Radio Equipment Regulations, 2016

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 19,586, 6 ta’ Ġunju, 2016

L.N. 213 of 2016

PRODUCT SAFETY ACT

(CAP. 427)

Radio Equipment 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 Radio Equipment Title and

commencement.

Regulations, 2016.

(2) These regulations

(a)

transpose Directive 2014/53/EU of the European

Parliament and of the Council of 16 April 2014 on radio

equipment; and

(b

lay down requirements for products referred to in

regulation 2 and made available on the market.

(3) These regulations shall apply as from 13 th June 2016.

EQUIPMENT NOT COVERED BY THESE REGULATIONS

1. Radio equipment used by radio amateurs within the meaning of Article 1,

definition 56, of the International Telecommunications Union (ITU) Radio

Regulations, unless the equipment is made available on the market. The

following shall be regarded as not being made available on the market

(a)

radio kits for assembly and use by radio amateurs;

(b)

radio equipment modified by and for the use of radio amateurs;

(c)

equipment constructed by individual radio amateurs for experimental

and scientific purposes related to amateur radio.

2. Marine equipment falling within the scope of Council Directive 96/98/

EC (*) .

3. Airborne products, parts and appliances falling within the scope of Article 3

of Regulation (EC) No 216/2008 of the European Parliament and of the

Council ( ** ).

4. Custom-built evaluation kits destined for professionals to be used solely at

research and development facilities for such purposes.

(1)

These regulations shall apply to radio equipment.

Applicability.

(2)

These regulations shall not apply

(a

to the equipment listed in Schedule I; and

(b to radio equipment exclusively used for

activities concerning public security, defence, State

security, including the economic well-being of the State in

the case of activities pertaining to State security matters,

and the activities of the State in the area of criminal law.

(4) Radio equipment falling within the scope of

these regulations shall not be subject to the Low Voltage S.L. 427.34

Electrical Equipment Regulations except as set out in

regulation 4(1)(a).

CONFORMITY ASSESSMENT MODULE A

INTERNAL PRODUCTION CONTROL

1. Internal production control is the conformity assessment procedure whereby

the manufacturer fulfils the obligations laid down in points 2, 3 and 4 of this

Schedule, and ensures and declares on his sole responsibility that the radio

equipment concerned satisfies the essential requirements set out in

regulation 4.

2. Technical documentation

The manufacturer shall establish the technical documentation in accordance

with regulation 21.

* Council Directive 96/98/EC of 20 December 1996 on marine equipment (OJ L 46, 17.2.1997, p. 25).

** 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 (OJ L

79, 19.3.2008, p. 1).

3. Manufacturing

The manufacturer shall take all measures necessary so that the

manufacturing process and its monitoring ensure compliance of the

manufactured radio equipment with the technical documentation referred to

in point 2 of this Schedule and with the relevant essential requirements set

out in regulation 4.

4. CE marking and EU declaration of conformity

(i)

The manufacturer shall affix the CE marking in accordance with

regulations 19 and 20 to each item of radio equipment that satisfies the

applicable requirements of these regulations.

(ii) The manufacturer shall draw up a written EU declaration of conformity

for each radio equipment type and keep it together with the technical

documentation at the disposal of the MSD for 10 years after the radio

equipment has been placed on the market. The EU declaration of

conformity shall identify the radio equipment for which it has been

drawn up. A copy of the EU declaration of conformity shall be made

available to the MSD upon request.

5. Authorised representative

The manufacturer's obligations set out in point 4 may be fulfilled by his

authorised representative, on his behalf and under his responsibility,

provided that they are specified in the mandate.

In these regulations, unless the context otherwise requires

Definitions.

"accreditation" means accreditation as defined in point 10 of

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

"authorised representative" means any natural or legal person

established within the European 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 radio equipment 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

radio equipment have been fulfilled;

"conformity assessment body" means a body that performs

conformity assessment activities;

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

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

equipment available on the market;

"economic operators" means the manufacturer, the authorised

representative, the importer and the distributor;

"electromagnetic

disturbance"

means

electromagnetic

disturbance as defined in point 5 of Article 3(1) of Directive 2014/30/

EU;

"harmful interference" means harmful interference as defined in

point (r) of Article 2 of Directive 2002/21/EC of the European

Parliament and of the European Council;

"harmonised standard" means harmonised standard as defined in

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

"importer" means any natural or legal person established within

the European Union who places radio equipment from a third country

on the European Union market;

"making available on the market" means any supply of radio

equipment 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 radio equipment or has radio equipment designed or

manufactured, and markets that equipment under his name or trade

mark;

"MCA" means the Malta Communications Authority as Cap. 418

established by the Malta Communications Authority Act;

"MCCAA" means the Malta Competition and Consumer Affairs Cap. 510

Authority as established by the Malta Competition and Consumer

Affairs Act;

"MSD" means the Market Surveillance Directorate within the

TRD;

"national accreditation body" means national accreditation body

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

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

radio equipment on the European Union market;

"putting into service" means the first use of radio equipment in

the European Union by its end-user;

"radio communication" means communication by means of

radio waves;

"radiodetermination" means the determination of the position,

velocity and, or other characteristics of an object, or the obtaining of

information relating to those parameters, by means of the propagation

properties of radio waves;

"radio equipment" means an electrical or electronic product,

which intentionally emits and, or receives radio waves for the purpose

of radio communication and, or radiodetermination, or an electrical or

electronic product which must be completed with an accessory, such

as antenna, so as to intentionally emit and, or receive radio waves for

the purpose of radio communication and, or radiodetermination;

"radio equipment class" means a class identifying particular

categories of radio equipment which, under these regulations, are

considered similar and those radio interfaces for which the radio

equipment is designed;

"radio interface" means the specification of the regulated use of

radio spectrum;

"radio waves" means electromagnetic waves of frequencies

lower than3 000 GHz, propagated in space without artificial guide;

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

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

"technical specification" means a document that prescribes

technical requirements to be fulfilled by radio equipment;

"TRD" means the Technical Regulations Division of the

MCCAA established by the Malta Competition and Consumer Affairs

Act;

"Union harmonisation legislation" means any Union legislation

harmonising the conditions for the marketing of products;

"withdrawal" means any measure aimed at preventing radio

equipment in the supply chain from being made available on the

market.

