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L.S. 427.41 Regolamenti dwar Radio Equipment

[ S.L.427.41 RADIO EQUIPMENT 1 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.

(1)The title of these regulations is the Radio Equipment Regulations.
(2)Citation. These regulations: (
  1. a)transpose Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on radio equipment; and (
  2. b)lay down requirements for products referred to in regulation 2 and made available on the market. 2.
(1)These regulations shall apply to radio equipment.
(2)These regulations shall not apply: Applicability. (
  1. a)to the equipment listed in Schedule I; and (
  2. 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). 3. 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. S.L. 427.34 Definitions. Amended by: L.N. 202 of 2025. 2 [ S.L.427.41 RADIO EQUIPMENT "crisis-relevant goods" means goods that are non-substitutable, nondiversifiable 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 (
  1. 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 (
  2. 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; Cap. 418 Cap. 510 "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; RADIO EQUIPMENT [ S.L.427.41 "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 enduser; "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. Cap. 510 3 4 [ S.L.427.41 Essential requirements. Amended by: L.N. 7 of 2024; L.N. 202 of 2025. S.L. 427.34 S.L. 427.35 4. RADIO EQUIPMENT
(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: (
  1. a)interworks with accessories, common chargers; in particular with (
  2. b)interworks via networks with other radio equipment; (
  3. c)can be connected to interfaces of the appropriate type throughout the European Union; (
  4. d)does not harm the network or its functioning nor misuse network resources, thereby causing an unacceptable degradation of service; (
  5. e)incorporates safeguards to ensure that the personal data and privacy of the user and of the subscriber are protected; (
  6. f)supports certain features ensuring protection from fraud; (
  7. g)supports certain features ensuring access to emergency services; (
  8. h)supports certain features in order to facilitate its use by users with a disability; (
  9. 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 (
  1. a)to (
  2. 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. RADIO EQUIPMENT [ S.L.427.41
(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: (
  1. a)internet-connected radio equipment, other than the equipment referred to in paragraphs (b), (
  2. c)or (d); (
  3. b)radio equipment designed or intended exclusively for childcare; (
  4. c)radio equipment regulated by the Safety of Toys Regulations; S.L. 427.40. (
  5. d)radio equipment designed or intended, whether exclusively or not exclusively, to be worn on, strapped to, or hung from any of the following: (
  6. i)any part of the human body, including the head, neck, trunk, arms, hands, legs and feet; (
  7. 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)(
  1. 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(
  2. 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), (
  1. e)and (
  2. f)shall not apply to radio equipment to which either of the following Union harmonisation legislation also applies: (
  3. 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 S.L. 586.01. Cap. 9. 5 6 [ S.L.427.41 RADIO EQUIPMENT repealing Council Directives 90/385/EEC and 93/42/ EEC; and (
  4. 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)(
  1. e)and (
  2. f)shall not apply to radio equipment to which any of the following Union harmonisation legislation also applies: (
  3. 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; S.L. 65.29. (
  4. 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 (
  5. 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 WiFi 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 RADIO EQUIPMENT [ S.L.427.41 7 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. 4A.
(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. 5.
(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
  1. 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. Possibility for consumers and other end-users to acquire certain categories or classes of radio equipment without a charging device. Added by: L.N. 7 of
  2. Information on compliance of radio equipment and, or software combinations.
(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. 6.
(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), (
  1. h)and (
  2. i)of Schedule V. Manufacturers Radio equipment type registration within categories. 8 [ S.L.427.41 RADIO EQUIPMENT shall affix on radio equipment placed on the market a registration number as allocated by the European Commission to each registered radio equipment type.
(2)The categories of radio equipment concerned by the requirement set out in sub-regulation
(1)and the technical documentation to be provided, taking into account the information on the compliance of radio equipment provided by Member States following an evaluation of the risk of non-implementation of the essential requirements shall be specified through delegated acts adopted by the European Commission.
(3)The operational rules for affixing the registration number on radio equipment for the categories specified by the delegated acts adopted pursuant to sub-regulation
(2)shall be laid down in implementing acts adopted by the European Commission.
(4)Manufacturers shall register the required information in a central system ensuring control of access to information of confidential nature and made available by the European Commission. Making available on the market and putting into service and use. 7.
(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: (
  1. a)the effective and efficient use of the radio spectrum; (
  2. b)the avoidance of harmful interference; (
  3. c)the avoidance of electromagnetic disturbances, (
  4. 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. Notification of radio interface specifications and assignment of radio equipment classes. Amended by: L.N. 202 of 2025. 8.
(1)The MCA shall notify the TRD with the interfaces which it intends to regulate, except: (
  1. 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 (
  2. 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. Free movement of radio equipment.
