METHOD FOR DESIGNATING CONFORMITY ASSESSMENT BODIES REGULATIONS

SUBSIDIARY LEGISLATION 427.45

METHOD FOR DESIGNATING CONFORMITY

ASSESSMENT BODIES REGULATIONS

1st July, 2003

LEGAL NOTICE 136 of 2003.

1. The title of these regulations is the Method for Designating

Conformity Assessment Bodies Regulations.

IMPLEMENTATION OF THE "NEW APPROACH"

CE MARKING DIRECTIVES IN MALTA

The implementation dates of the regulations published by the Ministry of Finance

and Economic Affairs, acting on the advice of the Malta Standards Authority, are

given in the table below. All current publications in the Government Gazette are

a v a i l a b l e o n t h e M a l t a St a n d a r d s A u t o r i t y w e b s i t e ( w w w. m s a . o rg . m t ) a s

downloadable documents.

Published originally under the Quality Control (Exports, Imports and Local

Goods) Act and kept in force by virtue of article 41 of the new Product Safety Act,

Cap. 427

Legal Notice

Citation

Published

Coming into

force

L.N. 16 of 1996

Safety of toys (88/378/EEC)

26th January 1996

1st July 1996

L.N. 52 of 1996

Appliances burning gaseous fuels

18th

March 1996

31st May 1996

(90/396/EEC)

L.N. 122 of 1998 Personal protective equipment

8th May 1998

1st July 1998

(89/686/EEC)

L.N. 229 of 1998 Simple pressure vessels

23rd October 1998

1st March 1998

(87/404/EEC)

L.N. 23 of 1999 Low voltage electrical equipment 5th February 1999

1st March 1999

(73/23/EEC)

L.N. 24 of 1999 Electromagnetic compatibility

5th February 1999

1st April 1999

(89/336/EEC)

L.N. 107 of 1999 Equipment and protective systems 22nd June 1999

1st January 2000

in

potentially

explosive

atmospheres (94/9/EC)

Published under the new Metrology Act, Act No: XXV of 2002

Legal Notice

Citation

Published

Coming into

force

L.N. 396 of 2002 Non-Automatic Weighing

31st December

1st January 2004

Instruments (90/384/EC)

Published following the enactment of the new Product Safety Act, Cap. 427, in

March 2001

Legal Notice

Citation

Published

Coming into

force

L.N. 66 of 2001

Active implantable medical

30th March 2001

1st April 2001

devices (90/385/EEC)

L.N. 231 of 2001 Recreational craft (94/25/EC)

28th September

1st July 2002

L.N. 249 of 2001 Lifts (95/16/EC)

26th October 2001

1st July 2002

L.N. 250 of 2001 Machinery (98/37/EC)

26th October 2001

1st July 2002

L.N. 270 of 2001 Construction products

2nd November

1st July 2002

a s a m e n d e d b y (89/106/EEC)

L.N. 330 of 2002

L.N. 329 of 2001 Radio equipment and

28th December

1st January 2002

telecommunications terminal

equipment and mutual recognition

of their conformity (1999/05/EC)

L.N. 61 of 2002

In-vitro diagnostic medical devices 12th March 2002

1st January 2003

(98/79/EC)

L.N. 62 of 2002 New hot-water boilers fired with

12th March 2002

1st January 2003

liquid or gaseous fuels (efficiency

requirements) (92/42/EEC)

L.N. 63 of 2002 Energy efficiency requirements for 12th March 2002

1st January 2003

household electric refrigerators,

freezers and combinations thereof

(96/57/EC)

L.N. 64 of 2002 Noise emission in the environment 12th March 2002

1st January 2003

by equipment for use outdoors

(2000/14/EC)

L.N. 248 of 2002 Pressure equipment (97/23/EC)

3rd September

3rd September

L.N. 331 of 2002 Transportable pressure equipment 12th November

1st January 2003

(1999/36/EC)

L.N. 332 of 2002 Interoperability of the trans-

12th November

1st January 2003

European high-speed rail system

(96/48/EC)

L.N. 333 at 2002 Cableway installations designed to 12th November

1st January 2003

carry persons (2000/9/EC)

L.N. 334 of 2002 Interoperability of the trans-

12th November

20th April 2003

European conventional rail system 2002

(2001/16/EC)

L.N. 47 of 2003 Medical devices (93/42/EEC)

31st January 2003

31st January

1. For the purposes of these regulations, all the definitions of

the Product Safety Act, hereinafter referred to as "the Act", shall

apply, and in addition

2.1.1.

"Authority" means the Malta Standards Authority

as established by virtue of the Malta Standards

Authority Act;

2.1.2.

"the Decision" means Council Decision 93/465/

EEC * 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 harmonization directives,

reproduced as Schedule IV;

2.1.3.

"accreditation" means the procedure by which an

authoritative body gives formal recognition that a

body or person is competent to carry out specific

tasks; the Establishment of the Accreditation

Directorate Order lays down the establishment,

organisation and operation of the Accreditation

Directorate within the Malta Standards Authority,

acting as the only recognised national

accreditation body in Malta;

2.1.4.

"certification" means the process whereby a third

party (certification body) provides written

assurance that a product, operation or service

conforms with the stipulated requirements;

2.1.5.

"conformity" means the fulfilment by a product,

process or service of specified requirements;

2.1.6.

"conformity assessment" means any activity

concerned with determining directly or indirectly

that relevant requirements are fulfilled;

2.1.7.

"conformity assessment body" is a body that

conducts conformity assessment;

2.1.8.

"conformity assessment procedure" means the

procedure by which conformity assessment is

attained;

*OJ No. L 220, 30-08-93, p.23.

2.1.9.

"Directorate" means the Consumer and Industrial

Goods Directorate of the Malta Standards

Authority, established by virtue of the Malta

Standards

Authority

(Establishment

of

Directorates) Order;

2.1.10.

"inspection" means the examination of a product

design, product, service, process or plant, and the

determination of their conformity with specific

requirements or, on the basis of professional

judgement, general requirements;

2.1.11.

"inspection body" is a body that performs

inspection;

2.1.12.

"OJ" means the Official Journal of the European

Union;

2.1.13.

"Community" means the European Community;

2.1.14.

"CE marking" means the CE conformity marking

consisting of the symbol 'CE' as set out in

Schedule IV.

RECOGNITION OF TECHNICAL COMPETENCE

This Schedule sets out the framework and conditions for recognition of the

technical competence of bodies, required under regulation 7.2.6, in carrying out

industrial product certification and/or inspection work within the framework of the

application of the regulatory provisions falling under the Act.

In all cases, responsibility for their approval lies with the Minister of Finance and

Economic Affairs, acting on the advice of the Directorate.

Recognition of technical competence involves the preparation by the body

concerned of a "Qualifications Dossier for this purpose, composed of two documents

namely a "Minimum Criteria Report" issued by an expert chosen by the Directorate

and an "Accreditation Certificate" issued by the National Accreditation Body, or by

another National Accreditation Body as recognised by the Authority

A. CRITERIA TO BE TAKEN INTO ACCOUNT FOR THE EXPERT’S REPORT

1. The body, its director and the staff responsible for carrying out the

verification tests shall not be the designer, manufacturer, supplier or installer of the

product which they inspect, nor the authorised representative of any of these parties.

They shall not become either involved directly or as authorised representatives in the

design, construction, marketing or maintenance of the product. This does not

preclude the possibility of exchanges of technical information between the

manufacturer and the body.

2. The body and its staff shall carry out the verification tests with the highest

degree of professional integrity and technical competence and shall be free from all

pressures and inducements, particularly financial, which might influence their

judgement or the results of the inspection, especially from persons or groups of

persons with an interest in the result of verifications.