CONFORMITY ASSESSMENT MODULES B AND C

EU-TYPE EXAMINATION AND CONFORMITY TO TYPE BASED ON

INTERNAL PRODUCTION CONTROL

When reference is made to this Schedule, the conformity assessment

procedure shall follow Modules B (EU-type examination) and C

(Conformity to type based on internal production control) of this Schedule.

Module B

EU-type examination

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

which a notified body examines the technical design of the radio equipment

and verifies and attests that the technical design of the radio equipment

meets the essential requirements set out in regulation 4.

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

the technical design of the radio equipment through examination of the

technical documentation and supporting evidence referred to in point 3,

without examination of a specimen (design type).

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

single notified body of his choice. The application shall include

(a)

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

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

(b)

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

any other notified body;

(c)

the technical documentation. The technical documentation shall make it

possible to assess the radio equipment's 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 radio

equipment. The technical documentation shall contain, wherever

applicable, the elements set out in Schedule V;

(d)

the supporting evidence for the adequacy of the technical design

solution. That supporting evidence shall mention any documents that

have been used, in particular where the relevant harmonised standards

have not been applied or have not been fully applied. The supporting

evidence shall include, where necessary, the results of tests carried out

in accordance with other relevant technical specifications by the

appropriate laboratory of the manufacturer, or by another testing

laboratory on his behalf and under his responsibility.

4. The notified body shall examine the technical documentation and supporting

evidence to assess the adequacy of the technical design of the radio

equipment.

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 as provided in point 8, the notified body shall

release the content of that report, in full or in part, only with the agreement

of the manufacturer.

6. (i) Where the type meets the requirements of these regulations that apply to the

radio equipment 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 assessed type. The EU-type examination certificate may have one or

more annexes attached.

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

relevant information to allow the conformity of manufactured radio

equipment with the examined type to be evaluated and to allow for in-

service control.

(iii)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. (i) 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.

(ii)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

radio equipment 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. (i)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.

(ii)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.

(iii)Each notified body shall inform the Member States of EU-type

examination certificates it has issued and, or additions thereto in those cases

where harmonised standards the references of which have been published in

the Official Journal of the European Union have not been applied or not

been fully applied. The Member States, the European Commission and the

other notified bodies may, on request, obtain a copy of the EU-type

examination certificates and, or additions thereto. On request, the Member

States and the European Commission 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 for 10 years after the

radio equipment has been assessed or 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 radio equipment has

been placed on the market.

10. The manufacturer's authorised representative may lodge the application

referred to in point 3 and fulfil the obligations set out in points 7 and 9,

provided that they are specified in the mandate.

Module C

Conformity to type based on internal production control

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

conformity assessment procedure whereby the manufacturer fulfils the

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

radio equipment concerned is in conformity with the type described in the

EU-type examination certificate and satisfies the requirements of these

regulations that apply to it.

2. Manufacturing

The manufacturer shall take all measures necessary so that the

manufacturing process and its monitoring ensure conformity of the

manufactured radio equipment with the approved type described in the EU-

type examination certificate and with the requirements of these regulations

that apply to it.

3. CE marking and EU declaration of conformity

(i)

The manufacturer shall affix the CE marking in accordance with

regulations 19 and 20 to each item of radio equipment that is in

conformity with the type described in the EU-type examination

certificate and satisfies the applicable requirements of these regulations.

(ii)

The manufacturer shall draw up a written EU declaration of conformity

for each radio equipment type and keep it at the disposal of the national

authorities for 10 years after the radio equipment has been placed on the

market. The EU declaration of conformity shall identify the radio

equipment type 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 above may be fulfilled by

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

provided that they are specified in the mandate.

(1)

Radio equipment shall be constructed so as to

ensure

(a)

the protection of health and safety of persons and of

domestic animals and the protection of property, including the

objectives with respect to safety requirements set out in the Low

Voltage Electrical Equipment Regulations but with no voltage

limit applying;

(b) an adequate level of electromagnetic compatibility

as set out in the Electromagnetic Compatibility Regulations.

(2 Radio equipment shall be so constructed that it both

effectively uses and supports the efficient use of radio spectrum in

order to avoid harmful interference.

(3) Radio equipment, within certain categories or classes shall

be so constructed that it complies with the following essential

requirements, which

(a)

interworks with accessories, in particular with

common chargers;

(b)

interworks via networks with other radio equipment;

(c)

can be connected to interfaces of the appropriate

type throughout the European Union;

(d) does not harm the network or its functioning nor

misuse network resources, thereby causing an unacceptable

degradation of service;

(e) incorporates safeguards to ensure that the personal

data and privacy of the user and of the subscriber are protected;

(f)

supports certain features ensuring protection from

fraud;

(g) supports certain

features

ensuring

access

to

emergency services;

(h) supports certain features in order to facilitate its use

by users with a disability;

(i)

supports certain features in order to ensure that

software can only be loaded into the radio equipment where the

compliance of the combination of the radio equipment and

software has been demonstrated.

