Electromagnetic Compatibility Regulations, 2016

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 19,549, 22 ta’ Marzu, 2016

L.N. 98 of 2016

PRODUCT SAFETY ACT

(CAP. 427)

Electromagnetic Compatibility Regulations, 2016

IN exercise of the powers conferred by articles 38 and 39 of the

Product Safety Act, the Minister for Social Dialogue, Consumer

Affairs and Civil Liberties, on the advice of the Malta Competition

and Consumer Affairs Authority, has made the following regulations:-

(1) The title of these regulations is the Electromagnetic Title and

commencement.

Compatibility Regulations, 2016.

(2) These regulations transpose Directive 2014/30/EU of the

European Parliament and of the Council of 26 February 2014 on

electromagnetic compatibility, repealing Directive 2004/108/EC.

(3) Notwithstanding the provisions of sub-regulation (2), the

placing on the market or putting into service of equipment

(a)

which is in compliance with the Electromagnetic S.L. 427.35

Compatibility Regulations; and

(b) which was placed on the market before the 20th

April, 2016, shall not be impeded.

(4) These regulations lay down electromagnetic compatibility

requirements for equipment as defined in regulation 2 and made

available on the market.

(5) These regulations shall apply from the 20th April, 2016.

ESSENTIAL REQUIREMENTS

1. General requirements

Equipment shall be so designed and manufactured, having regard to the

state of the art, as to ensure that

(a)

the electromagnetic disturbance generated does not exceed the

level above which radio and telecommunications equipment or

other equipment cannot operate as intended;

(b)

it has a level of immunity to the electromagnetic disturbance to

be expected in its intended use which allows it to operate without

unacceptable degradation of its intended use.

2. Specific requirements for fixed installations

Installation and intended use of components

A fixed installation shall be installed applying good engineering

practices and respecting the information on the intended use of its

components, with a view to meeting the essential requirements set out

in point 1.

(1)

In these regulations, unless the context otherwise Interpretation.

requires

"accreditation" means an attestation by a national accreditation

body that a conformity assessment body meets the requirements set

by harmonised standards and, where applicable, any additional

requirements including those set out in relevant sectoral schemes, to

carry out a specific conformity assessment activity;

"apparatus" means any finished appliance or combination

thereof made commercially available as a single functional unit,

intended for the end user and liable to generate electromagnetic

disturbance, or the performance of which is liable to be affected by

such disturbance;

"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 apparatus is in conformity with the applicable

requirements set out in Union harmonisation legislation providing for

its affixing.

"conformity assessment" means the process demonstrating

whether the essential requirements of these regulations relating to an

apparatus have been fulfilled;

"conformity assessment body" means a body that performs

conformity assessment activities including calibration, testing,

certification and inspection;

"Director General" means the Director General (Technical

Regulations) as defined in article 2 of the Malta Competition and

Consumer Affairs Act;

"distributor" means any natural or legal person in the supply

chain, other than the manufacturer or the importer, who makes

apparatus available on the market;

"economic operators" means the manufacturer, the authorised

representative, the importer and the distributor;

"electromagnetic compatibility" means the ability of equipment

to function satisfactorily in its electromagnetic environment without

introducing intolerable electromagnetic disturbances to other

equipment in that environment;

"electromagnetic disturbance" means any electromagnetic

phenomenon which may degrade the performance of equipment. An

electromagnetic disturbance may be electromagnetic noise, an

unwanted signal or a change in the propagation medium itself;

"electromagnetic environment" means all electromagnetic

phenomena observable in a given location;

"equipment" means any apparatus or fixed installation;

"European standard’ means a standard adopted by a European

standardisation organisation;

"fixed installation" means a particular combination of several

types of apparatus and, where applicable, other devices, which are

assembled, installed and intended to be used permanently at a

predefined location;

"harmonised standard" means a European standard adopted on

the basis of a request made by the Commission for the application of

Union harmonization legislation;

"immunity" means the ability of equipment to perform as

intended without degradation in the presence of an electromagnetic

disturbance;

"importer" means any natural or legal person established within

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

market;

"making available on the market" means any supply of

apparatus 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 apparatus or has apparatus designed or manufactured,

and markets that apparatus under his name or trade mark;

"MCCAA" means the Malta Competition and Consumer Affairs

Authority, as established by the Malta Competition and Consumer Cap. 510.

