level of performance of notified
bodies throughout the Community. It is, however, essential
that all notified bodies perform their functions to the same
fair competition. That
level and under conditions of
requires
for
conformity assessment bodies wishing to be notified in
order to provide conformity assessment services.

setting of obligatory requirements

the

(38)

In order to ensure a consistent level of quality in the
performance of conformity assessment it is necessary not
only to consolidate the requirements that conformity
assessment bodies wishing to be notified must fulfil, but
also,
that notifying
authorities and other bodies involved in the assessment,
notification and monitoring of notified bodies must fulfil.

requirements

in parallel,

to set

(39) The system set out in this Decision is complemented by the
accreditation system provided for in Regulation (EC) No
765/2008. Since accreditation is an essential means of
verifying the competence of conformity assessment bodies,
its use should also be encouraged for the purposes of
notification.

(41) Where Community harmonisation legislation provides for
the selection of conformity assessment bodies for
its
implementation, transparent accreditation as provided for
in Regulation (EC) No 765/2008, ensuring the necessary
level of confidence in conformity certificates, should be
considered by the national public authorities throughout
the Community the preferred means of demonstrating the
technical competence of those bodies. However, national
authorities may consider that they possess the appropriate
means of carrying out this evaluation themselves. In such
cases, in order to ensure the appropriate level of credibility
of evaluations carried out by other national authorities,
they should provide the Commission and the other Member
States with the necessary documentary evidence demon-
the conformity assessment
strating the compliance of
bodies evaluated with the relevant regulatory requirements.

(42) Conformity assessment bodies frequently subcontract parts
of their activities linked to the assessment of conformity or
have recourse to a subsidiary. In order to safeguard the level
of protection required for the products to be placed on the
Community market, it is essential that conformity assess-
ment
the same
requirements
in relation to the
performance of conformity assessment tasks. Therefore, it
is important that the assessment of the competence and the
performance of bodies to be notified and the monitoring of
bodies already notified cover also activities carried out by
subcontractors and subsidiaries.

subcontractors and subsidiaries

as notified bodies

fulfil

(43)

It is necessary to increase the efficiency and transparency of
the notification procedure and, in particular, to adapt it to
new technologies so as to enable online notification.

(44) Since notified bodies may offer their services throughout
the Community, it is appropriate to give the other Member
States and the Commission the opportunity to raise
objections concerning a notified body.
is therefore
important to provide for a period during which any doubts
or concerns as to the competence of conformity assessment
bodies can be clarified before they start operating as
notified bodies.

It

(45)

In the interests of competitiveness, it is crucial that notified
bodies apply the modules without creating unnecessary
burdens for economic operators. For the same reason, and
to ensure equal treatment of economic operators, consis-
tency in the technical application of the modules must be
ensured. That can best be achieved through appropriate
coordination and cooperation between notified bodies.

(40)

If a conformity assessment body demonstrates conformity
with the criteria laid down in harmonised standards,
it
should be presumed to comply with the corresponding
requirements set out in the relevant sectoral legislation.

(46) To ensure the proper functioning of

the certification
process, certain procedures, such as exchanges of experi-
ence
and
and information between notified bodies
notifying authorities and between notified bodies, should
be consolidated.

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(47) Community harmonisation legislation already provides for
a safeguard procedure which applies only in the event of
disagreement between Member States over measures taken
by a Member State. In order to increase transparency and to
reduce processing time,
it is necessary to improve the
existing safeguard clause procedure, with a view to making
it more efficient and drawing on the expertise available in
Member States.

(48) The

existing system should be

supplemented by a
procedure under which interested parties are informed of
measures intended to be taken with regard to products
presenting a risk to the health and safety of persons or to
other aspects of public interest protection. It should also
allow market surveillance authorities, in cooperation with
the relevant economic operators, to act at an earlier stage in
respect of such products.

(49) Where the Member States and the Commission agree as to
the justification of a measure taken by a Member State, no
further involvement of the Commission should be required,
except where non-compliance can be attributed to short-
comings of a harmonised standard.

situation for

the national market

in setting the rules

(50) Community legislation should take account of the specific
situation of small and medium-sized enterprises as regards
administrative burdens. However, rather than providing for
general exceptions and derogations for such enterprises,
which might imply that they or their products are second-
rate or sub-quality and which might result in a complex
legal
surveillance
authorities to supervise, Community legislation should
provide for the situation of such enterprises to be taken into
account
the selection and
implementation of
the most appropriate conformity
assessment procedures and concerning the obligations
placed on conformity assessment bodies to operate in a
proportionate manner in relation to the size of under-
takings and to the small serial or non-serial nature of the
production concerned. This Decision provides the legislator
with the flexibility necessary to take account of such a
and
situation, without
inappropriate
and medium-sized
enterprises, and without compromising the protection of
public interests.

creating unnecessary specific

solutions

small

for

for

(51) This Decision establishes provisions for conformity assess-
ment bodies to perform their functions, while taking into
consideration the specific situation of small and medium-
sized enterprises and respecting the degree of rigour and
level of protection required for products to comply with the
legislative instruments applicable to them.

Journal of

(52) Within one year of the publication of this Decision in the
Official
the Commission
the European Union,
should present an in-depth analysis in the field of consumer
if
safety markings,
necessary,

followed by legislative proposals

HAVE DECIDED AS FOLLOWS:

Article 1

General principles

Products placed on the Community market shall comply

1.
with all applicable legislation.

2. When placing products on the Community market,
economic operators shall, in relation to their respective roles
in the supply chain, be responsible for the compliance of their
products with all applicable legislation.

3.
Economic operators shall be responsible for ensuring that all
information they provide with regard to their products is
accurate, complete and in compliance with Community rules
applicable.

Article 2

Subject matter and scope

This Decision sets out
the common framework of general
principles and reference provisions for
the drawing up of
the
Community legislation harmonising the conditions for
marketing of products (Community harmonisation legislation).

Community harmonisation legislation shall have recourse to the
general principles set out in this Decision and to the relevant
reference provisions of Annexes
II and III. However,
Community legislation may depart from those general principles
and reference provisions if that is appropriate on account of the
specificities of the sector concerned, especially if comprehensive
legal systems are already in place.

I,

Article 3

Level of protection of public interests

1. As regards the protection of public interests, Community
harmonisation legislation shall restrict itself to setting out the
essential requirements determining the level of such protection
and shall express those requirements in terms of the results to be
achieved.

Where recourse to essential requirements is not possible or not
appropriate, in view of the objective of ensuring the adequate
protection of consumers, public health and the environment or
other aspects of public interest protection, detailed specifications
may be set out in the Community harmonisation legislation
concerned.

2. Where Community harmonisation legislation sets out
essential requirements, it shall provide for recourse to be had
to harmonised standards, adopted in accordance with Directive
98/34/EC, which shall express those requirements in technical
terms and which shall, alone or in conjunction with other
harmonised standards, provide for the presumption of conform-
ity with those requirements, while maintaining the possibility of
setting the level of protection by other means.

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Article 4

Conformity assessment procedures

appropriate requirements will be carried out, by examina-
tion and testing of every product, or by examination and
testing of the products on a statistical basis;

1. Where Community harmonisation legislation requires
conformity assessment to be performed in respect of a particular
product, the procedures which are to be used shall be chosen
from among the modules set out and specified in Annex II, in
accordance with the following criteria:

(e)

(f)

(a) whether the module concerned is appropriate to the type of

product;

(b)

the nature of the risks entailed by the product and the
extent to which conformity assessment corresponds to the
type and degree of risk;

(c) where third party involvement is mandatory, the need for
the manufacturer
to have a choice between quality
assurance and product certification modules set out in
Annex II;

(d)

the need to avoid imposing modules which would be too
burdensome in relation to the risks covered by the
legislation concerned.

2. Where a product is subject to several Community acts
within the scope of this Decision, consistency among conformity
assessment procedures shall be ensured by the legislator.

3. The modules referred to in paragraph 1 shall be applied as
appropriate to the product concerned and in accordance with the
instructions set out in those modules.

4.
For custom-made products and small series production, the
technical and administrative conditions relating to conformity
assessment procedures shall be alleviated.

5. When applying the modules referred to in paragraph 1, and
wherever applicable and relevant, the legislative instrument may:

(a)

(b)

(c)

regarding technical documentation, require information
additional
to that which is already stipulated in the
modules;

regarding the time for which the manufacturer and/or
notified body are obliged to keep any kind of documenta-
tion, alter the period stipulated in the modules;

specify the manufacturer's choice as to whether the tests are
carried out either by an accredited in-house body or under
the responsibility of a notified body chosen by the
manufacturer;

provide for the EC-type examination certificate to have a
period of validity;

regarding the EC-type examination certificate,
specify
information relating to conformity assessment
relevant
and in-service control to be included in it or its annexes;

(g)

provide for different arrangements regarding the obligations
of the notified body to inform its notifying authorities;

(h)

if the notified body carries out periodic audits, specify their
frequency.

6. When applying the modules referred to in paragraph 1, and
wherever applicable and relevant, the legislative instrument shall:

(a) where product checks and/or verification are performed,
determine the products concerned, the appropriate tests,
the adequate sampling schemes, the operational character-
istics of
the statistical method to be applied and the
corresponding action to be taken by the notified body and/
or the manufacturer;

(b) where EC-type examination is performed, determine the
appropriate manner (design type, production type, design
and production type) and the specimens required.

7. An appeal procedure against decisions of the notified body
shall be available.

Article 5

EC declaration of conformity

Where Community harmonisation legislation requires a state-
ment by the manufacturer that fulfilment of the requirements
relating to a product has been demonstrated (EC declaration of
conformity), the legislation shall provide that a single declaration
shall be drawn up in respect of all Community acts applicable to
the product containing all
the
identification of Community harmonisation legislation to which
the declaration relates, and giving the publication references of
the acts concerned.

information required for

Article 6

Conformity assessment

(d) where product verification is performed,

specify the
manufacturer's choice as to whether the examinations and
tests to check the conformity of the products with the

1. Where Community harmonisation legislation requires
conformity assessment, it may provide for that assessment to
be carried out by public authorities, manufacturers or notified
bodies.

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2. Where Community harmonisation legislation provides for
conformity assessment to be carried out by public authorities,
the legislation shall provide that the conformity assessment
bodies on which those authorities rely for technical assessments
must comply with the same criteria as those set out in this
Decision for notified bodies.

Article 7

Reference provisions

The reference provisions for Community harmonisation legisla-
tion for products shall be as set out in Annex I.

Article 8

Repeal

Decision 93/465/EEC is hereby repealed.

References to the repealed Decision shall be construed as
references to this Decision.

Done at Strasbourg, 9 July 2008.

For the European Parliament

For the Council

The President

H.-G. PÖTTERING

The President

J.P. JOUYET

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REFERENCE PROVISIONS FOR COMMUNITY HARMONISATION LEGISLATION FOR PRODUCTS

ANNEX I

Chapter R1

D e f i n i t i o n s

Article R1

Definitions

13.

‘conformity assessment body’ shall mean a body that performs
conformity assessment activities including calibration,
testing,
certification and inspection;

14.

‘recall’ shall mean any measure aimed at achieving the return of a
product that has already been made available to the end user;

For the purposes of this ... [act] the following definitions shall apply:

15.

‘withdrawal’ shall mean any measure aimed at preventing a product
in the supply chain from being made available on the market;

‘making available on the market’ shall mean any supply of a
product for distribution, consumption or use on the Community
market in the course of a commercial activity, whether in return for
payment or free of charge;

16.

‘CE marking’ shall mean a marking by which the manufacturer
indicates that the product is in conformity with the applicable
requirements set out in Community harmonisation legislation
providing for its affixing;

1.

2.

3.

4.

5.

6.

7.

8.

9.

