ELECTROMAGNETIC COMPATIBILITY REGULATIONS

SUBSIDIARY LEGISLATION 427.35

ELECTROMAGNETIC COMPATIBILITY

REGULATIONS

20th April, 2016 *

LEGAL NOTICE 98 of 2016.

(1) The title of these regulations is the Electromagnetic

Compatibility Regulations.

(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

Compatibility Regulations, 2007; 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.

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

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

* See regulation 1(5) of these Regulations as originally promulgated.

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

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;

" T R D " m e a n s t h e Te c h n i c a l R e g u l a t i o n s D i vi s i o n o f t h e

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.

2. Electromagnetic compatibility assessment

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.

3. Technical documentation

The manufacturer shall establish the technical documentation. The documentation

s h a l l m a k e i t p o s s i b l e t o a ss e s s t h e a p p a r a t u s c o n f o r m i t y t o t h e r e l e v a n t

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

ELECTROMAGNETIC COMPATIBILITY

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.

4. Manufacturing

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.

5. CE marking and EU declaration of conformity

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.

6. Authorised representative

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

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

they are specified in the mandate.

(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 n ot 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

ELECTROMAGNETIC COMPATIBILITY

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

ELECTROMAGNETIC COMPATIBILITY

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.

ELECTROMAGNETIC COMPATIBILITY

2. Manufacturing

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.

3. CE marking and EU declaration of conformity

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.

4. Authorised representative

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

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

they are specified in the mandate.

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

service only if it complies with the requirements of these

regulations when properly installed, maintained and used for its

intended purpose.

(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

m a y i n c l u d e a c o l o u r i m a g e o f s u ff i c i e n t c l a r i t y w h e r e n e c e s sa r y f o r t h e

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

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.

(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

c orrective measure s n ece ssary t o bring tha t appa ratus i nto

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 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 nec essary t o b ri ng th at ap p aratu s in to

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

distributors shall act with due care in relation to the requirements

of 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

co nformi ty wi th th ese regu lat io ns sh all m ake su re th at the

c orrective measure s n ece ssary t o bring tha t appa ratus i nto

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

requirements set out in Schedule I shall be demonstrated by means

of either of the following conformity assessment procedures

(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

fulfillment of the essential requirements set out in Schedule I has

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

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

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

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

possible or not warranted on account of the nature of the apparatus,

it 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

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

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 regulation 26.

The assessment and monitoring referred to in regulation 21

shall be carried out by the National Accreditation Board as the

national accreditation body within the meaning of and in

accordance with Regulation (EC) No 765/2008.

Conformity assessment bodies shall be notified to the

European Commission and the other Member States by the TRD

using the electronic notification tool developed and managed by the

European Commission.

(1) For the purposes of notification, a conformity

assessment body shall meet the requirements laid down in sub-

regulations (2) to (11).

(2) A conformity assessment body shall be established as

stipulated in the Method for Designating Conformity Assessment

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

a p p a r a t u s w h i c h i t a s s e s s e s , m a y, o n c o n d i t i o n t h a t i t s

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

c o n n e c t ed w i t h t h e c o n f o r m i t y as s e s s m en t a c t i v i t i e s i n a n

a p p r o p r i a t e m an n e r a n d sh al l h a v e a c c e s s t o a l l n e c es s a r y

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

c o n f o r m i t y a s s e s s m e n t t a s k s a re i n f o r m e d o f , t h e r el ev a n t

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)

The 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

assessment bodies which have satisfied the requirements laid down

in 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

ac creditation certificate is u sed o r wi th in t wo m on ths 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

been informed that a notified body no longer meets the

requirements 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

designated representatives, in the appropriate coordination and

cooperation groups for notified bodies organised by the European

Commission.

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

765/2008 shall apply to apparatus.

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

apparatus covered by these regulations presents a risk to aspects of

public interest protection covered by these regulations, it shall

carry 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

e i t h e r a M e m b e r St a t e o r t h e C o m m i s s i o n i n r e s p e c t o f 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

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 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

requirements of these regulations are subject to the provisions of

article 26 of the Product Safety Act.

ELECTROMAGNETIC COMPATIBILITY