Affairs Act;

"Member State" means a member state of the European Union;

"mobile installations" are defined as a combination of apparatus

and, where applicable, other devices, intended to be moved and

operated in a range of locations;

"MSD" means the Market Surveillance Directorate within the

TRD;

"national accreditation body" means the sole body in a Member

State that performs accreditation with authority derived from the

State;

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

apparatus on the Union market;

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

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

"safety purposes" means the purposes of safeguarding human

life or property.

"technical specification" means a document that prescribes

technical requirements to be fulfilled by the equipment;

"TRD" means the Technical Regulations Division of the

MCCAA, established by the Malta Competition and Consumer

Affairs Act ;

"Union harmonization legislation" means any Union legislation

harmonising the conditions for the marketing of products;

"withdrawal" means any measure aimed at preventing apparatus

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

(2) For the purposes of these regulations, the following shall

be considered as apparatus

(a)

"components" or "sub-assemblies" intended for

incorporation into an apparatus by the end-user, which are liable

to generate electromagnetic disturbance, or the performance of

which is liable to be affected by such disturbance; and

(b) "mobile installations" defined as a combination of

apparatus and, where applicable, other devices, intended to be

moved and operated in a range of locations.

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, 4 and 5 of this Schedule, and ensures and declares on his sole

responsibility that the apparatus concerned satisfy the requirements of

these regulations that apply to it.

Electromagnetic compatibility assessment

2. The manufacturer shall perform an electromagnetic compatibility

assessment of the apparatus, on the basis of the relevant phenomena,

with a view to meeting the essential requirements set out in point 1 of

Schedule I.

The electromagnetic compatibility assessment shall take into account

all normal intended operating conditions. Where the apparatus is

capable of taking different configurations, the electromagnetic

compatibility assessment shall confirm whether the apparatus meets the

essential requirements set out in point 1 of Schedule I in all the possible

configurations identified by the manufacturer as representative of its

intended use.

Technical documentation

3. The manufacturer shall establish the technical documentation. The

documentation shall make it possible to assess the apparatus 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 apparatus. The technical documentation shall,

wherever applicable, contain at least the following elements

(a)

a general description of the apparatus;

(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 apparatus;

(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 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.;

(f)

test reports.

Manufacturing

4. The manufacturer shall take all measures necessary so that the

manufacturing process and its monitoring ensure compliance of the

manufactured apparatus with the technical documentation referred to in

point 3 of this schedule and with the essential requirements set out in

point 1 of Schedule I.

CE marking and EU declaration of conformity

5.

5.1 The manufacturer shall affix the CE marking to each individual

apparatus that satisfies the applicable requirements of these regulations.

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

for an apparatus model and keep it together with the technical

documentation at the disposal of the national authorities for 10 years

after the apparatus has been placed on the market. The EU declaration

of conformity shall identify the apparatus for which it has been drawn

up.

A copy of the EU declaration of conformity shall be made available to

the relevant authorities upon request.

Authorised representative

6. The manufacturer’s obligations set out in point 5 may be fulfilled by his

authorised representative, on his behalf and under his responsibility,

provided that they are specified in the mandate.

(1) These regulations shall apply to equipment as

defined in regulation 2.

(2) These regulations shall not apply to

(a) equipment covered by Directive 1999/5/EC and

made available on the market before 13 th June, 2016;

(b) aeronautical products, parts and appliances as

referred to in Regulation (EC) No 216/2008 of the European

Parliament and of the Council of 20 February 2008 on common

rules in the field of civil aviation and establishing a European

Aviation Safety Agency, and repealing Council Directive 91/

670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/

36/EC;

(c)

radio equipment used by radio amateurs within the

meaning of the Radio Regulations adopted in the framework of

the Constitution of the International Telecommunication Union

and the Convention of the International Telecommunication

Union, unless the equipment is made available on the market;

(d) equipment the inherent nature of the physical

characteristics of which is such that

(i) it is incapable of generating or contributing to

electromagnetic emissions which exceed a level allowing

radio and telecommunication equipment and other

equipment to operate as intended; and

(ii) it operates without unacceptable degradation

in the presence of the electromagnetic disturbance

normally consequent upon its intended use;

(e)

custom built evaluation kits destined for

professionals to be used solely at research and development

facilities for such purposes.