‘placing on the market’ shall mean the first making available of a
product on the Community market;

‘manufacturer’ shall mean any natural or
legal person who
manufactures a product or has a product designed or manufac-
tured, and markets that product under his name or trademark;

‘authorised representative’ shall mean any natural or legal person
established within the Community who has received a written
mandate from a manufacturer to act on his behalf in relation to
specified tasks;

‘importer’ shall mean any natural or legal person established within
the Community who places a product from a third country on the
Community market;

‘distributor’ shall mean any natural or legal person in the supply
chain, other than the manufacturer or the importer, who makes a
product available on the market;

‘economic operators’ shall mean the manufacturer, the authorised
representative, the importer and the distributor;

‘technical specification’ shall mean a document that prescribes
technical requirements to be fulfilled by a product, process or
service;

‘harmonised standard’ shall mean a standard adopted by one of the
European standardisation bodies listed in Annex I to Directive 98/
34/EC on the basis of a request made by the Commission in
accordance with Article 6 of that Directive;

10.

‘accreditation’ shall have the meaning assigned to it by Regulation
(EC) No 765/2008;

11.

‘national accreditation body’ shall have the meaning assigned to it
by Regulation (EC) No 765/2008;

12.

‘conformity assessment’ shall mean the process demonstrating
whether specified requirements relating to a product, process,
service, system, person or body have been fulfilled;

17.

‘Community harmonisation legislation’ shall mean any Commu-
nity legislation harmonising the conditions for the marketing of
products.

Chapter R2

O b l i g a t i o n s o f e c o n o m i c o p e r a t o r s

Article R2

Obligations of manufacturers

1. When placing their products on the market, manufacturers shall
ensure that they have been designed and manufactured in accordance
with the requirements set out in … [reference to the relevant part of the
legislation].

2. Manufacturers shall draw up the required technical documentation
and carry out the conformity assessment procedure applicable or have it
carried out.

Where compliance of a product with the applicable requirements has
been demonstrated by that procedure, manufacturers shall draw up an EC
declaration of conformity and affix the conformity marking.

3. Manufacturers shall keep the technical documentation and the EC
declaration of conformity for ... [period to be specified in proportion to
the lifecycle of the product and the level of risk] after the product has
been placed on the market.

4. Manufacturers shall ensure that procedures are in place for series
production to remain in conformity. Changes in product design or
characteristics and changes in the harmonised standards or in technical
specifications by reference to which conformity of a product is declared
shall be adequately taken into account.

When deemed appropriate with regard to the risks presented by a
product, manufacturers shall,
the health and safety of
consumers, carry out sample testing of marketed products, investigate,
and,
if necessary, keep a register of complaints, of non-conforming
products and product recalls, and shall keep distributors informed of any
such monitoring.

to protect

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5. Manufacturers shall ensure that their products bear a type, batch or
serial number or other element allowing their identification, or, where
the size or nature of the product does not allow it, that the required
information is provided on the packaging or
in a document
accompanying the product.

Article R4

Obligations of importers

6. Manufacturers shall indicate their name, registered trade name or
registered trade mark and the address at which they can be contacted on
the product or, where that is not possible, on its packaging or in a
document accompanying the product. The address must indicate a single
point at which the manufacturer can be contacted.

7. Manufacturers shall ensure that the product is accompanied by
instructions and safety information in a language which can be easily
understood by consumers and other end-users, as determined by the
Member State concerned.

8. Manufacturers who consider or have reason to believe that a product
which they have placed on the market is not in conformity with the
applicable Community harmonisation legislation shall immediately take
the necessary corrective measures to bring that product into conformity,
to withdraw it or recall it, if appropriate. Furthermore, where the product
presents a risk, manufacturers shall immediately inform the competent
national authorities of the Member States in which they made the
product available to that effect, giving details, in particular, of the non-
compliance and of any corrective measures taken.

9. Manufacturers shall, further to a reasoned request from a competent
national authority, provide it with all the information and documentation
necessary to demonstrate the conformity of the product, in a language
which can be easily understood by that authority. They shall cooperate
with that authority, at its request, on any action taken to eliminate the
risks posed by products which they have placed on the market.

Article R3

Authorised representatives

1. A manufacturer may, by a written mandate, appoint an authorised
representative.

The obligations laid down in Article [R2(1)] and the drawing up of
technical documentation shall not
the authorised
representative's mandate.

form part of

2. An authorised representative shall perform the tasks specified in the
mandate received from the manufacturer. The mandate shall allow the
authorised representative to do at least the following:

(a)

(b)

(c)

keep the EC declaration of conformity and the technical
documentation at the disposal of national surveillance authorities
for … [period to be specified in proportion to the lifecycle of the
product and the level of risk];

further to a reasoned request from a competent national authority,
provide that authority with all the information and documentation
necessary to demonstrate the conformity of a product;

cooperate with the competent national authorities, at their request,
on any action taken to eliminate the risks posed by products
covered by their mandate.

Importers shall place only compliant products on the Community

1.
market.

2. Before placing a product on the market importers shall ensure that
the appropriate conformity assessment procedure has been carried out
by the manufacturer. They shall ensure that the manufacturer has drawn
up the technical documentation, that the product bears the required
conformity marking or markings and is accompanied by the required
complied with the
the manufacturer has
documents, and that
requirements set out in Article [R2(5) and (6)].

Where an importer considers or has reason to believe that a product is
the
in conformity with … [reference to the relevant part of
not
legislation], he shall not place the product on the market until it has been
brought into conformity. Furthermore, where the product presents a risk,
the importer shall inform the manufacturer and the market surveillance
authorities to that effect.

Importers shall

3.
indicate their name, registered trade name or
registered trade mark and the address at which they can be contacted on
the product or, where that is not possible, on its packaging or in a
document accompanying the product.

Importers

shall ensure that

4.
is accompanied by
instructions and safety information in a language which can be easily
understood by consumers and other end-users, as determined by the
Member State concerned.

the product

Importers

5.
their
shall ensure that, while a product
responsibility, storage or transport conditions do not jeopardise its
compliance with the requirements set out in … [reference to the relevant
part of the legislation].

is under

6. When deemed appropriate with regard to the risks presented by a
product, importers shall, to protect the health and safety of consumers,
carry out sample testing of marketed products,
if
necessary, keep a register of complaints, of non-conforming products
and product recalls, and shall keep distributors informed of such
monitoring.

investigate, and,

7.
Importers who consider or have reason to believe that a product
which they have placed on the market is not in conformity with the
Community harmonisation legislation applicable shall immediately take
the corrective measures necessary to bring that product into conformity,
to withdraw it or recall it, if appropriate. Furthermore, where the product
presents a risk,
immediately inform the competent
national authorities of the Member States in which they made the
product available to that effect, giving details, in particular, of the non-
compliance and of any corrective measures taken.

importers shall

8.
Importers shall, for ... [period to be specified in proportion to the
lifecycle of the product and the level of risk], keep a copy of the EC
declaration of conformity at the disposal of the market surveillance
authorities and ensure that the technical documentation can be made
available to those authorities, upon request.

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9.
Importers shall, further to a reasoned request from a competent
national authority, provide it with all the information and documentation
necessary to demonstrate the conformity of a product in a language
which can be easily understood by that authority. They shall cooperate
with that authority, at its request, on any action taken to eliminate the
risks posed by products which they have placed on the market.

Article R7

Identification of economic operators

Economic operators shall, on request,
...
surveillance authorities,
market
proportion to the lifecycle of the product and the level of risk]:

identify the following to the
[period to be specified in

for

Article R5

Obligations of distributors

(a)

any economic operator who has supplied them with a product;

(b)

any economic operator to whom they have supplied a product.

1. When making a product available on the market distributors shall
act with due care in relation to the requirements applicable.

2. Before making a product available on the market distributors shall
verify that
the product bears the required conformity marking or
markings, that it is accompanied by the required documents and by
instructions and safety information in a language which can be easily
understood by consumers and other end-users in the Member State in
which the product is to be made available on the market, and that the
manufacturer and the importer have complied with the requirements set
out in Article [R2(5) and (6)] and Article [R4(3)].

Where a distributor considers or has reason to believe that a product is
not
the
in conformity with … [reference to the relevant part of
legislation], he shall not make the product available on the market until it
has been brought into conformity. Furthermore, where the product
presents a risk, the distributor shall
inform the manufacturer or the
importer to that effect as well as the market surveillance authorities.

is under their
3. Distributors shall ensure that, while a product
responsibility, storage or transport conditions do not jeopardise its
compliance with the requirements set out in ... [reference to the relevant
part of the legislation].

4. Distributors who consider or have reason to believe that a product
which they have made available on the market is not in conformity with
the Community harmonisation legislation applicable shall make sure that
the corrective measures necessary to bring that product into conformity,
to withdraw it or recall it, if appropriate, are taken. Furthermore, where
the product presents a risk, distributors shall immediately inform the
competent national authorities of the Member States in which they made
the product available to that effect, giving details, in particular, of the
non-compliance and of any corrective measures taken.

5. Distributors shall, further to a reasoned request from a competent
national authority, provide it with all the information and documentation
necessary to demonstrate the conformity of a product. They shall
cooperate with that authority, at its request, on any action taken to
eliminate the risks posed by products which they have made available on
the market.

Chapter R3

C o n f o r m i t y o f

t h e p r o d u c t

Article R8

Presumption of conformity

Products which are in conformity with harmonised standards or parts
thereof the references of which have been published in the Official Journal
of the European Union shall be presumed to be in conformity with the
requirements covered by those standards or parts thereof, set out in …
[reference to the relevant part of the legislation].

Article R9

Formal objection to a harmonised standard

1. When a Member State or
the Commission considers that a
harmonised standard does not entirely satisfy the requirements which
it covers and which are set out in … [reference to the relevant part of the
legislation], the Commission or the Member State concerned shall bring
the matter before the Committee set up by Article 5 of Directive 98/34/
EC, giving its arguments. The Committee shall, having consulted the
relevant European standardisation bodies, deliver its opinion without
delay.

2.
In the light of the Committee's opinion, the Commission shall decide
to publish, not to publish, to publish with restriction, to maintain, to
maintain with restriction or
to the
harmonised standard concerned in or from the Official Journal of the
European Union.

to withdraw the references

3. The Commission shall inform the European standardisation body
concerned and,
if necessary, request the revision of the harmonised
standards concerned.

Article R10

EC declaration of conformity

Article R6

1. The EC declaration of conformity shall state that the fulfilment of
requirements specified in … [reference to relevant part of the legislation]
has been demonstrated.

Cases in which obligations of manufacturers apply to importers
and distributors

An importer or distributor shall be considered a manufacturer for the
purposes of this ... [act] and he shall be subject to the obligations of the
manufacturer under Article [R2], where he places a product on the
market under his name or trademark or modifies a product already
placed on the market in such a way that compliance with the applicable
requirements may be affected.

in Annex III of Decision No 768/2008/EC of

2. The EC declaration of conformity shall have the model structure set
the European
out
Parliament and of the Council of 9 July 2008 on a common framework
for the marketing of products, shall contain the elements specified in the
relevant modules set out in Annex II of that Decision and shall be
continuously updated.
It shall be translated into the language or
languages required by the Member State in which market the product is
placed or made available.

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3. By drawing up the EC declaration of conformity, the manufacturer
shall assume responsibility for the compliance of the product.

Article R11

General principles of the CE marking

3. Where the notifying authority delegates or otherwise entrusts the
assessment, notification or monitoring referred to in paragraph 1 to a
body which is not a governmental entity, that body shall be a legal entity
and shall comply mutatis mutandis with the requirements laid down in
Article [R15(1) to (6)]. In addition it shall have arrangements to cover
liabilities arising out of its activities.

The CE marking shall be subject to the general principles set out in
Article 30 of Regulation (EC) No 765/2008.

4. The notifying authority shall take full responsibility for the tasks
performed by the body referred to in paragraph 3.

Article R12

Article R15

Rules and conditions for affixing the CE marking

Requirements relating to notifying authorities

1. The CE marking shall be affixed visibly, legibly and indelibly to the
product or to its data plate. Where that is not possible or not warranted
on account of the nature of the product,
it shall be affixed to the
packaging and to the accompanying documents, where the legislation
concerned provides for such documents.

2. The CE marking shall be affixed before the product is placed on the
market. It may be followed by a pictogram or any other mark indicating a
special risk or use.

3. The CE marking shall be followed by the identification number of
the notified body, where that body is involved in the production control
phase.

The identification number of the notified body shall be affixed by the
body itself or, under its instructions, by the manufacturer or his
authorised representative.