3. In addition to being technically competent, applicant bodies shall be legal

persons under public law, legal persons under private law, private-sector bodies or

associations of these, with a legal form of public or private limited companies,

whose financial standing can be proved by means of the following supporting

documents or records

Certificate of insurance and tax observance;

Balance sheets for the last three years;

Certificate stating that the body is not bankrupt, in liquidation, being

wound up, in official receivership, in bankruptcy proceedings or in a

similar situation arising from legal provisions;

Certificate stating that the body is not in proceedings for bankruptcy,

official receivership, creditor arrangements or other similar proceeding

under legal provisions.

4. The body shall have at its disposal the necessary staff and possess the

necessary facilities to enable it to perform properly the administrative and technical

tasks connected with verification; it shall also have access to the equipment required

for special verification.

5. The staff responsible for testing/inspection shall have

sound technical and professional training,

knowledge of the Directive or regulations being applied,

satisfactory knowledge of the requirements of the tests they carry out

and adequate experience of such tests,

knowledge of the technology used to manufacture the products to be

checked, of the way they are used, of problems that may arise during

their use and the likely consequences of these,

the ability to exercise professional judgment in respect of the

conformity of the product with the requirements of the regulations being

applied,

the ability to draw up the certificates, records and reports required to

authenticate the performance of the tests.

6. In each instance, the body shall be in a position to assess the conformity of

products against the essential requirements set out in the regulations and

Where harmonised standards are used for conformity assessment,

compliance with the essential requirements is assumed.

Where harmonised standards are not used for conformity assessment, or

where standards do not specify a conformity assessment method, the

body shall use its own method and be able to demonstrate that this

method meets all the essential requirements for assessing the

conformity of the product.

7. The impartiality of inspection staff shall be guaranteed. Their remuneration

shall not depend on the number of tests carried out or on the results of such tests.

8. The body shall take out civil liability insurance for the services it provides

and shall be able to justify the amount of this. This does not apply if its liability is

assumed by the Government of Malta in accordance with national law, or the

Government of Malta itself is directly responsible for the tests.

9. The staff of the body shall be bound to observe professional secrecy with

regard to all information gained in carrying out its tasks (except vis-à-vis the

competent administrative authorities) under a specific Directive or any provision of

national regulations giving effect to it.

B. CRITERIA TO BE TAKEN INTO ACCOUNT FOR ACCREDITATION

1. Accreditation shall be based on the accreditation criteria defined in

international standards, as applied by the National Accreditation Body, or by another

National Accreditation Body as recognised by the Authority.

2. The applicant body shall specify

-

The products or group of products whose conformity is to be assessed;

-

The standards used to evaluate product conformity, or the body’s own

method where standards are not used;

-

The conformity assessment procedures (modules) provided for in the

Directive or law in question and selected for use.

International standards as applied by the National Accreditation Body, or by

another National Accreditation Body as recognised by the Authority, depend on the

module applied by the body, as provided for in Council Decision 93/465/EEC,

reproduced as Schedule IV, or on the corresponding procedure provided for in the

regulations in question.

3. During evaluation of the body to be accredited, account shall be taken of the

following

-

The guidelines for the application of the international standards issued

by the EA (European Co-operation for Accreditation);

-

The Special Guidelines issued by the EA concerning additional

requirements for Notified Bodies;

-

The documents from the European Commission’s CERTIF series

containing additional guidelines for the implementation of the

Directives and on Notified Bodies.

4. After approval has been granted, bodies shall be subject to monitoring in

order to ensure their consistent compliance with the above requirements, in

accordance with the regulations for Accredited Bodies as established by the National

Accreditation Body, or by another National Accreditation Body as recognised by the

Authority.

5. In Malta, accreditation certificates are issued by the National Accreditation

Body, which was set up pursuant to the Establishment of the Accreditation

Directorate Order, acting on the advise of the Accreditation Advisory Board.

METHOD FOR DESIGNATING

CONFORMITY ASSESSMENT BODIES

1. These regulations set out the conditions for the recognition

of the competence and the subsequent approval of bodies to carry

out work on the certification and, or inspection of industrial

products pursuant to regulations issued under the Act, either to

bring Maltese legislation in line with the European Union’s New

Approach Directives, or as national regulations governing the

manufacture and control of industrial products.

3.2. These regulations shall regulate the method of designating

conformity assessment bodies, the method of determining whether

they fulfil the requirements and the method of withdrawing

applicable decisions.

MONITORING OF BODIES

As part of the surveillance referred to in regulations 7.1 to 7.6, bodies shall be

monitored by the Directorate, as follows

1. Each year, at the end of each four-month period, the body sends to the

Directorate a list of all the inspections or certifications it has carried out during the

period in question.

2. The body sends to the Directorate the quality and procedural handbook and

details of the inspections or certifications it carries out.

3. Monitoring includes

-

A check of the documentation submitted pursuant to paragraph 2 above;

-

A sample check of manufacturers on whom inspections or certifications

have been completed;

-

Completion of at least one site inspection or certification;

-

Evaluation of compliance with the obligations set out in paragraphs 1

and 2 of Schedule III.

4. At any stage, the Directorate may involve the National Accreditation Body

in drawing up the monitoring programme and during its execution.

1. The Authority shall guarantee the confidentiality of data

obtained on conformity assessment bodies.

4.1.1.

The Directorate shall keep a register of conformity

assessment bodies carrying out the tasks of

conformity assessment on the basis of technical

regulations.

4.1.2.

This register shall be public and published by the

Directorate in the most appropriate form.

Council Decision 93/465/EEC

COUNCIL DECISION

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 harmonization directives

(93/465/EEC)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and

in particular Article 100a thereof,

Having regard to the proposal from the Commission ( * ),

In cooperation with the European Parliament ( † ),

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

Whereas Council Decision 90/683/EEC of 13 December 1990 concerning the

modules for the various phases of the conformity assessment procedures which are

intended to be used in the technical harmonization directives ( § ) needs to be

*OJ No C 160, 20.6.1991, p. 14; and OJ No C 28, 2.2.1993, p. 16.

†OJ No C 125, 18.5.1992, p.178; OJ No C 115, 26.4.1993, p.117; and Decision of 14 July 1993 (not yet

published in the Official Journal).

‡OJ No C 14, 20.1.1992, p. 15; and OJ No C 129, 10.5.1993, p. 3.

§OJ No L 380, 31.12.1990, p. 13.

substantially amended in various places; whereas it is necessary, in a spirit of clarity

and rationality, to consolidate its provisions by means of this Decision;

Whereas the Council adopted a Resolution on 21 December 1989 concerning a

global approach to conformity assessments ( * );

Whereas the introduction of harmonized methods for the assessment of conformity

and the adoption of a common doctrine for their implementation are likely to

facilitate the adoption of future technical harmonization directives concerning the

placing on the market of industrial products and thus be conducive to the

implementation of the internal market;

Whereas such methods should ensure that products are in full conformity with the

essential requirements laid down in the technical harmonization directives, in order

to provide, in particular, for the health and safety of users and consumers;

Whereas such conformity should be assured without imposing unnecessarily

onerous conditions on manufacturers, and by means of clear and comprehensible

procedures;

Whereas limited flexibility should be introduced as regards use of additional

modules, or variations in the modules, when the specific circumstances of a

particular sector or directive so warrant, but not to such a degree as to undercut the

purpose of the current Decision and only when explicitly justified;

Whereas in the abovementioned Resolution of 21 December 1989 the Council

approved as a guiding principle the adoption of common rules on the use of the CE

marking;

Whereas in its Decision 90/683/EEC the Council laid down that the industrial

products covered by the technical harmonization directives can be placed on the

market only after the manufacturer has affixed the CE marking to them;

Whereas a single CE marking should be used in order to facilitate controls on the

Community market by inspectors and to clarify the obligations of economic

operators in respect of marking under the various Community regulations;

Whereas the aim of the CE marking is to symbolize the conformity of a product

with the levels of protection of collective interests imposed by the total

harmonization directives and to indicate that the economic operator has undergone

all the evaluation procedures laid down by Community law in respect of his product,

HAS DECIDED AS FOLLOWS

Article 1

1. The procedures for conformity assessment which are to be used in the

technical harmonization directives relating to the marketing of industrial products

will be chosen from among the modules listed in the Annex and in accordance with

the criteria set out in this Decision and in the general guidelines in the Annex. These

procedures may only depart from the modules when the specific circumstances of a

particular sector or directive so warrant. Such departures from the modules must be

limited in extent and must be explicitly justified in the relevant directive.