(4) The categories or classes of radio equipment concerned by

each of the requirements set out in paragraphs (a) to (i) shall be

specified through delegated acts adopted by the European

Commission.

CONFORMITY ASSESSMENT MODULE H

CONFORMITY BASED ON FULL QUALITY ASSURANCE

1. Conformity based on full quality assurance is the conformity assessment

procedure whereby the manufacturer fulfils the obligations laid down in

points 2 and 5, and ensures and declares on his sole responsibility that the

radio equipment concerned satisfies the requirements of these regulations

that apply to it.

2. Manufacturing

The manufacturer shall operate an approved quality system for design,

manufacture, final radio equipment inspection and testing of the radio

equipment concerned as specified in point 3 and shall be subject to

surveillance as specified in point 4.

3. Quality system

(1)

The manufacturer shall lodge an application for assessment of his quality

system with the notified body of his choice, for the radio equipment

concerned.

The application shall include

(a)

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

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

(b)

the technical documentation for each radio equipment type intended to

be manufactured. The technical documentation shall contain, wherever

applicable, the elements set out in Schedule V;

(c)

the documentation concerning the quality system; and

(d)

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

any other notified body.

(2)

The quality system shall ensure compliance of the radio equipment with the

requirements of these regulations that apply to it.

All the elements, requirements and provisions adopted by the manufacturer

shall be documented in a systematic and orderly manner in the form of

written policies, procedures and instructions. That quality system

documentation shall permit a consistent interpretation of the quality

programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of

(i)

the quality objectives and the organisational structure, responsibilities

and powers of the management with regard to design and product

quality;

(ii)

the technical design specifications, including standards, that will be

applied and, where the relevant harmonised standards will not be

applied in full, the means that will be used to ensure that the essential

requirements of these regulations that apply to the radio equipment will

be met;

(iii) the design control and design verification techniques, processes and

systematic actions that will be used when designing radio equipment

pertaining to the radio equipment type covered;

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

techniques, processes and systematic actions that will be used;

(v)

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

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

out;

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

data, reports concerning the qualifications of the personnel, etc.;

(vii) the means of monitoring the achievement of the required design and

product quality and the effective operation of the quality system.

(3) (a)

The notified body shall assess the quality system to determine

whether it satisfies the requirements referred to in point 3(2)

(b)

It shall presume conformity with those requirements in respect of

the elements of the quality system that comply with the

corresponding specifications of the relevant harmonised standard.

(c)

In addition to experience in quality management systems, the

auditing team shall have at least one member experienced as an

assessor in the relevant radio equipment field and radio equipment

technology concerned, and knowledge of the applicable

requirements of these regulations. The audit shall include an

assessment visit to the manufacturer's premises. The auditing team

shall review the technical documentation referred to in point 3(1)(b)

to verify the manufacturer's ability to identify the applicable

requirements of these regulations and to carry out the necessary

examinations with a view to ensuring compliance of the radio

equipment with those requirements.

(d)

The manufacturer or his authorised representative shall be notified

of the decision. The notification shall contain the conclusions of the

audit and the reasoned assessment decision.

(e)

The manufacturer shall undertake to fulfil the obligations arising

out of the quality system as approved and to maintain it so that it

remains adequate and efficient.

(f)

The manufacturer shall keep the notified body that has approved the

quality system informed of any intended change to the quality

system. The notified body shall evaluate any proposed changes and

decide whether the modified quality system will continue to satisfy

the requirements referred to in point 3(2) or whether a reassessment

is necessary. It shall notify the manufacturer of its decision. The

notification shall contain the conclusions of the examination and the

reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

(1)

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

fulfils the obligations arising out of the approved quality system.

(2)

The manufacturer shall, for assessment purposes, allow the notified body

access to the design, manufacture, inspection, testing and storage sites, and

shall provide it with all necessary information, in particular

(a)

the quality system documentation;

(b)

the quality records as provided for by the design part of the quality

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

(c)

the quality records as provided for by the manufacturing part of the

quality system, such as inspection reports and test data, calibration data,

reports concerning the qualifications of the personnel, etc.

(3)

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and shall provide the

manufacturer with an audit report.

(4)

In addition, the notified body may pay unexpected visits to the

manufacturer. During such visits, the notified body may, if necessary, carry

out radio equipment tests, or have them carried out, in order to check the

proper functioning of the quality system. It shall provide the manufacturer

with a visit report and, if tests have been carried out, with a test report.

5. CE marking and EU declaration of conformity

(1)

The manufacturer shall affix the CE marking in accordance with regulations

19 and 20 and, under the responsibility of the notified body referred to in

point 3(1), the latter's identification number to each item of radio equipment

that satisfies the applicable requirements set out in regulation 4.

(2)

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

each radio equipment type and keep it at the disposal of the national

authorities for 10 years after the radio equipment has been placed on the

market. The EU declaration of conformity shall identify the radio equipment

type 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. The manufacturer shall, for a period ending 10 years after the radio

equipment has been placed on the market, keep at the disposal of the

national authorities

(a)

the technical documentation referred to in point 3(1);

(b)

the documentation concerning the quality system referred to in point

3(1);

(c)

the change referred to in point 3(5), as approved;

(d)

the decisions and reports of the notified body referred to in points 3(5),

4(3) and 4(4).

7. Each notified body shall inform its notifying authority of quality system

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

available to its notifying authority the list of quality system approvals

refused, suspended or otherwise restricted. Each notified body shall inform

the other notified bodies of quality system approvals which it has refused,

suspended or withdrawn, and, upon request, of quality system approvals

which it has issued.

8. Authorised representative

The manufacturer's obligations set out in points 3(1), 3(5), 5 and 6 may be

fulfilled by his authorised representative, on his behalf and under his

responsibility, provided that they are specified in the mandate.