4. Member States shall build upon existing mechanisms to ensure
correct application of the regime governing the CE marking and take
appropriate action in the event of improper use of the marking. Member
States shall also provide for penalties for infringements, which may
include criminal sanctions for serious infringements. Those penalties
shall be proportionate to the seriousness of the offence and constitute an
effective deterrent against improper use.

1. A notifying authority shall be established in such a way that no
conflict of interest with conformity assessment bodies occurs.

2. A notifying authority shall be organised and operated so as to
safeguard the objectivity and impartiality of its activities.

3. A notifying authority shall be organised in such a way that each
decision relating to notification of a conformity assessment body is taken
by competent persons different
the
assessment.

from those who carried out

4. A notifying authority shall not offer or provide any activities that
conformity assessment bodies perform or consultancy services on a
commercial or competitive basis.

5. A notifying authority shall safeguard the confidentiality of
information it obtains.

the

6. A notifying authority shall have a sufficient number of competent
personnel at its disposal for the proper performance of its tasks.

Article R16

Information obligation on notifying authorities

Chapter R4

N o t i f i c a t i o n o f c o n f o r m i t y a s s e s s m e n t b o d i e s

Member States shall inform the Commission of their procedures for the
assessment and notification of conformity assessment bodies and the
monitoring of notified bodies, and of any changes thereto.

Article R13

Notification

The Commission shall make that information publicly available.

Member States shall notify the Commission and the other Member States
of bodies authorised to carry out third-party conformity assessment tasks
under this ... [act].

Article R17

Requirements relating to notified bodies

Article R14

Notifying authorities

1. Member States shall designate a notifying authority that shall be
responsible for setting up and carrying out the necessary procedures for
the assessment and notification of conformity assessment bodies and the
monitoring of notified bodies, including compliance with the provisions
of Article [R20].

For the purposes of notification, a conformity assessment body shall

1.
meet the requirements laid down in paragraphs 2 to 11.

2. A conformity assessment body shall be established under national
law and have legal personality.

3. A conformity assessment body shall be a third-party body
independent of the organisation or the product it assesses.

2. Member States may decide that the assessment and monitoring
referred to in paragraph 1 shall be carried out by a national accreditation
body within the meaning of and in accordance with Regulation (EC) No
765/2008.

A body belonging to a business association or professional federation
representing undertakings
involved in the design, manufacturing,
provision, assembly, use or maintenance of products which it assesses,
may, on condition that its independence and the absence of any conflict
of interest are demonstrated, be considered such a body.

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4. A conformity assessment body, its top level management and the
personnel responsible for carrying out the conformity assessment tasks
shall not be the designer, manufacturer, supplier,
installer, purchaser,
owner, user or maintainer of the products which they assess, nor the
authorised representative of any of those parties. This shall not preclude
the use of assessed products that are necessary for the operations of the
conformity assessment body or the use of such products for personal
purposes.

its top level management and the
A conformity assessment body,
personnel responsible for carrying out the conformity assessment tasks
shall not be directly involved in the design, manufacture or construction,
the marketing, installation, use or maintenance of those products, or
represent the parties engaged in those activities. They shall not engage in
any activity that may conflict with their independence of judgement or
integrity in relation to conformity assessment activities for which they
are notified. This shall in particular apply to consultancy services.

Conformity assessment bodies shall ensure that the activities of their
subsidiaries or subcontractors do not affect the confidentiality, objectivity
or impartiality of their conformity assessment activities.

5. Conformity assessment bodies and their personnel shall carry out
the conformity assessment activities with the highest degree of
professional
integrity and the requisite technical competence in the
specific field and shall be free from all pressures and inducements,
particularly financial, which might influence their judgement or the
results of their conformity assessment activities, especially as regards
persons or groups of persons with an interest in the results of those
activities.

6. A conformity assessment body shall be capable of carrying out all
the conformity assessment tasks assigned to it by … [reference to
relevant part of the legislation] and in relation to which it has been
notified, whether
those tasks are carried out by the conformity
assessment body itself or on its behalf and under its responsibility.

At all times and for each conformity assessment procedure and each kind
or category of products in relation to which it has been notified, a
conformity assessment body shall have at its disposal the necessary:

(a)

personnel with technical knowledge and sufficient and appropriate
experience to perform the conformity assessment tasks;

(b)

(c)

descriptions of procedures in accordance with which conformity
assessment is carried out, ensuring the transparency and the ability
of reproduction of those procedures. It shall have appropriate
policies and procedures in place that distinguish between tasks it
carries out as a notified body and other activities;

procedures for the performance of activities which take due
account of the size of an undertaking, the sector in which it
operates, its structure, the degree of complexity of the product
technology in question and the mass or serial nature of
the
production process.

7. The personnel responsible for carrying out conformity assessment
activities shall have the following:

(a)

(b)

(c)

sound technical and vocational training covering all the conformity
assessment activities in relation to which the conformity assess-
ment body has been notified;

satisfactory knowledge of the requirements of the assessments they
carry out and adequate authority to carry out those assessments;

appropriate knowledge and understanding of
essential
requirements, of the applicable harmonised standards and of the
relevant provisions of Community harmonisation legislation and
of its implementing regulations;

the

(d)

the ability to draw up certificates, records and reports demonstrat-
ing that assessments have been carried out.

8. The impartiality of the conformity assessment bodies, their top level
management and of the assessment personnel shall be guaranteed.

The remuneration of
the top level management and assessment
personnel of a conformity assessment body shall not depend on the
number of assessments carried out or on the results of those assessments.

9. Conformity assessment bodies shall take out liability insurance
unless liability is assumed by the State in accordance with national law, or
the Member State itself
is directly responsible for the conformity
assessment.

10. The personnel of a conformity assessment body shall observe
professional secrecy with regard to all information obtained in carrying
out their tasks under … [reference to the relevant part of the legislation]
or any provision of national law giving effect to it, except in relation to
the competent authorities of the Member State in which its activities are
carried out. Proprietary rights shall be protected.

11. Conformity assessment bodies shall participate in, or ensure that
their assessment personnel are informed of, the relevant standardisation
activities and the activities of the notified body coordination group
established under the relevant Community harmonisation legislation and
apply as general guidance the administrative decisions and documents
produced as a result of the work of that group.

Article R18

Presumption of conformity

Where a conformity assessment body demonstrates its conformity with
the criteria laid down in the relevant harmonised standards or parts
thereof the references of which have been published in the Official Journal
the European Union it shall be presumed to comply with the
of
requirements set out
in so far as the applicable
harmonised standards cover those requirements.

in Article [R17]

Article R19

Formal objection to a harmonised standard

It shall have the means necessary to perform the technical and
administrative tasks connected with the conformity assessment activities
in an appropriate manner and shall have access to all necessary
equipment or facilities.

Where a Member State or the Commission has a formal objection to the
harmonised standards referred to in Article [R18], the provisions of
Article [R9] shall apply.

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Article R20

Subsidiaries of and subcontracting by notified bodies

1. Where a notified body subcontracts specific tasks connected with
conformity assessment or has recourse to a subsidiary, it shall ensure that
the subcontractor or the subsidiary meets the requirements set out in
Article [R17] and shall inform the notifying authority accordingly.

2. Notified bodies shall take full responsibility for the tasks performed
by subcontractors or subsidiaries wherever these are established.

3. Activities may be subcontracted or carried out by a subsidiary only
with the agreement of the client.

4. Notified bodies shall keep at the disposal of the notifying authority
the relevant documents concerning the assessment of the qualifications
of the subcontractor or the subsidiary and the work carried out by them
under … [reference to the relevant part of the legislation].

Article R21

Accredited in-house bodies

1. An accredited in-house body may be used to carry out conformity
assessment activities for the undertaking of which it forms a part for the
purpose of implementing the procedures set out in [Annex II — mod-
ules A1, A2, C1 or C2]. That body shall constitute a separate and distinct
part of
the undertaking and shall not participate in the design,
production, supply, installation, use or maintenance of the products it
assesses.

2. An accredited in-house body shall meet the following requirements:

it shall be accredited in accordance with Regulation (EC) No 765/
2008;

modules and the product or products for which that body claims to be
competent, as well as by an accreditation certificate, where one exists,
issued by a national accreditation body attesting that the conformity
assessment body fulfils the requirements laid down in Article [R17] of
this ... [act].

3. Where the conformity assessment body concerned cannot provide
an accreditation certificate, it shall provide the notifying authority with
all the documentary evidence necessary for the verification, recognition
and regular monitoring of its compliance with the requirements laid
down in Article [R17].

Article R23

Notification procedure

1. Notifying authorities may notify only conformity assessment bodies
which have satisfied the requirements laid down in Article [R17].

2. They shall notify the Commission and the other Member States
using the electronic notification tool developed and managed by the
Commission.

3. The notification shall
the conformity
assessment activities, the conformity assessment module or modules
and product or products concerned and the relevant attestation of
competence.

include full details of

4. Where a notification is not based on an accreditation certificate as
referred to in Article [R22(2)], the notifying authority shall provide the
Commission and the other Member States with documentary evidence
which attests to the conformity assessment body's competence and the
arrangements in place to ensure that that body will be monitored
regularly and will continue to satisfy the requirements laid down in
Article [R17].

the body and its personnel shall be organisationally identifiable and
have reporting methods within the undertaking of which they
form a part which ensure their impartiality and demonstrate it to
the relevant national accreditation body;

5. The body concerned may perform the activities of a notified body
only where no objections are raised by the Commission or the other
Member States within two weeks of a notification where an accreditation
certificate is used or within two months of a notification where
accreditation is not used.

neither the body nor its personnel shall be responsible for the
design, manufacture, supply, installation, operation or maintenance
of the products they assess nor shall they engage in any activity
that might conflict with their independence of
judgment or
integrity in relation to their assessment activities;

(d)

the body shall supply its services exclusively to the undertaking of
which it forms a part.

3. An accredited in-house body shall not be notified to the Member
States or the Commission, but information concerning its accreditation
shall be given by the undertaking of which it forms a part or by the
national accreditation body to the notifying authority at the request of
that authority.

Article R22

Application for notification

Only such a body shall be considered a notified body for the purposes of
this ... [act].

6. The Commission and the other Member States shall be notified of
any subsequent relevant changes to the notification.

Article R24

Identification numbers and lists of notified bodies

1. The Commission shall assign an identification number to a notified
body.

It shall assign a single such number even where the body is notified under
several Community acts.

1. A conformity assessment body shall submit an application for
notification to the notifying authority of the Member State in which it is
established.

2. The Commission shall make publicly available the list of the bodies
notified under this ... [act], including the identification numbers that have
been allocated to them and the activities for which they have been
notified.

2. That application shall be accompanied by a description of the
conformity assessment activities, the conformity assessment module or

The Commission shall ensure that that list is kept up to date.

(a)

(b)

(c)

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Article R25

Changes to notifications

1. Where a notifying authority has ascertained or has been informed
that a notified body no longer meets the requirements laid down in
Article [R17], or that it is failing to fulfil its obligations, the notifying
authority shall restrict, suspend or withdraw notification as appropriate,
depending on the seriousness of the failure to meet those requirements
or fulfil those obligations. It shall immediately inform the Commission
and the other Member States accordingly.

2.
In the event of restriction, suspension or withdrawal of notification,
or where the notified body has ceased its activity, the notifying Member
State shall take appropriate steps to ensure that the files of that body are
either processed by another notified body or kept available for the
responsible notifying and market surveillance authorities at their request.

Article R26

Challenge of the competence of notified bodies

1. The Commission shall investigate all cases where it doubts, or doubt
is brought to its attention regarding, the competence of a notified body
or the continued fulfilment by a notified body of the requirements and
responsibilities to which it is subject.

complies, it shall require the manufacturer to take appropriate corrective
measures and shall suspend or withdraw the certificate if necessary.

5. Where corrective measures are not taken or do not have the required
effect,
restrict, suspend or withdraw any
certificates, as appropriate.

the notified body shall

Article R28

Information obligation on notified bodies

1. Notified bodies shall inform the notifying authority of the following:

(a)

any refusal, restriction, suspension or withdrawal of a certificate;

(b)

(c)

(d)

any circumstances affecting the scope of and conditions for
notification;

any request for information which they have received from market
surveillance authorities regarding conformity assessment activities;

on request, conformity assessment activities performed within the
their notification and any other activity performed,
scope of
including cross-border activities and subcontracting.