2. This Decision lays down rules for affixing the CE conformity marking

provided for in Community legislation concerning the design, manufacture, placing

on the market, entry into service or use of industrial products.

3. The Commission shall report periodically on the functioning of this

Decision, and on whether conformity assessment and CE marking procedures are

*OJ No C 10, 16.1.1990, p.1.

working satisfactorily or need to be modified.

No later than the end of the transitional period in 1997, or earlier if the matter is

found to be urgent, the Commission shall also report back on any special problems

raised by the incorporation of Council Directive 73/23/EEC of 19 February 1973

relating to electrical equipment designed for use within certain voltage limits within

the scope of CE marking procedures, and, in particular, whether safety is being

compromised. It shall also review any problems raised by the issue of overlapping

Council directives, and whether any further Community measures are required.

Article 2

1. Decision 90/683/EEC is hereby repealed.

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

Done at Brussels, 22 July 1993.

For the Council

The President

M. OFFECIERS-VAN DE WIELE

ANNEX

CONFORMITY ASSESSMENT PROCEDURES AND CE MARKING IN THE

TECHNICAL HARMONIZATION DIRECTIVES

1. GENERAL GUIDELINES

The principal guidelines for the use of conformity assessment procedures in

technical harmonization directives are the following

(a) the essential objective of a conformity assessment procedure is to

enable the public authorities to ensure that products placed on the

market conform to the requirements as expressed in the provisions of

the directives, in particular with regard to the health and safety of users

and consumers;

(b) conformity assessment can be subdivided into modules which relate to

the design phase of products and to their production phase;

(c) as a general rule a product should be subject to both phases before being

able to be placed on the market if the results are positive ( * );

(d) there are a variety of modules which cover the two phases in a variety of

ways. The directives must set the range of possible choices which can

be considered by the Council to give the public authorities the high

level of safety they seek, for a given product or product sector;

(e) in setting the range of possible choices open to the manufacturer, the

directives, will take into consideration, in particular, such issues as the

appropriateness of the modules to the type of products, the nature of the

risks involved, the economic infrastructures of the given sector (e.g.

existence or non-existence of third parties), the types and importance of

production, etc. The factors that have been taken into account must be

explicitly spelled out by the Commission in these directives;

(f)

the directives will, in setting the range of possible modules for a given

product or product sector, attempt to leave as wide a choice to the

*The specific directives may provide for different arrangements.

manufacturer as is consistent with ensuring compliance with the

requirements.

The directives will set out the criteria governing the conditions in which

the manufacturer chooses the most appropriate modules for his

production from the modules laid down by the directives;

(g) the directives should avoid imposing unnecessarily modules which

would be too onerous relative to the objectives of the directive

concerned;

(h) notified bodies should be encouraged to apply the modules without

unnecessary burden for the economic operators. The Commission, in

cooperation with the Member States, must ensure that close cooperation

is organized between the notified bodies in order to ensure consistent

technical application of the modules;

(i)

in order to protect the manufacturers, the technical documentation

provided to notified bodies has to be limited to that which is required

solely for the purpose of assessment of conformity. Legal protection of

confidential information is required;

(j)

whenever directives provide the manufacturer with the possibility of

using modules based on quality assurance techniques, the manufacturer

must also be able to have recourse to a combination of modules not

using quality assurance, and vice versa, except where compliance with

the requirements laid down by the directives requires the exclusive

application of a certain procedure;

(k) for the purposes of operating the modules, Member States must notify

on their own responsibility bodies under their jurisdiction which they

have chosen from the technically competent bodies complying with the

requirements of the directives. This responsibility involves the

obligation for the Member States to ensure that the notified bodies

permanently have the technical qualifications required by the directives

and that the latter keep their competent national authorities informed of

the performance of their tasks. Where a Member State withdraws its

notification of a body, it must take appropriate steps to ensure that the

dossiers are processed by another notified body to ensure continuity;

(l)

in addition, with regard to conformity assessment, the sub-contracting

of work shall be subject to certain conditions guaranteeing

-

the competence of the establishment operating as sub-contractor,

on the basis of conformity with series EN 45 000 standards, and

the capability of the Member State that has notified the sub-

contracting body to ensure effective monitoring of such

compliance,

-

the ability of the body notified to exercise effective responsibility

for the work carried out under sub-contract;

(m) notified bodies which can prove their conformity with harmonized

standards (EN 45 000 series) by submitting an accreditation certificate

or other documentary evidence, are presumed to conform to the

requirements of the directives. Member States having notified bodies

unable to prove their conformity with the harmonized standards (EN 45

000 series) may be requested to provide the Commission with the

appropriate supporting documents on the basis of which notification

was carried out;

(n) a list of notified bodies must be published by the Commission in the

Official Journal of the European Communities and constantly updated.

The principal guidelines for the affixing and use of the CE marking are the

(a) The CE marking symbolizes conformity to all the obligations incumbent

on manufacturers for the product by virtue of the Community directives

providing for its affixing.

Thus such conformity is not Iimited to the essential requirements

relating to safety, public health, consumer protection etc., as certain

directives may impose specific obligations not necessarily forming part

of the essential requirements.

(b) The CE marking affixed to industrial products symbolizes the fact that

the natural or legal person having affixed or been responsible for the

affixing of the said marking has verified that the product conforms to all

the Community total harmonization provisions which apply to it and has

been the subject or the appropriate conformity evaluation procedures.

(c) Where the industrial products are subject to other directives concerning

other aspects and which also provide for the affixing of the CE marking,

the latter must indicate that the products are also presumed to conform

to the provisions of those other directives.

However, where one or more of these directives allow the manufacturer,

during a transitional period, to choose which arrangements to apply, the

CE marking indicates conformity to the provisions only of those

directives applied by the manufacturer. In this case, particulars of the

directives applied, as published in the Official Journal of the European

Communities, must be given in the documents, notices or instructions

accompanying the products or, where appropriate, on the data plate.

(d)

1. The CE conformity marking must consist of the initials 'CE'

taking the following form

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

the above graduated drawing must be respected.

2. Where the directive concerned does not impose specific

dimensions, the CE marking must have a height of at least 5 mm.

3. The CE marking must be affixed to the product or to its data plate.

However, where this is not possible or not warranted on account

of the nature of the product, it must be affixed to the packaging, if

any, and to the accompanying documents, where the directive

concerned provides for such documents.

4. The CE marking must be affixed visibly, legibly and indelibly.

(e) Any industrial product covered by the technical harmonization

directives based on the principles of the global approach must bear the

CE marking, save where the specific directives provide otherwise; such

exceptions constitute derogations not from the marking requirement but

from the administrative procedures for conformity evaluation, which

may in certain cases be considered too cumbersome. Appropriate

grounds must accordingly be given for any exception to or derogation

from the marking requirement.

The CE marking is the only marking which certifies that the industrial

products conform to the directives based on the principles of the global

approach.

Member States must refrain from introducing into their national

regulations any reference to a conformity marking other than the CE

marking in connection with conformity to all the provisions contained

in the directives on CE marking.

(f)

The CE marking must be affixed at the end of the production control

phase.

(g) The CE conformity marking must be followed by the identification

number of the notified body within the meaning of paragraph I.A where

the said body is involved in the production control phase within the

meaning of this Decision.