(1) Manufacturers of radio equipment and of software Information on

allowing radio equipment to be used as intended shall provide the compliance

radio equipment

MSD and the European Commission with information on the and,

combinations.

compliance of intended combinations of radio equipment and

software with the essential requirements set out in regulation 4. Such

information shall result from a conformity assessment carried out in

accordance with regulation 17, and shall be given in the form of a

statement of compliance which includes the elements set out in

Schedule VI. Depending on the specific combinations of radio

equipment and software, the information shall precisely identify the

radio equipment and the software which have been assessed, and it

shall be continuously updated.

(2) The categories or classes of radio equipment concerned by

the requirement set out in sub-regulation (1) shall be specified

through delegated acts adopted by the European Commission.

(3) The operational rules for making the information on

compliance available for the categories and classes specified by the

delegated acts adopted pursuant to sub-regulation (2), shall be laid

down in implementing acts adopted by the European Commission.

CONTENTS OF TECHNICAL DOCUMENTATION

The technical documentation shall, wherever applicable, contain at least the

following elements

(a)

a general description of the radio equipment including

(i)

photographs or illustrations showing external features, marking

and internal layout;

(ii)

versions of software or firmware affecting compliance with

essential requirements;

(iii) user information and installation instructions;

(b)

conceptual design and manufacturing drawings and schemes of

components, sub-assemblies, circuits and other relevant similar

elements;

(c)

descriptions and explanations necessary for the understanding of those

drawings and schemes and the operation of the radio equipment;

(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 set out in regulation 4, 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)

copy of the EU declaration of conformity;

(f)

where the conformity assessment module in Annex III has been applied,

copy of the EU-type examination certificate and its annexes as

delivered by the notified body involved;

(g)

results of design calculations made, examinations carried out, and other

relevant similar elements;

(h)

test reports;

(i)

an explanation of the compliance with the requirement of regulation

10(2) and of the inclusion or not of information on the packaging in

accordance with regulation 10(10).

(1) As from 12 June 2018, manufacturers shall register Radio

radio equipment types within categories of radio equipment affected equipment

registration

by a low level of compliance with the essential requirements set out within

categories.

in regulation 4 within a central system referred to in sub-regulation

(4) prior to radio equipment within those categories being placed on

the market. When registering such radio equipment types,

manufacturers shall provide some, or where justified all, elements of

the technical documentation listed in points (a), (d), (e), (f), (g), (h)

and (i) of Schedule V. Manufacturers shall affix on radio equipment

placed on the market a registration number as allocated by the

European Commission to each registered radio equipment type.

(2) The categories of radio equipment concerned by the

requirement set out in sub-regulation (1) and the

technical

documentation to be provided, taking into account the information on

the compliance of radio equipment provided by Member States

following an evaluation of the risk of non-implementation of the

essential requirements shall be specified through delegated acts

adopted by the European Commission.

(3) The operational rules for affixing the registration number

on radio equipment for the categories specified by the delegated acts

adopted pursuant to sub-regulation (2) shall be laid down in

implementing acts adopted by the European Commission.

(4) Manufacturers shall register the required information in a

central system ensuring control of access to information of

confidential nature and made available by the European Commission.

Making available on the market and putting into service and

use.

EU DECLARATION OF CONFORMITY (No XXX) (1)

1. Radio equipment (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 the radio equipment allowing

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

necessary for the identification of the radio equipment)

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

relevant Union harmonisation legislation

Directive 2014/53/EU

Other Union harmonisation legislation where applicable.

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

other technical specifications in relation to which conformity is declared.

References must be listed with their identification number and version and,

where applicable, date of issue

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

7. ….... (description of intervention) ......… and issued the EU-type

examination certificate: ...…

8. Where applicable, description of accessories and components, including

software, which allow the radio equipment to operate as intended and

covered by the EU declaration of conformity

9. Additional information

Signed for and on behalf of: …

(place and date of issue)

(name, function) (signature)

€1.71

(1) Radio equipment compliant with these regulations

shall be made available on the market however it may only be

allowed to be put into service when properly installed, maintained

and used for its intended purpose.

(2) The MSD, in coordination with the MCA, may introduce

additional requirements for the putting into service and, or use of

radio equipment solely for reasons related to

(a)

the effective and efficient use of the radio spectrum;

(b) the avoidance of harmful interference;

(c)

the avoidance of electromagnetic disturbances,

(d) public health,

without prejudice to its obligations under Decision No 676/2002/EC

and to the conditions attached to authorisations for the use of

frequencies in conformity with European Union law, in particular

under Article 9(3) and (4) of Directive 2002/21/EC.

(1) The MCA shall notify the TRD with the interfaces Notification of

radio interface

which it intends to regulate, except

specifications

and assignment

of radio

(a) the radio interfaces which fully and without any deviation equipment

comply with the European Commission decisions on the harmonised classes.

use of radio spectrum adopted pursuant to Decision No 676/2002/EC;

and

(b) the radio interfaces which, in accordance with

implementing acts adopted pursuant to sub-regulation (2), correspond

to radio equipment which can be put into service and used without

restrictions within the European Union.

(2) The TRD shall immediately inform the European

Commission, which shall adopt implementing acts establishing the

equivalence between notified radio interfaces and assigning a radio

equipment class, details of which shall be published in the Official

Journal of the European Communities.

(1) Radio equipment compliant with Directive 2014/53/ Free movement

EU shall not be impeded from being made available on the market for of

equipment.

reasons relating to aspects covered by these regulations.

