EQUIPMENT AND PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE ATMOSPHERES REGULATIONS

SUBSIDIARY LEGISLATION 427.39

EQUIPMENT AND PROTECTIVE SYSTEMS

INTENDED FOR USE IN POTENTIALLY

EXPLOSIVE ATMOSPHERES REGULATIONS

20th April, 2016 *

LEGAL NOTICE 100 of 2016.

(1) The title of these regulations is the Equipment and

Protective Systems intended for Use in Potentially Explosive

Atmospheres Regulations.

(2) These regulations transpose Directive 2014/34/EU of the

European Parliament and of the Council of 26 February 2014 on the

harmonisation of the laws of the Member States relating to the

equipment and protective systems intended for use in potentially

explosive atmospheres (recast).

(1) The making available on the market or putting into

service of products covered by the Equipment and Protective

Systems intended for use in Potentially Explosive Atmospheres

Regulations, 2002, and which were placed on the market before the

20th April 2016 shall not be impeded.

(2) Certificates and decision by notified bodies issued under

the Equipment and Protective Systems Intended For Use In

Potentially Explosive Atmospheres Regulations, 2002 shall be

valid under these regulations.

(1) These regulations shall apply to the following,

hereinafter referred to as "products"

(a) equipment and protective systems intended for use in

potentially explosive atmospheres;

(b) safety devices, controlling devices and regulating

devices intended for use outside potentially explosive

atmospheres but required for or contributing to the

safe functioning of equipment and protective systems

with respect to the risks of explosion;

(c) components intended to be incorporated into

equipment and protective systems referred to in

paragraph (a).

(2)

These regulations shall not apply to

(a) medical devices intended for use in a medical

environment;

(b) equipment and protective systems where the explosion

hazard results exclusively from the presence of

explosive substances or unstable chemical substances;

* see regulation 2(1) of these Regulations as originally promulgated.

(c) equipment intended for use in domestic and non-

commercial environments where potentially explosive

atmospheres may only rarely be created, solely as a

result of the accidental leakage of fuel gas;

(d) personal protective equipment covered by Council

Directive 89/686/EEC of 21 December 1989 on the

approximation of the laws of the Member States

relating to personal protective equipment;

(e) seagoing vessels and mobile offshore units together

with equipment on board such vessels or units;

(f)

means of transport, i.e. vehicles and their trailers

intended solely for transporting passengers by air or by

road, rail or water networks, as well as means of

transport in so far as such means are designed for

transporting goods by air, by public road or rail

networks or by water. Vehicles intended for use in a

potentially explosive atmosphere shall not be excluded

from the scope of these regulations;

(g) the equipment covered by point (b) of Article 346 of

the Treaty on the Functioning of the European Union.

For the purpose of these regulations, the following

definitions shall apply

"accreditation" means accreditation as defined in point 10 of

Article 2 of Regulation (EC) No 765/2008;

"authorised representative" means any natural or legal person

established within the Union who has received a written mandate

from a manufacturer to act on his behalf in relation to specified

tasks;

"CE marking" means a marking by which the manufacturer

indicates that the product is in conformity with the applicable

requirements set out in Union harmonisation legislation providing

for its affixing;

"components" means any item essential to the safe functioning of

equ ipm ent and p rot ect ive system s bu t wi th n o aut onom ou s

function;

"conformity assessment" means the process demonstrating

whether the essential health and safety requirements of these

regulations relating to a product have been fulfilled;

"conformity assessment body" means a body that performs

conformity assessment activities including calibration, testing,

certification and inspection;

"distributor" means 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" means the manufacturer, the authorised

representative, the importer and the distributor;

"equipment" means machines, apparatus, fixed or mobile

devices, control components and instrumentation thereof and

detection or prevention systems which, separately or jointly, are

intended for the generation, transfer, storage, measurement, control

and conversion of energy and/or the processing of material and

which are capable of causing an explosion through their own

potential sources of ignition;

"equipment category" means the classification of equipment,

within each equipment-group, specified in Schedule I, determining

the requisite level of protection to be ensured;

"equipment-group I" means equipment intended for use in

u n d e rg r o u n d p a r t s o f m i n e s , a n d i n t h o s e p a r t s o f s u r f a c e

installations of such mines, liable to be endangered by firedamp

and/or combustible dust, comprising equipment categories M 1 and

M 2 as set out in Schedule I;

"equipment-group II" means equipment intended for use in other

places liable to be endangered by explosive atmospheres,

comprising equipment categories 1, 2 and 3 as set out in Schedule

I;

" e xp l o s i v e a tm os ph e r e " m e a ns a m i x tu r e wi t h ai r, u n d e r

atmospheric conditions, of flammable substances in the form of

gases, vapours, mists or dusts in which, after ignition has occurred,

combustion spreads to the entire unburned mixture;

"harmonised standard" means harmonised standard as defined in

point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;

"importer" means any natural or legal person established within

the Union who places a product from a third country on the Union

market;

"intended use" means the use of a product prescribed by the

manufacturer by assigning the equipment to a particular equipment-

group and category or by providing all the information which is

required for the safe functioning of a protective system, device or

component;

"making available on the market" means any supply of a product

for distribution, consumption or use on the Union market in the

course of a commercial activity, whether in return for payment or

free of charge;

"manufacturer" means any natural or legal person who

manufactures a product or has a product designed or manufactured,

and markets that product under his name or trade mark or uses it for

his own purposes;

"national accreditation body" means national accreditation body

as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;

"placing on the market" means the first making available of a

product on the Union market;

"potentially explosive atmosphere" means an atmosphere which

could become explosive due to local and operational conditions;

"protective systems" means devices other than components of

e q u i p m e n t w hi c h a r e in t e nd e d to h a l t i n c i p i e n t e xp l o s i o n s

immediately and/or to limit the effective range of an explosion and

which are separately made available on the market for use as

autonomous systems;

"recall" means any measure aimed at achieving the return of a

product that has already been made available to the end- user;

"technical specification" means a document that prescribes

technical requirements to be fulfilled by a product;

"withdrawal" means any measure aimed at preventing a product

in the supply chain from being made available on the market;

"Union harmonisation legislation" means any Union legislation

harmonising the conditions for the marketing of products;

(1) Products falling within the scope of these regulations

may be made available on the market and put into service only if,

they are properly installed and maintained and used in accordance

with their intended use,

(2) The provisions of these regulations shall not prevent from

laying down any requirements deemed necessary to ensure that

persons and, in particular, workers are protected when using

relevant products provided that this does not mean that such

products are modified in a way not specified in these regulations.

(3) At trade fairs, exhibitions and demonstrations, the showing

of products which do not comply with these regulations shall not be

prevented, provided that a visible sign clearly indicates that such

products do not comply with these regulations and that they are not

for sale until they have been brought into conformity by the

manufacturer. During demonstrations, adequate safety measures

shall be taken to ensure the protection of persons.

Products shall meet the essential health and safety

requirements set out in Schedule II which apply to them, account

being taken of their intended use.

The making available on the market and putting into

service in Malta of products which comply with these regulations

shall not be prohibited, restricted or impeded.

(1) When placing their products on the market or using

them for their own purposes, manufacturers shall ensure that they

have been designed and manufactured in accordance with the

essential safety requirements set out in Schedule I.

(2) Manufacturers shall draw up the technical documentation

r e f e r r e d t o i n S c h e d u l e I I t o I X a n d c a r r y ou t th e r e l e v a n t

c o n f or m i ty a s s e s s m e n t p r o c e d u re r e f e r r e d t o i n r e g u l a t i o n

15.Where compliance of a product, other than a component, with

the applicable requirements has been dem onstrated by that

procedure, manufacturers shall draw up an EU declaration of

conformity and affix the CE marking. Where compliance of a

component with the applicable requirements has been demonstrated

by the relevant conformity assessment procedure, manufacturers

shall draw up a written attestation of conformity as referred to in

regulation 15(3). Manufacturers shall ensure that each product is

accompanied by a copy of the EU declaration of conformity or of

the attestation of conformity, as appropriate. However, where a

large number of products are delivered to a single user, the batch or

consignment concerned may be accompanied by a single copy.

(3) Manufacturers shall keep the technical documentation and

the EU declaration of conform ity or, where applicable, the

attestation of conformity for 10 years 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 with these regulations.

Changes in a product design or characteristics and changes in the

harmonised standards or in other 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, to

protect the health and safety of end-users, carry out sample testing

of products made available on the market, 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.

(5) Manufacturers shall ensure that products which they have

placed on the market 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.

