RADIO EQUIPMENT REGULATIONS

SUBSIDIARY LEGISLATION 427.41

RADIO EQUIPMENT REGULATIONS

13th June, 2016 *

LEGAL NOTICE 213 of 2016, as amended by Legal Notices 7 of 2024

and 202 of 2025.

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

Regulations.

(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.

Amended by

L.N. 7 of 2024.

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. Aviation equipment intended exclusively for airborne use falling within the

scope of article 138 of Regulation (EU) 2018/1139 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.

(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.

(3) Radio equipment falling within the scope of these

regulations shall not be subject to the Low Voltage 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.

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

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

† Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in

the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations

(EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and

2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and

(EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ

L 212, 22.8.2018, p.1)

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

"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;

* See regulation 1(3) of these Regulations as originally promulgated.

"crisis-relevant goods" means goods that are non-substitutable, non-

diversifiable or indispensable in the maintenance of vital societal

functions or economic activities in order to ensure the proper

functioning of the internal market and its supply chains and that are

considered essential for responding to a crisis during the internal

market emergency mode that may be activated pursuant to Article

18(4) of Regulation (EU) 2024/2747;

"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;

"internal market emergency mode" shall have the same meaning

assigned to it by point (3) of Article 3 of Regulation (EU) 2024/2747;

"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

established by the Malta Communications Authority Act;

"MCCAA" means the Malta Competition and Consumer Affairs

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;

"notified bodies" means conformity assessment bodies designated

by a Member State to assess the conformity of certain products before

being placed on the market;

"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;

"Regulation (EU) 2016/679 means Regulation 2016/679 of the

European Parliament and of the Council of 27 April 2016 on the

protection of natural persons with regard to the processing of

personal data and on the free movement of such data, and repealing

Directive 95/46/EC (General Data Protection Regulation);

Regulation (EU) 2024/2747" means Regulation (EU) 2024/2747 of

the European Parliament and of the Council of 9 October 2024

establishing a framework of measures related to an internal market

emergency and to the resilience of the internal market and amending

Council Regulation (EC) No 2679/98 (Internal Market Emergency and

Resilience Act);

"technical specification" means a document that prescribes

technical requirements to be fulfilled by radio 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 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.

RADIO EQUIPMENT

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;

RADIO EQUIPMENT

(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

RADIO EQUIPMENT

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) radio equipment interworks with accessories other than

the charging devices for the categories or classes of radio

equipment, specified in Part I of Schedule VIII, which

are specifically referred to in sub-regulation (5);

(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.

(5) Radio equipment falling within the categories or classes

specified in Part I of Schedule VIII shall be so constructed that it

complies with the specifications relating to charging capabilities

set out in thesaid Schedule for the relevant category or class of

radio equipment.

(6) The provisions of sub-regulation (5) and other provisions

which make reference thereto shall apply as from 28 December 2024,

for radio equipment falling within the categories or classes specified in

points 1.1 to 1.12 of Part I of Schedule VIII, and from 28 April 2026

for the categories or classes of radio equipment referred to in point

1.13 of Part I of Schedule VIII.

(7) The essential requirement established in sub-regulation (3)(d)

shall apply to any radio equipment which may communicate itself over

the internet, whether it communicates directly or via any other

equipment, also referred as internet-connected radio equipment.

(8) The essential requirement established in sub-regulation (3)(e),

shall apply to any of the following radio equipment

(a) internet-connected radio equipment, other than the

equipment referred to in paragraphs (b), (c) or (d);

(b) radio equipment designed or intended exclusively for

childcare;

(c) radio equipment regulated by the Safety of Toys

Regulations;

(d) radio equipment designed or intended, whether

exclusively or not exclusively, to be worn on, strapped

to, or hung from any of the following

(i)

any part of the human body, including the head,

neck, trunk, arms, hands, legs and feet;

(ii) any clothing, including headwear, hand wear and

footwear, which is worn by human beings

Provided that such radio equipment is capable of

processing, in accordance with the meaning of

Article 4(2) of Regulation (EU) 2016/679

(a) personal data, as defined in Article 4(1) of

Regulation (EU) 2016/679, or;

(b) traffic data or location data, as defined in

regulation 2(2) of the Processing of Personal

Data (Electronic Communications Sector)

Regulations.

(9) The essential requirement established in regulation 4(3)(f)

shall apply to any internet connected radio equipment, if that

equipment enables the holder or user to transfer money, monetary

value or virtual currency as defined in article 310E(d) of the

Criminal Code.