2. The notifying Member State shall provide the Commission, on
request, with all information relating to the basis for the notification or
the maintenance of the competence of the body concerned.

2. Notified bodies shall provide the other bodies notified under this ...
[act] carrying out similar conformity assessment activities covering the
same products with relevant information on issues relating to negative
and, on request, positive conformity assessment results.

3. The Commission shall ensure that all sensitive information obtained
in the course of its investigations is treated confidentially.

4. Where the Commission ascertains that a notified body does not
meet or no longer meets the requirements for its notification, it shall
inform the notifying Member State accordingly and request it to take the
necessary corrective measures, including de-notification if necessary.

Article R29

Exchange of experience

The Commission shall provide for the organisation of exchange of
experience between the Member States' national authorities responsible
for notification policy.

Article R27

Article R30

Operational obligations of notified bodies

Coordination of notified bodies

1. Notified bodies
in
carry out
accordance with the conformity assessment procedures provided for in
… [the relevant part of the legislation].

conformity assessments

shall

avoiding unnecessary burdens

2. Conformity assessments shall be carried out in a proportionate
manner,
economic operators.
Conformity assessment bodies shall perform their activities taking due
account of the size of an undertaking, the sector in which it operates, its
structure, the degree of complexity of the product technology in question
and the mass or serial nature of the production process.

for

In so doing they shall nevertheless respect the degree of rigour and the
level of protection required for the compliance of the product with the
provisions of this ... [act].

3. Where a notified body finds that requirements laid down in … [the
relevant part of the legislation] or corresponding harmonised standards
or technical specifications have not been met by a manufacturer, it shall
require that manufacturer to take appropriate corrective measures and
shall not issue a conformity certificate.

4. Where, in the course of the monitoring of conformity following the
issue of a certificate, a notified body finds that a product no longer

The Commission shall ensure that appropriate coordination and
cooperation between bodies notified under … [the relevant act or other
Community legislation] are put in place and properly operated in the
form of a … [sectoral or cross sectoral] group or groups of notified
bodies.

Member States shall ensure that the bodies notified by them participate
in the work of that or those group or groups, directly or by means of
designated representatives.

Chapter R5

S a f e g u a r d p r o c e d u r e s

Article R31

Procedure for dealing with products presenting a risk at national
level

1. Where the market surveillance authorities of one Member State have
taken action pursuant to Article 20 of Regulation (EC) No 765/2008, or
where they have sufficient reason to believe that a product covered by
this ... [act] presents a risk to the health or safety of persons or to other
aspects of public interest protection covered by this ... [act], they shall

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carry out an evaluation in relation to the product concerned covering all
the requirements laid down in this ... [act]. The relevant economic
operators shall cooperate as necessary with the market surveillance
authorities.

in the event of disagreement with the notified national measure, of their
objections.

in the course of

Where,
the market surveillance
that evaluation,
authorities find that the product does not comply with the requirements
laid down in this ... [act], they shall without delay require the relevant
economic operator to take all appropriate corrective action to bring the
product into compliance with those requirements, to withdraw the
product from the market, or to recall it within a reasonable period,
commensurate with the nature of the risk, as they may prescribe.

[period to be specified] of receipt of

7. Where, within ….
the
information referred to in paragraph 4, no objection has been raised by
either a Member State or the Commission in respect of a provisional
measure taken by a Member State, that measure shall be deemed justified.

8. Member States shall ensure that appropriate restrictive measures are
taken in respect of the product concerned, such as withdrawal of the
product from their market, without delay.

The market surveillance authorities shall inform the relevant notified
body accordingly.

Article R32

Article 21 of Regulation (EC) No 765/2008 shall apply to the measures
referred to in the second subparagraph.

2. Where the market surveillance authorities consider
that non-
compliance is not restricted to their national territory, they shall inform
the Commission and the other Member States of the results of the
evaluation and of the actions which they have required the economic
operator to take.

Community safeguard procedure

1. Where, on completion of the procedure set out in Article [R31(3)
and (4)], objections are raised against a measure taken by a Member State,
or where the Commission considers a national measure to be contrary to
Community legislation, the Commission shall without delay enter into
consultation with the Member States and the relevant economic operator
or operators and shall evaluate the national measure. On the basis of the
results of that evaluation, the Commission shall decide whether the
national measure is justified or not.

3. The economic operator shall ensure that all appropriate corrective
action is taken in respect of all the products concerned that it has made
available on the market throughout the Community.

The Commission shall address its decision to all Member States and shall
immediately communicate it to them and the relevant economic operator
or operators.

4. Where the relevant economic operator does not take adequate
corrective action within the period referred to in the
second
subparagraph of paragraph 1, the market surveillance authorities shall
take all appropriate provisional measures to prohibit or restrict the
product's being made available on their national market, to withdraw the
product from that market or to recall it.

They shall inform the Commission and the other Member States, without
delay, of those measures.

5. The information referred to in paragraph 4 shall include all available
details, in particular the data necessary for the identification of the non-
compliant product, the origin of the product, the nature of the non-
compliance alleged and the risk involved, the nature and duration of the
national measures taken and the arguments put forward by the relevant
economic operator. In particular, the market surveillance authorities shall
indicate whether the non-compliance is due to either:

(a)

(b)

failure of the product to meet requirements relating to the health or
safety of persons or to other aspects of public interest protection
laid down in this ... [act]; or

shortcomings in the harmonised standards referred to in …
[reference to the relevant part of the legislation] conferring a
presumption of conformity.

2.
If the national measure is considered justified, all Member States
shall take the measures necessary to ensure that the non-compliant
inform the
product
Commission accordingly.
considered
unjustified, the Member State concerned shall withdraw the measure.

is withdrawn from their market, and shall
is

the national measure

If

the product

3. Where the national measure is considered justified and the non-
is attributed to shortcomings in the
compliance of
harmonised standards referred to in [Article R31(5)(b)], the Commission
shall inform the relevant European standardisation body or bodies and
shall bring the matter before the Committee set up by Article 5 of
Directive 98/34/EC. That Committee shall consult the relevant European
standardisation body or bodies and deliver its opinion without delay.

Article R33

Compliant products which present a risk to health and safety

1. Where, having performed an evaluation under Article [R31(1)], a
Member State finds that although a product is in compliance with this ...
[act], it presents a risk to the health or safety of persons or to other
aspects of public interest protection,
it shall require the relevant
economic operator to take all appropriate measures to ensure that the
product concerned, when placed on the market, no longer presents that
risk, to withdraw the product from the market or to recall it within a
reasonable period, commensurate with the nature of the risk, as it may
prescribe.

6. Member States other than the Member State initiating the procedure
shall without delay inform the Commission and the other Member States
information at their
of any measures adopted and of any additional
disposal relating to the non-compliance of the product concerned, and,

2. The economic operator shall ensure that corrective action is taken in
respect of all the products concerned that he has made available on the
market throughout the Community.

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3. The Member State shall immediately inform the Commission and
the other Member States. That information shall include all available
details,
in particular the data necessary for the identification of the
product concerned, the origin and the supply chain of the product, the
nature of the risk involved and the nature and duration of the national
measures taken.

4. The Commission shall without delay enter into consultation with the
Member States and the relevant economic operator or operators and shall
evaluate the national measures taken. On the basis of the results of that
evaluation, the Commission shall decide whether the measure is justified
or not, and where necessary, propose appropriate measures.

5. The Commission shall address its decision to all Member States and
shall immediately communicate it to them and the relevant economic
operator or operators.

Article R34

Formal non-compliance

(a)

the conformity marking has been affixed in violation of Arti-
cle [R11] or of Article [R12];

(b)

the conformity marking has not been affixed;

(c)

the EC declaration of conformity has not been drawn up;

(d)

the EC declaration of conformity has not been drawn up correctly;

(e)

technical documentation is either not available or not complete.

1. Without prejudice to Article [R31], where a Member State makes
one of the following findings, it shall require the relevant economic
operator to put an end to the non-compliance concerned:

2. Where the non-compliance referred to in paragraph 1 persists, the
Member State concerned shall take all appropriate measures to restrict or
prohibit the product being made available on the market or ensure that it
is recalled or withdrawn from the market.

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ANNEX II

CONFORMITY ASSESSMENT PROCEDURES

Module A

Internal production control

1.

Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations
laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the products concerned satisfy
the requirements of the legislative instrument that apply to them.

2.

Technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the
product's conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s).
The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment,
the design, manufacture and operation of the product. The technical documentation shall, wherever applicable,
contain at least the following elements:

— a general description of the product,

— conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.

— descriptions and explanations necessary for the understanding of those drawings and schemes and the operation

of the product,

— a list of the harmonised standards and/or other relevant technical specifications the references of which have
been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the essential requirements of the legislative instrument where those harmonised
standards have not been applied.
the technical
documentation shall specify the parts which have been applied,

In the event of partly applied harmonised standards,

— results of design calculations made, examinations carried out, etc., and

— test reports.

3.

Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure
compliance of the manufactured products with the technical documentation referred to in point 2 and with the
requirements of the legislative instruments that apply to them.

4.

Conformity marking and declaration of conformity

4.1. The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual

product that satisfies the applicable requirements of the legislative instrument.

4.2. The manufacturer shall draw up a written declaration of conformity for a product model and keep it together with the
technical documentation at the disposal of the national authorities for 10 years after the product has been placed on
the market. The declaration of conformity shall identify the product for which it has been drawn up.

A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

5.

Authorised representative

The manufacturer's obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and
under his responsibility, provided that they are specified in the mandate.

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Module A1

Internal production control plus supervised product testing

1.

Internal production control plus supervised product testing is the conformity assessment procedure whereby the
manufacturer fulfils the obligations laid down in points 2, 3, 4, and 5, and ensures and declares on his sole
responsibility that the products concerned satisfy the requirements of the legislative instrument that apply to them.

2.

Technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the
product's conformity with the relevant requirements, and shall include an adequate analysis and assessment of the
risk(s).

The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment,
the design, manufacture and operation of the product. The technical documentation shall contain, wherever
applicable, at least the following elements:

— a general description of the product,

— conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.

— descriptions and explanations necessary for the understanding of those drawings and schemes and the operation

of the product,

— a list of the harmonised standards and/or other relevant technical specifications the references of which have
been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the essential requirements of the legislative instrument where those harmonised
the technical
standards have not been applied.
documentation shall specify the parts which have been applied,

In the event of partly applied harmonised standards,

— results of design calculations made, examinations carried out, etc., and

— test reports.

3.

Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure
compliance of the manufactured products with the technical documentation referred to in point 2 and with the
requirements of the legislative instruments that apply to them.

4.

Product checks

For each individual product manufactured, one or more tests on one or more specific aspects of the product shall be
carried out by the manufacturer or on his behalf, in order to verify conformity with the corresponding requirements
of the legislative instrument. At the choice of the manufacturer, the tests are carried out either by an accredited in-
house body or under the responsibility of a notified body chosen by the manufacturer.

Where the tests are carried out by a notified body, the manufacturer shall, under the responsibility of the notified
body, affix the notified body's identification number during the manufacturing process.

5.

Conformity marking and declaration of conformity

5.1. The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual

product that satisfies the applicable requirements of the legislative instrument.

5.2. The manufacturer shall draw up a written declaration of conformity for a product model and keep it together with the
technical documentation at the disposal of the national authorities for 10 years after the product has been placed on
the market. The declaration of conformity shall identify the product for which it has been drawn up.

A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

6.

Authorised representative

The manufacturer's obligations set out in point 5 may be fulfilled by his authorised representative, on his behalf and
under his responsibility, provided that they are specified in the mandate.

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Module A2

Internal production control plus supervised product checks at random intervals

1.

Internal production control plus supervised product checks at random intervals is the conformity assessment
procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4, and 5, and ensures and
declares on his sole responsibility that the products concerned satisfy the requirements of the legislative instrument
that apply to them.

2.

Technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the
product's conformity with the relevant requirements, and shall include an adequate analysis and assessment of the
risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the
assessment, the design, manufacture and operation of the product. The technical documentation shall contain,
wherever applicable, at least the following elements:

— a general description of the product,

— conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.