(6) Manufacturers shall ensure that products, other than

components, which they have placed on the market bear the

specific marking of explosion protection and, where applicable, the

other markings and information referred to in point 1.0.5 of

Schedule II.

(7) Manufacturers shall indicate, on the product, their name,

registered trade name or registered trade mark and the postal

address at which they can be contacted or, where that is not

possible, on its packaging or in a document accompanying the

product. The address shall indicate a single point at which the

manufacturer can be contacted. The contact details shall be in at

least the Maltese or English language.

(8) Manufacturers shall ensure that the product is accompanied

by instructions and safety information in at least the Maltese or

English language. Such instructions and safety information, as well

as any labelling, shall be clear, understandable and intelligible.

(9) Manufacturers who consider or have reason to believe that

a product which they have placed on the market is not in

conformity with these regulations 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, manufacturers shall immediately

inform the Technical Regulations Division, giving details, in

particular, of the non-compliance and of any corrective measures

taken.

(10) Manufacturers shall, further to a reasoned request from the

Technical Regulations Division, provide it with all the information

and documentation in paper or electronic form necessary to

demonstrate the conformity of the product with these regulations,

in at least the Maltese and English language. They shall cooperate

with the Technical Regulations Division, at its request, on any

action taken to eliminate the risks posed by products which they

have placed on the market.

(1) A manufacturer may, by a written mandate, appoint an

authorised representative. The obligations laid down in regulation

8(1) and the obligation to draw up technical documentation referred

to in regulation 8(2) shall not form part of the authorised

representative’s mandate.

(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) keep the EU declaration of conformity or, where

applicable, the attestation of conformity and the

technical documentation at the disposal of national

market surveillance authorities for 10 years after the

product has been placed on the market;

(b) further to a reasoned request from the Technical

Regulations Division, provide the Technical

Regulations Division with all the information and

documentation necessary to demonstrate the

conformity of a product;

(c) cooperate with the Technical Regulations Division, at

their request, on any action taken to eliminate the risks

posed by products covered by the authorised

representative’s mandate.

(1) Importers shall place only compliant products on the

market.

(2) Before placing a product on the market importers shall

ensure that the appropriate conformity assessment procedure

referred to in regulation 15 has been carried out by the

manufacturer. They shall ensure that the manufacturer has drawn

up the technical documentation, that the product bears the CE

marking, where applicable, is accompanied by the EU declaration

of conformity or the attestation of conformity and the required

documents, and that the manufacturer has complied with the

requirements set out in regulations 8(5), (8) and (9).

Where an importer considers or has reason to believe that a

product is not in conformity with the essential health and safety

requirements set out in Schedule II, he shall not place the product

o n t h e m a r k e t u n t i l i t h a s b e e n b r o u g h t i n t o c o n f o r m i t y.

Furthermore, where the product presents a risk, the importer shall

inform the manufacturer and the market surveillance authorities to

that effect.

(3) Importers shall indicate on the product their name, registered

trade name or registered trade mark and the postal address at which

they can be contacted or, where that is not possible, on its

packaging or in a document accompanying the product. The contact

details shall be in at least the Maltese or English language.

(4) Importers shall ensure that the product is accompanied by

instructions and safety information in at least the Maltese or

English language.

(5) Importers shall ensure that, while a product is under their

responsibility, its storage or transport conditions do not jeopardise

its compliance with the essential health and safety requirements set

out in Schedule II.

(6) When deemed appropriate with regard to the risks presented

by a product, importers shall, to protect the health and safety of

end-users, carry out sample testing of products made available on

the market, 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.

(7) Importers who consider or have reason to believe that a

product which they have placed on the market is not in conformity

with these regulations 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, importers shall immediately inform the

Technical Regulations Division to that effect, giving details, in

particular, of the non-compliance and of any corrective measures

taken.

(8) Importers shall, for 10 years after the product has been

placed on the market, keep a copy of the EU declaration of

conformity or, where applicable, of the attestation of conformity at

the disposal of the market surveillance authorities and ensure that

the technical documentation can be made available to the Technical

Regulations Division, upon request.

(9) Importers shall, further to a reasoned request from a

competent national authority, provide it with all the information

and documentation in paper or electronic form necessary to

demonstrate the conformity of a product in at least the Maltese or

Eng lish language. They sh al l cooperate w ith th e Techn ical

Regulations Division, at its request, on any action taken to

eliminate the risks posed by products which they have placed on

the market.

(1) When making a product available on the market

distributors shall act with due care in relation to the requirements

of these regulations.

(2) Before making a product available on the market

distributors shall verify that the product bears the CE marking,

where applicable, that it is accompanied by the EU declaration of

conformity or the attestation of conformity and the required

documents and by instructions and safety information, in at least

the Maltese and English language, and that the manufacturer and

the importer have complied with the requirements set out in

regulation 8(5), (6) and (7) and regulation 10(3) respectively.

Where a distributor considers or has reason to believe that a

product is not in conformity with the essential health and safety

requirements set out in Schedule II, 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.

(3) Distributors shall ensure that, while a product is under their

responsibility, its storage or transport conditions do not jeopardise

its compliance with the essential health and safety requirements set

out in Schedule II.

(4) Distributors who consider or have reason to believe that a

product which they have made available on the market is not in

co nformi ty wi th th ese regu lat io ns sh all m ake su re th at 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 Technical Regulations Division in which

they made the product available on the market 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 the

Technical Regulations Division, provide it with all the information

and documentation in paper or electronic form necessary to

demonstrate the conformity of a product. They shall cooperate with

the Technical Regulations Division, at its request, on any action

taken to eliminate the risks posed by products which they have

made available on the market.

An importer or distributor shall be considered a

manufacturer for the purposes of these regulations and he shall be

subject to the obligations of the manufacturer under regulation 4,

where he places a product on the market under his name or trade

mark or modifies a product already placed on the market in such a

way that compliance with these regulations may be affected.

(1) Economic operators shall, on request, identify the

following to the market surveillance authorities

(a) any economic operator who has supplied them with a

product;

(b) any economic operator to whom they have supplied a

product.

(2) Economic operators shall be able to present the information

referred to in sub-regulation (1) for 10 years after they have been

supplied with the product and for 10 years after they have supplied

the product.

(1) 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 essential health and safety

requirements set out in Schedule II covered by those standards or

parts thereof.

(2) In the absence of harmonised standards, the Technical

Regulations Division shall take any steps which they deem

necessary to bring to the attention of the parties concerned the

existing national standards and technical specifications regarded as

important or relevant to the proper implementation of the essential

health and safety requirements set out in Schedule II.

(1) The procedures to be followed for assessing the

conformity of equipment and, where necessary, the devices referred

to in paragraph (b) of regulation 3(1) shall be as follows

(a) for equipment-groups I and II, equipment-categories

M1 and 1, the EU-type examination set out in

Schedule III, in conjunction with either of the

following

(i)

conformity to type based on quality assurance of

the production process set out in Schedule IV,

(ii) conformity to type based on product verification

set out in Schedule V;

(b) for equipment-groups I and II, equipment categories

M2 and 2

(i)

in the case of internal combustion engines and

electrical equipment in these groups and

categories, the EU-type examination set out in

Schedule III, in conjunction with either of the

following

- conformity to type based on internal

production control plus supervised product

testing set out in Schedule VI,

- conformity to type based on product quality

assurance set out in Schedule VII;

(ii) in the case of other equipment in these groups

and categories, internal production control set

out in Schedule VIII and the communication of

the technical documentation provided for in

Schedule VIII, point 2, to a notified body, which

shall acknowledge receipt of it as soon as

possible and shall retain it;

(c) for equipment-group II, equipment category 3, internal

production control set out in Schedule VIII;

(d) for equipment-groups I and II, in addition to the

procedures referred to in paragraphs (a), (b) and (c),

conformity based on unit verification set out in

Schedule IX may also be followed.

(2) The procedure referred to in paragraphs (a) or (d) of sub-

regulation (1) shall be used for conformity assessment of protective

systems.

(3) The procedures referred to in sub-regulation (1) shall be

applied in respect of components with the exception of the affixing

of the CE marking and the drawing up of the EU declaration of

conformity. A written attestation of conformity shall be issued by

the manufacturer, declaring the conformity of the components with

the applicable provisions of these regulations and stating their

characteristics and how they must be incorporated into equipment

or protective systems to assist compliance with the essential health

and safety requirements set out in Schedule II applicable to

finished equipment or protective systems.

(4) With regard to the safety aspects referred to in point 1.2.7

of Schedule II, in addition to the conformity assessment procedures

referred to in sub-regulations (1) and (2), the procedure referred to

in Schedule VIII may also be followed.