(10) By way of derogation from sub-regulations (7), (8) and (9),

the essential requirements established in sub-regulation (3)(d), (e)

and (f) shall not apply to radio equipment to which either of the

following Union harmonisation legislation also applies

(a) Regulation (EU) 2017/745 of the European Parliament

and of the Council of 5 April 2017 on medical devices,

amending Directive 2001/83/EC, Regulation (EC) No

178/2002 and Regulation (EC) No 1223/2009 and

repealing Council Directives 90/385/EEC and 93/42/

EEC; and

(b) Regulation (EU) 2017/746 of the European Parliament

and of the Council of 5 April 2017 on in vitro

diagnostic medical devices and repealing Directive 98/

79/EC and Commission Decision 2010/227/EU.

(11) By way of derogation from sub-regulations (8) and (9), the

essential requirements established in sub-regulation (3)(e) and (f)

shall not apply to radio equipment to which any of the following

Union harmonisation legislation also applies

(a) Regulation (EU) 2018/1139 of the European

Parliament and of the Council of 4 July 2018 on

common rules in the field of civil aviation and

establishing a European Union Aviation Safety

Agency, and amending Regulations (EC) No 2111/

2005, (EC) No 1008/2008, (EU) No 996/2010, (EU)

No 376/2014 and Directives 2014/30/EU and 2014/53/

EU of the European Parliament and of the Council, and

repealing Regulations (EC) No 552/2004 and (EC) No

216/2008 of the European Parliament and of the

Council and Council Regulation (EEC) No 3922/91;

(b) Regulation (EU) 2019/2144 of the European

Parliament and of the Council of 27 November 2019

on type-approval requirements for motor vehicles and

their trailers, and systems, components and separate

technical units intended for such vehicles, as regards

their general safety and the protection of vehicle

occupants and vulnerable road users, amending

Regulation (EU) 2018/858 of the European Parliament

and of the Council and repealing Regulations (EC) No

78/2009, (EC) No 79/2009 and (EC) No 661/2009 of

the European Parliament and of the Council and

Commission Regulations (EC) No 631/2009, (EU) No

406/2010, (EU) No 672/2010, (EU) No 1003/2010,

(EU) No 1005/2010, (EU) No 1008/2010, (EU) No

1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU)

No 458/2011, (EU) No 65/2012, (EU) No 130/2012,

(EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/

2012 and (EU) 2015/166; and

(c) the Motor Vehicles (Interoperability of Electronic

Road Tolls Systems) Regulations.

(12) The essential requirements established in sub-regulation

(3)(g) shall apply to hand-held mobile phones with features similar

to those of a computer in terms of capability to treat and store data.

(13) Compliance with sub-regulation (9) shall be ensured

through technical solutions for the reception and processing of Wi-

Fi data, data from Global Navigation Satellite Systems compatible

and interoperable with at least the Galileo system referred to

Regulation (EU) 2021/696 of the European Parliament and of the

Council of 28 April 2021 establishing the Union Space Programme

and the European Union Agency for the Space Programme and

repealing Regulations (EU) No 912/2010, (EU) No 1285/2013 and

(EU) No 377/2014 and Decision No 541/2014/EU and for the

making available of that data for transmission in emergency

communications.

(1)

Where an economic operator offers to consumers

and other end-users the possibility to acquire the radio equipment

referred to in regulation 4(5) together with a charging device, the

economic operator shall also offer the consumers and other end-users

the possibility of acquiring that radio equipment without any charging

device.

(2) Economic operators shall ensure that the information on

whether or otherwise a charging device is included with the radio

equipment referred to in regulation 4(5) is displayed in a graphic form

using a user-friendly and easily accessible pictogram as set out in Part

III of Schedule VIII when such radio equipment is made available to

consumers and other end-users. The pictogram shall be printed on the

packaging or affixed to the packaging as a sticker. When the radio

equipment is made available to consumers and other end-users, the

pictogram shall be displayed in a visible and legible manner, and in the

case of distance selling, close to the price indication.

Amended by

L.N. 7 of 2024.

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

RADIO EQUIPMENT

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(3)(f), as approved;

(d) the decisions and reports of the notified body referred to in points

3(3)(f), 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(3)(f), 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

allowing radio equipment to be used as intended shall provide the

MSD and the European Commission with information on the

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.