— descriptions and explanations necessary for the understanding of those drawings and schemes and the operation

of the product,

— a list of the harmonised standards and/or other relevant technical specifications the references of which have
been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the essential requirements of the legislative instrument where those harmonised
standards have not been applied.
the technical
documentation shall specify the parts which have been applied,

In the event of partly applied harmonised standards,

— results of design calculations made, examinations carried out, etc., and

— test reports.

3.

Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure
compliance of the manufactured products with the technical documentation referred to in point 2 and with the
requirements of the legislative instruments that apply to them.

4.

Product checks

At the choice of the manufacturer, either an accredited in-house body or a notified body, chosen by the manufacturer,
shall carry out product checks or have them carried out at random intervals determined by the body, in order to verify
the quality of the internal checks of the product, taking into account, inter alia, the technological complexity of the
products and the quantity of production. An adequate sample of the final products, taken on site by the body before
the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the
harmonised standard and/or technical specifications, or equivalent tests, shall be carried out to check the conformity
of the product with the relevant requirements of the legislative instrument.

The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the
product performs within acceptable limits, with a view to ensuring conformity of the product.

Where the tests are carried out by a notified body, the manufacturer shall, under the responsibility of the notified
body, affix the notified body's identification number during the manufacturing process.

5.

Conformity marking and declaration of conformity

5.1. The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual

product that satisfies the applicable requirements of the legislative instrument.

5.2. The manufacturer shall draw up a written declaration of conformity for a product model and keep it together with the
technical documentation at the disposal of the national authorities for 10 years after the product has been placed on
the market. The declaration of conformity shall identify the product for which it has been drawn up.

A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

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6.

Authorised representative

The manufacturer's obligations set out in point 5 may be fulfilled by his authorised representative, on his behalf and
under his responsibility, provided that they are specified in the mandate.

Module B

EC-type examination

1.

EC-type examination is the part of a conformity assessment procedure in which a notified body examines the technical
design of a product and verifies and attests that the technical design of the product meets the requirements of the
legislative instrument that apply to it.

2.

EC-type examination may be carried out in either of the following manners:

— examination of a specimen, representative of the production envisaged, of the complete product (production

type),

— assessment of the adequacy of the technical design of the product through examination of the technical
documentation and supporting evidence referred to in point 3, plus examination of specimens, representative of
the production envisaged, of one or more critical parts of the product (combination of production type and
design type),

— assessment of the adequacy of the technical design of the product through examination of the technical
documentation and supporting evidence referred to in point 3, without examination of a specimen (design
type).

3.

The manufacturer shall lodge an application for EC-type examination with a single notified body of his choice.

The application shall include:

— the name and address of the manufacturer and, if the application is lodged by the authorised representative, his

name and address as well,

— a written declaration that the same application has not been lodged with any other notified body,

— the technical documentation. The technical documentation shall make it possible to assess the product's
conformity with the applicable requirements of the legislative instrument and shall include an adequate analysis
and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover,
as far as relevant for the assessment, the design, manufacture and operation of the product. The technical
documentation shall contain, wherever applicable, at least the following elements:

— a general description of the product,

— conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

— descriptions and explanations necessary for the understanding of those drawings and schemes and the

operation of the product,

— a list of the harmonised standards and/or other relevant technical specifications the references of which
have been published in the Official Journal of the European Union, applied in full or in part, and descriptions
of the solutions adopted to meet the essential requirements of the legislative instrument where those
harmonised standards have not been applied. In the event of partly applied harmonised standards, the
technical documentation shall specify the parts which have been applied,

— results of design calculations made, examinations carried out, etc., and

— test reports,

— the specimens representative of the production envisaged. The notified body may request further specimens if

needed for carrying out the test programme,

— the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall
mention any documents that have been used, in particular where the relevant harmonised standards and/or
technical specifications have not been applied in full. The supporting evidence shall include, where necessary,
the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing
laboratory on his behalf and under his responsibility.

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4.

The notified body shall:

For the product:

4.1.

examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the
product;

For the specimen(s):

4.2. verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the
elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards
and/or technical specifications, as well as the elements which have been designed without applying the relevant
provisions of those standards;

4.3.

carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has
chosen to apply the solutions in the relevant harmonised standards and/or technical specifications, these have been
applied correctly;

4.4.

carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the
relevant harmonised standards and/or technical specifications have not been applied, the solutions adopted by the
manufacturer meet the corresponding essential requirements of the legislative instrument;

4.5.

agree with the manufacturer on a location where the examinations and tests will be carried out.

5.

The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4
and their outcomes. Without prejudice to its obligations vis-à vis the notifying authorities, the notified body shall
release the content of that report, in full or in part, only with the agreement of the manufacturer.

6. Where the type meets the requirements of the specific legislative instrument that apply to the product concerned, the
notified body shall issue an EC-type examination certificate to the manufacturer. The certificate shall contain the name
and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the
necessary data for identification of the approved type. The certificate may have one or more annexes attached.

The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products
with the examined type to be evaluated and to allow for in-service control.

Where the type does not satisfy the applicable requirements of the legislative instrument, the notified body shall refuse
to issue an EC-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its
refusal.

7.

The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which
indicate that the approved type may no longer comply with the applicable requirements of the legislative instrument,
and shall determine whether such changes require further investigation. If so, the notified body shall inform the
manufacturer accordingly.

The manufacturer shall inform the notified body that holds the technical documentation relating to the EC-type
examination certificate of all modifications to the approved type that may affect the conformity of the product with
the essential requirements of the legislative instrument or the conditions for validity of the certificate. Such
modifications shall require additional approval in the form of an addition to the original EC-type examination
certificate.

8.

Each notified body shall inform its notifying authorities concerning the EC-type examination certificates and/or any
additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its
notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies concerning the EC-type examination certificates and/or any
additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning
the certificates and/or additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC-type
examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a
copy of the technical documentation and the results of the examinations carried out by the notified body. The notified
body shall keep a copy of the EC-type examination certificate, its annexes and additions, as well as the technical file
including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.

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9.

The manufacturer shall keep a copy of the EC-type examination certificate, its annexes and additions together with the
technical documentation at the disposal of the national authorities for 10 years after the product has been placed on
the market.

10. The manufacturer's authorised representative may lodge the application referred to in point 3 and fulfil the obligations

set out in points 7 and 9, provided that they are specified in the mandate.

Module C

Conformity to type based on internal production control

1.

Conformity to type based on internal production control is the part of a conformity assessment procedure whereby
the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares that the products
concerned are in conformity with the type described in the EC-type examination certificate and satisfy the
requirements of the legislative instrument that apply to them.

2.

Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure
conformity of the manufactured products with the approved type described in the EC-type examination certificate and
with the requirements of the legislative instrument that apply to them.

3.

Conformity marking and declaration of conformity

3.1. The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual
product that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable
requirements of the legislative instrument.

3.2. The manufacturer shall draw up a written declaration of conformity for a product model and keep it at the disposal of
the national authorities for 10 years after the product has been placed on the market. The declaration of conformity
shall identify the product model for which it has been drawn up.

A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

4.

Authorised representative

The manufacturer's obligations set out in point 3 may be fulfilled by his authorised representative, on his behalf and
under his responsibility, provided that they are specified in the mandate.

Module C1

Conformity to type based on internal production control plus supervised product testing

1.

Conformity to type based on internal production control plus supervised product testing is the part of a conformity
assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures
and declares on his sole responsibility that the products concerned are in conformity with the type described in the
EC-type examination certificate and satisfy the requirements of the legislative instrument that apply to them.

2.

Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure
conformity of the manufactured products with the type described in the EC-type examination certificate and with the
requirements of the specific legislative instrument that apply to them.

3.

Product checks

For each individual product manufactured one or more tests on one or more specific aspects of the product shall be
carried out by the manufacturer or on his behalf, in order to verify conformity with the corresponding requirements
of the legislative instrument. At the choice of the manufacturer, the tests shall be carried out either by an accredited in-
house body or under the responsibility of a notified body, chosen by the manufacturer.

Where the tests are carried out by a notified body, the manufacturer shall, under the responsibility of the notified
body, affix the notified body's identification number during the manufacturing process.

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4.

Conformity marking and declaration of conformity

4.1. The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual
product that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable
requirements of the legislative instrument.

4.2. The manufacturer shall draw up a written declaration of conformity for a product model and keep it at the disposal of
the national authorities for 10 years after the product has been placed on the market. The declaration of conformity
shall identify the product model for which it has been drawn up.

A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

5.

Authorised representative

The manufacturer's obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and
under his responsibility, provided that they are specified in the mandate.

Module C2

Conformity to type based on internal production control plus supervised product checks at random
intervals

1.

Conformity to type based on internal production control plus supervised product checks at random intervals is the
part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3
and 4, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type
described in the EC-type examination certificate and satisfy the requirements of the legislative instrument that apply to
them.

2.

Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure
conformity of the manufactured products with the type described in the EC-type examination certificate and with the
requirements of the specific legislative instrument that apply to them.

3.

Product checks

At the choice of the manufacturer, either an accredited in-house body or a notified body, chosen by the manufacturer,
shall carry out product checks or have them carried out at random intervals determined by the body, in order to verify
the quality of the internal checks on the product, taking into account, inter alia, the technological complexity of the
products and the quantity of production. An adequate sample of the final products, taken on site by the notified body
before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the
harmonised standards and/or technical specifications, or equivalent tests, shall be carried out to check the conformity
of the product with the relevant requirements of the legislative instrument. Where a sample does not conform to the
acceptable quality level, the body shall take appropriate measures.

The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the
product performs within acceptable limits, with a view to ensuring conformity of the product.

Where the tests are carried out by notified body, the manufacturer shall, under the responsibility of the notified body,
affix the notified body's identification number during the manufacturing process.

4.

Conformity marking and declaration of conformity

4.1. The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual
product that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable
requirements of the legislative instrument.

4.2. The manufacturer shall draw up a written declaration of conformity for a product model and keep it at the disposal of
the national authorities for 10 years after the product has been placed on the market. The declaration of conformity
shall identify the product model for which it has been drawn up.

A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

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5.

Authorised representative

The manufacturer's obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and
under his responsibility, provided that they are specified in the mandate.

Module D

Conformity to type based on quality assurance of the production process

1.

Conformity to type based on quality assurance of the production process is the part of a conformity assessment
procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on
his sole responsibility that the products concerned are in conformity with the type described in the EC-type
examination certificate and satisfy the requirements of the legislative instrument that apply to them.

2.

Manufacturing

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the
products concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.

3.

Quality system

3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice,

for the products concerned.

The application shall include:

— the name and address of the manufacturer and, if the application is lodged by the authorised representative, his

name and address as well,

— a written declaration that the same application has not been lodged with any other notified body,

— all relevant information for the product category envisaged,

— the documentation concerning the quality system,

— the technical documentation of the approved type and a copy of the EC-type examination certificate.

3.2. The quality system shall ensure that the products are in conformity with the type described in the EC-type
examination certificate and comply with the requirements of the legislative instrument that apply to them.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and
orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall
permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

— the quality objectives and the organisational structure, responsibilities and powers of the management with

regard to product quality,

— the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic

actions that will be used,

— the examinations and tests that will be carried out before, during and after manufacture, and the frequency with

which they will be carried out,

— the quality records, such as inspection reports and test data, calibration data, qualification reports on the

personnel concerned, etc., and

— the means of monitoring the achievement of the required product quality and the effective operation of the

quality system.

3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in

point 3.2.

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It shall presume conformity with those requirements in respect of the elements of the quality system that comply with
the corresponding specifications of the national standard that implements the relevant harmonised standard and/or
technical specifications.

In addition to experience in quality management systems, the auditing team shall have at least one member with
experience of evaluation in the relevant product field and product technology concerned, and knowledge of the
applicable requirements of the legislative instrument. The audit shall include an assessment visit to the manufacturer's
premises. The auditing team shall review the technical documentation referred to in point 3.1, fifth indent, to verify
the manufacturer's ability to identify the relevant requirements of the legislative instrument and to carry out the
necessary examinations with a view to ensuring compliance of the product with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the
reasoned assessment decision.