(2) Radio equipment not compliant with Directive 2014/53/

EU may be displayed at trade fairs, exhibitions and similar events,

provided that a visible sign clearly indicates that such radio

equipment may not be made available on the market or put into

service until it has been brought into conformity.

(3) Demonstration of radio equipment may only take place

provided that demonstrable adequate measures have been taken to

avoid harmful interference, electromagnetic disturbances and risk to

the health or safety of persons or of domestic animals or to property.

(1) When placing their radio equipment on the market, Obligations of

manufacturers shall ensure that it has been designed and manufacturers.

manufactured in accordance with the essential requirements set out in

regulation 4.

(2) Manufacturers shall ensure that radio equipment shall be

so constructed that it can be operated in at least one Member State

without infringing applicable requirements on the use of radio

spectrum.

(3) (a)

Manufacturers shall draw up the technical

documentation referred to in regulation 21 and carry out the relevant

conformity assessment procedure referred to in regulation 17 or have

it carried out.

(b) Where compliance of radio equipment with the

applicable requirements has been demonstrated by that conformity

assessment 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 radio

equipment has been placed on the market.

(5) (a)

Manufacturers shall ensure that procedures are in

place for series production to remain in conformity with these

regulations. Changes in radio equipment design or characteristics and

changes in the harmonised standards or in other technical

specifications by reference to which conformity of radio equipment is

declared shall be adequately taken into account.

(b) When deemed appropriate with regard to the risks

presented by radio equipment, manufacturers shall, to protect the

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

equipment made available on the market, investigate, and, if

necessary, keep a register of complaints, of non-conforming radio

equipment and radio equipment recalls, and shall keep distributors

informed of any such monitoring.

(6) Manufacturers shall ensure that radio equipment which

they have placed on the market bears a type, batch or serial number or

other element allowing its identification, or, where the size or nature

of the radio equipment does not allow it, that the required information

is provided on the packaging, or in a document accompanying the

radio equipment.

(7) Manufacturers shall indicate on the radio equipment their

name, registered trade name or registered trade mark and the postal

address at which they can be contacted or, where the size or nature of

radio equipment does not allow it, on its packaging, or in a document

accompanying the radio equipment. 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) (a)

Manufacturers shall ensure that the radio equipment

is accompanied by instructions and safety information in a language

which can be easily understood by consumers and other end-users, as

determined by the TRD. Instructions shall include the information

required to use radio equipment in accordance with its intended use.

Such information shall include, where applicable, a description of

accessories and components, including software, which allow the

radio equipment to operate as intended. Such instructions and safety

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

and intelligible.

(b) The following information shall also be included in

the case of radio equipment intentionally emitting radio waves

(i) frequency

band(s)

in

which

the

radio

equipment operates;

(ii) maximum radio-frequency power transmitted

in the frequency band(s) in which the radio equipment

operates.

(9) Manufacturers shall ensure that each item of radio

equipment is accompanied by a copy of the EU declaration of

conformity or by a simplified EU declaration of conformity. Where a

simplified EU declaration of conformity is provided, it shall contain

the exact internet address where the full text of the EU declaration of

conformity can be obtained.

(10) In cases of restrictions on putting into service or of

requirements for authorisation of use, information available on the

packaging shall allow the identification of the Member States or the

geographical area within a Member State where restrictions on

putting into service or requirements for authorisation of use exist.

Such information shall be completed in the instructions

accompanying the radio equipment.

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

radio equipment which they have placed on the market is not in

conformity with these regulations shall immediately take the

corrective measures necessary to bring that radio equipment into

conformity, to withdraw it or recall it, if appropriate. Furthermore,

where the radio equipment presents a risk, manufacturers shall

immediately inform the MSD, giving details, in particular, of the non-

compliance, of any corrective measures taken and of the results

thereof.

(12) 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

radio equipment with these regulations, in either Maltese or English.

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

to eliminate the risks posed by radio equipment which they have

placed on the market.

Authorised representatives.

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

an authorised representative. The obligations laid down in regulation

10(1) and the obligation to draw up technical documentation referred

to in regulation 10(3) shall not form part of the authorised

representative’s mandate.

(2) An authorised representative shall perform the tasks

specified in the mandate received from the manufacturer. The

mandate shall allow the authorised representative to do at least the

following

(a)

keep the EU declaration of conformity and the

technical documentation at the disposal of the MSD for 10 years

after the radio equipment has been placed on the market;

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

that authority with all the information and documentation

necessary to demonstrate the conformity of radio equipment;

(c)

co-operate with the MSD, at its request, on any

action taken to eliminate the risks posed by radio equipment

covered by the authorised representative’s mandate.

(1) Importers

shall

only

place

compliant

radio

equipment on the market.

(2) (a) Before placing radio equipment on the market

importers shall ensure that the appropriate conformity assessment

procedure referred to in regulation 17 has been carried out by the

manufacturer and that the radio equipment is so constructed that it

can be operated in at least one Member State without infringing

applicable requirements on the use of radio spectrum. They shall

ensure that the manufacturer has drawn up the technical

documentation, that the radio equipment bears the CE marking and is

accompanied by the information and documents referred to in

regulations 10(8), (9) and (10), and that the manufacturer has

complied with the requirements set out in regulations 10(6) and 10

(7).

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

radio equipment is not in conformity with the essential requirements

set out in regulation 4, he/she shall not place the radio equipment on

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

where the radio equipment presents a risk, the importer shall inform

the manufacturer and the MSD to that effect.

(3) Importers shall indicate on the radio equipment 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 radio equipment. The

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

and the MSD.

(4) Importers shall ensure that

(a)

the radio equipment is accompanied by instructions

and safety information in either Maltese or English; and

(b) while radio equipment is under their responsibility, its

storage or transport conditions do not jeopardise its compliance

with the essential requirements set out in regulation 4.