Such identification numbers must be assigned by the Commission as

part of the body notification procedure. The Commission must publish

lists of the notified bodies in the Official Journal of the European

Communities; such lists must be updated regularly.

A notified body must be assigned the same number when it is notified

under several directives. The Commission must ensure that each

notified body receives a single identification number, however many

directives it is notified under.

(h) It is necessary to lay down provisions concerning the use of certain

products. In this case, the CE marking and the identification number of

the notified body may be followed by a pictogram or any other mark

indicating, for example, the category of use.

(i)

The affixing for any other marking liable to deceive third parties as to

the meaning and form of the CE marking must be prohibited.

(j)

A product may bear different marks, for example marks indicating

conformity to national or European standards or with traditional

optional directives, provided such marks are not liable to cause

confusion with the CE marking.

Such marks may therefore only be affixed to the product; its packaging

or the documentation accompanying the product on condition that the

legibility and visibility of the CE marking are not thereby reduced.

(k) The CE marking must be affixed by the manufacturer or his agent

established within the Community. In exceptional duly warranted cases

the specific directives may provide that the CE marking can be affixed

by the person respensible for placing the product on the Community

METHOD FOR DESIGNATING

CONFORMITY ASSESSMENT BODIES

market.

The identification number of the notified body must be affixed under its

responsibility either by the body itself or by the manufacturer or his

agent established within the Community.

(l)

Member States must take all provisions of national law necessary to

exclude any possibility of confusion and to prevent abuse of the CE

marking.

Without prejudice to the provisions in the directive concerned relating

to the application of the safeguard clause, where a Member State

establishes that the CE marking has been affixed unduly, the

manufacturer, his agent or, exceptionally, where the specific directives

so provide, the person responsible for placing the product in question on

the Community market is obliged to make the product comply and to

end the infringement under conditions imposed by the Member State.

Where non-compliance continues, the Member State must take all

appropriate measures to restrict or prohibit the placing on the market of

the pnþduct in question or to ensure that it is withdrawn from the market

in accordance with the procedures laid down in the safeguard clauses.

II.

MODULES FOR CONFORMITY ASSESSMENT

Explanatory notes

Specific directives may allow the CE marking to be affixed to the packaging or the

accompanying documentation, instead of to the product itself.

The declaration of conformity or the certificate of conformity (whichever of the

two applies in the directive concerned) must cover either individual or several

products and shall either accompany the product(s) covered or be kept by the

manufacturer. The appropriate solution for the directive concerned will be specified.

References to Articles refer to the standard paragraphs of Annex II.B to the

Council resolution of 7 May 1985 (OJ No C 136, 4.6.1985, p.1), which have become

standard Articles in the 'new approach' directives.

The development of computerized communication of certificates and other

documents issued by notified bodies is envisaged within INSIS.

Specific directives may use modules A, C and H with additional provisions

containing supplementary requirements which figure in the boxes in the modules.

Module C is designed to be used in combination with module B (EC type-

examination). Modules D, E and F will also normally be used in combination with

module B; however, in special cases (for example, when dealing with certain

products of very simple design and construction) they may be used on their own.

Module A (internal production control)

1. This module describes the procedure whereby the manufacturer or his

authorized representative established within the Community, who carries out the

obligations laid down in point 2, ensures and declares that the products concerned

satisfy the requirements of the directive that apply to them. The manufacturer or his

authorized manufacturer established within the Community must affix the CE

marking to each product and draw up a written declaration of conformity.

2. The manufacturer must establish the technical documentation described in

paragraph 3 and he or his authorized representative established within the

Community must keep it for a period ending at least 10 years ( * ) after the last

product has been manufactured at the disposal of the relevant national authorities for

inspection purposes.

Where neither the manufacturer nor his authorized representative is

e s t a b l i s h e d w i t h i n t h e C o m m u n i t y, t h e o b l i g a t i o n t o k e e p t h e t e c h n i c a l

documentation available is the responsibility of the person who places the product

on the Community market.

3. Technical documentation must enable the conformity of the product with the

requirements of the directive to be assessed. It must, as far as relevant for such

assessment, cover the design, manufacture and operation of the product ( † ).

4. The manufacturer or his authorized representative must keep a copy of the

declaration of conformity with the technical documentation.

5. The manufacturer must take all measures necessary in order that the

manufacturing process ensures compliance of the manufactured products with the

technical documentation referred to in point 2 and with the requirements of the

directive that apply to them.

Module Aa

This module consists of module A, plus the following supplementary

requirements

For each product manufactured one or more tests on one or more specific aspects of the

product must be carried out by the manufacturer or on his behalf (*). The tests are carried out

on the responsibility of a notified body chosen by the manufacturer.

On the responsibility of the notified body, the manufacturer must affix the former ’s

identification number during the manufacturing process.

(*) If this option is adopted in a specific directive, the products concerned and the tests to be carried out

must be specified.

or

A notified body chosen by the manufacturer must carry out or have carried out product

checks at random intervals. An adequate sample of the final products, taken on site by the

notified body, must be examined and appropriate tests as set out in the relevant standard(s)

referred to in Article 5, or equivalent tests must be carried out to check the conformity of the

product with the relevant requirements of the directive.

In those cases where one or more of the products checked do not conform the notified body

must take appropriate measures.

The product checking must include the following aspects

(Relevant aspects must be specified here such as for example the statistical method to be

applied, the sampling plan with its operational characteristics, etc.)

On the responsibility of the notified body, the manufacturer must affix the former ’s

identification number during the manufacturing process.

*The specific directives may alter this period.

†The content of the technical documentation shall be laid down directive by directive in accordance with the

product concerned. For example, the documentation must contain so far as relevant for assessment

- 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 said drawings and schemes and the

operation of the product,

- a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solu-

tions adopted to meet the essential requirements of the directive where the standards referred to in

Article 5 have not been applied,

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

- test reports.

Module B (EC type-examination)

1. This module describes that part of the procedure by which a notified body

ascertains and attests that a specimen, representative of the production envisaged,

meets the provisions of the directive that apply to it.

2. The application for the EC type-examination must be lodged by the

manufacturer or his authorized representative established within the Community

with a notified body of his choice.

The application must include

the name and address of the manufacturer and, if the application is

lodged by the authorized representative, his name and address in

addition,

a written declaration that the same application has not been lodged with

any other notified body,

the technical documentation, as described in point 3.

The applicant must place at the disposal of the notified body a specimen,

repesentative of the production envisaged and hereinafter called 'type' ( * ). The

notified body may request further specimens if needed for carrying out the test

3. The technical documentation must enable the conformity of the product with

the requirements of the directive to be assessed. It must, as far as relevant for such

assessment, cover the design, manufacture and operation of the product ( † ).

4. The notified body must

examine the technical documentation, verify that the type has been

manufactured in conformity with the technical documentation and

identify the elements which have been designed in accordance with

the relevant provisions of the standards referred to in Article 5, as well

as the components which have been designed without applying the

relevant provisions of those standards;

perform or have performed the appropriate examinations and

necessary tests to check whether, where the standards referred to in

Article 5 have not been applied, the solutions adopted by the

manufacturer meet the essential requirements of the directive;

perform or have performed the appropriate examinations and

necessary tests or check whether, where the manufacturer has chosen

to apply the relevant standards, these have actually been applied;

agree with the applicant the location where the examinations and

necessary tests will be carried out.

*A type may cover several versions of the product provided that the differences between the versions do not

affect the level of safety and the other requirements concerning the performance of the product.

†The content of the technical documentation shall be laid down directive by directive in accordance with the

product concerned. For example, the documentation must contain so far as relevant for assessment

- a general description,

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

- descriptions and explanations necessary for the understanding of said drawings and schemes and the

operation of the product,

- a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solu-

tions adopted to meet the essential requirements of the directive where the standards referred to in

Article 5 have not been applied,

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

- test reports.