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to

maintain it so that it remains adequate and efficient.

3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change

to the quality system.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue
to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and
the reasoned assessment decision.

4.

Surveillance under the responsibility of the notified body

4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the

approved quality system.

4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection,

testing and storage sites and shall provide it with all necessary information, in particular:

— the quality system documentation,

— the quality records, such as inspection reports and test data, calibration data, qualification reports on the

personnel concerned, etc.

4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality

system and shall provide the manufacturer with an audit report.

4.4.

In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body
may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is
functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been
carried out, with a test report.

5.

Conformity marking and declaration of conformity

5.1. The manufacturer shall affix the required conformity marking set out in the legislative instrument, and, under the
responsibility of the notified body referred to in point 3.1, the latter's identification number to each individual product
that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable
requirements of the legislative instrument.

5.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal
of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity
shall identify the product model for which it has been drawn up.

A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

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6.

The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at
the disposal of the national authorities:

— the documentation referred to in point 3.1,

— the change referred to in point 3.5, as approved,

— the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.

7.

Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall,
periodically or upon request, make available to its notifying authorities the list of quality system approvals refused,
suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended,
withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.

8.

Authorised representative

The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on
his behalf and under his responsibility, provided that they are specified in the mandate.

Module D1

Quality assurance of the production process

1.

Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils
the obligations laid down in points 2, 4 and 7, and ensures and declares on his sole responsibility that the products
concerned satisfy the requirements of the legislative instrument that apply to them.

2.

Technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the
product's conformity with the relevant requirements, and shall include an adequate analysis and assessment of the
risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the
assessment, the design, manufacture and operation of the product. The technical documentation shall, wherever
applicable, contain at least the following elements:

— a general description of the product,

— conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

— descriptions and explanations necessary for the understanding of those drawings and schemes and the operation

of the product,

— a list of the harmonised standards and/or other relevant technical specifications the references of which have
been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the essential requirements of the legislative instrument where those harmonised
standards have not been applied.
the technical
documentation shall specify the parts which have been applied,

In the event of partly applied harmonised standards,

— results of design calculations made, examinations carried out, etc., and

— test reports.

3.

The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for
10 years after the product has been placed on the market.

4.

Manufacturing

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the
products concerned as specified in point 5, and shall be subject to surveillance as specified in point 6.

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5.

Quality system

5.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice,

for the products concerned.

The application shall include:

— the name and address of the manufacturer and, if the application is lodged by the authorised representative, his

name and address as well,

— a written declaration that the same application has not been lodged with any other notified body,

— all relevant information for the product category envisaged,

— the documentation concerning the quality system,

— the technical documentation referred to in point 2.

5.2. The quality system shall ensure compliance of the products with the requirements of the legislative instrument that

apply to them.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and
orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall
permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

— the quality objectives and the organisational structure, responsibilities and powers of the management with

regard to product quality,

— the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic

actions that will be used,

— the examinations and tests that will be carried out before, during and after manufacture, and the frequency with

which they will be carried out,

— the quality records, such as inspection reports and test data, calibration data, qualification reports on the

personnel concerned, etc.,

— the means of monitoring the achievement of the required product quality and the effective operation of the

quality system.

5.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in

point 5.2.

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with
the corresponding specifications of the national standard that implements the relevant harmonised standard and/or
technical specification.

In addition to experience in quality management systems, the auditing team shall have at least one member with
experience of evaluation in the relevant product field and product technology concerned, and knowledge of the
applicable requirements of the legislative instrument. The audit shall include an assessment visit to the manufacturer's
premises. The auditing team shall review the technical documentation referred to in point 2 in order to verify the
manufacturer's ability to identify the relevant requirements of the legislative instrument and to carry out the necessary
examinations with a view to ensuring compliance of the product with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the
reasoned assessment decision.

5.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to

maintain it so that it remains adequate and efficient.

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5.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change

to the quality system.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue
to satisfy the requirements referred to in point 5.2 or whether reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and
the reasoned assessment decision.

6.

Surveillance under the responsibility of the notified body

6.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the

approved quality system.

6.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection,

testing and storage sites and shall provide it with all necessary information, in particular:

— the quality system documentation,

— the technical documentation referred to in point 2,

— the quality records, such as inspection reports and test data, calibration data, qualification reports on the

personnel concerned, etc.

6.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality

system and shall provide the manufacturer with an audit report.

6.4.

In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body
may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is
functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been
carried out, with a test report.

7.

Conformity marking and declaration of conformity

7.1. The manufacturer shall affix the required conformity marking set out in the legislative instrument, and, under the
responsibility of the notified body referred to in point 5.1, the latter's identification number to each individual product
that satisfies the applicable requirements of the legislative instrument.

7.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal
of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity
shall identify the product model for which it has been drawn up.

A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

8.

The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at
the disposal of the national authorities:

— the documentation referred to in point 5.1,

— the change referred to in point 5.5, as approved,

— the decisions and reports of the notified body referred to in points 5.5, 6.3 and 6.4.

9.

Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall,
periodically or upon request, make available to its notifying authorities the list of quality system approvals refused,
suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended
or withdrawn, and, upon request, of quality system approvals which it has issued.

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10. Authorised representative

The manufacturer's obligations set out in points 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorised representative,
on his behalf and under his responsibility, provided that they are specified in the mandate.

Module E

Conformity to type based on product quality assurance

1.

Conformity to type based on product quality assurance is that part of a conformity assessment procedure whereby the
manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility
that the products concerned are in conformity with the type described in the EC-type examination certificate and
satisfy the requirements of the legislative instrument that apply to them.

2.

Manufacturing

The manufacturer shall operate an approved quality system for final product inspection and testing of the products
concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.

3.

Quality system

3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice,

for the products concerned.

The application shall include:

— the name and address of the manufacturer and, if the application is lodged by the authorised representative, his

name and address as well,

— a written declaration that the same application has not been lodged with any other notified body,

— all relevant information for the product category envisaged,

— the documentation concerning the quality system, and

— the technical documentation of the approved type and a copy of the EC-type examination certificate.

3.2. The quality system shall ensure compliance of the products with the type described in the EC-type examination

certificate and with the applicable requirements of the legislative instrument.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and
orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall
permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

— the quality objectives and the organisational structure, responsibilities and powers of the management with

regard to product quality,

— the examinations and tests that will be carried out after manufacture,

— the quality records, such as inspection reports and test data, calibration data, qualification reports on the

personnel concerned, etc.,

— the means of monitoring the effective operation of the quality system.

3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in

point 3.2.

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with
the corresponding specifications of the national standard that implements the relevant harmonised standard and/or
technical specification.

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In addition to experience in quality management systems, the auditing team shall have at least one member with
experience of evaluation in the relevant product field and product technology concerned, and knowledge of the
applicable requirements of the legislative instrument. The audit shall include an assessment visit to the manufacturer's
premises. The auditing team shall review the technical documentation referred to in point 3.1, fifth indent, in order to
verify the manufacturer's ability to identify the relevant requirements of the legislative instrument and to carry out the
necessary examinations with a view to ensuring compliance of the product with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the
reasoned assessment decision.

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to

maintain it so that it remains adequate and efficient.

3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change

to the quality system.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue
to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and
the reasoned assessment decision.

4.

Surveillance under the responsibility of the notified body

4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the

approved quality system.

4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection,

testing and storage sites and shall provide it with all necessary information, in particular:

— the quality system documentation,

— the quality records, such as inspection reports and test data, calibration data, qualification reports on the

personnel concerned, etc.

4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality

system and shall provide the manufacturer with an audit report.

4.4.

In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body
may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is
functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been
carried out, with a test report.

5.

Conformity marking and declaration of conformity

5.1. The manufacturer shall affix the required conformity marking set out in the legislative instrument, and, under the
responsibility of the notified body referred to in point 3.1, the latter's identification number to each individual product
that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable
requirements of the legislative instrument.

5.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal
of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity
shall identify the product model for which it has been drawn up.

A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

6.

The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at
the disposal of the national authorities:

— the documentation referred to in point 3.1,

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— the change referred to in point 3.5, as approved,

— the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.

7.

Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall,
periodically or upon request, make available to its notifying authorities the list of quality system approvals refused,
suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended
or withdrawn, and, upon request, of quality system approvals which it has issued.

8.

Authorised representative

The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on
his behalf and under his responsibility, provided that they are specified in the mandate.

Module E1

Quality assurance of final product inspection and testing

1.

Quality assurance of final product inspection and testing is the conformity assessment procedure whereby the
manufacturer fulfils the obligations laid down in points 2, 4 and 7, and ensures and declares on his sole responsibility
that the products concerned satisfy the requirements of the legislative instrument that apply to them.

2.

Technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the
product's conformity with the relevant requirements, and shall include an adequate analysis and assessment of the
risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the
assessment, the design, manufacture and operation of the product. The technical documentation shall, wherever
applicable, contain at least the following elements:

— a general description of the product,

— conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

— descriptions and explanations necessary for the understanding of those drawings and schemes and the operation

of the product,

— a list of the harmonised standards and/or other relevant technical specifications the references of which have
been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the essential requirements of the legislative instrument where those harmonised
standards have not been applied.
the technical
documentation shall specify the parts which have been applied,

In the event of partly applied harmonised standards,

— results of design calculations made, examinations carried out, etc., and

— test reports.

3.

The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for
10 years after the product has been placed on the market.

4.

Manufacturing

The manufacturer shall operate an approved quality system for final product inspection and testing of the products
concerned as specified in point 5 and shall be subject to surveillance as specified in point 6.

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5.

Quality system

5.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice,

for the products concerned.

The application shall include:

— the name and address of the manufacturer and, if the application is lodged by the authorised representative, his

name and address as well,

— a written declaration that the same application has not been lodged with any other notified body,

— all relevant information for the product category envisaged,

— the documentation concerning the quality system, and

— the technical documentation referred to in point 2.

5.2. The quality system shall ensure compliance of the products with the requirements of the legislative instrument that

apply to them.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and
orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall
permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

— the quality objectives and the organisational structure, responsibilities and powers of the management with

regard to product quality,

— the examinations and tests that will be carried out after manufacture,

— the quality records, such as inspection reports and test data, calibration data, qualification reports on the

personnel concerned, etc.,

— the means of monitoring the effective operation of the quality system.

5.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in

point 5.2.

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with
the corresponding specifications of the national standard that implements the relevant harmonised standard and/or
technical specification.

In addition to experience in quality management systems, the auditing team shall have at least one member with
experience of evaluation in the relevant product field and product technology concerned, and knowledge of the
applicable requirements of the legislative instrument. The audit shall include an assessment visit to the manufacturer's
premises. The auditing team shall review the technical documentation referred to in point 2 in order to verify the
manufacturer's ability to identify the relevant requirements of the legislative instrument and to carry out the necessary
examinations with a view to ensuring compliance of the product with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the
reasoned assessment decision.

5.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to

maintain it so that it remains adequate and efficient.

5.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change

to the quality system.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue
to satisfy the requirements referred to in point 5.2 or whether a reassessment is necessary.

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It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and
the reasoned assessment decision.

6.

Surveillance under the responsibility of the notified body

6.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the

approved quality system.

6.2. The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection,

testing and storage sites and shall provide it with all necessary information, in particular:

— the quality system documentation,

— the technical documentation referred to in point 2,

— the quality records, such as inspection reports and test data, calibration data, qualification reports on the

personnel concerned, etc.

6.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality

system and shall provide the manufacturer with an audit report.

6.4.

In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body
may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is
functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been
carried out, with a test report.

7.

Conformity marking and declaration of conformity

7.1. The manufacturer shall affix the required conformity marking set out in the legislative instrument, and, under the
responsibility of the notified body referred to in point 5.1, the latter's identification number to each individual product
that satisfies the applicable requirements of the legislative instrument.

7.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal
of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity
shall identify the product model for which it has been drawn up.

A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

8.

The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at
the disposal of the national authorities:

— the documentation referred to in point 5.1,

— the change referred to in point 5.5, as approved,

— the decisions and reports of the notified body referred to in points 5.5, 6.3 and 6.4.