(5) By derogation from sub-regulations (1), (2) and (4), the

Technical Regulations Division may, on a duly justified request,

authorise the placing on the market and putting into service on the

territory of the Malta concerned of the products other than

components in respect of which the procedures referred to in sub-

regulations (1), (2) and (4) have not been applied and the use of

which is in the interests of protection.

(6) Documents and correspondence relating to the conformity

assessment procedures referred to in sub-regulations (1) to (4) shall

be drawn up in at least the Maltese and English language.

(1) The EU declaration of conformity shall state that the

fulfilment of the essential health and safety requirements set out in

Schedule II has been demonstrated.

(2) The EU declaration of conformity shall have the model

structure set out in Schedule X, shall contain the elements specified

in the relevant conformity assessment procedures set out in

Schedules III to IX and shall be continuously updated. It shall be

translated into at least the Maltese or English language.

(3) Where a product is subject to more than one Union act

requiring an EU declaration of conformity, a single EU declaration

of conformity shall be drawn up in respect of all such Union acts.

That declaration shall contain the identification of the Union acts

concerned, including their publication references.

(4) By drawing up the EU declaration of conformity, the

manufacturer shall assume responsibility for the compliance of the

product with the requirements laid down in these regulations.

(1) The CE marking shall be subject to the general

principles set out in Article 30 of Regulation (EC) No 765/2008.

(2) 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.

(3) The CE marking shall be affixed before the product is

placed on the market.

(4)

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.

(5) The CE marking and, where applicable, the identification

number of the notified body shall be followed by the specific

marking of explosion protection

, the symbols of the equipment-

group and category and, where applicable, the other markings and

information referred to in point 1.0.5 of Schedule II.

(6) The CE marking and the markings, symbols and

information referred to in sub-regulation (4), and, where

applicable, the identification number of the notified body, may be

followed by any other mark indicating a special risk or use.

Products that are designed for a particular explosive atmosphere

shall be marked accordingly.

(7) The Technical Regulations Division shall build upon

existing mechanisms to ensure correct application of the regime

governing the CE marking and shall take appropriate action in the

event of improper use of that marking.

(1) The Technical Regulations Division shall notify the

Commission and the other Member States of bodies authorised to

carry out third-party conformity assessment tasks under these

regulations.

(2) The Technical Regulations Division shall 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 regulations 19(3) to 19(16).

(3) The assessment and monitoring referred to in sub-

regulation (2) shall be carried out by the National Accreditation

Board (Malta).

(4) The Technical Regulations Division shall take full

responsibility for the tasks performed by National Accreditation

Board (Malta) referred to in sub-regulation (3).

(5) The Technical Regulations Division shall inform the

European Commission of its procedures for the assessment and

notification of conformity assessment bodies and the monitoring of

notified bodies, and of any changes thereto.

(1) For the purposes of notification under these

regulations, a conformity assessment body shall meet the

requirements laid down in sub-regulations (2) to (16) and in the

Method for Designating Conformity Assessment Bodies

Regulations.

(2) A conformity assessment body shall be established under

Maltese 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. 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.

(4)

(a) 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 representative of any of those parties.

This shall not preclude the use of assessed products

that are necessary for the operations of the conformity

assessm ent body or the use of such products for

personal purposes.

(b) A conformity assessment body, its top level

management and the 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.

(c) 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) A conformity assessment body shall be capable of

carrying out all the conformity assessment tasks

assigned to it by Schedules III to VII and Schedules IX

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.

(b) 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

(i)

personnel

with

technical

knowledge

and

sufficient and appropriate experience to perform

the conformity assessment tasks;

(ii) 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;

(iii) 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.

(c) A conformity assessment body 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.

(7) The personnel responsible for carrying out conformity

assessment tasks shall have the following

(a) sound technical and vocational training covering all

the conformity assessment activities in relation to

which the conformity assessment body has been

notified;

(b) satisfactory knowledge of the requirements of the

assessments they carry out and adequate authority to

carry out those assessments;

(c) appropriate knowledge and understanding of the

essential health and safety requirements set out in

Schedule II, of the applicable harmonised standards, of

the relevant provisions of Union harmonisation

legislation and of national legislation;

(d) the ability to draw up certificates, records and reports

demonstrating that assessments have been carried out.

(8) The impartiality of the conformity assessment bodies, their

top level management, and of the personnel responsible for

carrying out the conformity assessment tasks shall be guaranteed.

The remuneration of the top level management and personnel

responsible for carrying out the conformity assessment tasks 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 Schedules III to VII and

Schedule IX or any provision of national law giving effect to it,

e x c e p t i n r e l a t i o n t o t h e Te c h n i c a l R e g u l a t i o n s D i v i s i o n .

Proprietary rights shall be protected.

(11) Conformity assessment bodies shall participate in, or

ensure that their personnel responsible for carrying out the

conformity assessment tasks are informed of, the relevant

standardisation activities and the activities of the notified body

coordination group established under the relevant Union

harmonisation legislation and shall apply as general guidance the

administrative decisions and documents produced as a result of the

work of that group.

(12) 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 of the European Union, it shall be

presumed to comply with the requirements set out in regulation 19

in so far as the applicable harmonised standards cover those

requirements.

(13) 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 regulation 19 and shall inform the

Technical Regulations Division accordingly.

(14) Notified bodies shall take full responsibility for the tasks

performed by subcontractors or subsidiaries wherever these are

established.

(15) Activities may be subcontracted or carried out by a

subsidiary only with the agreement of the client.

(16) Notified bodies shall keep at the disposal of the Technical

Regulations Division the relevant documents concerning the

assessment of the qualifications of the subcontractor or the

subsidiary and the work carried out by them under Schedules III to

VII and Schedule IX.

(1) A conformity assessment body established in Malta

shall submit an application for notification to the Technical

Regulations Division.

(2) The application referred to in the preceding sub-regulation

shall be accompanied by a description of the conformity assessment

activities, the conformity assessment module or modules and the

product or products for which that body claims to be competent, as

well as by an accreditation certificate, issued by the National

Accreditation Board (Malta) attesting that the conformity

assessment body fulfils the requirements laid down in regulation 19

and the Method for Designating Conformity Assessment Bodies

Regulations.

(3) The Technical Regulations Division may notify only

conformity assessment bodies which have satisfied the

requirements laid down in regulation 19 and the Method for

Designating Conformity Assessment Bodies Regulations.

(4) The Technical Regulations Division shall notify conformity

assessment bodies to the European Commission and the other

Member States using the electronic notification tool developed and

managed by the European Commission.

(5) The notification shall include full details of the conformity

assessment activities, the conformity assessment module or

modules and the product or products concerned and the relevant

attestation of competence.

(6) The body concerned may perform the activities of a notified

bo d y o nl y w he r e no ob j e c t i on s ar e r a i s e d by t h e E u ro p e a n

Commission or the other Member States within two weeks of a

notification. Only such a body shall be considered a notified body

for the purposes of these regulations.

(7) The Technical Regulations Division shall notify the

European Co mmission and the ot her Mem ber Stat es of any

subsequent relevant changes to the notification.

(8) Where the Technical Regulations Division has ascertained

or has been informed that a notified body no longer meets the

requirem ents laid down in regulation 19 or t he Method for

Designating Conformity Assessment Bodies Regulations, or that it

is failing to fulfil its obligations, the Technical Regulations

Division 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 European Commission and the other Member States

accordingly.

(9) In the event of restriction, suspension or withdrawal of

notification, or where the notified body has ceased its activity, the

Technical Regulations Division 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.

(10) The Technical Regulations Division shall provide the

European Commission, on request, with all information relating to

the basis for the notification or the maintenance of the competence

of the notified body concerned.

(1) Notified bodies shall carry out conformity assessments

in accordance with the conformity assessment procedures provided

for in Schedules III to VII and Schedule IX.

(2) Conformity assessments shall be carried out in a

proportionate manner, avoiding unnecessary burdens for 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. 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 requirements of these

regulations.

(3)

Where a notified body finds that the essential health and

safety requirements set out in Schedule II or corresponding

harmonised standards or other technical specifications have not

been met by a manufacturer, it shall require that manufacturer to

t a k e a p pr op r i a t e c o r r e c t i v e m e a s u r e s an d s ha l l n ot i s s u e a

certificate of conformity.

(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 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, the notified body shall restrict, suspend or

withdraw any certificates, as appropriate.

(6) Notified bodies shall inform the notifying authority of the

following

(a) any refusal, restriction, suspension or withdrawal of a

certificate;

(b) any circumstances affecting the scope of or conditions

for notification;

(c) any request for information which they have received

from market surveillance authorities regarding

conformity assessment activities;

(d) on request, conformity assessment activities

performed within the scope of their notification and

any other activity performed, including cross-border

activities and subcontracting.