(5) When deemed appropriate with regard to the risks

presented by radio equipment, importers shall, to protect the health

and safety of consumers, carry out sample testing of radio equipment

made available on the market, investigate and, if necessary, keep a

register of complaints, of non- conforming radio equipment and radio

equipment recalls, and shall keep distributors informed of any such

monitoring.

(6) Importers:-

(a)

who consider or have reason to believe that radio

equipment which they have placed on the market is not in

conformity with these regulations shall immediately take the

corrective measures necessary to bring that radio equipment

into conformity, to withdraw it or recall it, if appropriate.

Furthermore, where the radio equipment presents a risk,

importers shall immediately inform the MSD, giving details, in

particular, of the non-compliance and of any corrective

measures taken;

(b) shall for 10 years after the radio equipment 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 the MSD,

upon request;

(8) 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 radio equipment in

Maltese or English. They shall cooperate with the MSD, at its request,

on any action taken to eliminate the risks posed by radio equipment

which they have placed on the market.

(1) When making radio equipment available on the

market distributors shall act with due care in relation to the

requirements of these regulations.

(2) Before making radio equipment available on the market

distributors shall verify that the radio equipment bears the CE

marking, that it is accompanied by the documents required by these

regulations and by the instructions and safety information in Maltese

or English, and that the manufacturer and the importer have complied

with the requirements set out in regulations 10(2) and (6) to (10) and

regulation 12(3) respectively.

Where a distributor considers or has reason to believe that radio

equipment is not in conformity with the essential requirements set out

in regulation 4, he shall not make the radio equipment available on

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

where the radio equipment presents a risk, the distributor shall inform

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

(3) Distributors shall ensure that, while radio equipment is

under their responsibility, its storage or transport conditions do not

jeopardise its compliance with the essential requirements set out in

regulation 4.

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

radio equipment 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 equipment into

conformity, to withdraw it or recall it, if appropriate, are taken.

Furthermore, where the radio equipment presents a risk, distributors

shall immediately inform the MSD, giving details, in particular, of the

non-compliance and of any corrective measures taken.

(5) 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 radio

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

action taken to eliminate the risks posed by radio equipment which

they have made available on the market.

An importer or distributor shall be considered a Application of

manufacturer for the purposes of these regulations and he shall be obligations

manufacturers

subject to the obligations of the manufacturer under regulation 10, to

distributors.

where he places radio equipment on the market under his name or

trade mark or modifies radio equipment 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 Economic

operators.

following to the MSD

(a)

any economic operator who has supplied them with

radio equipment;

(b) any economic operator to whom they have supplied

radio equipment.

(2) Economic operators shall be able to present the

information referred to in this regulation for 10 years after they have

been supplied with the radio equipment and for 10 years after they

have supplied the radio equipment.

Radio equipment which is in conformity with harmonised Presumption of

standards or parts thereof the references of which have been conformity.

published in the Official Journal of the European Union shall be

presumed to be in conformity with the essential requirements set out

in regulation 4 covered by those standards or parts thereof.

(1) The manufacturer shall perform a conformity Conformity

assessment of the radio equipment with a view to meeting the assessment

procedures.

essential requirements set out in regulation 4. The conformity

assessment shall take into account all intended operating conditions

and, for the essential requirement set out regulation 4(1)(a), the

assessment shall also take into account the reasonably foreseeable

conditions. Where the radio equipment is capable of taking different

configurations, the conformity assessment shall confirm whether the

radio equipment meets the essential requirements set out in regulation

4 in all possible configurations.

(2)

Manufacturers shall demonstrate compliance of radio

equipment with the essential requirements set out in regulation 4(1)

using any of the following conformity assessment procedures

(a)

internal production control set out in Schedule II;

(b) EU-type examination that is followed by the

conformity to type based on internal production control set out

in Schedule III;

(c)

conformity based on full quality assurance set out in

Schedule IV.

(3) Where, in assessing the compliance of radio equipment

with the essential requirements set out in regulation 4(2) and (3), the

manufacturer has applied harmonised standards the references of

which have been published in the Official Journal of the European

Union, he shall use any of the following procedures

(a)

internal production control set out in Schedule II;

(b) EU-type examination that is followed by the

conformity to type based on internal production control set out

in Schedule III;

(c)

conformity based on full quality assurance set out in

Schedule IV.

(4) Where, in assessing the compliance of radio equipment

with the essential requirements set out in regulation 4(2) and (3), the

manufacturer has not applied or has applied only in part harmonised

standards the references of which have been published in the Official

Journal of the European Union, or where such harmonised standards

do not exist, radio equipment shall be submitted with regard to those

essential requirements to either of the following procedures

(a)

EU-type examination that is followed by the

conformity to type based on internal production control set out

in Schedule III;

(b) conformity based on full quality assurance set out in

Schedule IV.

(1)

The EU declaration of conformity shall state that

the fulfilment of the essential requirements set out in regulation 4 has

been demonstrated.

(2) (a)

The EU declaration of conformity shall have the

model structure set out in Schedule VI, shall contain the elements set

out in that Schedule and shall be continuously updated. It shall be

translated into Maltese or English.

(b)

The simplified EU declaration of conformity

referred to in regulation 10(9) shall contain the elements set out in

Schedule VII and shall be continuously updated. It shall be translated

into Maltese or English. The full text of the EU declaration of

conformity shall be available at the internet address referred to in the

simplified EU declaration of conformity, in Maltese or English.

(3) Where radio equipment 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

radio equipment with the requirements laid down in these regulations.

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

principles of the

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

CE marking.