5. Where the type meets the provisions of the directive, the notified body must

issue an EC type-examination certificate to the applicant. The certificate must

contain the name and address of the manufacturer, conclusions of the examination,

conditions for its validity and the necessary data for identification of the approved

type ( * ).

A list of the relevant technical documentation must be annexed to the

certificate and a copy kept by the notified body.

If the manufacturer is denied a type certification, the notified body must

provide detailed reasons for such denial.

Provision must be made for an appeals procedure.

6. The applicant must inform the notified body that holds the technical

documentation concerning the EC type-examination certificate of all modifications

to the approved product which must receive additional approval where such changes

may affect the conformity with the essential requirements or the prescribed

conditions for use of the product. This additional approval is given in the form of an

addition to the original EC type-examination certificate.

7. Each notified body must communicate to the other notified bodies the

relevant information concerning the EC type-examination certificates and additions

issued and withdrawn ( † ).

8. The other notified bodies may receive copies of the EC type-examination

certificates and, or their additions. The Annexes to the certificates must be kept at

the disposal of the other notified bodies.

9. The manufacturer or his authorized representative must keep with the

technical documentation copies of EC type-examination certificates and their

additions for a period ending at least 10 years ( ‡ ) after the last product has been

manufactured.

Where neither the manufacturer nor his authorized representative is

e s t a b l i s h e d w i t h i n t h e C o m m u n i t y, t h e o b l i g a t i o n t o k e e p t h e t e c h n i c a l

documentation available is the responsibility of the person who places the product

on the Community market.

Module C (conformity to type)

1. This module describes that part of the procedure whereby the manufacturer

or his authorized representative established within the Community ensures and

declares that the products concerned are in conformity with the type as described in

the EC type-examination certificate and satisfy the requirements of the directive that

applies to them. The manufacturer or his authorized representative established

within the Community must affix the CE marking to each product and draw up a

written declaration of conformity.

2. The manufacturer must take all measures necessary to ensure that the

manufacturing process assures compliance of the manufactured products with the

type as described in the EC type-examination certificate and with the requirements

of the directive that apply to them.

3. The manufacturer or his authorized representative must keep a copy of the

declaration of conformity for a period ending at least 10 years ( § ) after the last

*The specific directives may provide for the certificate to have a period of validity.

†The specific directive may provide for different arrangements.

‡The specific directives may alter this period.

§The specific directives may alter this period.

METHOD FOR DESIGNATING

CONFORMITY ASSESSMENT BODIES

product has been manufactured.

Where neither the manufacturer nor his authorized representative is

e s t a b l i s h e d w i t h i n t h e C o m m u n i t y, t h e o b l i g a t i o n t o k e e p t h e t e c h n i c a l

documentation available is the responsibility of the person who places the product

on the Community market.

Possible supplementary requirements

For each product manufactured one or more tests on one or more specific aspects of the

product must be carried out by the manufacturer or on his behalf (*). The tests are carried out

on the responsibility of a notified body chosen by the manufacturer.

On the responsibility of the notified body, the manufacturer must affix the former ’s

identification number during the manufacturing process.

(*) If this option is adopted in a specific directive, the products concerned and the tests to be carried out

must be specified.

or

A notified body chosen by the manufacturer must carry out or have carried out product

checks at random intervals. An adequate sample of the final products, taken on site by the

notified body, must be examined and appropriate tests as set out in the relevant standard(s)

referred to in Article 5, or equivalent tests must be carried out to check the conformity of the

product with the relevant requirements of the directive. In those cases where one or more of

the products checked do not conform the notified body must take appropriate measures.

The product checking must include the following aspects

(Relevant aspects must be specified here such as for example the statistical method to be

applied, the sampling plan with its operational characteristics, etc.)

On the responsibility of the notified body, the manufacturer must affix the former ’s

identification number during the manufacturing process.

Module D ( * ), (production quality assurance)

1. This module describes the procedure whereby the manufacturer who

satisfies the obligations of point 2 ensures and declares that the products concerned

[are in conformity with the type as described in the EC type-examination certificate

and] satisfy the requirements of the directive that apply to them. The manufacturer

or his authorized representative established within the Community must affix the CE

marking to each product and draw up a written declaration of conformity. The CE

marking must be accompanied by the identification symbol of the notified body

responsible for EC monitoring as specified in point 4.

2. The manufacturer must operate an approved quality system for production,

final product inspection and testing as specified in paragraph 3 and is subject to

monitoring as specified in point 4.

3. Quality system

3.1.

The manufacturer must lodge an application for assessment of his

quality system with a notified body of his choice, for the products

concerned.

The application must include

-

all relevant information for the product category envisaged,

-

the documentation concerning the quality system,

*Where this module is used without module B

- points 2 and 3 of module A must be added between points 1 and 2 in order to incorporate the need for

technical documentation,

- the words in square brackets must be deleted.

-

if applicable, the technical documentation of the approved type

and a copy of the EC type-examination certificate.

The quality system must ensure compliance of the products [with the

type as described in the EC type-examination certificate and] with the

requirements of the directive 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 must permit a consistent interpretation

of the quality programmes, plan, manuals and records.

It must contain in particular and adequate description of

-

the quality objectives and the organizational structure,

responsibilities and powers of the management with regard to

product quality,

-

the 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 of the personnel concerned,

etc.,

-

the means to monitor the achievement of the required product

quality and the effective operation of the quality system.

The notified body must assess the quality system to determine whether

it satisfies the requirements referred to in point 3.2. It presumes

conformity with these requirements in respect of quality systems that

implement the relevant harmonized standard ( * ).

The auditing team must have at least one member with experience of

evaluation in the product technology concerned. The evaluation

procedure must include an inspection visit to the manufacturer’s

premises.

The decision must be notified to the manufacturer. The notification

must contain the conclusions of the examination and the reasoned

assessment decision.

The manufacturer must undertake to fulfil the obligations arising out

of the quality system as approved and to uphold it so that it remains

adequate and efficient.

The manufacturer or his authorized representative shall keep the

notified body that has approved the quality system informed of any

intended updating of the quality system.

The notified body must evaluate the modifications proposed and

decide whether the amended quality system will still satisfy the

requirements referred to in paragraph 3.2 or whether a re-assessment

is required.

It must notify its decision to the manufacturer. The notification must

*This harmonized standard will be EN 29 002, supplemented, if necessary, to take into account the specific

nature of the products for which it is implemented.

contain the conclusions of the examination and the reasoned

assessment decision.

4. Surveillance under the responsibility of the notified body

The purpose of surveillance is to make sure that the manufacturer duly

fulfils the obligations arising out of the approved quality system.

The manufacturer must allow the notified body entrance for inspection

purposes to the locations of manufacture, inspection and testing, and

storage and must 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 of the personnel concerned,

etc.

The notified body must periodically ( * ) carry out audits to make sure

that the manufacturer maintains and applies the quality system and

must provide an audit report to the manufacturer.

Additionally the notified body may pay unexpected visits to the

manufacturer. During such visits the notified body may carry out, or

cause to be carried out, tests to verify that the quality system is

functioning correctly, if necessary. The notified body must provide the

manufacturer with a visit report and, if a test has taken place, with a

test report.

The manufacturer must, for a period ending at least 10 years ( † ) after the last

5. product has been manufactured, keep or the disposal of the national authorities

the documentation referred to in the second indent of point 3.1,

the updating referred to in the second paragraph of point 3.4,

the decisions and reports from the notified body which are referred to in

the final paragraph of point 3.4, points 4.3 and 4.4.

6. Each notified body must give the other notified bodies the relevant

information concerning the quality system approvals issued and withdrawn ( ‡ ).