Amended by

L.N. 7 of 2024.

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 Schedule 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 equipment types within categories of radio equipment

affected by a low level of compliance with the essential

requirements set out 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.

Amended by

L.N. 7 of 2024.

EU DECLARATION OF CONFORMITY (No ) 1 (Regulation 18)

- It is optional for the manufacturer to assign a number to the EU declaration of

conformity.

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

RADIO EQUIPMENT

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

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

................. performed .................................................. (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)

Added by

(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.

L.N. 7 of 2024.

SIMPLIFIED EU DECLARATION OF CONFORMITY

The simplified EU declaration of conformity referred to in regulation 10(9) shall

be provided as follows

Hereby, [Name of manufacturer] declares that the radio equipment type

[designation of type of radio equipment] is in compliance with Directive 2014/53/EU.

The full text of the EU declaration of conformity is available at the following internet

address

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

which it intends to regulate, except

(a) the radio interfaces which fully and without any

deviation comply with the European Commission

decisions on the harmonised 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)

Deleted by Legal Notice 202 of 2025.

Added by

L.N. 7 of 2024.

SPECIFICATIONS AND INFORMATION RELATING TO

CHARGING APPLICABLE TO CERTAIN CATEGORIES OR

CLASSES OF RADIO EQUIPMENT

Part I

Specifications relating to charging capabilities

1. The requirements set out in points 2 and 3 of this Part shall apply to the

following categories or classes of radio equipment

1.1.

handheld mobile phones;

1.2.

tablets;

1.3.

digital cameras;

1.4.

headphones;

1.5.

headsets;

1.6.

handheld videogame consoles;

1.7.

portable speakers;

1.8.

e-readers;

1.9.

keyboards;

1.10. mice;

1.11. portable navigation systems;

1.12. earbuds;

1.13. laptops.

2. In so far as they are capable of being recharged by means of wired

charging, the categories or classes of radio equipment referred to in point 1 of this Part

shall

2.1. be equipped with the USB Type-C receptacle, as described in the

standard EN IEC 62680-1-3:2022 "Universal serial bus interfaces for data and

power – Part 1-3: Common components – USB Type-C® Cable and Connector

Specification", and that receptacle shall remain accessible and operational at all

times*;

2.2. be capable of being charged with cables which comply with the

standard EN IEC 62680-1-3:2022 "Universal serial bus interfaces for data and

power – Part 1-3: Common components – USB Type-C® Cable and Connector

Specification"*.

RADIO EQUIPMENT

3. In so far as they are capable of being recharged by means of wired charging

at voltages higher than 5 Volts, currents higher than 3 Amperes or powers higher than 15

Watts, the categories or classes of radio equipment referred to in point 1 of this Part

shall

3.1. incorporate the USB Power Delivery, as described in the standard EN IEC

62680-1-2:2022 "Universal serial bus interfaces for data and power – Part 1-2: Common

components – USB Power Delivery Specification"*;

3.2. ensure that any additional charging protocol allows for the full

functionality of the USB Power Delivery referred to in point 3.1, irrespective of the

charging device used.

Part II

Information on specifications relating to charging capabilities and the compatible charging

devices

In the case of radio equipment falling within the scope of regulation 4(5) the

following information shall be indicated in accordance with the requirements set out in

regulation 10(8), and may be made available in addition by means of QR codes or

similar electronic solutions

(a)

in the case of all categories or classes of radio equipment which are

subject to the requirements set out in Part I, a description of the power

requirements of the wired charging devices that can be used with that radio

equipment, including the minimum power required to charge the radio equipment,

and the maximum power required to charge the radio equipment at the maximum

charging speed expressed in Watts by displaying the text: "the power delivered by

the charger must be between min [xx] Watts required by the radio equipment, and

max [yy] Watts in order to achieve the maximum charging speed". The number of

Watts shall express, respectively, the minimum power required by the radio

equipment, and the maximum power required by the radio equipment to achieve

the maximum charging speed;

(b)

in the case of radio equipment which is subject to the requirements

set out in point 3 of Part I, a description of the specifications relating to charging

capabilities of the radio equipment, in so far as it is capable of being recharged by

means of wired charging at voltages higher than 5 Volts or currents higher than 3

Amperes or powers higher than 15 Watts, including an indication that the radio

equipment supports the USB Power Delivery charging protocol by displaying the

text "USB PD fast charging" and an indication of any other supported charging

protocol by displaying its name in text format.