9.

Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall,
periodically or upon request, make available to its notifying authorities the list of quality system approvals refused,
suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended
or withdrawn, and, upon request, of quality system approvals which it has issued.

10. Authorised representative

The manufacturer's obligations set out in points 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorised representative,
on his behalf and under his responsibility, provided that they are specified in the mandate.

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Module F

Conformity to type based on product verification

1.

Conformity to type based on product verification is the part of a conformity assessment procedure whereby the
manufacturer fulfils the obligations laid down in points 2, 5.1 and 6, and ensures and declares on his sole
responsibility that the products concerned, which have been subject to the provisions of point 3, are in conformity
with the type described in the EC-type examination certificate and satisfy the requirements of the legislative
instrument that apply to them.

2.

Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure
conformity of the manufactured products with the approved type described in the EC-type examination certificate and
with the requirements of the legislative instrument that apply to them.

3.

Verification

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the
conformity of the products with the approved type described in the EC-type examination certificate and with the
appropriate requirements of the legislative instrument.

The examinations and tests to check the conformity of the products with the appropriate requirements shall be carried
out, at the choice of the manufacturer either by examination and testing of every product as specified in point 4 or by
examination and testing of the products on a statistical basis as specified in point 5.

4.

Verification of conformity by examination and testing of every product

4.1. All products shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or
technical specifications, or equivalent tests, shall be carried out in order to verify conformity with the approved type
described in the EC-type examination certificate and with the appropriate requirements of the legislative instrument.
In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be
carried out.

4.2. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall

affix its identification number to each approved product or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for
10 years after the product has been placed on the market.

5.

Statistical verification of conformity

5.1. The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the
homogeneity of each lot produced, and shall present his products for verification in the form of homogeneous lots.

5.2. A random sample shall be taken from each lot according to the requirements of the legislative instrument. All
products in a sample shall be individually examined and appropriate tests set out in the relevant harmonised stand-
ard(s) and/or technical specifications, or equivalent tests, shall be carried out in order to ensure their conformity with
the applicable requirements of the legislative instrument and to determine whether the lot is accepted or rejected. In
the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be
carried out.

5.3.

If a lot is accepted, all products of the lot shall be considered approved, except for those products from the sample that
have been found not to satisfy the tests.

The notified body shall issue a certificate of conformity in respect to the examinations and tests carried out, and shall
affix its identification number to each approved product or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after
the product has been placed on the market.

5.4.

If a lot is rejected, the notified body or the competent authority shall take appropriate measures to prevent that lot's
being placed on the market. In the event of the frequent rejection of lots the notified body may suspend the statistical
verification and take appropriate measures.

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6.

Conformity marking and declaration of conformity

6.1. The manufacturer shall affix the required conformity marking set out in the legislative instrument, and, under the
responsibility of the notified body referred to in point 3, the latter's identification number to each individual product
that is in conformity with the approved type described in the EC-type examination certificate and satisfies the
applicable requirements of the legislative instrument.

6.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal
of the national authorities, for 10 years after the product has been placed on the market. The declaration of
conformity shall identify the product model for which it has been drawn up.

A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the
notified body's identification number to the products.

7.

If the notified body agrees and under its responsibility, the manufacturer may affix the notified body's identification
number to the products during the manufacturing process.

8.

Authorised representative

The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his
responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the
manufacturer's obligations set out in points 2 and 5.1.

Module F1

Conformity based on product verification

1.

Conformity based on product verification is the conformity assessment procedure whereby the manufacturer fulfils
the obligations laid down in points 2, 3, 6.1 and 7 and ensures and declares on his sole responsibility that the
products concerned, which have been subject to the provisions of point 4, are in conformity with the requirements of
the legislative instrument that apply to them.

2.

Technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the
product's conformity with the relevant requirements, and shall include an adequate analysis and assessment of the
risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the
assessment, the design, manufacture and operation of the product. The technical documentation shall, wherever
applicable, contain at least the following elements:

— a general description of the product,

— conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

— descriptions and explanations necessary for the understanding of those drawings and schemes and the operation

of the product,

— a list of the harmonised standards and/or other relevant technical specifications the references of which have
been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the essential requirements of the legislative instrument where those harmonised
standards have not been applied.
the technical
documentation shall specify the parts which have been applied,

In the event of partly applied harmonised standards,

— results of design calculations made, examinations carried out, etc., and

— test reports.

The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for
10 years after the product has been placed on the market.

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3.

Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure
conformity of the manufactured products with the applicable requirements of the legislative instrument.

4.

Verification

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests to check the
conformity of the products with the applicable requirements of the legislative instrument.

The examinations and tests to check the conformity with those requirements shall be carried out, at the choice of the
manufacturer, either by examination and testing of every product as specified in point 5, or by examination and
testing of the products on a statistical basis as specified in point 6.

5.

Verification of conformity by examination and testing of every product

5.1. All products shall be individually examined and appropriate tests, set out in the relevant harmonised standards and/or
technical specifications, or equivalent tests, shall be carried out to verify conformity with the requirements that apply
to them. In the absence of such a harmonised standard and/or technical specification the notified body concerned
shall decide on the appropriate tests to be carried out.

5.2. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall

affix its identification number to each approved product or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after
the product has been placed on the market.

6.

Statistical verification of conformity

6.1. The manufacturer shall take all measures necessary so that the manufacturing process ensures the homogeneity of

each lot produced, and shall present his products for verification in the form of homogeneous lots.

6.2. A random sample shall be taken from each lot according to the requirements of the legislative instrument. All
products in the sample shall be individually examined and appropriate tests set out in the relevant harmonised
standards and/or technical specifications, or equivalent tests, to establish conformity with the requirements that apply
to them, shall be carried out to determine whether the lot is accepted or rejected. In the absence of such a harmonised
standard and/or technical specification the notified body concerned shall decide on the appropriate tests to be carried
out.

6.3.

If a lot is accepted, all products of the lot shall be considered approved, except for those products from the sample that
have been found not to satisfy the tests.

The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall
affix its identification number to each approved product or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after
the product has been placed on the market.

If a lot is rejected, the notified body shall take appropriate measures to prevent that lot being placed on the market. In
the event of the frequent rejection of lots the notified body may suspend the statistical verification and take
appropriate measures.

7.

Conformity marking and declaration of conformity

7.1. The manufacturer shall affix the conformity marking set out in the legislative instrument, and, under the responsibility
of the notified body referred to in point 4, the latter's identification number to each individual product that satisfies
the applicable requirements of the legislative instrument.

7.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal
of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity
shall identify the product model for which it has been drawn up.

A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

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If the notified body referred to in point 5 agrees and under its responsibility, the manufacturer may also affix the
notified body's identification number to the products.

8.

If the notified body agrees and under its responsibility, the manufacturer may affix the notified body's identification
number to the products during the manufacturing process.

9.

Authorised representative

The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his
responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the
manufacturer's obligations set out in points 3 and 6.1.

Module G

Conformity based on unit verification

1.

Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the
obligations laid down in points 2, 3 and 5, and ensures and declares on his sole responsibility that the product
concerned, which has been subject to the provisions of point 4, is in conformity with the requirements of the
legislative instrument that apply to it.

2.

Technical documentation

The manufacturer shall establish the technical documentation and make it available to the notified body referred to in
point 4. The documentation shall make it possible to assess the product's conformity with the relevant requirements,
and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the
applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the
product. The technical documentation shall, wherever applicable, contain at least the following elements:

— a general description of the product,

— conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

— descriptions and explanations necessary for the understanding of those drawings and schemes and the operation

of the product,

— a list of the harmonised standards and/or other relevant technical specifications the references of which have
been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the essential requirements of the legislative instrument where those harmonised
standards have not been applied.
the technical
documentation shall specify the parts which have been applied,

In the event of partly applied harmonised standards,

— results of design calculations made, examinations carried out, etc., and

— test reports.

The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for
10 years after the product has been placed on the market.

3.

Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure
conformity of the manufactured product with the applicable requirements of the legislative instrument.

4.

Verification

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant
harmonised standards and/or technical specifications, or equivalent tests, to check the conformity of the product with
the applicable requirements of the legislative instrument, or have them carried out. In the absence of such a
harmonised standard and/or technical specification the notified body concerned shall decide on the appropriate tests
to be carried out.

The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall
affix its identification number to the approved product, or have it affixed under its responsibility.

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The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after
the product has been placed on the market.

5.

Conformity marking and declaration of conformity

5.1. The manufacturer shall affix the required conformity marking set out in the legislative instrument and, under the
responsibility of the notified body referred to in point 4, the latter's identification number to each product that
satisfies the applicable requirements of the legislative instrument.

5.2. The manufacturer shall draw up a written declaration of conformity and keep it at the disposal of the national
authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify
the product for which it has been drawn up.

A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

6.

Authorised representative

The manufacturer's obligations set out in points 2 and 5 may be fulfilled by his authorised representative, on his behalf
and under his responsibility, provided that they are specified in the mandate.

Module H

Conformity based on full quality assurance

1.

Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils
the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the products
concerned satisfy the requirements of the legislative instrument that apply to them.

2.

Manufacturing

The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and
testing of the products concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.

3.

Quality system

3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice,

for the products concerned.

The application shall include:

— the name and address of the manufacturer and, if the application is lodged by the authorised representative, his

name and address as well,

— the technical documentation for one model of each category of products intended to be manufactured. The

technical documentation shall, wherever applicable, contain at least the following elements:

— a general description of the product,

— conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

— descriptions and explanations necessary for the understanding of those drawings and schemes and the

operation of the product,

— a list of the harmonised standards and/or other relevant technical specifications the references of which
have been published in the Official Journal of the European Union, applied in full or in part, and descriptions
of the solutions adopted to meet the essential requirements of the legislative instrument where those
harmonised standards have not been applied. In the event of partly applied harmonised standards, the
technical documentation shall specify the parts which have been applied,

— results of design calculations made, examinations carried out, etc.,

— test reports,

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— the documentation concerning the quality system, and

— a written declaration that the same application has not been lodged with any other notified body.

3.2. The quality system shall ensure compliance of the products with the requirements of the legislative instrument that

apply to them.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and
orderly manner in the form of written policies, procedures and instructions. That quality system documentation shall
permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

— the quality objectives and the organisational structure, responsibilities and powers of the management with

regard to design and product quality,

— the technical design specifications, including standards, that will be applied and, where the relevant harmonised
standards and/or technical specifications will not be applied in full, the means that will be used to ensure that
the essential requirements of the legislative instrument that apply to the products will be met,

— the design control and design verification techniques, processes and systematic actions that will be used when

designing the products pertaining to the product category covered,

— the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic

actions that will be used,

— the examinations and tests that will be carried out before, during and after manufacture, and the frequency with

which they will be carried out,

— the quality records, such as inspection reports and test data, calibration data, qualification reports on the

personnel concerned, etc.,

— the means of monitoring the achievement of the required design and product quality and the effective operation

of the quality system.

3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in

point 3.2.

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with
the corresponding specifications of the national standard that implements the relevant harmonised standard and/or
technical specification.

In addition to experience in quality management systems, the auditing team shall have at least one member
experienced as an assessor in the relevant product field and product technology concerned, and knowledge of the
applicable requirements of the legislative instrument. The audit shall include an assessment visit to the manufacturer's
premises. The auditing team shall review the technical documentation referred to in point 3.1, second indent, to verify
the manufacturer's ability to identify the applicable requirements of the legislative instrument and to carry out the
necessary examinations with a view to ensuring compliance of the product with those requirements.

The manufacturer or his authorised representative shall be notified of the decision.

The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to

maintain it so that it remains adequate and efficient.

3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change

to the quality system.

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The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue
to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and
the reasoned assessment decision.

4.

Surveillance under the responsibility of the notified body

4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the

approved quality system.

4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture,

inspection, testing and storage sites, and shall provide it with all necessary information, in particular:

— the quality system documentation,

— the quality records as provided for by the design part of the quality system, such as results of analyses,

calculations, tests, etc.,

— the quality records as provided for by the manufacturing part of the quality system, such as inspection reports

and test data, calibration data, qualification reports on the personnel concerned, etc.