For the purposes of sub-regulation (2)(c), kits of components to

be assembled by radio amateurs and equipment made available on the

market and modified by and for the use of radio amateurs are not

regarded as equipment made available on the market.

(3) Where, for the equipment referred to in sub-regulation (1),

the essential requirements set out in Schedule I are wholly or partly

laid down more specifically by other Union legislation, these

regulations shall not apply, or shall cease to apply, to that equipment

in respect of such requirements from the date of implementation of

that Union legislation.

(4) These regulations shall not affect the application of Union

or national legislation regulating the safety of equipment.

PART A

MODULE B: EU-TYPE EXAMINATION

EU-type examination is the part of a conformity assessment procedure

in which a notified body examines the technical design of an apparatus

and verifies and attests that the technical design of the apparatus meets

the essential requirements set out in point 1 of Schedule I.

EU-type examination shall be carried out by assessment of the

adequacy of the technical design of the apparatus through examination

of the technical documentation referred to in point 3, without

examination of a specimen (design type). It may be restricted to some

aspects of the essential requirements as specified by the manufacturer or

his authorised representative.

The manufacturer shall lodge an application for EU-type examination

with a single notified body of his choice.

The application shall specify the aspects of the essential requirements

for which examination is requested and 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)

the technical documentation. The technical documentation shall

make it possible to assess the apparatus conformity 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 apparatus. The technical

documentation shall contain, wherever applicable, at least the

following elements

(i)

a general description of the apparatus;

(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 apparatus;

(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 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.;

(vi) test reports.

4. The notified body shall examine the technical documentation to assess

the adequacy of the technical design of the apparatus in relation to the

aspects of the essential requirements for which examination is

requested.

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 apparatus 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 aspects of the essential requirements covered by

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 annexes attached.

The EU-type examination certificate and its annexes shall contain all

relevant information to allow the conformity of manufactured apparatus

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

apparatus with the essential 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 annexes

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 annexes and additions together with the technical

documentation at the disposal of the national authorities for 10 years

after the apparatus 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.

PART B

MODULE C: CONFORMITY TO TYPE BASED ON INTERNAL

PRODUCTION CONTROL

1. Conformity to type based on internal production control is the part of a

conformity assessment procedure whereby the manufacturer fulfils the

obligations laid down in points 2 and 3, and ensures and declares that

the apparatus 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.

Manufacturing

2. The manufacturer shall take all measures necessary so that the

manufacturing process and its monitoring ensure conformity of the

manufactured apparatus with the approved type described in the EU-

type examination certificate and with the requirements of these

regulations that apply to them.

CE marking and EU declaration of conformity

3.

3.1 The manufacturer shall affix the CE marking to each individual

apparatus that is in conformity with the type described in the EU-type

examination certificate and satisfies the applicable requirements of

these regulations.

3.2 The manufacturer shall draw up a written EU declaration of conformity

for each apparatus model and keep it at the disposal of the national

authorities for 10 years after the apparatus has been placed on the

market. The EU declaration of conformity shall identify the apparatus

model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to

the relevant authorities upon request.

Authorised representative

4. The manufacturer’s obligations set out in point 3 may be fulfilled by his

authorised representative, on his behalf and under his responsibility,

provided that they are specified in the mandate.

(1) Equipment shall be placed on the market or put into Making

service only if it complies with the requirements of these regulations available

market/putting

when properly installed, maintained and used for its intended into

freedom of

purpose.

movement.

(2) The placing on the market or the putting into service of

equipment which complies with these regulations shall not be

impeded, for reasons relating to electromagnetic compatibility.

(3) The display and, or demonstration at trade fairs,

exhibitions or similar events of equipment which does not comply

with these regulations shall not be impeded, provided that a visible

sign clearly indicates that such equipment shall not be placed on the

market or put into service until it has been brought into conformity

with these regulations. Demonstration shall only take place provided

that adequate measures are taken to avoid electromagnetic

disturbances.

EU declaration of conformity (No Xxxx) ( * )

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

2. Name and address of the manufacturer or his authorised representative

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

the manufacturer.