(7) Notified bodies shall provide the other bodies notified

under these regulations 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.

(8) Notified bodies shall participate, directly or by means of

designated representatives, in the appropriate coordination and

cooperation groups for notified bodies organised by the European

Commission.

(1) Regulation 15(3) and regulations 16 to 29 of

regulation (EC) No 765/2008 shall apply to products covered by

Schedule 1 of these regulations.

(2) Where the market surveillance authorities have sufficient

reason to believe that a product presents a risk to the health or

safety of persons or to domestic animals or property, they shall

carry out an evaluation in relation to the product concerned

covering all relevant requirements laid down in these regulations.

The relevant economic operators shall cooperate as necessary with

the market surveillance authorities for that purpose.

(3) Where, in the course of the evaluation referred to sub-

regulation (1), the market surveillance authorities find that the

product does not comply with the requirements laid down in these

regulations, they shall without delay require the relevant economic

operator to take all appropriate corrective actions 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.The market surveillance authorities shall inform the

relevant notified body accordingly.

(4) Regulation 21 of Regulation (EC) No 765/2008 shall apply

to the measures referred to in the sub-regulation (3).

(5) 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.

(6) 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 Union.

(7) Where the relevant economic operator does not take

adequate corrective action within the period referred to in sub-

regulation (3), the Technical Regulations Division shall take all

appropriate provisional measures to prohibit or restrict the products

being made available on their national market, to withdraw the

product from that market or to recall it. The market surveillance

authorities shall inform the European Commission and the other

Member States, without delay, of those measures.

(8) The information referred to in the regulation 8 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 Technical Regulations Division shall indicate

whether the non-compliance is due to either of the following

(a) failure of the product to meet requirements relating to

the health or safety of persons or to the protection of

domestic animals or property; or

(b) shortcomings in the harmonised standards referred to

in regulation 14 conferring a presumption of

conformity.

(9) When the procedure under this Regulation is initiated by

another Member State, the Technical Regulations Division, shall

without delay inform the European Commission and the other

Member States of any measures adopted and of any additional

information at their disposal relating to the non-compliance of

product concerned, and, in the event of disagreement with the

adopted national measure, of their objections.

(10) Where, within three months of receipt of the information

referred to in sub-regulation (7), no objection has been raised by

either a Member State or the European Commission in respect of a

provisional measure taken by a Member State, that measure shall be

deemed justified.

(11) In such cases, the Technical Regulations Division shall

ensure that appropriate restrictive measures, such as withdrawal of

the product from the market, are taken in respect of the product

concerned without delay.

(12) Where on completion of the procedure set out in sub-

regulations (6) and (7), objections are raised against the measures

t a k e n b y Te c h n i c a l R e g u l a t i o n s D i v i s i o n ; t h e E u r o p e a n

Commission shall conduct an evaluation including appropriate

consultations with these entities and the relevant economic operator

or operators.

(13) If, on the basis of this evaluation, the national measure is

considered justified, the Technical Regulations Division shall take

the necessary measures to ensure that the placing on the market or

use non-compliant product is withdrawn from the Maltese market,

and shall inform the European Commission accordingly. If, on the

basis of this evaluation, the national measure is considered

unjustified, the national measure shall be withdraw.

(14) Where, having carried out an evaluation under sub-

regulation (2), the Technical Regulations Division finds that

although a product is in compliance with these Regulations, it

presents a risk to the health or safety of persons or to domestic

animals or property, it shall require the relevant economic operator

to take all approp riate measures to ensure that th e p roduct

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.

(15) 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 European Union.

(16) The Technical Regulations Division, upon consultation

with the Commissioner of Police, shall immediately inform the

E u r o p e a n C o m m i s s i o n a n d t h e o t h e r M e m b e r St a t e s . T h a t

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.

(17) Without prejudice to sub-regulations (2) to (11), where the

Technical Regulations Division and/or the Commissioner of Police

makes one of the following findings, it shall require the relevant

economic operator to put an end to the non-compliance concerned

(a) the CE marking has been affixed in violation of article

30 of Regulation (EC) No 765/2008 or of regulation 17

of these regulations;

(b) the CE marking, where required, has not been affixed;

(c) the specific marking of explosion protection

, the

symbols of the equipment-group and category and,

where applicable, the other markings and information

have been affixed in violation of point 1.0.5 of

Schedule II or have not been affixed;

(d) the identification number of the notified body, where

that body is involved in the production control phase,

has been affixed in violation of regulation 17 or has

not been affixed;

(e) the EU declaration of conformity or the attestation of

conformity, as appropriate, does not accompany the

product;

(f)

the EU declaration of conformity or, where required,

the attestation of conformity has not been drawn up

correctly;

(g) technical documentation is either not available or not

complete;

(h) the information referred to in regulation 8(7) or 10(3)

is absent, false or incomplete;

(i)

any other administrative requirement provided for in

regulation 8 or 10 is not fulfilled.

(19) Where the non-compliance referred to in sub-regulation (1)

persists, the Technical Regulations Division 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 Maltese market.

The penalties applicable for the infringement of any of the

provisions of these regulations shall be those provided for in Part

IV of the Product Safety Act.

Schedule I

CRITERIA DETERMINING THE CLASSIFICATION OF EQUIPMENT-GROUPS

INTO CATEGORIES

1. Equipment-group I

(a) Equipment category M 1 comprises equipment designed and, where

necessary, equipped with additional special means of protection to be

capable of functioning in conformity with the operational parameters

established by the manufacturer and ensuring a very high level of

protection.

Equipment in this category is intended for use in underground parts of

mines as well as those parts of surface installations of such mines

endangered by firedamp and/or combustible dust.

Equipment in this category is required to remain functional, even in the

event of rare incidents relating to equipment, with an explosive

atmosphere present, and is characterised by means of protection such

that

-

either, in the event of failure of one means of protection, at least

an independent second means provides the requisite level of

protection,

-

or the requisite level of protection is assured in the event of two

faults occurring independently of each other.

Equipment in this category must comply with the supplementary

requirements referred to in point 2.0.1 of Schedule II.

(b) Equipment category M 2 comprises equipment designed to be capable

of functioning in conformity with the operational parameters

established by the manufacturer and ensuring a high level of protection.

Equipment in this category is intended for use in underground parts of

mines as well as those parts of surface installations of such mines likely

to be endangered by firedamp and/or combustible dust.

This equipment is intended to be de-energised in the event of an

explosive atmosphere.

The means of protection relating to equipment in this category assure

the requisite level of protection during normal operation and also in the

case of more severe operating conditions, in particular those arising

from rough handling and changing environmental conditions.

Equipment in this category must comply with the supplementary

requirements referred to in point 2.0.2 of Schedule II.

2. Equipment-group II

(a) Equipment category 1 comprises equipment designed to be capable of

functioning in conformity with the operational parameters established

by the manufacturer and ensuring a very high level of protection.

Equipment in this category is intended for use in areas in which

explosive atmospheres caused by mixtures of air and gases, vapours or

mists or by air/dust mixtures are present continuously, for long periods

or frequently.

Equipment in this category must ensure the requisite level of protection,

even in the event of rare incidents relating to equipment, and is

characterised by means of protection such that

-

either, in the event of failure of one means of protection, at least

an independent second means provides the requisite level of

protection,

-

or the requisite level of protection is assured in the event of two

faults occurring independently of each other.

Equipment in this category must comply with the supplementary

requirements referred to in point 2.1 of Schedule II.

(b) Equipment category 2 comprises equipment designed to be capable of

functioning in conformity with the operational parameters established

by the manufacturer and of ensuring a high level of protection.

Equipment in this category is intended for use in areas in which

explosive atmospheres caused by gases, vapours, mists or air/dust

mixtures are likely to occur occasionally.

The means of protection relating to equipment in this category ensure

the requisite level of protection, even in the event of frequently

occurring disturbances or equipment faults which normally have to be

taken into account.

Equipment in this category must comply with the supplementary

requirements referred to in point 2.2 of Schedule II.

(c) Equipment category 3 comprises equipment designed to be capable of

functioning in conformity with the operating parameters established by

the manufacturer and ensuring a normal level of protection.

Equipment in this category is intended for use in areas in which

explosive atmospheres caused by gases, vapours, mists, or air/dust

mixtures are unlikely to occur or, if they do occur, are likely to do so

only infrequently and for a short period only.

Equipment in this category ensures the requisite level of protection

during normal operation.