Module E ( § ) (product quality assurance)

1. This module describes the procedure whereby the manufacturer who

satisfies the obligations of point 2 ensures and declares that the products concerned

[are in conformity with the type as described in the EC type-examination certificate

and] satisfy the requirements of the directive that apply to them. The manufacturer

or his authorized representative established within the Community must affix the CE

mark to each product and draw up a written declaration of conformity. The CE mark

must be accompanied by the identification symbol of the notified body responsible

for surveillance as specified in point 4.

2. The manufacturer must operate an approved quality system for final product

*In the specific directives, the frequency may be specified.

†The specific directives may alter this period.

‡The specific directives may provide for different arrangements.

§When this module is used without module B

- points 2 and 3 of module A must be added between points 1 and 2 in order to incorporate the need for

technical documentation,

- the words in square brackets must be deleted.

inspection and testing as specified in paragraph 3 and must be subject to surveillance

as specified in point 4.

3. Quality system

The manufacturer must lodge an application for assessment of his

quality system for the products concerned, with a notified body of his

choice.

The application must include

-

all relevant information for the product category envisaged,

-

the quality system’s documentation,

-

if applicable, the technical documentation of the approved type

and a copy of the EC type-examination certificate.

Under the quality system, each product must be examined and

appropriate tests as set out in the relevant standard(s) referred to in

Article 5 or equivalent tests shall be carried out in order to ensure its

conformity with the relevant requirements of the directive. All the

elements, requirements and provisions adopted by the manufacturer

must be documented in a systematic and orderly manner in the form at

wùritten policies, procedures and instructions. This quality system

documentation must ensure a common understanding of the quality

programmes, plans, manuals and records.

It must contain in particular and adequate description of

-

the quality objectives and the organizational structure,

responsibilities and powers of the management with regard to

product quality,

-

the examinations and tests that will he carried out after

manufacture,

-

the means to monitor the effective operation of the quality

syþstem,

-

quality records, such as inspection reports and test data,

calibration data, qualification reports of the personnel concerned,

etc.

The notified body must assess the quality system to determine whether

it satisfies the requirements referred to in point 3.2. It presumes

conformity with these requirements in respect of quality systems that

implement the relevant harmonized standard ( * ).

The auditing team must have at least one member experienced as an

assessor in the product technology concerned. The assessment

procedure must include an assessment visit to the manufacturer’s

premises.

The decision must be notified to the manufacturer. The notification

must contain the conclusions of the examination and the reasoned

assessment decision.

The manufacturer must undertake to discharge the obligations arising

from the quality system as approved and to maintain it in an

appropriate and efficient manner.

*This harmonized standard will be EN 29 003, supplemented if necessary to allow for the specific features

of the products for which it is implemented.

The manufacturer or his authorized representative must keep the

notified body which has approved the quality system informed of any

intended updating of the quality system.

The notified body must evaluate the modifications proposed and

decide whether the modified quality system will still satisfy the

requirements referred to in paragraph 3.2 or whether a re-assessment

is required.

It must notify its decision to the manufacturer. The notification must

contain the conclusions of the examination and the reasoned

assessment decision.

4. Surveillance under the responsibility of the notified body

The purpose of surveillance is to make sure that the manufacturer duly

fulfils the obligations arising out of the approved quality system.

The manufacturer must allow the notified body entrance for inspection

purposes to the locations of inspection, testing and storage and shall

provide it with all necessary information, in particular

-

the quality system documentation,

-

the technical documentation,

-

the quality records, such as inspection reports and test data,

calibration data, qualification reports of the personnel concerned,

etc.

The notified body must periodically ( * ) carry out audits to ensure that

the manufacturer maintains and applies the quality system and must

provide an audit report to the manufacturer.

Additionally, the notified body may pay unexpected visits to the

manufacturer. At the time of such visits, the notified body may carry

out tests or have them carried out in order to check the proper

functioning of the quality system where necessary; it must provide the

manufacturer with a visit report and, if a test has been carried out,

with a test report.

The manufacturer must, for a period ending at least 10 years ( † ) after the last

5. product has been manufactured, keep at the disposal of the national authorities

the documentation referred to in the third indent of point 3.1,

the updating referred to in the second paragraph of point 3.4,

the decisions and reports from the notified body which are referred to in

the final paragraph of point 3.4, points 4.3 and 4.4.

6. Each notified body must forward to the other notified bodies the relevant

information concerning the quality system approvals issued and withdrawn ( ‡ ).

Module F ( § ) (product verification)

1. This module describes the procedure whereby a manufacturer or his

*The intervals between audits may be specified in the specific directives.

†The specific directives may alter this period.

‡The specific directives may provide for different arrangements.

§Where this module is used without module B

- it must be supplemented by points 2 and 3 of module A (between points 1 and 2) so as to introduce the

need for technical documentation,

- the words in square brackets must be deleted.

authorized representative established within the Community checks and attests that

the products subject to the provisions of point 3 [are in conformity with the type as

described in the EC-type examination certificate and] satisfy the requirements of the

directive that apply to them.

2. The manufacturer must take all measures necessary in order that the

manufacturing process ensures conformity of the products [with the type as

described in the EC type-examination certificate and] with the requirements of the

directive that apply to them. He shall affix the CE marking to each product and shall

draw up a declaration of conformity.

3. The notified body must carry out the appropriate examinations and tests in

order to check the conformity of the product with the requirements of the directive

either by examination and testing of every product as specified in point 4 or by

examination and testing of products on a statistical basis, as specified in point 5, at

the choice of the manufacturer ( * ).

3a. The manufacturer or his authorized representative must keep a copy of the

declaration of conformity for a period ending at least 10 years( † ) after the last

product has been manufactured.

4. Verification by examination and testing of every product

All products must be individually examined and appropriate tests as

set out in the relevant standard(s) referred to in Article 5 or equivalent

tests shall be carried out in order to verify their conformity with [the

type as described in the EC-type examination certificate and] the

requirements of the directive that apply to them.

The notified body must affix or cause to be affixed, its identification

symbol to each approved product and draw up a written certificate of

conformvty relating to the tests carried out.

The manufacturer or his authorized representative must ensure that he

is able to supply the notified body’s certificates of conformity on

request.

5. Statistical verification

The manufacturer must present his products in the form of

homogeneous lots and shall take all measures necessary in order that

the manufacturing process ensures the homogeneity of each lot

produced.

All products must be available for verification in the form of

homogeneous lots. A random sample shall he drawn from each lot.

Products in a sample shall be individually examined and appropriate

tests as set out in the relevant standard(s) referred to in Article 5, or

equivalent tests, shall be carried out to ensure their conformity with

the requirements of the directive which apply to them and to

determine whether the lot is accepted or rejected.

The statistical procedure must use the following elements

(Relevant elements must be specified here such as, for example, the

statistical method to be applied, the sampling plan with its operational

characteristics, etc.)

In the case of accepted lots, the notified body must affix, or cause to

*The manufacturer’s discretion may be limited in the specific directives.

†The specific directives may alter this period.

METHOD FOR DESIGNATING

CONFORMITY ASSESSMENT BODIES

be affixed, its identification symbol to each product and shall draw up

a written certificate of conformity relating to the tests carried out. All

products in the lot may be put on the market except those products

from the sample which were found not to be in conformity.

If a lot is rejected, the notified body or the competent authority must

take appropriate measures to prevent the putting on the market of that

lot. In the event of frequent rejection of lots the notified body may

suspend the statistical verification.

The manufacturer may, under the responsibility of the notified body,

affix the latter’s identification symbol during the manufacturing

process.

5.5.

The manufacturer or his authorized representative must ensure that he

is able to supply the notified body’s certificates of conformity on

request.

Module G (unit verification)

1. This module describes the procedure whereby the manufacturer ensures and

declares that the product concerned, which has been issued with the certificate

referred to in point 2, conforms to the requirements of the directive that apply to it.

The manufacturer or his authorized representative established within the Community

must affix the CE marking to the product and draw up a declaration of conformity.