4. Object of the declaration (identification of apparatus allowing

traceability; it may include a colour image of sufficient clarity where

necessary for the identification of the apparatus)

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, including the

date of the standard, or references to the other technical specifications,

including the date of the specification, in relation to which conformity

is declared

7. Where applicable, the notified body … (name, number) performed …

(description of intervention) and issued the certificate

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

8. Additional information

Signed for and on behalf of

(place and date of issue)

(name, function) (signature)

B

B

B

€1.44

(1) These regulations shall not prevent the application

of the following special measures by any Authority or regulator in

Malta concerning the putting into service or use of equipment

(a)

measures to overcome an existing or predicted

electromagnetic compatibility problem at a specific site; and

(b) measures taken for safety reasons to protect public

telecommunications networks or receiving or transmitting

stations when used for safety purposes in well-defined spectrum

situations.

(2) The measures taken in sub-regulation (1) shall be notified

immediately to the TRD, giving details of the measures, including

whether the measures are to be applied for an indefinite or definite

period, and the reasons justifying their implementation.

(3) The TRD shall deliver its opinion on the measures taken

and shall notify these measures to the Commission and the other

Member States.

(4) Sub-regulations (2) and (3) shall be without prejudice to

the provisions of the Notification Procedure Regulations.

The equipment shall meet the essential requirements set

out in Schedule I.

(1) When placing their apparatus on the market,

manufacturers shall ensure that they have been designed and

manufactured in accordance with the essential requirements set out in

Schedule I.

(2) Manufacturers shall draw up the technical documentation

referred to in Schedule II or Schedule III and carry out the relevant

conformity assessment procedure referred to in regulation 14 or have

it carried out.

(3) Where compliance of apparatus with the applicable

requirements has been demonstrated by that procedure, manufacturers

shall draw up an EU declaration of conformity and affix the CE

marking.

(4) Manufacturers shall keep the technical documentation and

the EU declaration of conformity for 10 years after the apparatus has

been placed on the market.

(5) Manufacturers shall ensure that procedures are in place for

series production to remain in conformity with these regulations.

Changes in apparatus design or characteristics and changes in the

harmonised standards or in other technical specifications by reference

to which conformity of apparatus is declared shall be adequately

taken into account.

(6) Manufacturers shall ensure that apparatus 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 apparatus does not allow it, that the required information is

provided on the packaging or in a document accompanying the

apparatus.

(7) Manufacturers shall indicate, on the apparatus, 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 apparatus. The address

shall indicate a single point at which the manufacturer can be

contacted. The contact details shall be in a language easily understood

by end-users and the MSD.

(8) Manufacturers shall ensure that the apparatus is

accompanied by instructions and the information referred to in

regulation 18, in Maltese or English. Such instructions and

information, as well as any labelling, shall be clear, understandable

and intelligible.

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

an apparatus which they have placed on the market is not in

conformity with these regulations shall immediately take the

corrective measures necessary to bring that apparatus into conformity,

to withdraw it or recall it, if appropriate. Furthermore, where the

apparatus presents a risk, manufacturers shall immediately inform the

MSD, giving details, in particular, of the non-compliance and of any

corrective measures taken.

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

MSD, provide it with all the information and documentation in paper

or electronic form necessary to demonstrate the conformity of the

apparatus with these regulations, in Maltese or English. They shall

cooperate with the MSD, at its request, on any action taken to

eliminate the risks posed by apparatus which they have placed on the

market.

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

representatives.

an authorised representative.

(2) The obligations laid down in regulation 7(1) and the

obligation to draw up technical documentation referred to in

regulation 7(2) shall not form part of the authorised representative’s

mandate.

(3) 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 and the

technical documentation at the disposal of the MSD for 10 years

after the apparatus has been placed on the market;

(b) further to a reasoned request from the MSD, provide

it with all the information and documentation necessary to

demonstrate the conformity of the apparatus; and

(c)

cooperate with the MSD, at their request, on any

action taken to eliminate the risks posed by the apparatus

covered by the authorised representative’s mandate.

(1)

Importers shall place only compliant apparatus on

the market.

(2) Before placing apparatus on the market importers shall

ensure that the appropriate conformity assessment procedure referred

to in regulation 14 has been carried out by the manufacturer. They

shall ensure that the manufacturer has drawn up the technical

documentation, that the apparatus bears the CE marking and is

accompanied by the required documents, and that the manufacturer

has complied with the requirements set out in regulations 7(6) and

7(7).