Equipment in this category must comply with the supplementary

requirements referred to in point 2.3 of Schedule II.

Schedule II

ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO THE

DESIGN AND CONSTRUCTION OF EQUIPMENT AND PROTECTIVE

SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE

ATMOSPHERES

Preliminary observations

Technological knowledge, which can change rapidly, must be taken into

account as far as possible and be utilised immediately.

For the devices referred to in point (b) of Article 1(1), the essential health

and safety requirements shall apply only in so far as they are necessary for the safe

and reliable functioning and operation of those devices with respect to the risks of

1. Common requirements for Equipment and protective systems

General requirements

Principles of integrated explosion safety

Equipment and protective systems intended for use in potentially

explosive atmospheres must be designed from the point of view of

integrated explosion safety.

In this connection, the manufacturer must take measures

above all, if possible, to prevent the formation of explosive

atmospheres which may be produced or released by equipment and

by protective systems themselves,

to prevent the ignition of explosive atmospheres, taking into

account the nature of every electrical and non- electrical source of

ignition,

should an explosion nevertheless occur which could directly or

indirectly endanger persons and, as the case may be, domestic

animals or property, to halt it immediately and/or to limit the range

of explosion flames and explosion pressures to a sufficient level of

safety.

Equipment and protective systems must be designed and manufactured

after due analysis of possible operating faults in order as far as possible

to preclude dangerous situations.

Any misuse which can reasonably be anticipated must be taken into

account.

Special checking and maintenance conditions

Equipment and protective systems subject to special checking and

maintenance conditions must be designed and constructed with such

conditions in mind.

Surrounding area conditions

Equipment and protective systems must be so designed and constructed

as to be capable of coping with actual or foreseeable surrounding area

conditions.

Marking

All equipment and protective systems must be marked legibly and

indelibly with the following minimum particulars

name, registered trade name or registered trade mark, and address

of the manufacturer,

CE marking (see Schedule II to Regulation (EC) No 765/2008),

designation of series or type,

batch or serial number, if any,

year of construction,

the specific marking of explosion protection followed by the

symbol of the equipment-group and category,

for equipment-group II, the letter ‘G’ (concerning explosive

atmospheres caused by gases, vapours or mists), and/or

the letter ‘D’ (concerning explosive atmospheres caused by dust).

Furthermore, where necessary, they must also be marked with all

information essential to their safe use.

Instructions

(a) All equipment and protective systems must be accompanied by

instructions, including at least the following particulars

a recapitulation of the information with which the equipment

or protective system is marked, except for the batch or serial

number (see point 1.0.5), together with any appropriate

additional information to facilitate maintenance (e.g. address

of the repairer, etc.);

instructions for safe

- putting into service,

- use,

- assembling and dismantling,

- maintenance (servicing and emergency repair),

- installation,

- adjustment;

where necessary, an indication of the danger areas in front of

pressure-relief devices;

where necessary, training instructions;

details which allow a decision to be taken beyond any doubt

as to whether an item of equipment in a specific category or a

protective system can be used safely in the intended area

under the expected operating conditions;

electrical and pressure parameters, maximum surface

temperatures and other limit values;

where necessary, special conditions of use, including

particulars of possible misuse which experience has shown

might occur;

where necessary, the essential characteristics of tools which

may be fitted to the equipment or protective system.

(b) The instructions must contain the drawings and diagrams necessary

for the putting into service, maintenance, inspection, checking of

correct operation and, where appropriate, repair of the equipment

or protective system, together with all useful instructions, in

particular with regard to safety.

(c) Literature describing the equipment or protective system must not

contradict the instructions with regard to safety aspects.

Selection of materials

The materials used for the construction of equipment and protective

s y s t e m s m u s t n o t t r i g g e r o ff a n ex p l o s i o n , t a k i n g i n t o a c c o u n t

foreseeable operational stresses.

Within the limits of the operating conditions laid down by the

manufacturer, it must not be possible for a reaction to take place between

the materials used and the constituents of the potentially explosive

atmosphere which could impair explosion protection.

Materials must be so selected that predictable changes in their

characteristics and their compatibility in combination with other

materials will not lead to a reduction in the protection afforded; in

particular, due account must be taken of the material’s corrosion and

wear resistance, electrical conductivity, mechanical strength, ageing

resistance and the effects of temperature variations.

Design and construction

Equipment and protective systems must be designed and constructed

with due regard to technological knowledge of explosion protection so

that they can be safely operated throughout their foreseeable lifetime.

Components to be incorporated into or used as replacements in

equipment and protective systems must be so designed and constructed

that they function safely for their intended purpose of explosion

protection when they are installed in accordance with the manufacturer’s

instructions.

Enclosed structure and prevention of leaks

Equipment which may release flammable gases or dusts must wherever

possible employ enclosed structures only.

If equipment contains openings or non-tight joints, these must as far as

possible be designed in such a way that releases of gases or dusts cannot

give rise to explosive atmospheres outside the equipment.

Points where materials are introduced or drawn off must, as far as

possible, be designed and equipped so as to limit releases of flammable

materials during filling or draining.

Dust-deposits

Equipment and protective systems which are intended to be used in areas

exposed to dust must be so designed that deposit dust on their surfaces is

not ignited.

In general, dust deposits must be limited where possible. Equipment and

protective systems must be easily cleanable.

The surface temperatures of equipment parts must be kept well below the

glow temperature of the deposit dust.

The thickness of deposit dust must be taken into consideration and, if

appropriate, means must be taken to limit the temperature in order to

prevent a heat build up.

Additional means of protection

Equipment and protective systems which may be exposed to certain

types of external stresses must be equipped, where necessary, with

additional means of protection.

Equipment must withstand relevant stresses, without adverse effect on

explosion protection.

Safeopening

If equipment and protective systems are in a housing or a locked

container forming part of the explosion protection itself, it must be

possible to open such housing or container only with a special tool or by

means of appropriate protection measures.

Protection against other hazards

Equipment and protective

systems

must

be

so

designed

and

manufactured as to

(a) avoid physical injury or other harm which might be caused by

direct or indirect contact;

(b) assure that surface temperatures of accessible parts or radiation

which would cause a danger, are not produced;

(c) eliminate non-electrical dangers which are revealed by experience;

(d) assure that foreseeable conditions of overload do not give rise to

dangerous situations.

Where, for equipment and protective systems, the risks referred to in this

point are wholly or partly covered by other Union legislation, these

regulations shall not apply or shall cease to apply in the case of such

equipment and protective systems and of such risks upon application of

that specific Union legislation.

Overloading of equipment

Dangerous overloading of equipment must be prevented at the design

stage by means of integrated measurement, regulation and control

devices, such as over-current cut-off switches, temperature limiters,

differential pressure switches, flowmeters, time-lag relays, overspeed

monitors and/or similar types of monitoring devices.

Flame proof enclosure systems

If parts which can ignite an explosive atmosphere are placed in an

enclosure, m easures m ust be taken to ensure that th e en closure

withstands the pressure developed during an internal explosion of an

explosive mixture and prevents the transmission of the explosion to the

explosive atmosphere surrounding the enclosure.

Potential ignition sources

Hazards arising from different ignition sources

Potential ignition sources such as sparks, flames, electric arcs, high

surface temperatures, acoustic energy, optical radiation, electromagnetic

waves and other ignition sources must not occur.

Hazards arising from static electricity

Electrostatic charges capable of resulting in dangerous discharges must

be prevented by means of appropriate measures.

Hazards arising from stray electric and leakage currents

Stray electric and leakage currents in conductive equipment parts which

could result in, for example, the occurrence of dangerous corrosion,

overheating of surfaces or sparks capable of provoking an ignition must

be prevented.

Hazards arising from overheating

Overheating caused by friction or impacts occurring, for example,

between materials and parts in contact with each other while rotating or

through the intrusion of foreign bodies must, as far as possible, be

prevented at the design stage.

Hazards arising from pressure compensation operations

Equipment and protective systems must be so designed or fitted with

integrated measuring, control and regulation devices that pressure

compensations arising from them do not generate shock waves or

compressions which may cause ignition.

Hazards arising from external effects

Equipment and protective systems must be so designed and constructed

as to be capable of performing their intended function in full safety, even

in changing environmental conditions and in the presence of extraneous

voltages, humidity, vibrations, contamination and other external effects,

taking into account the limits of the operating conditions established by

the manufacturer.

Equipment parts used must be appropriate to the intended mechanical

and thermal stresses and capable of withstanding attack by existing or

foreseeable aggressive substances.

Requirements in respect of safety-related devices

Safety devices must function independently of any measurement and/or

control devices required for operation.