2. The notified body must examine the individual product and carry out the

appropriate tests as set out in the relevant standard(s) referred to in Article 5, or

equivalent tests, to ensure its conformity with the relevant requirements of the

directive.

The notified body must affix, or cause to be affixed, its identification

number on the approved product and shall draw up a certificate of conformity

concerning the tests carried out.

3. The aim of the technical documentation is to enable conformity with the

requirements of the directive to be assessed and the design, manufacture and

operation of the product to be understood ( * ).

Module H (full quality assurance)

1. This module describes the procedure whereby the manufacturer who

satisfies the obligations of paragraph 2 ensures and declares that the products

concerned satisfy the requirements of the directive that apply to them. The

manufacturer or his authorized representative established within the Community

must affix the CE marking to each product and draw up a written declaration of

conformity. The CE marking must be accompanied by the identification symbol of

the notified body responsible for the surveillance as specified in point 4.

2. The manufacturer must operate an approved quality system for design,

*The content of the technical documentation shall be laid down directive by directive in accordance with the

products concerned. As an example the documentation shall contain so far as relevant for assessment

- 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 said drawings and schemes and the

operation of the product,

- a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions

adopted to meet the essential requirements of the directive where the standards referred to in Article 5

have not been applied,

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

- test reports.

manufacture and final product inspection and testing as specified in point 3 and shall

be subject to surveillance as specified in point 4.

3. Quality system

The manufacturer must lodge an application for assessment of his

quality system with a notified body.

The application must include

all relevant information for the product category envisaged,

the quality system’s documentation.

The quality system must ensure compliance of the products with the

requirements of the directive that apply to them.

All the elements, requirements and provisions adopted by the

manufacturer must be documented in a systematic and orderly manner

in the form of written policies, procedures and instructions. This

quality system documentation shall ensure a common understanding

of the quality policies and procedures such as quality programmes,

plans, manuals and records.

It must contain in particular an adequate description of

the quality objectives and the organizational 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 standards referred to in Article 5 will

not be applied in full, the means that will be used to ensure that

the essential requirements of the directive 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 frequencyù with which they will be

carried out,

the quality records, such as inspection reports and test data,

calibration data, qualification reports of the personnel concerned,

etc.,

the means to monitor the achievement of the required design and

product quality and the effective operation of the quality system.

The notified body must assess the quality system to determine whether

it satisfies the re uirements referred to in point 3.2. It shall presume

compliance with these requirements in respect of quality systems that

implement the relevant harmonized standard ( * ).

The auditing team must have at least one member experienced as an

assessor in the product technology concerned. The evaluation

*This harmonized standard shall be EN 29 001, completed if necessary to take into consideration the

specificity of the products in which it is implemented.

procedure shall include an assessment visit to the manufacturer’s

premises.

The decision must be notified to the manufacturer. The notification

must contain the conclusions of the examination and the reasoned

assessment decision.

The manufacturer must undertake to fulfil the obligations arising out

of the quality system as approved and to uphold it so that it remains

adequate and efficient.

The manufacturer or his authorized representative must keep the

notified body that has approved the quality system informed of any

intended updating of the quality system.

The notified body must evaluate the modifications proposed and

decide whether the amended quality system will still satisfy the

requirements referred to in paragraph 3.2 or whether a re-assessment

is required.

It must notify its decision to the manufacturer. The notification shall

contain the conclusions of the examination and the reasoned

assessment decision.

4. EC surneillance under the responsibility of the notified body

The purpose of surveillance is to make sure that the manufacturer duly

fulfils the obligations arising out of the approved quality system.

The manufacturer must allow the notified body entrance for inspection

purposes to the locations of design, manufacture, inspection and

testing, and storage, and shall provide it with all necessary

information, in particular

-

the quality system documentation,

-

the quality records as foreseen by the design part of the quality

system, such as results of analyses, calculations, tests, etc.,

-

the quality records as foreseen by the manufacturing part of the

quality system, such as inspection reports and test data,

calibration data, qualification reports of the personnel concerned,

etc.

The notified body must periodically ( * ) carry out audits to make sure

that the manufacturer maintains and applies the quality system and

shall provide an audit report to the manufacturer.

Additionally the notified body may pay unexpected visits to the

manufacturer. At the time of such visits, the notified body may carry

out tests or have them carried out in order to check the proper

functioning of the quality system where necessary; it must provide the

manufacturer with a visit report and, if a test has been carried out,

with a test report.

The manufacturer must, for a period ending at least 10 years ( † ) after the last

5. product has been manufactured, keep at the disposal of the national authorities

the documentation referred to in the second indent of the second

subparagraph of point 3.1,

*In the specific directives, the frequency may be specified.

†The specific directives may alter this period.

-

the updating referred to in the second subparagraph of point 3.4,

-

the decisions and reports from the notified body which are referred to in

the final subparagraph of point 3.4, points 4.3 and 4.4.

6. Each notified body must forward to the other notified bodies the relevant

information concerning the quality system approvals issued and withdrawn ( * ).

Possible supplementary requirements

Design examination

1. The manufacturer must lodge an application for examination of the design with a single

notified body.

2. The application must enable the design, manufacture and operation of the product to be

understood, and shall enable conformity with the requirements of the directive to be

assessed.

It must include

- the technical design specifications, including standards, that have been applied,

- the necessary supporting evidence for their adequacy, in particular where the

standards referred to in Article 5 have not been applied in full. This supporting

evidence must include the results of tests carried out by the appropriate laboratory of

the manufacturer or on his behalf.

3. The notified body must examine the application and where the design meets the

provisions of the directive that apply to it must issue an EC design examination certificate

to the applicant. The certificate shall contain the conclusions of the examination

conditions for its validity, the necessary data for identification of the approved design

and, if relevant, a description of the product’s functioning.

4. The applicant must keep the notified body that has issued the EC design examination

certificate informed of any modification to the approved design. Modifications to the

approved design must receive additional approval from the notified body that issued the

EC design examination certificate where such changes may affect the conformity with the

essential requirements of the directive or the prescribed conditions for use of the product.

This additional approval is given in the form of an addition to the original EC design

examination certificate.

5. The notified bodies must forward to the other notified bodies the relevant information

concerning

- the EC design examination certificates and additions issued,

- the EC design approvals and additional approvals withdrawn (*).

(*) The specific directives may provide for different arrangements.

*The specific directives may provide for different arrangements.

METHOD FOR DESIGNATING

CONFORMITY ASSESSMENT BODIES

1. Maltese bodies wishing to operate within the scope of the

"New Approach", CE Marking Directives, as implemented by

virtue of the regulations listed in Schedule I, shall follow the

procedure listed in regulations 7.1 to 8.6.

5.2. Bodies in Member States of the Community wishing to

operate in Malta within the scope of the "New Approach", CE

Marking Directives shall

5.2.1.

be notified for this purpose by the Member State

in which they have their registered office;

5.2.2.

declare in writing to the Directorate that they

intend to carry out the activity in question and that

they agree to the terms of these regulations;

5.2.3.

provide evidence of their notification.

1. Bodies in Malta and in Member States of the Community

wishing to operate within the scope of national regulations that

have been issued for purpo ses ot her th an bri nging Maltese

legislation into line with European Union New Approach

Directives, shall follow the procedure listed in regulations 7.1 to

6.

7.1. The procedure for designating a conformity assessment

body, hereinafter referred to as the "applicant" shall commence

with the submission of an application to perform conformity

assessment tasks to the Directorate, in accordance with the general

administrative procedure.