(2)Deleted by Legal Notice 202 of 2025. 9.
(1)Radio equipment compliant with Directive 2014/53/EU RADIO EQUIPMENT [ S.L.427.41 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. 10.
(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)(
  1. 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. (
  2. 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)(
  1. 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. (
  2. 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 Obligations of manufacturers. Added by: L.N. 7 of 2024. 9 10 [ S.L.427.41 RADIO EQUIPMENT 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 endusers and the MSD.
(8)(
  1. 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. (
  2. b)The following information shall also be included in the instructions in the case of radio equipment intentionally emitting radio waves: (
  3. i)frequency bands in which the radio equipment operates; and (
  4. ii)maximum radio-frequency power transmitted in the frequency bands in which the radio equipment operates. (
  5. 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. RADIO EQUIPMENT [ S.L.427.41 (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 endusers, 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. 11.
(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: (
  1. 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; (
  2. 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; Authorised representatives. 11 12 [ S.L.427.41 RADIO EQUIPMENT (
  3. 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. Obligations of importers. Amended by: L.N. 7 of 2024. 12.
(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: (
  1. a)the radio equipment is accompanied by instructions and safety information in either Maltese or English; and (
  2. 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; (
  3. c)when making the radio equipment referred to in regulation 4
(5)available to consumers and other endusers, importers shall ensure that: (
  1. i)(
  2. ii)such radio equipment displays, or is supplied with, a label in accordance with regulation 10
(8)(c); and that label is displayed in a visible and legible manner and, in the case of distance selling, close to the price indication. RADIO EQUIPMENT [ S.L.427.41
(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:(
  1. 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; (
  2. 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; (
  3. 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. 13.
(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. (
  1. 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. (
  2. c)When making the radio equipment referred to in regulation 4
(5)available to consumers and other endusers, distributors shall ensure that: Obligations of distributors. Amended by: L.N. 7 of 2024. 13 14 [ S.L.427.41 RADIO EQUIPMENT (i) (ii) such radio equipment displays, or is supplied with, a label in accordance with regulation 10
(8)(c); and 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. Application of obligations of manufacturers to importers and distributors. 14. 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. Economic operators. 15.
(1)Economic operators shall, on request, identify the following to the MSD: (
  1. a)any economic operator who has supplied them with radio equipment; (
  2. 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. Presumption of conformity. 16. 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. RADIO EQUIPMENT [ S.L.427.41 17.
(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. 15 Conformity assessment procedures. Amended by: L.N. 7 of 2024.
(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: (
  1. a)internal production control set out in Schedule II; (
  2. b)EU-type examination that is followed by the conformity to type based on internal production control set out in Schedule III; (
  3. 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: (
  1. a)internal production control set out in Schedule II; (
  2. b)EU-type examination that is followed by the conformity to type based on internal production control set out in Schedule III; (
  3. 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. 18.
(1)The EU declaration of conformity shall state that the fulfilment of the essential requirements set out in regulation 4 has been demonstrated.
(2)(
  1. a)The EU declaration of conformity shall have the model EU declaration of conformity. 16 [ S.L.427.41 RADIO EQUIPMENT 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. (
  2. 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. General principles of the CE marking. 19.
(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. Rules and conditions for affixing the CE marking and the identification number of the notified body. Amended by: L.N. 7 of 2024. 20.
(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. Technical documentation. 21.
(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 RADIO EQUIPMENT [ S.L.427.41 17 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. 22. 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. Notifying authorities. 23. 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. National Accreditation Board. 24. A notifying authority shall: (
  1. a)be established in such a way that no conflict of interest with conformity assessment bodies occurs; Requirements relating to notifying authorities. (
  2. b)be organised and operated so as to safeguard the objectivity and impartiality of its activities; (
  3. 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; (
  4. d)not offer or provide any activities that conformity assessment bodies perform or consultancy services on a commercial or competitive basis; (
  5. e)safeguard the confidentiality of the information it obtains; and (
  6. f)have a sufficient number of competent personnel at its disposal for the proper performance of its tasks. 25. 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. Information obligation on notifying authorities. 26.