(2) On account of the nature of radio equipment, the height of

the CE marking affixed to radio equipment may be lower than 5 mm,

provided that it remains visible and legible.

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

indelibly to the radio equipment or to its data plate, unless that is not conditions

affixing the CE

possible or not warranted on account of the nature of radio marking

identification

equipment. The CE marking shall also be affixed visibly and legibly number of the

notified body.

to the packaging.

(2) The CE marking shall be affixed before the radio

equipment is placed on the market.

(3) The CE marking shall be followed by the identification

number of the notified body where the conformity assessment

procedure set out in Schedule IV is applied. The identification

number of the notified body shall have the same height as the CE

marking. The identification number of the notified body shall be

affixed by the notified body itself or, under its instructions, by the

manufacturer or his authorised representative.

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

economic operator/s to the measures described in regulation 40.

(1) The technical documentation shall contain all Technical

relevant data or details of the means used by the manufacturer to documentation.

ensure that radio equipment complies with the essential requirements

set out in regulation 4. It shall, at least, contain the elements set out in

Schedule V.

(2) The technical documentation shall be drawn up before

radio equipment is placed on the market and shall be continuously

updated.

(3) The technical documentation and correspondence relating

to any EU-type examination procedure shall be drawn up in Maltese

or English.

(4) Where the technical documentation does not comply with

sub-regulations (1), (2) or (3), and in so doing fails to present

sufficient relevant data or means used to ensure compliance of radio

equipment with the essential requirements set out in regulation 4, the

MSD may ask the manufacturer or the importer to have a test

performed by a body acceptable to the MSD at the expense of the

manufacturer or the importer within a specified period in order to

verify compliance with the essential requirements set out in

regulation 4.

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 28.

The assessment and monitoring referred to in regulation 22

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.

A notifying authority shall

(a)

be established in such a way that no conflict of

interest with conformity assessment bodies occurs;

(b) be organised and operated so as to safeguard the

objectivity and impartiality of its activities;

(c) be organised in such a way that each decision

relating to notification of a conformity assessment body is taken

by competent persons different from those who carried out the

assessment.

(d) not offer or provide any activities that conformity

assessment bodies perform or consultancy services on a

commercial or competitive basis;

(e)

safeguard the confidentiality of the information it

obtains; and

(f)

have a sufficient number of competent personnel at

its disposal for the proper performance of its tasks.

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 this relating

notified bodies.

regulation.

(2) A conformity assessment body shall

(a)

be established as stipulated in the Method for S.L. 427.45

Designating Conformity Assessment Bodies Regulations;

(b) be a third-party body independent

of

the

organisation or the radio equipment it assesses;

(c)

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

Provided that if a body belonging to a business

association or professional federation representing undertakings

involved in the design, manufacturing, provision, assembly, use

or maintenance of radio equipment which it assesses, may, on

condition that its independence and the absence of any conflict

of interest are demonstrated, be considered such a body;

(d) at all times and for each conformity assessment

procedure and each kind or category of radio equipment in

relation to which it has been notified, have at its disposal the

necessary

(e)

personnel with technical knowledge and sufficient

and appropriate experience to perform the conformity

assessment tasks;

(f)

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;

(g) 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

radio equipment technology in question and the mass or serial

nature of the production process;

(h) 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;

(i)

ensure that the activities of its subsidiaries or

subcontractors do not affect the confidentiality, objectivity or

impartiality of its conformity assessment activities;

(j)

including its personnel, 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 its judgement or

the results of its conformity assessment activities, especially as

regards persons or groups of persons with an interest in the

results of those activities;

(k) take out liability insurance unless liability is

assumed by the State in accordance with national law;

(l)

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.

(3) The body’s top level management and the personnel

responsible for carrying out the conformity assessment tasks shall

(a) not be the designer, manufacturer, supplier, installer,

purchaser, owner, user or maintainer of the radio equipment

which they assess, nor the representative of any of those parties.

This shall not preclude the use of assessed radio equipment that

are necessary for the operations of the conformity assessment

body or the use of such radio equipment for personal purposes;

(b) not be directly involved in the design, manufacture or

construction, the marketing, installation, use or maintenance of

those radio equipment, 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.

(4) The persons responsible for carrying out conformity

assessment tasks shall

(a)

have sound technical and vocational training

covering all the conformity assessment activities in relation to

which the conformity assessment body has been notified;

(b) have the satisfactory knowledge of the requirements

of the assessments they carry out and adequate authority to

carry out those assessments;

(c)

have the 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) have the ability to draw up certificates, records and

reports demonstrating that assessments have been carried out.

(5) The impartiality of a body, its top level management and of

the personnel responsible for carrying out the conformity assessment

tasks, shall be guaranteed and the remuneration to carry out such

assessments shall not depend on the number of assessments carried

out or on the results of those assessments.

(6) The personnel of a 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.

Where a conformity assessment body demonstrates its Presumption of

conformity with the criteria laid down in the relevant harmonised conformity

notified bodies.

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 25 in

so far as the applicable harmonised standards cover those

requirements.

(1) Where a notified body subcontracts specific tasks Subsidiaries of

connected with conformity assessment or has recourse to a subsidiary, and

subcontracting

it shall ensure that the subcontractor or the subsidiary meets the by

bodies.

requirements set out in regulation 24 and shall inform the notifying

authority accordingly

Provided that such activities may be subcontracted or carried

out by a subsidiary only with the agreement of the client.

(2) Notified bodies

(a)

shall take full responsibility for the tasks performed

by subcontractors or subsidiaries wherever these are

established; and

(b) 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 Schedules III and IV.