(3) Where an importer considers or has reason to believe that

apparatus is not in conformity with the essential requirements set out

in Schedule I, he shall not place the apparatus on the market until it

has been brought into conformity. Furthermore, where the apparatus

presents a risk, the importer shall inform the manufacturer and the

MSD to that effect.

(4) Importers shall indicate on the apparatus 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 apparatus. The contact

details shall be in a language easily understood by end-users and the

MSD.

(5) Importers shall ensure that the apparatus is accompanied

by instructions and the information referred to in regulation 18 in

Maltese or English.

(6) Importers shall ensure that, while an apparatus is under

their responsibility, its storage or transport conditions do not

jeopardise its compliance with the essential requirements set out in

Schedule I.

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

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

with these regulations shall immediately take the corrective measures

necessary to bring that apparatus into conformity, to withdraw it or

recall it, if appropriate.

(8) Furthermore, where the apparatus presents a risk,

importers shall immediately inform the MSD to that effect, giving

details, in particular, of the non-compliance and of any corrective

measures taken.

(9) Importers shall, for 10 years after the apparatus has been

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

conformity at the disposal of the MSD and ensure that the technical

documentation can be made available to it, upon request.

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

MSD, provide it with all the information and documentation in paper

or electronic form, necessary to demonstrate the conformity of

apparatus in Maltese or English. They shall cooperate with the MSD,

at its request, on any action taken to eliminate the risks posed by

apparatus which they have placed on the market.

(1) When making apparatus available on the market Obligations of

distributors shall act with due care in relation to the requirements of distributors.

these regulations.

(2) Before making apparatus available on the market

distributors shall verify that the apparatus bears the CE marking, that

it is accompanied by the required documents and by instructions and

the information referred to in regulation 18 in Maltese or English and

that the manufacturer and the importer have complied with the

requirements set out in regulations 7(6), 7(7) and 9(4) respectively.

(3) Where a distributor considers or has reason to believe that

apparatus is not in conformity with the essential requirements set out

in Schedule I, he shall not make the apparatus available on the market

until it has been brought into conformity. Furthermore, where the

apparatus presents a risk, the distributor shall inform the

manufacturer or the importer to that effect as well as the MSD.

(4) Distributors shall ensure that, while apparatus is under

their responsibility, its storage or transport conditions do not

jeopardise its compliance with the essential requirements set out in

Schedule I.

(5) Distributors who consider or have reason to believe that

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

conformity with these regulations shall make sure that the corrective

measures necessary to bring that apparatus into conformity, to

withdraw it or recall it, if appropriate, are taken. Furthermore, where

the apparatus presents a risk, distributors shall immediately inform

the MSD to that effect, giving details, in particular, of the non-

compliance and of any corrective measures taken.

(6) Distributors shall, further to a reasoned request from the

MSD, provide it with all the information and documentation in paper

or electronic form, necessary to demonstrate the conformity of the

apparatus. They shall cooperate with the MSD, at its request, on any

action taken to eliminate the risks posed by apparatus 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 7,

where he places apparatus on the market under his name or trade

mark or modifies apparatus 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 TRD

(a)

any economic operator who has supplied them with

apparatus;

(b) any economic operator to whom they have supplied

apparatus.

(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 apparatus and for 10 years after they

have supplied the apparatus.

Equipment which is 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 requirements set out

in Schedule I covered by those standards or parts thereof.

(1) Compliance of apparatus with the essential Conformity

requirements set out in Schedule I shall be demonstrated by means of assessment

procedures for

either of the following conformity assessment procedures

apparatus.

(a)

internal production control set out in Schedule II;

(b) EU type examination that is followed by Conformity

to type based on internal production control set out in Schedule

III.

(2) The manufacturer may choose to restrict the application of

the procedure referred to in sub-regulation (1)(b) to some aspects of

the essential requirements, provided that for the other aspects of the

essential requirements the procedure referred to in sub-regulation

(1)(a) is applied.

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

fulfillment of the essential requirements set out in Schedule I has of conformity.

been demonstrated.

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

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

in the relevant modules set out in Schedules II and III and shall be

continuously updated. It shall be translated into Maltese or English.

(3) Where apparatus 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

apparatus with the requirements laid down in these regulations.