(1)For the purposes of notification, a conformity assessment body shall meet the requirements laid down in this regulation. Requirements relating to notified bodies. Amended by: L.N. 7 of 2023. 18 [ S.L.427.41
(2)S.L. 427.45 RADIO EQUIPMENT A conformity assessment body shall: (
  1. a)be established as stipulated in the Method for Designating Conformity Assessment Bodies Regulations; (
  2. b)be a third-party body independent of the organisation or the radio equipment it assesses; (
  3. 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; (
  4. 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; (
  5. e)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks; (
  6. 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; (
  7. 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; (
  8. 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; (
  9. i)ensure that the activities of its subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of its conformity assessment activities; (
  10. j)including its personnel, carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical RADIO EQUIPMENT [ S.L.427.41 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; (
  11. k)take out liability insurance unless liability is assumed by the State in accordance with national law; (
  12. 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: (
  1. 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; (
  2. 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: (
  1. a)have sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified; (
  2. b)have the satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments; (
  3. 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; (
  4. d)have the ability to draw up certificates, records and 19 20 [ S.L.427.41 RADIO EQUIPMENT 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. Presumption of conformity of notified bodies. Amended by: L.N. 7 of
  2. 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. Subsidiaries of and subcontracting by notified bodies. Amended by: L.N. 7 of
  3. 28.
(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: (
  1. a)shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established; and (
  2. 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. Application for notification. Added by: L.N. 7 of 2024. 28A.
(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 RADIO EQUIPMENT [ S.L.427.41 21 documentary evidence necessary for the verification, recognition, and regular monitoring of its compliance with the requirements laid down in regulation 26. 29.
(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. Notification procedure. Amended by: L.N. 7 of 2024; L.N. 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)(
  1. 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. (
  2. b)Only such a body shall be considered a notified body for the purposes of these regulations. 30.
(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. Changes to notifications. Amended by: L.N. 202 of 2025.
(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. 31.
(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: (
  1. a)a notified body finds that the essential requirements set out in regulation 4 or corresponding harmonised Operational obligations of notified bodies. Amended by: L.N. 7 of 2024. 22 [ S.L.427.41 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; (
  2. 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; (
  3. 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. Appeal against decisions of notified bodies. 32. Notified bodies shall have an appeals procedure in place which is also publicly available. Information obligation on notified bodies. 33.
(1)Notified bodies shall inform the TRD of the following: (
  1. a)any refusal, restriction, suspension or withdrawal of a certificate; (
  2. b)any circumstances affecting the scope of or conditions for notification; (
  3. c)any request for information which they have received from the MSD regarding conformity assessment activities; (
  4. 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: (
  1. 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 (
  2. b)fulfil information obligations under Schedules III and IV. Coordination of notified bodies. 34. 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. Union market surveillance and control of radio equipment entering the Union market. 35. Article 15
(3)and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to radio equipment. RADIO EQUIPMENT [ S.L.427.41 36.
(1)(
  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. (
  2. 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. (
  3. c)The MSD shall inform the relevant notified body accordingly. (
  4. 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(
  1. 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 noncompliance is due to either of the following: (
  2. a)failure of the radio equipment to meet the requirements relating to aspects of public interest protection covered by these regulations; or (
  3. b)shortcomings in the harmonised standards referred to 23 Procedure at national level for dealing with radio equipment presenting a risk or otherwise in compliance with essential requirements. Amended by: L.N. 7 of 2024; L.N. 202 of 2025. 24 [ S.L.427.41 RADIO EQUIPMENT in regulation conformity.
(6)16 conferring a presumption of 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. Compliant radio equipment which presents a risk. Amended by: L.N. 7 of 2024; L.N. 202 of 2025. 37.
(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)Formal noncompliance. Amended by: L.N. 7 of
  1. Deleted by Legal Notice 202 of
  2. 38.
(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: (
  1. a)the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of regulation 20; (
  2. b)the CE marking has not been affixed; (
  3. 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; (
  4. d)the EU declaration of conformity has not been drawn up; (
  5. e)the EU declaration of conformity has not been drawn up correctly; (
  6. f)technical documentation is either not available or not complete; (
  7. 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 RADIO EQUIPMENT [ S.L.427.41 25 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; (
  1. i)requirements on identification of economic operators set out in regulation 15 are not fulfilled; (
  2. 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. 39. Economic operators failing to comply with the requirements of these regulations are subject to the provisions under article 26 of the Product Safety Act. Penalties. 39A.
(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. Application of emergency procedures. Added by: L.N. 202 of 2025
(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 crisisrelevant 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. Cap. 427 26 [ S.L.427.41 Prioritisation of the conformity assessment of radio equipment designated as crisis-relevant goods. Added by: L.N. 202 of 2025. RADIO EQUIPMENT 39B.
(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 subregulation
(1)in respect of which they have been notified. Derogation from the conformity assessment procedures requiring the mandatory involvement of a notified body. Added by: L.N. 202 of 2025 39C.
(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. RADIO EQUIPMENT [ S.L.427.41 27
(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: (
  1. a)a description of the procedures, by means of which compliance with the relevant essential requirements established in regulation 4 was successfully demonstrated; (
  2. b)any specific requirements regarding the traceability of the radio equipment concerned; (
  3. 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; (
  4. d)any specific requirements regarding the need to ensure a continuous conformity assessment with respect to the radio equipment concerned; (
  5. 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. S.L. 427.105.