As far as possible, failure of a safety device must be detected sufficiently

rapidly by appropriate technical means to ensure that there is only very

little likelihood that dangerous situations will occur.

The fail-safe principle is to be applied in general.

Safety-related switching must in general directly actuate the relevant

control devices without intermediate software command.

In the event of a safety device failure, equipment and/or protective

systems shall, wherever possible, be secured.

Emergency stop controls of safety devices must, as far as possible, be

fitted with restart lockouts. A new start command may take effect on

normal operation only after the restart lockouts have been intentionally

reset.

Control and display units

Where control and display units are used, they must be designed in

accordance with ergonomic principles in order to achieve the highest

possible level of operating safety with regard to the risk of explosion.

Requirements in respect of devices with a measuring function for

explosion protection

In so far as they relate to equipment used in explosive atmospheres,

devices with a measuring function must be designed and constructed so

that they can cope with foreseeable operating requirements and special

conditions of use.

Where necessary, it must be possible to check the reading accuracy and

serviceability of devices with a measuring function.

The design of devices with a measuring function must incorporate a

safety factor which ensures that the alarm threshold lies far enough

outside the explosion and/or ignition limits of the atmospheres to be

registered, taking into account, in particular, the operating conditions of

the installation and possible aberrations in the measuring system.

Risks arising from software

In the design of software-controlled equipment, protective systems and

safety devices, special account must be taken of the risks arising from

faults in the programme.

Integration of safety requirements relating to the system

Manual override must be possible in order to shut down the equipment

and protective systems incorporated within automatic processes which

deviate from the intended operating conditions, provided that this does

not compromise safety.

When the emergency shutdown system is actuated, accumulated energy

must be dispersed as quickly and as safely as possible or isolated so that

it no longer constitutes a hazard.

This does not apply to electrochemically-stored energy.

Hazards arising from power failure

Where equipment and protective systems can give rise to a spread of

additional risks in the event of a power failure, it must be possible to

maintain them in a safe state of operation independently of the rest of the

installation.

Hazards arising from connections

Equipment and protective systems must be fitted with suitable cable and

conduit entries.

When equipment and protective systems are intended for use in

combination with other equipment and protective systems, the interface

must be safe.

Placing of warning devices as parts of equipment

Where equipment or protective systems are fitted with detection or alarm

devices for monitoring the occurrence of explosive atmospheres, the

necessary instructions must be provided to enable them to be provided at

the appropriate places.

2. Supplementary requirements in respect of equipment

Requirements applicable to equipment in equipment-group I

Requirements applicable to equipment category M1 of equipment -

group I

2.0.1.1. Equipment must be so designed and constructed that sources of ignition

do not become active, even in the event of rare incidents relating to

equipment.

Equipment must be equipped with means of protection such that

-

either, in the event of failure of one means of protection, at least an

independent second means provides the requisite level of

protection,

-

or, the requisite level of protection is ensured in the event of two

faults occurring independently of each other.

Where necessary, equipment must be equipped with additional special

means of protection.

It must remain functional with an explosive atmosphere present.

2.0.1.2. Where necessary, equipment must be so constructed that no dust can

penetrate it.

2.0.1.3. The surface temperatures of equipment parts must be kept clearly below

the ignition temperature of the foreseeable air/dust mixtures in order to

prevent the ignition of suspended dust.

2.0.1.4. Equipment must be so designed that the opening of equipment parts

which may be sources of ignition is possible only under non-active or

intrinsically safe conditions. Where it is not p ossible to r ender

equipment non- active, the manufacturer must affix a warning label to

the opening part of the equipment.

If necessary, equipment must be fitted with appropriate additional

interlocking systems.

Requirements applicable to equipment category M2 of equipment-group

I

2.0.2.1. Equipment must be equipped with means of protection ensuring that

sources of ignition do not become active during normal operation, even

under more severe operating conditions, in particular those arising from

rough handling and changing environmental conditions.

The equipment is intended to be de-energised in the event of an

explosive atmosphere.

2.0.2.2. Equipment must be so designed that the opening of equipment parts

which may be sources of ignition is possible only under non-active

conditions or via appropriate interlocking systems. Where it is not

possible to render equipment non-active, the manufacturer must affix a

warning label to the opening part of the equipment.

2.0.2.3. The requirements regarding explosion hazards arising from dust

applicable to equipment category M 1 must be applied.

Requirements applicable to equipment category 1 of equipment-group II

Explosive atmospheres caused by gases, vapoursormists

2.1.1.1. Equipment must be so designed and constructed that sources of ignition

do not become active, even in event of rare incidents relating to

equipment.

It must be equipped with means of protection such that

-

either, in the event of failure of one means of protection, at least an

independent second means provides the requisite level of

protection,

-

or, the requisite level of protection is ensured in the event of two

faults occurring independently of each other.

2.1.1.2. For equipment with surfaces which may heat up, measures must be taken

to ensure that the stated maximum surface temperatures are not exceeded

even in the most unfavourable circumstances.

Temperature rises caused by heat build-ups and chemical reactions must

also be taken into account.

2.1.1.3. Equipment must be so designed that the opening of equipment parts

which might be sources of ignition is possible only under non-active or

intrinsically safe conditions. Where it is not p ossible to r ender

equipment non- active, the manufacturer must affix a warning label to

the opening part of the equipment.

If necessary, equipment must be fitted with appropriate additional

interlocking systems.

Explosive atmospheres caused by air/dust mixtures

2.1.2.1. Equipment must be so designed and constructed that ignition of air/dust

mixtures does not occur even in the event of rare incidents relating to

equipment.

It must be equipped with means of protection such that

-

either, in the event of failure of one means of protection, at least an

independent second means provides the requisite level of

protection,

-

or, the requisite level of protection is ensured in the event of two

faults occurring independently of each other.

2.1.2.2. Where necessary, equipment must be so designed that dust can enter or

escape from the equipment only at specifically designated points.

This requirement must also be met by cable entries and connecting

pieces.

2.1.2.3. The surface temperatures of equipment parts must be kept well below the

ignition temperature of the foreseeable air/dust mixtures in order to

prevent the ignition of suspended dust.

2.1.2.4. With regard to the safe opening of equipment parts, requirement 2.1.1.3

applies.

Requirements applicable to equipment category 2 of equipment-group II.

Explosive atmospheres caused by gases, vapoursormists.

2.2.1.1. Equipment must be so designed and constructed as to prevent ignition

sources arising, even in the event of frequently occurring disturbances or

equipment operating faults, which normally have to be taken into

account.

2.2.1.2. Equipment parts must be so designed and constructed that their stated

surface temperatures are not exceeded, even in the case of risks arising

from abnormal situations anticipated by the manufacturer.

2.2.1.3. Equipment must be so designed that the opening of equipment parts

which might be sources of ignition is possible only under non-active

conditions or via appropriate interlocking systems. Where it is not

possible to render equipment non-active, the manufacturer must affix a

warning label to the opening part of the equipment.

Explosive atmospheres cause by air/dust mixtures

2.2.2.1. Equipment must be designed and constructed so that ignition of air/dust

mixtures is prevented, even in the event of frequently occurring

disturbances or equipment operating faults which normally have to be

taken into account.

2.2.2.2. With regard to surface temperatures, requirement 2.1.2.3 applies.

2.2.2.3. With regard to protection against dust, requirement 2.1.2.2 applies.

2.2.2.4. With regard to the safe opening of equipment parts, requirement 2.2.1.3

applies.

Requirements applicable to equipment category 3 of equipment-group II

Explosive atmospheres caused by gases, vapours or mists

2.3.1.1. Equipment must be so designed and constructed as to prevent

foreseeable ignition sources which can occur during normal operation.

2.3.1.2. Surface temperatures must not exceed the stated maximum surface

temperatures under intended operating conditions. Higher temperatures

in exceptional circumstances may be allowed only if the manufacturer

adopts special additional protective measures.

Explosive atmospheres caused by air/dust mixtures

2.3.2.1. Equipment must be so designed and constructed that air/dust mixtures

cannot be ignited by foreseeable ignition sources likely to exist during

normal operation.

2.3.2.2. With regard to surface temperatures, requirement 2.1.2.3 applies.

2.3.2.3. Equipment, including cable entries and connecting pieces, must be so

constructed that, taking into account the size of its particles, dust can

neither develop explosive mixtures with air nor form dangerous

accumulations inside the equipment.

3. Supplementary requirements in respect of protective systems

General requirements

Protective systems must be dimensioned in such a way as to reduce the

effects of an explosion to a sufficient level of safety.