The CE marking shall be subject to the general principles General

principles of the

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

CE marking.

17 (1) The CE marking shall be affixed visibly, legibly and Rules and

indelibly to the apparatus or to its data plate. Where that is not conditions

affixing the CE

possible or not warranted on account of the nature of the apparatus, it marking.

shall be affixed to the packaging and to the accompanying

documents.

(2) The CE marking shall be affixed before the apparatus is

placed on the market.

(3) Improper use of the CE marking shall subject the relevant

economic operator/s to the measures described in regulation 37.

(1) Apparatus shall be accompanied by information on

any specific precautions that must be taken when the apparatus is

assembled, installed, maintained or used, in order to ensure that,

when put into service, the apparatus is in conformity with the

essential requirements set out in point 1 of Schedule I.

(2) Apparatus for which compliance with the essential

requirements set out in point 1 of Schedule I is not ensured in

residential areas shall be accompanied by a clear indication of such

restriction of use, where appropriate also on the packaging.

(3) The information required to enable apparatus to be used in

accordance with the intended purpose of the apparatus shall be

included in the instructions accompanying the apparatus.

(1) Apparatus which has been made available on the

market and which may be incorporated into a fixed installation shall

be subject to all relevant provisions for apparatus set out in these

regulations

Provided that, the requirements of regulations 6 to 12 and

regulations 14 to 18 shall not be compulsory in the case of apparatus

which is intended for incorporation into a particular fixed installation

and is otherwise not made available on the market.

In such cases, the accompanying documentation shall

identify the fixed installation and its electromagnetic compatibility

characteristics and shall indicate the precautions to be taken for the

incorporation of the apparatus into the fixed installation in order not

to compromise the conformity of that installation. It shall also include

the information referred to in regulations 7(6), 7(7) and 9(4).

The good engineering practices referred to in point 2 of

Schedule I shall be documented and the documentation shall be held

by the person or persons responsible at the disposal of the MSD for

inspection for as long as the fixed installation is in operation.

(2) Where there are indications of non-compliance of the fixed

installation, in particular, where there are complaints about

disturbances being generated by the installation, the MSD may

request evidence of compliance of the fixed installation, and, when

appropriate, initiate an evaluation.

Where non-compliance is established, the MSD shall impose

appropriate measures to bring the fixed installation into compliance

with the essential requirements set out in Schedule I.

(3) Member States shall set out the necessary provisions for

identifying the person or persons responsible for the establishment of

compliance of a fixed installation with the relevant essential

requirements.

Bodies authorised to carry out third-party conformity Notification.

assessment tasks under these regulations shall be notified to the

European Commission and the other Member States by the TRD.

The TRD shall be the designated notifying authority Notifying

responsible for setting up and carrying out the necessary procedures authorities.

for the assessment and notification of conformity assessment bodies

and the monitoring of notified bodies, including compliance with

regulation 26.

The assessment and monitoring referred to in regulation 21 National

shall be carried out by the National Accreditation Board as the Accreditation

Board.

national accreditation body within the meaning of and in accordance

with Regulation (EC) No 765/2008.

Conformity assessment bodies shall be notified to the Information

European Commission and the other Member States by the TRD obligation

notifying

using the electronic notification tool developed and managed by the authorities.

European Commission.

(1) For the purposes of notification, a conformity Requirements

assessment body shall meet the requirements laid down in sub- relating

notified bodies.

regulations (2) to (11).

(2) A conformity assessment body shall be established as

stipulated in the Method for Designating Conformity Assessment S.L. 427.45

Bodies Regulations.

(3) A conformity assessment body shall be a third-party body

independent of the organisation or the apparatus 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 apparatus

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 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 apparatus which

they assess, nor the representative of any of those parties. This shall

not preclude the use of assessed apparatus that are necessary for the

operations of the conformity assessment body or the use of such

apparatus for personal purposes.

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

apparatus, or represent the parties engaged in those activities. They

shall not engage in any activity that may conflict with their

independence of judgement or integrity in relation to conformity

assessment activities for which they are notified. This shall in

particular apply to consultancy services.

Conformity assessment bodies shall ensure that the activities of

their subsidiaries or subcontractors do not affect the confidentiality,

objectivity or impartiality of their conformity assessment activities.