7.2. The application shall contain the following data, and the

following evidence shall be enclosed

7.2.1.

general data (name or firm and address, legal

status, organisational structure with a description

of relations between individual organisational

units, and data on the activities that could affect

the impartiality of work);

7.2.2.

document from a court register or from other

register;

7.2.3.

technical and staff capacities, and the locations of

performance of conformity assessment tasks;

7.2.4.

the technical regulation on the basis of which

conformity assessment tasks are to be performed;

7.2.5.

the definition of the type, area and scope of tasks

and products to which the tasks refer;

7.2.6.

the "Qualifications Dossier" drawn up according

to Schedule II and made up of

7.2.6.1.

the "Minimum Criteria Report"

prepared by an expert chosen by the

Authority as per Schedule II(A); and

7.2.6.2.

the "Accreditation Certificate" issued

by the National Accreditation Body, or

by another National Accreditation

Body as recognised by the Authority,

as per Schedule II(B).

7.3. The Directorate shall determine the applicant’s

qualifications on the basis of the documents submitted by the

applicant in accordance with regulation 7.2.

7.3.1.

After examining the submitted application, it shall

assess whether it is necessary to make an

assessment visit to the applicant's head office or

any other locations where the activities relevant to

the procedure are performed, or to obtain further

evidence.

7.4. When the applicant demonstrates its qualifications with the

document referred to in regulation 7.2.6, the Directorate shall

examine the compliance of the scope of tasks relevant to the

application with the scope of tasks for which the applicant has been

accredited, or with the scope of tasks referred to in the

qualifications report.

7.4.1.

The costs of the provision of evidence on

qualifications shall always be covered by the

applicant.

7.4.2.

Should the Directorate determine that the

submitted evidence of qualifications is incomplete

and fails to demonstrate the fulfilment of all

requirements under the relevant technical

regulation, it may instruct the applicant to

complete them by the end of the procedure.

7.4.3.

The Directorate shall regard the applicant to be

qualified if it has submitted a complete document

referred to in regulation 7.2.6 as defined by a

relevant technical regulation. In this event, the

Directorate shall issue an opinion communicated

to the Minister who shall issue a decision on

designation to perform particular tasks in

conformity assessment procedures.

7.4.4.

Should the scopes of tasks referred to in

regulation 7.4 fail to agree, the Directorate shall

define the applicant’s scope of tasks which are not

covered in the submitted documents, and shall

instruct the applicant to submit additional

evidence, or shall adopt an opinion as to what type

of additional evidence is needed. This opinion is

communicated to the Minister who shall issue the

relevant decision.

7.5. If the applicant fails to submit the document referred to in

regulation 7.2.6 and is instructed by the Directorate to subsequently

submit evidence on meeting the conditions for carrying out the

tasks, the Directorate shall issue an opinion which is communicated

to the Minister who shall adopt a decision on obtaining additional

evidence.

7.6. On the basis of facts found out, the Directorate shall issue

an opinion on

(a) the applicant’s fulfilment of the conditions for the

issuing and extension of the decision, and the opinion

on the total or partial compliance of the document with

the requirements of the relevant technical regulation in

relation to regulation 7.2.6;

(b) the measures necessary for the elimination of

deficiencies found out during the surveillance pursuant

to the provisions of regulations 7.1 to 7.5;

(c) notification under regulation 8.1,

that shall be communicated to the Minister who shall issue a

decision on the application.

7.7. The decision on designating a conformity assessment body

shall contain at least the following data

7.7.1.

the title of the relevant technical regulation;

7.7.2.

a detailed description of the scope of work

determined in the decision for which

qualifications have been found out;

7.7.3.

period of validity of the decision;

7.7.4.

identification number assigned to the conformity

assessment body by the Minister;

7.7.5.

name of signatory who has been empowered to

sign on documents issued by the conformity

assessment body.

7.8. A decision shall be issued to the conformity assessment

body which has demonstrated its credentials by means of the

"Qualifications Dossier" made up of a "Minimum Criteria Report"

not older that three months, for a maximum of four years, and an

"Accreditation Cerificate" for not longer than the duration of

validity of the accreditation certificate.

7.9. The decision on designating the conformity assessment

body may be extended after the expiry of the period of validity, or

after the expiry of the validity of the documents referred to in

regulation 7.8, if the applicant submits the valid evidence referred

to in regulation 7.2.

7.10. The conformity assessment body may subcontract some

clearly defined tasks to a subcontractor, if the sub-contractor can

provide evidence that it meets the prescribed requirements referred

to in regulation 7.2.

7.10.1.

The subcontracted tasks shall supplement the

activities carried out by the conformity assessment

body, and shall form, with them, an indivisible

whole.

7.10.2.

The conformity assessment body shall be able to

provide proof of the qualification of the sub-

contractor, keep records thereof and assume total

responsibility for the work executed by the sub-

contractor.

7.10.3.

The conformity assessment body shall keep a

register of sub-contractors and the tasks granted to

them.

8.1. The conformity assessment body shall permanently meet

the requirements for designation, keep records of all procedures of

conformity assessment for which it has been designated, and

immediately notify the Directorate of any changes that could affect

its qualification, the scope of activities from the decision or the

fulfilment of the requirements for designation.

8.1.1.

The conformity assessment body shall keep the

records of all working tasks carried out and their

results for at least ten years.

8.2. At the request of the Directorate, the conformity

assessment body shall take part in qualification tests or other

comparisons determined for conformity assessment bodies.

8.2.1.

The conformity assessment body shall allow the

Directorate access to all data related to the

fulfilment of requirements for conformity

assessment, and access to all premises where the

tasks included in the scope of conformity

assessment, as defined in the issued decision, are

carried out.

8.3. Bodies carrying out industrial product certification or

inspection work in accordance with the above provisions shall have

their activities monitored in accordance with the provisions of

Schedule III.

8.4. The Directorate may carry out extraordinary surveillance

of the conformity assessment body if the regularity of its actions is

in doubt.

8.4.1.

If necessary, it may involve the National

Accreditation Body in the implementation of

extraordinary surveillance.

8.5. Should the surveillance referred to in regulations 8.3 and

8.4 found out that the conformity assessment body does not comply

with the requirements for designation, the Directorate shall issue a

decision determining measures and a deadline for the elimination

of irregularities.

8.5.1.

The conformity assessment body shall be obliþþed

to notify the Directorate of the implementation of

the measures determined in the decision by the set

deadline.

8.5.2.

Should the conformity assessment body fail to

eliminate the determined irregularities by the set

deadline, the Minister shall issue a decision on

withdrawal and remove the name of that

conformity assessment body from the register

referred to in regulations 4.1.1 and 4.1.2.

8.6. The Minister shall also withdraw a decision in the event

that the conformity assessment body notifies the Directorate that it

wishes to cease performing the tasks referred to in that decision.

8.7. Manufacturers or producers of products falling within the

scope of the provisions of regulation 3.1 shall, in order to certify or

inspect their products, in accordance with the provisions of the

relevant regulations, make use of the bodies that appear on the list

pubished in the register referred to in regulations 4.1.1 and 4.1.2.

1. The body in question shall, inter alia, co-operate with the

competent authorities responsible for implementation of the

regulations and contribute to the work of the relevant group of

bodies meeting at national and, or European level.

9.2. For market surveillance work, which also includes the

inspections carried out by the bodies, the latter shall

9.2.1.

send to the Directorate the Type Examination

Certificates they issue or other testimonials issued

further to the application of the regulations in

question, as and when these are officially

requested;

9.2.2.

where possible, facilitate the work of the

competent authorities during the conduct of

sample checks.

1. In the event of its being established that a body, producer

or manufacturer is engaged in activities that breach the terms of

these regulations, Part IV of the Act is applicable and the granted

authorisation shall be suspended or revoked or, if the body is a

notified body from abroad, the authority responsible for

notification will be informed.

10.1.1.

In such cases, the name of the body shall be struck

from the register provided for under regulations

4.1.1 and 4.1.2.

1. The Minister shall inform the Commission and the other

Member States of the designation and withdrawal of designation of

conformity assessment bodies carrying out procedures under

technical regulations which are subject to regulation 5.1.

METHOD FOR DESIGNATING

CONFORMITY ASSESSMENT BODIES