Part III

Pictogram indicating whether or not a charging device is included with the radio equipment

1. The pictogram shall have the following formats

1.1

If a charging device is included with the radio equipment

1.2.

If no charging device is included with the radio equipment

2. The pictogram may vary in appearance (e.g. as to its colour, solid or

hollow, line thickness), provided that it remains visible and legible. If the pictogram

is reduced or enlarged, the proportions set out in the drawings in point 1 of this Part

shall be maintained. The dimension "a" referred to in point 1 of this Part shall be

greater than or equal to 7 mm, irrespective of the variation.

RADIO EQUIPMENT

Part IV

Content and format of the label

1. The label shall have the following format

2. The letters "XX" shall be replaced by the figure corresponding to the

minimum power required by the radio equipment to charge, which determines the

minimum power that a charging device needs to supply to charge the radio equipment.

The letters "YY" shall be replaced by the figure corresponding to the maximum power

required by the radio equipment to achieve maximum charging speed, which determines

the power that a charging device needs to supply at least to achieve that maximum

charging speed. The abbreviation "USB PD" (USB Power Delivery) shall be displayed if

the radio equipment supports that charging communication protocol. "USB PD" is a

protocol that negotiates the fastest delivery of current from the charging device to the

radio equipment without shortening the battery lifetime.

3. The label may vary in appearance (e.g. as to its colour, solid or hollow, line

thickness) provided that it remains visible and legible. If the label is reduced or enlarged,

the proportions set out in the drawing in point 1 of this Part shall be maintained. The

dimension "a" referred to in point 1 of this Part shall be greater than or equal to 7 mm,

irrespective of the variation.

* - Standards as per Commission Delegated Regulation (EU) 2023/1717 of 27 June 2023

amending Directive 2014/53/EU of the European Parliament and of the Council as regards

the technical specifications for the charging receptacle and charging communication

protocol for all the categories or classes of radio equipment capable of being recharged by

means of wired charging.

(1)

Radio equipment compliant with Directive 2014/53/EU

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

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,

manufacturers shall ensure that it has been designed and

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. 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 instructions in the case of radio equipment intentionally

emitting radio waves

(i)

frequency bands in which the radio

equipment operates; and

(ii)

maximum

radio-frequency

power

transmitted in the frequency bands in which the radio

equipment operates.

(c) In the case of radio equipment referred to in regulation

4(5), the instructions shall contain information on the

specifications relating to the radio equipment’s

charging capabilities and the compatible charging

devices, as set out in Part II of Schedule VIII. In

addition to being included in the instructions, when the

manufacturers make such radio equipment available to

consumers and other end-users, the information shall

be also displayed on a label, as set out in Part IV of

Schedule VIII. The label shall be printed in the

instructions and on the packaging or affixed to the

packaging as a sticker. In the absence of packaging,

the sticker with the label shall be affixed to the radio

equipment. When the radio equipment is made

available to consumers and other end-users, the label

shall be displayed in a visible and legible manner, and

in the case of distance selling, close to the price

indication. Where the size or nature of the radio

equipment does not allow otherwise, the label may be

printed as a separate document accompanying the

radio equipment.

(d) The instructions and safety information referred to in the

paragraphs (a), (b) and (c) shall be in a language which

can be easily understood by consumers and other end-

users, as determined by TRD..

(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.

(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;

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;

(c) when making the radio equipment referred to in

regulation 4(5) available to consumers and other end-

users, importers shall ensure that

(i)

such radio equipment displays, or is supplied

with, a label in accordance with regulation

10(8)(c); and

(ii)

that label is displayed in a visible and legible

manner and, in the case of distance selling, close

to the price indication.

(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;

(c) 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) (a) 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.

(b) 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.

(c) When making the radio equipment referred to in

regulation 4(5) available to consumers and other end-

users, distributors shall ensure that

(i)

such radio equipment displays, or is supplied

with, a label in accordance with regulation

10(8)(c); and

(ii)

such label is displayed in a visible and legible

manner, and in the case of distance selling, close

to the price indication.

(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

manufacturer for the purposes of these regulations and he shall be

subject to the obligations of the manufacturer under regulation 10,

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

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

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 regulation 4 covered by those standards or parts thereof.