(1) Notifying authorities may notify only conformity

assessment bodies which have satisfied the requirements laid down in

regulation 25.

(2) They shall notify the European 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 radio equipment concerned and the relevant attestation of

competence.

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

certificate as referred to in sub-regulation (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 26.

(5) (a)

The body concerned may perform the activities of a

notified body only where no objections are raised by the European

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.

(b) 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 26, 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 Operational

assessment obligations

assessments in accordance with the conformity

notified bodies.

procedures provided for in Schedules III and IV.

(2)

Conformity assessments shall be carried out in a

proportionate manner, avoiding unnecessary burdens for economic

operators and all bodies shall take due account of the size of an

undertaking, the sector in which it operates, its structure, the degree

of complexity of the radio equipment technology in question and the

mass or serial nature of the production process.

(3) In so doing they shall nevertheless respect the degree of

rigour and the level of protection required for the compliance of the

radio equipment with these regulations.

(4) Where

(a)

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;

(b) in the course of the monitoring of conformity

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

radio equipment no longer complies, it shall require the

manufacturer to take appropriate corrective measures and shall

suspend or withdraw the certificate if necessary;

(c)

corrective measures are not taken or do not have the

required effect, the notified body shall restrict, suspend or

withdraw any certificates, as appropriate.

Notified bodies shall have an appeals procedure in place Appeal against

decisions of

which is also publicly available.

notified bodies.

(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 the MSD 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

(a)

in accordance with the requirements of Schedules III

and IV, provide the other bodies notified under these regulations

carrying out similar conformity assessment activities covering

the same categories of radio equipment with relevant

information on issues relating to negative and, on request,

positive conformity assessment results; and

(b)

fulfil information obligations under Schedules III

and IV.

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 radio equipment.

(1) (a) Where the MSD has sufficient reason to believe

that radio equipment 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 radio equipment

concerned covering all relevant requirements laid down in these

regulations. The relevant economic operators shall cooperate as

necessary with the MSD for that purpose;

(b) Where, in the course of the evaluation referred to in

paragraph (a), the MSD finds that the radio equipment 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 radio equipment into

compliance with those requirements, to withdraw the radio equipment

from the market, or to recall it within a reasonable period,

commensurate with the nature of the risk, as they may prescribe.

(c)

The MSD shall inform the relevant notified body

accordingly.

(d) Article 21 of Regulation (EC) No 765/2008 shall

apply to the measures referred to in paragraph (b).

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

restricted to its national territory, it shall inform the European

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.

(3) The economic operator shall ensure that all appropriate

corrective action is taken in respect of all the radio equipment

concerned that it has made available on the market throughout the

European Union.

(4) (a)

Where the relevant economic operator does not take

adequate corrective action within the period referred to in sub-

regulation (1)(c), the MSD shall take all appropriate provisional

measures to prohibit or restrict the radio equipment being made

available on the national market, to withdraw the radio equipment

from that market or to recall it.

(b) The MSD shall inform the Commission and the

other Member States, without delay, of those measures.

(5) The information referred to in sub-regulation 4(b) shall

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

identification of the non-compliant radio equipment, the origin of the

radio equipment, 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 radio equipment 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 16 conferring a presumption of conformity.

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

procedure under these regulations shall without delay inform the

European Commission and the other Member States of any measures

adopted and of any additional information at their disposal relating to

the non-compliance of the radio equipment concerned, and, in the

event of disagreement with the adopted national measure, of their

objections.

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

referred to in sub-regulation 4(b), no objection has been raised by

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

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

deemed justified.

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

restrictive measures, such as withdrawal of the radio equipment from

the market, are taken in respect of the radio equipment concerned

without delay.

(1) Where, having carried out an evaluation under

regulation 33(1), the TRD finds that although radio equipment is in

compliance with these regulations, it presents a risk to the health or

safety of persons or to other aspects of public interest protection

covered by these regulations, it shall require the relevant economic

operator to take all appropriate measures to ensure that the radio

equipment concerned, when placed on the market, no longer presents

that risk, to withdraw the radio equipment from the market or to recall

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

risk, as it may prescribe.

(2) The economic operator shall ensure that corrective action

is taken in respect of all the radio equipment concerned that he has

made available on the market throughout the European Union.

(3) The TRD shall immediately inform the European

Commission and the other Member States. That information shall

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

identification of the radio equipment concerned, the origin and the

supply chain of radio equipment, the nature of the risk involved and

the nature and duration of the national measures taken.

(1) Without prejudice to regulation 36, 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 20;

(b)

the CE marking has not been affixed;

(c)

the identification number of the notified body, where

the conformity assessment procedure set out in Schedule IV is

applied, has been affixed in violation of regulation 20 or has not

been affixed;

(d) the EU declaration of conformity has not been

drawn up;

(e)

the EU declaration of conformity has not been

drawn up correctly;

(f)

technical documentation is either not available or

not complete;

(g) the information referred to in regulation 7(6) or

regulation 9(3) is absent, false or incomplete;

(h) information on the intended use of radio equipment,

the EU declaration of conformity or usage restrictions as set out

in regulation 10(8), (9) and (10) does not accompany the radio

equipment;

(i)

requirements on identification of

economic

operators set out in regulation 15 are not fulfilled;

(j)

regulation 6 is not complied with.

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

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

prohibit corresponding radio equipment 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 under Cap. 427

article 26 of the Product Safety Act.

The MSD shall provide the TRD by the 30th April, 2017 Review and

and at least every two years thereafter with regular presentations of reporting.

the market surveillance activities performed including compliance

statistics.

The Radio Equipment and Telecommunications Terminal

Equipment and the Mutual Recognition of their Conformity

Regulations are hereby repealed.