(9)The use of the authorisation procedure provided in subregulations
(1),
(2)
(4)and
(6)shall not affect the application of the relevant conformity assessment procedures provided in regulation 17. 39D.
(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. Presumption of conformity based on standards and common specifications. Added by: L.N. 202 of 2025. 28 [ S.L.427.41 RADIO EQUIPMENT
(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 subregulation
(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. Review and reporting. Amended by: L.N. 202 of 2025. 40. Deleted by Legal Notice 202 of 2025. RADIO EQUIPMENT Amended by: L.N. 7 of 2024. [ S.L.427.41 29 SCHEDULE I 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: (
  1. a)radio kits for assembly and use by radio amateurs; (
  2. b)radio equipment modified by and for the use of radio amateurs; (
  3. 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. SCHEDULE II 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 (
  4. 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) 30 [ S.L.427.41 RADIO EQUIPMENT regulations 19 and 20 to each item of radio equipment that satisfies the applicable requirements of these regulations. (
  5. 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. SCHEDULE III 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: (
  6. a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (
  7. b)a written declaration that the same application has not been lodged with any other notified body; (
  8. 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 [ S.L.427.41 31 (
  9. 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. (
  10. i)Where the type meets the requirements of these regulations that apply to the radio equipment concerned, the notified body shall issue an EUtype 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. (
  11. 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 inservice 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. (
  12. 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. (
  13. 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. (
  14. 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. (
  15. ii)Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and, or any additions thereto which it 32 [ S.L.427.41 RADIO EQUIPMENT 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 (
  16. 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. (
  17. 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 [ S.L.427.41 RADIO EQUIPMENT 33 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. Amended by: L.N. 7 of 2024. SCHEDULE IV 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: (
  1. a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (
  2. 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; (
  3. c)the documentation concerning the quality system; and (
  4. 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: (
  1. i)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality; (
  2. 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; 34 [ S.L.427.41 RADIO EQUIPMENT (
  3. iv)the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; (
  4. 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; (
  5. 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)(
  1. 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. (
  2. 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)(
  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. (
  2. 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. (
  3. 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. (
  4. f)4. 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. 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: (
  1. a)the quality system documentation; (
  2. b)the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.; (
  3. c)the quality records as provided for by the manufacturing part of the RADIO EQUIPMENT [ S.L.427.41 35 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).
  1. 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.
  2. 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. 36 [ S.L.427.41 RADIO EQUIPMENT SCHEDULE V CONTENTS OF TECHNICAL DOCUMENTATION Amended by: L.N. 7 of 2024. The technical documentation shall, wherever applicable, contain at least the following elements: (
  1. a)a general description of the radio equipment including: (
  2. i)photographs or illustrations showing external features, marking and internal layout; (
  3. ii)versions of software or firmware affecting compliance with essential requirements; (iii) user information and installation instructions; (
  4. b)conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits and other relevant similar elements; (
  5. c)descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the radio equipment; (
  6. 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; (
  7. e)copy of the EU declaration of conformity; (
  8. 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; (
  9. g)results of design calculations made, examinations carried out, and other relevant similar elements; (
  10. h)test reports; (
  11. i)Amended by: L.N. 7 of 2024. 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). SCHEDULE VI EU DECLARATION OF CONFORMITY (No )1(Regulation 18) 1 - 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 [ S.L.427.41 RADIO EQUIPMENT 37 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: L.N. 7 of
  10. SCHEDULE VII 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: 38 [ S.L.427.41 RADIO EQUIPMENT SCHEDULE VIII Added by: L.N. 7 of
  1. SPECIFICATIONS AND INFORMATION RELATING TO CHARGING APPLICABLE TO CERTAIN CATEGORIES OR CLASSES OF RADIO EQUIPMENT Part I Specifications relating to charging capabilities
  2. The requirements set out in points 2 and 3 of this Part shall apply to the following categories or classes of radio equipment: 1.
  3. handheld mobile phones; 1.
  4. tablets; 1.
  5. digital cameras; 1.
  6. headphones; 1.
  7. headsets; 1.
  8. handheld videogame consoles; 1.
  9. portable speakers; 1.
  10. e-readers; 1.
  11. keyboards; 1.
  12. mice; 1.
  13. portable navigation systems; 1.
  14. earbuds; 1.
  15. laptops.
  16. 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.
  17. 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.
  18. 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 [ S.L.427.41 39
  19. 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.
  20. 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.
  21. 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: (
  1. 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; (
  2. 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: 40 [ S.L.427.41 RADIO EQUIPMENT 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 [ S.L.427.41 41 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.

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