(1) The manufacturer shall perform a conformity

assessment of the radio equipment with a view to meeting the

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)

and (5) u s i n g a n y o f t h e f o l l o w i n g c o n f o r m i t y a s s e s s m e n t

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

r a d i o e q u i p m e n t w i t h t h e r e q u i r e m e n t s l a i d d o w n i n t h e se

regulations.

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

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

(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

indelibly to the radio equipment or to its data plate, unless that is

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

equipment. The CE marking shall also be affixed visibly and

legibly 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 39.

(1) The technical documentation shall contain all relevant

data or details of the means used by the manufacturer to 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

ra di o eq ui pm en t w it h t he essen t ial re qu irem en ts set ou t 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

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 this

regulation.

RADIO EQUIPMENT

(2)

A conformity assessment body shall

(a) be established as stipulated in the Method for

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 Schedules III and IV

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 Schedules III and IV 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

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 26

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 26 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) A conformity assessment body shall submit an

application for notification to the TRD.

(2)

The application for notification shall be accompanied by a

description of the conformity assessment activities, the conformity

assessment module or modules and the radio equipment 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 26.

(3)

Where the conformity assessment body concerned cannot

provide an accreditation certificate, it shall provide the TRD with all the

documentary evidence necessary for the verification, recognition, and

regular monitoring of its compliance with the requirements laid down in

regulation 26.

(1) Notifying authorities may notify only conformity

assessment bodies which have satisfied the requirements laid down

in regulation 26.

(2)

Deleted by Legal Notice 202 of 2025.

(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)

Deleted by Legal Notice 202 of 2025.

(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.

(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 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 regulation 4 or corresponding harmonised

RADIO EQUIPMENT

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

which is also publicly 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 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 have sufficient reason to believe that

radio equipment covered by these regulations presents a

risk to the health or safety of persons or to other aspects

of public interest protection covered by these regulations,

or that it does not comply with at least one of the

applicable essential requirements set out in regulation 4,

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)

Deleted by Legal Notice 202 of 2025.

(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

i n sub-regulation (1)(b), t h e M S D s h a l l t a k e a l l

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) Deleted by Legal Notice 202 of 2025.

(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

conferring

a

presumption

of

conformity.

(6)

Deleted by Legal Notice 202 of 2025.

(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 36(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)

Deleted by Legal Notice 202 of 2025.

(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;

(fa) the pictogram as referred to in regulation 4A(2) or the

label as referred to in regulation 10(8) has not been

drawn up correctly;

(fb) the label as referred to in regulation 10(8) does not

accompany the radio equipment concerned;

(fc) the pictogram or the label is not affixed or displayed in

accordance with regulation 4A(2) or regulation 10(8);

(g) the information referred to in regulations 10(6) or 10(7)

or regulation 12(3) is absent, false or incomplete;

(h) the information referred to in regulation 10(8), the EU

declaration of conformity referred to in regulation 10(9),

or the information on usage restrictions referred to in

regulation 10(10), does not accompany the radio

equipment;

(i)

requirements on identification of economic operators

set out in regulation 15 are not fulfilled;

(j)

regulation 4A(1) or 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

requirements of these regulations are subject to the provisions

under article 26 of the Product Safety Act.

(1) The TRD shall ensure that the measures taken in accordance

with this regulation and with regulations 39B to 39D apply only during

the activation of internal market emergency procedures pursuant to

Article 28 of Regulation (EU) 2024/2747 with respect to radio

equipment mentioned in these regulations. The emergency procedures

relevant to Union harmonisation legislation may be activated as

regards those crisis-relevant goods as defined by these regulations.

(2) The TRD shall ensure that the measures taken in

accordance with this regulation and with regulations 39B to 39D

apply only to radio equipment which has been designated as crisis-

relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/

2747. (3) The TRD shall ensure that the measures taken in

accordance with this regulation and with regulations 39B to 39D

apply only during the internal market emergency mode that may be

activated in accordance with article 18 of Regulation (EU) 2024/

2747

Provided that regulation 39C(7) shall apply during the

internal market emergency mode and after its expiry or

deactivation.

(1) The provisions of this regulation apply to radio

equipment referred to in regulation 39A(1) which is subject to the

conformity assessment procedures referred to in regulation 17 and

which require the mandatory involvement of a notified body.

(2)

The notified bodies shall as a matter of priority, process all

applications for a conformity assessment of radio equipment referred to

in sub-regulation (1), irrespective of whether those applications have

been submitted before or after the activation of the emergency

procedures pursuant to regulation 39A.