(5) Conformity assessment bodies and their personnel shall

carry out the conformity assessment activities with the highest degree

of professional integrity and the requisite technical competence in the

specific field and shall be free from all pressures and inducements,

particularly financial, which might influence their judgement or the

results of their conformity assessment activities, especially as regards

persons or groups of persons with an interest in the results of those

activities.

(6) A conformity assessment body shall be capable of carrying

out all the conformity assessment tasks assigned to it by Schedule III

and in relation to which it has been notified, whether those tasks are

carried out by the conformity assessment body itself or on its behalf

and under its responsibility.

At all times and for each conformity assessment procedure and

each kind or category of apparatus in relation to which it has been

notified, a conformity assessment body shall have at its disposal the

necessary

(a)

personnel with technical knowledge and sufficient

and appropriate experience to perform the conformity

assessment tasks;

(b) 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;

(c)

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

apparatus technology in question and the mass or serial nature

of the production process.

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)

per 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 requirements set out in Schedule I, of the applicable

harmonised standards and of the relevant provisions of

European 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.

(10) The personnel of a conformity assessment body shall

observe professional secrecy with regard to all information obtained

in carrying out their tasks under Schedule III or any provision of

national law giving effect to it, except in relation to the TRD.

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 European Union

harmonisation legislation and shall apply as general guidance the

administrative decisions and documents produced as a result of the

work of that group.

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 24 in

so far as the applicable harmonised standards cover those

requirements.

(1) Where a notified body subcontracts specific tasks

connected with conformity assessment or has recourse to a subsidiary,

it shall ensure that the subcontractor or the subsidiary meets the

requirements set out in regulation 24 and shall inform the notifying

authority accordingly.

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

performed by subcontractors or subsidiaries wherever these are

established.

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

subsidiary only with the agreement of the client.

(4) Notified bodies shall keep at the disposal of the TRD the

relevant documents concerning the assessment of the qualifications of

the subcontractor or the subsidiary and the work carried out by them

under Schedule III.

(1) A conformity assessment body shall submit an

application for notification to the notifying authority of the Member

State in which it is established.

(2) he application for notification shall be accompanied by a

description of the conformity assessment activities, the conformity

assessment module or modules and the apparatus for which that body

claims to be competent, as well as by an accreditation certificate,

where one exists, issued by a national accreditation body attesting

that the conformity assessment body fulfils the requirements laid

down in regulation 24.

(3) Where the conformity assessment body concerned cannot

provide an accreditation certificate, it shall provide the notifying

authority with all the documentary evidence necessary for the

verification, recognition and regular monitoring of its compliance

with the requirements laid down in regulation 24.

(1) Notifying authorities may notify only conformity Notification

assessment bodies which have satisfied the requirements laid down in procedure.

regulation 24.

(2) They shall notify the Commission and the other Member

States using the electronic notification tool developed and managed

by the European Commission.

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

assessment activities, the conformity assessment module or modules

and apparatus concerned and the relevant attestation of competence.

(4) Where a notification is not based on an accreditation

certificate as referred to in regulation 27(2), the notifying authority

shall provide the European Commission and the other Member States

with documentary evidence which attests to the conformity

assessment body’s competence and the arrangements in place to

ensure that that body will be monitored regularly and will continue to

satisfy the requirements laid down in regulation 24.

(5) The body concerned may perform the activities of a

notified body only where no objections are raised by the Commission

or the other Member States within two weeks of a notification where

an accreditation certificate is used or within two months of a

notification where accreditation is not used.

Only such a body shall be considered a notified body for the

purposes of these regulations.

(1) Where a notifying authority has ascertained or has Changes to

been informed that a notified body no longer meets the requirements notifications.

laid down in regulation 24, or that it is failing to fulfil its obligations,

the notifying authority shall restrict, suspend or withdraw notification

as appropriate, depending on the seriousness of the failure to meet

those requirements or fulfil those obligations. It shall immediately

inform the European Commission and the other Member States

accordingly.

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

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

TRD 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.

(1) Notified bodies shall carry out

conformity

assessments in accordance with the conformity

assessment

procedures provided for in Schedule III.

(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 apparatus

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

apparatus with these regulations.