Protective systems must be designed and capable of being positioned in

such a way that explosions are prevented from spreading through

dangerous chain reactions or flashover and incipient explosions do not

become detonations.

In the event of a power failure, protective systems must retain their

capacity to function for a period sufficient to avoid a dangerous

situation.

Protective systems must not fail due to outside interference.

Planning and design

Characteristics of materials

With regard to the characteristics of materials, the maximum pressure

and temperature to be taken into consideration at the planning stage are

the expected pressure during an explosion occurring under extreme

operating conditions and the anticipated heating effect of the flame.

Protective systems designed to resist or contain explosions must be

capable of withstanding the shock wave produced without losing system

integrity.

Accessories connected to protective systems must be capable of

withstanding the expected maximum explosion pressure without losing

their capacity to function.

The reactions caused by pressure in peripheral equipment and connected

pipe-work must be taken into consideration in the planning and design of

protective systems.

Pressure-relief systems

If it is likely that stresses on protective systems will exceed their

structural strength, provision must be made in the design for suitable

pressure-relief devices which do not endanger persons in the vicinity.

Explosion suppression systems

Explosion suppression systems must be so planned and designed that

they react to an incipient explosion at the earliest possible stage in the

event of an incident and counteract it to best effect, with due regard to

the maximum rate of pressure increase and the maximum explosion

pressure.

Explosion decoupling systems

Decoupling systems intended to disconnect specific equipment as swiftly

as possible in the event of incipient explosions by means of appropriate

devices must be planned and designed so as to remain proof against the

transmission of internal ignition and to retain their mechanical strength

under operating conditions.

Protective systems must be capable of being integrated into a circuit with

a suitable alarm threshold so that, if necessary, there is cessation of

product feed and output and shutdown of equipment parts which can no

longer function safely.

Schedule III

MODULE B: EU-TYPE EXAMINATION

1. EU-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 these

regulations that apply to it.

2. EU-type examination shall be carried out with the examination of a

specimen, representative of the production envisaged, of the complete product

(production type).

3. The manufacturer shall lodge an application for EU-type examination with a

single notified body of his choice.

The application shall include

(a) the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as well,

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

any other notified body,

(c) possible to assess the product’s conformity the technical documentation.

The technical documentation shall make it with the applicable

requirements of these regulations 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 at least the following elements

(i)

a general description of the product,

(ii) conceptual design and manufacturing drawings and schemes of

components, sub-assemblies, circuits, etc.,

(iii) descriptions and explanations necessary for the understanding of

those drawings and schemes and the operation of the product,

(iv) a list of the harmonised standards applied in full or in part the

references of which have been published in the Official Journal of

the European Union and, where those harmonised standards have

not been applied, descriptions of the solutions adopted to meet the

essential health and safety requirements of these regulations,

including a list of other relevant technical specifications applied.

In the event of partly applied harmonised standards, the technical

documentation shall specify the parts which have been applied,

(v) results of design calculations made, examinations carried out,

etc., and

(vi) test reports,

(d) the specimens representative of the production envisaged. The notified

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

programme.

4. The notified body shall

4.1. examine the technical documentation, 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, as well as the elements which have been designed

in accordance with other relevant technical specifications;

4.2. 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, these have been applied correctly;

4.3. carry out appropriate examinations and tests, or have them carried out, to

check whether, where the solutions in the relevant harmonised standards have not

been applied, the solutions adopted by the manufacturer applying other relevant

technical specifications meet the corresponding essential health and safety

requirements of these regulations;

4.4. 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 these regulations that apply to the

product concerned, the notified body shall issue an EU-type examination certificate

to the manufacturer. That 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 EU-type

examination certificate may have one or more Schedules attached.

The EU-type examination certificate and its Schedules 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 these

regulations, the notified body shall refuse to issue an EU-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 these regulations, 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 EU-type examination certificate of all modifications to

the approved type that may affect the conformity of the product with the essential

health and safety requirements of these regulations or the conditions for validity of

that certificate. Such modifications shall require additional approval in the form of

an addition to the original EU-type examination certificate.

8. Each notified body shall inform its notifying authority concerning the EU-

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

authority the list of such certificates and/or any additions thereto refused, suspended

or otherwise restricted.

Each notified body shall inform the other notified bodies concerning the

EU-type examination certificates and/or any additions thereto which it has refused,

withdrawn, suspended or otherwise restricted, and, upon request, concerning such

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 EU-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 EU-type examination certificate,

its Schedules and additions, as well as the technical file including the documentation

submitted by the manufacturer, until the expiry of the validity of that certificate.

9. The manufacturer shall keep a copy of the EU-type examination certificate,

its Schedules 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.

Schedule IV

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 EU-type examination certificate and satisfy the requirements of these

regulations 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

(a) the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as well,

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

any other notified body,

(c) all relevant information for the product category envisaged,

(d) the documentation concerning the quality system,

(e) the technical documentation of the approved type and a copy of the EU-

type examination certificate.

3.2. The quality system shall ensure that the products are in conformity with the

type described in the EU-type examination certificate and comply with the

requirements of these regulations 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

(a) the quality objectives and the organisational structure, responsibilities

and powers of the management with regard to product quality,

(b) the corresponding manufacturing, quality control and quality assurance

techniques, processes and systematic actions that will be used,

(c) the examinations and tests that will be carried out before, during and

after manufacture, and the frequency with which they will be carried

out,

(d) the quality records, such as inspection reports and test data, calibration

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

(e) 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.

It shall presume conformity with those requirements in respect of the

elements of the quality system that comply with the corresponding specifications of

the relevant harmonised standard.

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 pro duct techn ology concerned, and k nowledge of the applicable

requirements of these regulations. The audit shall include an assessment visit to the

m a n u f a c t u r e r ’s p r e m i s e s . T h e a u d i t i n g t e a m s h a l l r e v i e w t h e t e c h n i c a l

documentation referred to in point 3.1(e) to verify the manufacturer’s ability to

identify the relevant requirements of these regulations 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

(a) the quality system documentation,

(b) 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. CE marking, EU declaration of conformity and attestation of

conformity

5.1. The manufacturer shall affix the CE marking and, under the responsibility of

the notified body referred to in point 3.1, the latter’s identification number to each

individual product other than a component that is in conformity with the type

described in the EU-type examination certificate and satisfies the applicable

requirements of these regulations.

5.2. The manufacturer shall draw up a written EU declaration of conformity for

each product model, other than a component and keep it at the disposal of the

national authorities for 10 years after the product other than a component has been

placed on the market. The EU declaration of conformity shall identify such product

model for which it has been drawn up.

A copy of the EU declaration of conformity shall accompany every product,

other than a component.

5.3. The manufacturer shall draw up a written attestation of conformity for each

component model and keep it at the disposal of the national authorities for 10 years

after the component has been placed on the market. The attestation of conformity

shall identify the component model for which it has been drawn up. A copy of the

attestation of conformity shall accompany every component.

6. The manufacturer shall, for a period ending 10 years after the product has

been placed on the market, keep at the disposal of the national authorities

(a) the documentation referred to in point 3.1,

(b) the information relating to the change referred to in point 3.5, as

approved,

(c) 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 authority of quality system

approvals issued or withdrawn, and shall, periodically or upon request, make

available to its notifying authority 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.

Schedule V

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 and 5 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 EU-type examination certificate and satisfy the

requirements of these regulations 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 EU-type examination certificate

and with the requirements of these regulations 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 EU-type examination certificate and with the

appropriate requirements of these regulations.

The examinations and tests to check the conformity of the products with the

appropriate requirements shall be carried out by examination and testing of every

product as specified in point 4.

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 equivalent tests set out in other

relevant technical specifications, shall be carried out in order to verify conformity

with the approved type described in the EU-type examination certificate and with the

appropriate requirements of these regulations.

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. CE marking, EU declaration of conformity and attestation of

conformity

5.1. The manufacturer shall affix the CE marking and, under the responsibility of

the notified body referred to in point 3, the latter’s identification number to each

individual product other than a component that is in conformity with the approved

type described in the EU-type examination certificate and satisfies the applicable

requirements of these regulations.

5.2. The manufacturer shall draw up a written EU declaration of conformity for

each product model other than a component and keep it at the disposal of the

national authorities, for 10 years after the product, other than a component, has been

placed on the market. The EU declaration of conformity shall identify such product

model for which it has been drawn up.

A copy of the EU declaration of conformity shall accompany every product

other than a component.

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 other than components.

5.3. The manufacturer shall draw up a written attestation of conformity for each

component model and keep it at the disposal of the national authorities for 10 years

after the component has been placed on the market. The attestation of conformity

shall identify the component model for which it has been drawn up. A copy of the

attestation of conformity shall accompany every component.