(3)

The prioritisation of applications for a conformity

assessment of radio equipment pursuant to sub-regulation (2) shall not

result in additional disproportionate costs for the manufacturers who

have submitted those applications.

(4)

The notified bodies shall take all reasonable measures to

increase their testing capacities for radio equipment referred to in sub-

regulation (1) in respect of which they have been notified.

(1) By way of derogation from regulation 17, the TRD may

authorise, on a duly justified request from an economic operator,

the placing on the market in Malta of specific radio equipment

referred to in regulation 39A(1) for which the conformity

assessment procedures referred to in regulation 17 which require

the mandatory involvement of a notified body have not been carried

out

Provided that compliance with all the relevant essential

requirements established in regulation 4 has been determined in

accordance with the procedures referred to in the said

authorisation.

(2) The radio equipment subject to the authorisation referred to

in sub-regulation (1) shall include the information that they are

placed on the market as a crisis-relevant good.

(3) The information referred to in sub-regulation (2), as well as

any labelling shall be clear, intelligible and which may be easily

understood by consumers and other end-users, and where relevant,

shall be written in the English or Maltese language.

(4) The authorisation granted by the TRD shall be valid only in

Malta and on the territories of any other Member State whose competent

authorities have recognised the validity of that authorisation before the

adoption of the derogation referred to in sub-regulation (1).

(5) Manufacturers of radio equipment subject to the

authorisation procedure referred to in sub-regulation (1) shall

declare their sole responsibility that the radio equipment concerned

complies with all the relevant essential requirements established in

regulation 4 and shall be responsible for the fulfilment of all the

conformity assessment procedures indicated by the TRD.

(6) Any authorisation issued pursuant to sub-regulation (1)

shall establish the conditions and requirements under which the

radio equipment may be placed on the market. Such authorisations

shall establish at least the following

(a)

a description of the procedures, by means of

which compliance with the relevant essential requirements

established in regulation 4 was successfully demonstrated;

(b)

any specific requirements regarding the traceability

of the radio equipment concerned;

(c)

an end date of validity of the authorisation, which

may not go beyond the last day of the period for which the

internal market emergency mode has been activated in

accordance with Article 18 of Regulation (EU) 2024/2747;

(d)

any specific requirements regarding the need to

ensure a continuous conformity assessment with respect to the

radio equipment concerned;

(e)

measures to be taken upon expiry or deactivation of

the internal market emergency mode with respect to the radio

equipment concerned that has been placed on the market.

(7) By way of derogation from regulations 9, 19 and 20, radio

equipment for which an authorisation has been granted in

accordance with sub-regulation (1) shall not contain the CE

marking and regulation 9 shall not apply.

(8) Where an authorisation pursuant to sub-regulations (1), (2) and

(4) is valid, the MSD shall with regard to such radio equipment, take all

corrective and restrictive actions provided for in accordance with the

Market Surveillance and Compliance of Products Regulations.

(9) The use of the authorisation procedure provided in sub-

regulations (1), (2) (4) and (6) shall not affect the application of the

relevant conformity assessment procedures provided in regulation

17.

(1) Without prejudice to regulation 16, radio equipment

which is in conformity with the standards or common specifications

referred to in Regulation (EU) No 1025/2012 of the European

Parliament and of the Council of 25 October 2012 on European

standardisation, amending Council Directives 89/686/EEC and 93/

15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC,

98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC

of the European Parliament and of the Council and repealing

Council Decision 87/95/EEC and Decision No 1673/2006/EC of the

European Parliament and of the Council shall be presumed to be in

conformity with the relevant essential requirements provided for in

regulation 4 which are covered by those standards, common

specifications, or parts thereof.

(2) From the day following the expiry or deactivation of the

internal market emergency mode, it shall no longer be possible for

manufacturers to rely on the presumption of conformity provided

by the standards, or the common specifications referred to in sub-

regulation (1).

(3) By way of derogation from regulation 39A(3), unless there is

sufficient reason to believe that the radio equipment covered by the

standards or common specifications referred to in sub-regulation (1)

presents a risk to the health or safety of persons, the radio equipment

which is in conformity with those standards or common specifications

and which has been placed on the market, shall be deemed to be in

conformity with the relevant essential requirements provided for in

regulation 4 after the expiry or deactivation of the internal market

emergency mode.

Deleted by Legal Notice 202 of 2025.

RADIO EQUIPMENT