(3) Where a notified body finds that the essential requirements

set out in Schedule I or corresponding harmonised standards or other

technical specifications have not been met by a manufacturer, it shall

require that manufacturer to take appropriate corrective measures and

shall not issue a certificate.

(4) Where, in the course of the monitoring of conformity

following the issue of a certificate, a notified body finds that an

apparatus 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.

Member States shall ensure that an appeal procedure

against decisions of the notified bodies is available.

(1)

Notified bodies shall inform the TRD 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.

(2) Notified bodies shall provide the other bodies notified

under these regulations carrying out similar conformity assessment

activities covering the same apparatus with relevant information on

issues relating to negative and, on request, positive conformity

assessment results.

Notified bodies shall participate, directly or by means of Coordination of

designated representatives, in the appropriate coordination and notified bodies

cooperation groups for notified bodies organised by the European

Commission.

Article 15(3) and Articles 16 to 29 of Regulation (EC) No Union market

surveillance and

765/2008 shall apply to apparatus.

control of

apparatus

entering the

Union market

(1) Where the MSD has sufficient reason to believe that Procedure for

an apparatus covered by these regulations presents a risk to aspects of dealing

apparatus

public interest protection covered by these regulations, it shall carry presenting

at national level.

out an evaluation in relation to the apparatus concerned covering all

relevant requirements laid down in these regulations. The relevant

economic operators shall cooperate as necessary with the MSD for

that purpose.

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

regulation (1), the MSD finds that the apparatus does not comply with

the requirements laid down in these regulations, it shall without delay

require the relevant economic operator to take all appropriate

corrective actions to bring the apparatus into compliance with those

requirements, to withdraw the apparatus from the market, or to recall

it within a reasonable period, commensurate with the nature of the

risk, as they may prescribe.

(3) The MSD shall inform the relevant notified body

accordingly.

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

the measures referred to in sub-regulation (2).

(5) Where the MSD considers that non-compliance is not

restricted to its national territory, it shall inform the Commission and

the other Member States of the results of the evaluation, and of the

actions which it has required the economic operator to take.

(6) The economic operator shall ensure that all appropriate

corrective action is taken in respect of all the apparatus concerned

that it has made available on the market throughout the European

Union.

(7) Where the relevant economic operator does not take

adequate corrective action within the period referred to in sub-

regulation (2), the MSD shall take all appropriate provisional

measures to prohibit or restrict the apparatus’s being made available

on the national market, to withdraw the apparatus from that market or

to recall it.

(8) The MSD shall inform the Commission and the other

Member States, without delay, of those measures.

(9) The information referred to in sub-regulation (8) shall

include all available details, in particular the data necessary for the

identification of the non-compliant apparatus, the origin of the

apparatus, 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 MSD shall indicate whether the non-compliance is due

to either of the following

(a)

failure of the apparatus to meet the requirements

relating to aspects of public interest protection covered by these

regulations; or

(b) shortcomings in the harmonised standards referred

to in regulation 13 conferring a presumption of conformity.

(10) Member States other than the Member State initiating the

procedure under these regulations shall without delay inform the

Commission and the other Member States of any measures adopted

and of any additional information at their disposal relating to the non-

compliance of the apparatus concerned, and, in the event of

disagreement with the adopted national measure, of their objections.

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

referred to in sub-regulation (8), no objection has been raised by

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

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

justified.

(12)The TRD in such instances shall ensure that appropriate

restrictive measures, such as withdrawal of the apparatus from the

market, are taken in respect of the apparatus concerned without delay.

(1) Without prejudice to regulation 35, where the MSD Formal non-

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

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 has not been affixed;

(c)

the EU declaration of conformity has not been

drawn up;

(d) the EU declaration of conformity has not been

drawn up correctly;

(e)

technical documentation is either not available or

not complete;

(f)

the information referred to in regulation 7(7) or

regulation 9(4) is absent, false or incomplete;

(g) any other administrative requirement provided for in

regulations 7 and 9 is not fulfilled.

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

persists, the MSD shall take all appropriate measures to restrict or

prohibit the apparatus being made available on the market or ensure

that it is recalled or withdrawn from the market.

Economic operators failing to comply with the Penalties.

requirements of these regulations are subject to the provisions of

article 26 of the Product Safety Act.

Electromagnetic Compatibility Regulations are hereby Repeal.

repealed.