Radio Equipment (Amendment) Regulations, 2025

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 21,508, 19 ta’ Settembru, 2025

L.N. 202 of 2025

PRODUCT SAFETY ACT

(CAP. 427)

Radio Equipment (Amendment) Regulations, 2025

IN EXERCISE of the powers conferred by articles 38, 39 and 40

of the Product Safety Act, the Minister responsible for consumer

affairs, on the advice of the Director General (Technical Regulations),

has made the following regulations:-

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

(Amendment) Regulations, 2025 and these regulations shall be read and

commencement.

and construed as one with the Radio Equipment Regulations, S.L. 427.41.

hereinafter referred to as the "principal regulations".

(2)

The scope of these regulations is to

(a) implement the requisites of Commission Delegated

Regulation (EU) 2019/320 of 12 December 2018 supplementing

of Directive 2014/53/EU of the European Parliament and of the

Council with regard to the application of the essential

requirements referred to in Article 3(3)(g) of that Directive in

order to ensure caller location in emergency communications

from mobile devices;

(b) implement the requisites of Commission Delegated

Regulation (EU) 2022/30 of 29 October 2021 supplementing

Directive 2014/53/EU of the European Parliament and of the

Council with regard to the application of the essential

requirements referred to in points (d), (e) and (f) of Article 3(3)

of the said Directive;

(c) implement the requisites of Commission Delegated

Regulation (EU) 2023/2444 of 20 July 2023 amending Delegated

Regulation (EU) 2022/30 as regards the date of application of the

essential requirements for radio equipment and correcting that

Regulation;

(d) transpose the provisions of Directive (EU) 2024/2749

of the European Parliament and of the Council of 9 October 2024

amending Directives 2000/14/EC, 2006/42/EC, 2010/35/EU,

2014/29/EU, 2014/30/EU, 2014/33/EU, 2014/34/EU, 2014/35/

EU, 2014/53/EU and 2014/68/EU as regards emergency

procedures for the conformity assessment, presumption of

conformity, adoption of common specifications and market

surveillance due to an internal market emergency; and

(e) transpose the provisions of Directive (EU) 2024/2839

of the European Parliament and of the Council of 23 October

2024 amending Directives 1999/2/EC, 2000/14/EC, 2011/24/EU

and 2014/53/EU as regards certain reporting requirements in the

fields of food and food ingredients, outdoor noise, patients’

rights, and radio equipment.

(3) Regulation 3 shall be deemed to have come into force on

1st August 2025

Provided that regulations 2 and 9 shall come into force on

30th May 2026.

Regulation 3 of the principal regulations shall be amended

as follows

(a) immediately after the definition "conformity

assessment body" thereof there shall be added the following new

definition

""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;";

(b) immediately after the definition "importer" thereof

there shall be added the following new definition

""internal market emergency mode" shall have the

same meaning assigned to it by point (3) of Article 3 of

Regulation (EU) 2024/2747;";

(c) immediately

after

the

definition

"national

accreditation body" thereof there shall be added the following

new definition

"notified bodies" means conformity assessment

bodies designated by a Member State to assess the

conformity of certain products before being placed on the

market;";

(d) immediately after the definition "recall" thereof there

shall be added the following new definitions

""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);".

Immediately after sub-regulation (6) of regulation 4 of the Amends

principal regulations there shall be added the following new sub- regulation

the principal

regulations

regulations.

"(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 S.L. 427.40.

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 S.L. 65.29.

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.".

Sub-regulation (2) of regulation 8 of the principal

regulations shall be deleted.

Sub-regulations (2) and (4) of regulation 29 of the principal

regulations shall be deleted.

In sub-regulation (1) of regulation 30 of the principal

regulations, the words "It shall immediately inform the European

Commission and the other Member States accordingly." shall be

Sub-regulations (2), (4)(b) and (6) of regulation 36 of the

principal regulations shall be deleted.

Sub-regulation (3) of regulation 37 of the principal

regulations shall be deleted.

Immediately after regulation 39 of the principal regulations

there shall be added the following new regulations

(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

Prioritisation of the

assessment of radio 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.".

10. Regulation 40 of the principal regulations shall be deleted.

Deletes

regulation 40 of

the principal

regulations.

€0.45