4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality

system and shall provide the manufacturer with an audit report.

4.4.

In addition, the notified body may pay unexpected visits to the manufacturer. During such visits, the notified body
may, if necessary, carry out product tests, or have them carried out, in order to check the proper functioning of the
quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test
report.

5.

Conformity marking and declaration of conformity

5.1. The manufacturer shall affix the required conformity marking set out in the legislative instrument, and, under the
responsibility of the notified body referred to in point 3.1, the latter's identification number to each individual product
that satisfies the applicable requirements of the legislative instrument.

5.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal
of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity
shall identify the product model for which it has been drawn up.

A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

6.

The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at
the disposal of the national authorities:

— the technical documentation referred to in point 3.1,

— the documentation concerning the quality system referred to in point 3.1,

— the change referred to in point 3.5, as approved,

— the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.

7.

Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall,
periodically or upon request, make available to its notifying authorities the list of quality system approvals refused,
suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended
or withdrawn, and, upon request, of quality system approvals which it has issued.

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8.

Authorised representative

The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on
his behalf and under his responsibility, provided that they are specified in the mandate.

Module H1

Conformity based on full quality assurance plus design examination

1.

Conformity based on full quality assurance plus design examination is the conformity assessment procedure whereby
the manufacturer fulfils the obligations laid down in points 2 and 6, and ensures and declares on his sole responsibility
that the products concerned satisfy the requirements of the legislative instrument that apply to them.

2.

Manufacturing

The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and
testing of the products concerned as specified in point 3 and shall be subject to surveillance as specified in point 5.
The adequacy of the technical design of the products shall have been examined in accordance with point 4.

3.

Quality system

3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice,

for the products concerned.

The application shall include:

— the name and address of the manufacturer and, if the application is lodged by the authorised representative, his

name and address as well,

— all relevant information for the product category envisaged,

— the documentation concerning the quality system,

— a written declaration that the same application has not been lodged with any other notified body.

3.2. The quality system shall ensure compliance of the products with the requirements of the legislative instrument that

apply to them.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and
orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall
permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

— the quality objectives and the organisational structure, responsibilities and powers of the management with

regard to design and product quality,

— the technical design specifications, including standards, that will be applied and, where the relevant harmonised
standards and/or technical specifications will not be applied in full, the means that will be used to ensure that
the essential requirements of the legislative instrument that apply to the products will be met,

— the design control and design verification techniques, processes and systematic actions that will be used when

designing the products pertaining to the product category covered,

— the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic

actions that will be used,

— the examinations and tests that will be carried out before, during and after manufacture, and the frequency with

which they will be carried out,

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— the quality records, such as inspection reports and test data, calibration data, qualification reports on the

personnel concerned, etc.,

— the means of monitoring the achievement of the required design and product quality and the effective operation

of the quality system.

3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in

point 3.2.

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with
the corresponding specifications of the national standard that implements the relevant harmonised standard and/or
technical specifications.

In addition to experience in quality management systems, the auditing team shall have at least one member
experienced as an assessor in the relevant product field and product technology concerned, and knowledge of the
applicable requirements of the legislative instrument. The audit shall include an assessment visit to the manufacturer's
premises.

The manufacturer or his authorised representative shall be notified of the decision.

The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to

maintain it so that it remains adequate and efficient.

3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change

to the quality system.

The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue
to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and
the reasoned assessment decision.

3.6. Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall,
periodically or upon request, make available to its notifying authorities the list of quality system approvals refused,
suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended
or withdrawn, and, upon request, of quality system approvals which it has issued.

4.

Design examination

4.1. The manufacturer shall lodge an application for examination of the design with the notified body referred to in

point 3.1.

4.2. The application shall make it possible to understand the design, manufacture and operation of the product, and to

assess the conformity with the requirements of the legislative instrument that apply to it. It shall include:

— the name and address of the manufacturer,

— a written declaration that the same application has not been lodged with any other notified body,

— the technical documentation. The documentation shall make it possible to assess the product's conformity with
the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical
documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the
design and operation of the product. The technical documentation shall, wherever applicable, contain at least
the following elements:

— a general description of the product,

— conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

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— descriptions and explanations necessary for the understanding of those drawings and schemes and the

operation of the product,

— a list of the harmonised standards and/or other relevant technical specifications the references of which
have been published in the Official Journal of the European Union, applied in full or in part, and descriptions
of the solutions adopted to meet the essential requirements of the legislative instrument where those
harmonised standards have not been applied. In the event of partly applied harmonised standards, the
technical documentation shall specify the parts which have been applied,

— results of design calculations made, examinations carried out, etc., and

— test reports,

— the supporting evidence for the adequacy of the technical design. This supporting evidence shall mention any
documents that have been used,
in particular where the relevant harmonised standards and/or technical
specifications have not been applied in full, and shall include, where necessary, the results of tests carried out by
the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his
responsibility.

4.3. The notified body shall examine the application, and where the design meets the requirements of the legislative
instrument that apply to the product it shall issue an EC design examination certificate to the manufacturer. The
certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if
any) for its validity and the data necessary for identification of the approved design. The certificate may have one or
more annexes attached.

The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products
with the examined design to be evaluated, and to allow for in-service control, where applicable.

Where the design does not satisfy the applicable requirements of the legislative instrument, the notified body shall
refuse to issue a design examination certificate and shall inform the applicant accordingly, giving detailed reasons for
its refusal.

4.4. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which
indicate that the approved design may no longer comply with the applicable requirements of the legislative
instrument, and shall determine whether such changes require further investigation. If so, the notified body shall
inform the manufacturer accordingly.

The manufacturer shall keep the notified body that has issued the EC design examination certificate informed of any
modification to the approved design that may affect the conformity with the essential requirements of the legislative
instrument or the conditions for validity of the certificate. Such modifications shall require additional approval —
from the notified body that issued the EC design examination certificate — in the form of an addition to the original
EC design examination certificate.

4.5. Each notified body shall inform its notifying authorities of the EC design examination certificates and/or any additions
thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying
authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of the EC design examination certificates and/or any
additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the
certificates and/or additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC design
examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a
copy of the technical documentation and of the results of the examinations carried out by the notified body.

The notified body shall keep a copy of the EC design examination certificate, its annexes and additions, as well as the
technical file including the documentation submitted by the manufacturer until the expiry of the validity of the
certificate.

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4.6. The manufacturer shall keep a copy of the EC design examination certificate, its annexes and additions together with
the technical documentation at the disposal of the national authorities for 10 years after the product has been placed
on the market.

5.

Surveillance under the responsibility of the notified body

5.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the

approved quality system.

5.2. The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture,

inspection, testing and storage sites, and shall provide it with all necessary information, in particular:

— the quality system documentation,

— the quality records as provided for by the design part of the quality system, such as results of analyses,

calculations, tests, etc.,

— the quality records as provided for by the manufacturing part of the quality system, such as inspection reports

and test data, calibration data, qualification reports on the personnel concerned, etc.

5.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality

system and shall provide the manufacturer with an audit report.

5.4.

In addition, the notified body may pay unexpected visits to the manufacturer. During such visits, the notified body
may, if necessary, carry out product tests, or have them carried out, in order to check the proper functioning of the
quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test
report.

6.

Conformity marking and declaration of conformity

6.1. The manufacturer shall affix the required conformity marking set out in the legislative instrument, and, under the
responsibility of the notified body referred to in point 3.1, the latter's identification number to each individual product
that satisfies the applicable requirements of the legislative instrument.

6.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal
of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity
shall identify the product model for which it has been drawn up and shall mention the number of the design
examination certificate.

A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

7.

The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at
the disposal of the national authorities:

— the documentation concerning the quality system referred to in point 3.1,

— the change referred to in point 3.5, as approved,

— the decisions and reports of the notified body referred to in points 3.5, 5.3 and 5.4.

8.

Authorised representative

The manufacturer's authorised representative may lodge the application referred to in points 4.1 and 4.2 and fulfil the
obligations set out in points 3.1, 3.5, 4.4, 4.6, 6 and 7, on his behalf and under his responsibility, provided that they
are specified in the mandate.

TABLE: CONFORMITY ASSESSMENT PROCEDURES IN COMMUNITY LEGISLATION

A.

Internal
production control

B. Type examination

G. Unit verification

H. Full quality

assurance

EN ISO 9001:2000 (4)

Manufacturer

Manufacturer submits to notified body

Manufacturer

Manufacturer

— keeps technical

— technical documentation

documentation at
the disposal of
national
authorities

— supporting evidence for the adequacy of the technical design solution

— specimen(s), representative of the production envisaged, as required

— submits technical
documentation

Notified body

— ascertains conformity with essential requirements

— examines technical documentation and supporting evidence to assess adequacy of the technical design

— for specimen(s): carries out tests, if necessary

— issues EC-type examination certificate

N
G
I
S
E
D

— operates an

approved quality
system for design

— submits technical
documentation

Notified body

— carries out

surveillance of the
QS

H1

Notified body

— verifies

conformity of
design (1)

— issues EC-design
examination
certificate (1)

L

2
1
8
/
1
2
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

U
n
o
n

i

.

.

1
3
8
2
0
0
8

C. Conformity to

D. Production quality

type

assurance

E.

Product quality
assurance

F.

Product
verification

EN ISO 9001:2000 (2)

EN ISO 9001:2000 (3)

A.
Manufacturer
— declares

conformity with
essential
requirements

— affixes required
conformity
marking

C.
Manufacturer
— declares

conformity with
approved type

— affixes required
conformity
marking

N
O
I
T
C
U
D
O
R
P

A1.
Accredited in-house
body
or notified body

— tests on specific
aspects of the
product (1)

C1.
Accredited in-house
body
or notified body

— tests on specific
aspects of the
product (1)

Manufacturer
— operates an

approved quality
system for
production, final
inspection and
testing

— declares

conformity with
approved type

— affixes required
conformity
marking

D1.
declares conformity to
essential requirements
— affixes required
conformity
marking

Manufacturer
— operates an

approved quality
system for final
inspection and
testing

— declares

conformity with
approved type

— affixes required
conformity
marking

Manufacturer
— declares

conformity with
approved type

— affixes required
conformity
marking

Manufacturer
— submits product

— declares

conformity

— aAffixes required
conformity
marking

Manufacturer
— operates an

approved QS for
production, final
inspection and
testing

— declares

conformity

— affixes required
conformity
marking

E1.
declares conformity to
essential requirements
— affixes required
conformity
marking

F1.
declares conformity to
essential requirements
— affixes required
conformity
marking

A2.

C2.

— approves the QS

— approves the QS

— verifies

— Product checks at
random inter-
vals (1)

— Product checks at
random inter-
vals (1)

— carries out

surveillance of
the QS

— carries out

surveillance of
the QS

conformity to
essential
requirements

Notified body

Notified body

Notified body

Notified body

— verifies

conformity to
essential
requirements

Notified body

— carries out

surveillance of
the QS

— issues certificate of

— issues certificate of

conformity

conformity

(1)
(2)
(3)
(4)

Supplementary requirements which may be used in sectoral legislation.
Except for subclause 7.3 and requirements relating to customer satisfaction and continual improvement.
Except for subclauses 7.1, 7.2.3, 7.3, 7.4, 7.5.1, 7.5.2, 7.5.3 and requirements relating to customer satisfaction and continual improvement.
Except for requirements relating to customer satisfaction and continual improvement.

.

.

1
3
8
2
0
0
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n

U
n
o
n

i

L

2
1
8
/
1
2
7

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ANNEX III

EC DECLARATION OF CONFORMITY

1.

2.

3.

4.

5.

6.

No … (unique identification of the product):

Name and address of the manufacturer or his authorised representative:

This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):

Object of the declaration (identification of product allowing traceability. It may include a photograph, where
appropriate):

The object of the declaration described above is in conformity with the relevant Community harmonisation
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
legislation:

References to the relevant harmonised standards used or references to the specifications in relation to which
conformity is declared:

7. Where applicable, the notified body ... (name, number) … performed … (description of intervention) … and issued

the certificate: …

8.

Additional information:

Signed for and on behalf of: …………………………………

(place and date of issue):

(name, function) (signature):