6. 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.

7. Authorised representative

The manufacturer’s obligations may be fulfilled by his authorised

representative, on his behalf and under his responsibility, provided that they are

s pe c i fi e d i n th e m a nd a t e . A n au th or i s e d r e p re s e nt a t iv e ma y no t fulfil t he

manufacturer’s obligations set out in point 2.

Schedule VI

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

t he ty p e d esc r ib e d i n t h e E U - t yp e e x am i na t io n cer t i f i cat e a n d sa ti sf y t he

requirements of these regulations 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 EU-type examination certificate and with the

requirements of these regulations 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 type described in the EU- type

examinat ion certificate and with the co rrespon din g r equi rem ent s of th ese

regulations. The tests shall be carried out under the responsibility of a notified body,

chosen by the manufacturer.

The manufacturer shall, under the responsibility of the notified body, affix

the notified body’s identification number during the manufacturing process.

4. CE marking, EU declaration of conformity and attestation of

conformity

4.1. The manufacturer shall affix the CE marking to each individual product

other than a component that is in conformity with the type described in the EU-type

examination certificate an d sati sfies th e appl icable r equi rem ents of th ese

regulations.

4.2. The manufacturer shall draw up a written EU declaration of conformity for a

product model other than a component and keep it at the disposal of the national

authorities for 10 years after the product, other than a component has been placed on

the market. The EU declaration of conformity shall identify such product model for

which it has been drawn up.

A copy of the EU declaration of conformity shall accompany every product,

other than a component.

4.3. The manufacturer shall draw up a written attestation of conformity for each

component model and keep it at the disposal of the national authorities for 10 years

after the component has been placed on the market. The attestation of conformity

shall identify the component model for which it has been drawn up. A copy of the

attestation of conformity shall accompany every component.

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.

Schedule VII

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 EU-type

examination certificate and satisfy the requirements of these regulations 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

(a) the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as well,

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

any other notified body,

(c) all relevant information for the product category envisaged,

(d) the documentation concerning the quality system, and

(e) the technical documentation of the approved type and a copy of the EU-

type examination certificate.

3.2. The quality system shall ensure compliance of the products with the type

de s c r i b e d i n t h e E U - ty p e ex a m in a t i on c e r t i f i c a t e a nd w i t h t h e ap p l ic a b l e

requirements of these regulations.

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

(a) the quality objectives and the organisational structure, responsibilities

and powers of the management with regard to product quality,

(b) the examinations and tests that will be carried out after manufacture,

(c) the quality records, such as inspection reports and test data, calibration

data, qualification reports on the personnel concerned, etc.,

(d) 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 relevant harmonised standard.

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, an d knowledge of t he ap pl icable

requirements of these regulations. The audit shall include an assessment visit to the

m a n u f a c t u r e r ’s p r e m i s e s . T h e a u d i t i n g t e a m s h a l l r e v i e w t h e t e c h n i c a l

documentation referred to in point 3.1(e) in order to verify the manufacturer’s ability

to identify the relevant requirements of these regulations 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

(a) the quality system documentation,

(b) 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. CE marking, EU declaration of conformity and attestation of

conformity

5.1. The manufacturer shall affix the CE marking and, under the responsibility of

the notified body referred to in point 3.1, the latter’s identification number to each

individual product other than a component that is in conformity with the type

described in the EU-type examination certificate and satisfies the applicable

requirements of these regulations.

5.2. The manufacturer shall draw up a written EU declaration of conformity for

each product model, other than a component and keep it at the disposal of the

national authorities for 10 years after the product other than a component has been

placed on the market. The EU declaration of conformity shall identify such product

model for which it has been drawn up.

A copy of the EU declaration of conformity shall accompany every product

other than a component.

5.3. The manufacturer shall draw up a written attestation of conformity for each

component model and keep it at the disposal of the national authorities for 10 years

after the component has been placed on the market. The attestation of conformity

shall identify the component model for which it has been drawn up. A copy of the

attestation of conformity shall accompany every component.

6. The manufacturer shall, for a period ending 10 years after the product has

been placed on the market, keep at the disposal of the national authorities

(a) the documentation referred to in point 3.1,

(b) the information relating to the change referred to in point 3.5, as

approved,

(c) 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 authority of quality system

approvals issued or withdrawn, and shall, periodically or upon request, make

available to its notifying authority 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.

Schedule VIII

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 these regulations 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 contain at least the following

elements

(a) a general description of the product,

(b) conceptual design and manufacturing drawings and schemes of

components, sub-assemblies, circuits, etc.

(c) descriptions and explanations necessary for the understanding of those

drawings and schemes and the operation of the product,

(d) a list of the harmonised standards applied in full or in part the

references of which have been published in the Official Journal of the

European Union and, where those harmonised standards have not been

applied, descriptions of the solutions adopted to meet the essential

health and safety requirements of these regulations, including a list of

other relevant technical specifications applied. In the event of partly

applied harmonised standards, the technical documentation shall specify

the parts which have been applied,

(e) results of design calculations made, examinations carried out, etc., and

(f)

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 these regulations that apply to them.

4. CE marking, EU declaration of conformity and attestation of

conformity

4.1. The manufacturer shall affix the CE marking to each individual product

other than a component that satisfies the applicable requirements of these

regulations.

4.2. The manufacturer shall draw up a written EU declaration of conformity for a

product model other than a component and keep it together with the technical

documentation at the disposal of the national authorities for 10 years after the

product, other than a component, has been placed on the market. The EU declaration

of conformity shall identify such product model for which it has been drawn up.

A copy of the EU declaration of conformity shall accompany every product

other than a component.

4.3. The manufacturer shall draw up a written attestation of conformity for each

component model and keep it together with the technical documentation at the

disposal of the national authorities for 10 years after the component has been placed

on the market. The attestation of conformity shall identify the component for which

it has been drawn up. A copy of the attestation of conformity shall accompany every

component.

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.

Schedule IX

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 these regulations that apply to it.

2. Technical documentation

2.1. 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 anal ysis and assessm ent of the ri sk (s). T he 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 at least the following elements

(a) a general description of the product,

(b) conceptual design and manufacturing drawings and schemes of

components, sub-assemblies, circuits, etc.,

(c) descriptions and explanations necessary for the understanding of those

drawings and schemes and the operation of the product,

(d) a list of the harmonised standards applied in full or in part the

references of which have been published in the Official Journal of the

European Union and, where those harmonised standards have not been

applied, descriptions of the solutions adopted to meet the essential

health and safety requirements of these regulations, including a list of

other relevant technical specifications applied. In the event of partly

applied harmonised standards, the technical documentation shall specify

the parts which have been applied,

(e) results of design calculations made, examinations carried out, etc., and

(f)

test reports.

2.2. 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 these regulations.

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

equivalent tests set out in other relevant technical specifications, to check the

conformity of the product with the applicable requirements of these regulations, or

have them carried out. In the absence of such a harmonised standard 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.

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. CE marking, EU declaration of conformity and attestation of

conformity

5.1. The manufacturer shall affix the CE marking and, under the responsibility of

the notified body referred to in point 4, the latter’s identification number to each

product other than a component that satisfies the applicable requirements of these

regulations.

5.2. The manufacturer shall draw up a written EU declaration of conformity and

keep it at the disposal of the national authorities for 10 years after the product, other

than a component has been placed on the market. The EU declaration of conformity

shall identify such product for which it has been drawn up.

A copy of the EU declaration of conformity shall accompany every product,

other than a component.

5.3. The manufacturer shall draw up a written attestation of conformity and keep

it at the disposal of the national authorities for 10 years after the component has been

placed on the market. The attestation of conformity shall identify the component for

which it has been drawn up. A copy of the attestation of conformity shall accompany

every component.

6. Authorised representative

The manufacturer’s obligations set out in points 2.2 and 5 may be fulfilled

by his authorised representative, on his behalf and under his responsibility, provided

that they are specified in the mandate.

Schedule X

EU DECLARATION OF CONFORMITY (No XXXX) ( * )

1. Product model/product (product, type, batch or serial number)

2. Name and address of the manufacturer and, where applicable, his authorised

representative

3. This declaration of conformity is issued under the sole responsibility of the

manufacturer.

4. Object of the declaration (identification of product allowing traceability; it

may, where necessary for the identification of the product, include an image)

5. The object of the declaration described above is in conformity with the

relevant Union harmonisation legislation

6. References to the relevant harmonised standards used or references to the

other technical 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)

It is optional for the manufacturer to assign a number to the declaration of conformity.