S.I. No. 14/2026 - European Union (Radio Equipment) Regulations 2026

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 23rd January, 2026.

TABLE OF CONTENTS

PART 1
PRELIMINARY
1. Citation
2. Interpretation
PART II
SCOPE AND APPLICATION
3. Application
4. Making Available on the Market, Putting into Service and Essential Requirements
5. Possibility for consumers and other end-users to acquire certain categories or classes of radio equipment without a charging device
6. Provision of information on the compliance of combinations of radio equipment and software
7. Registration of radio equipment types within some categories
8. Free movement
9. Competent Authority
10. Additional Requirements for Putting into Service and Use
11. Notification of Radio Interface Specifications
PART III
12. Obligations of Economic Operators
13. Obligations of Manufacturers
14. Authorised Representatives
15. Obligations of Importers
16. Obligations of Distributors
17. Cases Where Obligations of Manufacturers apply to Importer or Distributor
18. Identification of Economic Operators
PART IV
CONFORMITY OF RADIO EQUIPMENT
19. Presumption of Compliance with Conformity Assessment Procedures
20. Conformity Assessment Procedures
21. EU Declaration of Conformity
22. CE Marking
23. Technical Documentation
PART V
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
24. Notifying Authority
25. Application for Notification
26. Presumption of Conformity of Notified Bodies
27. Notification Procedure
28. Restriction, Suspension or Withdrawal of Notification
29. Challenge of the Competence of Notified Bodies
30. Operational Obligations of Notified Bodies
31. Appeal of Decision under Part 5
32. Information Obligation of Notified Bodies
33. Co-ordination of Notified Bodies
PART VI
UNION MARKET SURVEILLANCE, CONTROL OF RADIO EQUIPMENT ENTERING UNION MARKET AND SAFEGUARD PROCEDURE
34. Union Market Surveillance, Control of Radio Equipment Entering Union Market and Market Surveillance Authority
35. Procedure for Dealing with Radio Equipment Presenting a Risk at National Level
36. Procedures where Radio Equipment continues to present a Risk at National Level
37. Union Safeguard Procedure
38. Compliant Radio Equipment Presenting Risk
39. Formal Non-Compliance
PART VII
ENFORCEMENT
40. General
41. Appointment of Authorised Officers
42. Powers of Authorised Officers
43. Contravention Notice
44. Appeal against Contravention Notice
45. Order of High Court directing compliance with Contravention Notice
46. Radio Equipment presenting a serious risk
47. Prohibition Notice – Radio Equipment presenting a serious risk
48. Appeal against a Prohibition Notice
49. Order of the High Court to direct compliance with Prohibition Notice
50. Seizure Notice – Seizure and disposal of radio equipment presenting a serious risk
51. Forfeiture Order
52. Information Notice
53. Search Warrant
PART VIII
MISCELLANEOUS
54. Giving of Direction, Notice or Other Document
55. Offences
56. Prosecution of offences
57. Offences by bodies corporate
58. Penalties
59. Review and Reporting
60. Application of the wireless Telegraphy Act 1926
61. Revocation
62. Transitional Provisions and Continuation of Regulation of 2001 and 2017
63. Act of 2002

I, PATRICK O’DONOVAN, Minister for Culture, Communications and Sport, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972), for the purpose of giving effect to Directive 2014/53/EU of the European Parliament and Council of the 16 April 2014¹ as amended by Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018² , Directive (EU) 2022/2380 of the European Parliament and of the Council of 23 November 2022³ and Commission Delegated Regulation (EU) 2023/1717 of 27 June 2023⁴ and further effect to Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019⁵ , hereby make the following regulations:

PART 1 PRELIMINARY

Citation

1.

Interpretation

2.

“accreditation” has the meaning assigned to it by Article 2.10 of Regulation (EC) No 765/2008⁶ ;

“accreditation certificate” means a certificate issued by a national accreditation body attesting that a conformity assessment body fulfils the requirements laid down in Article 26 of the Directive;

“Act of 2002” means the Communications Regulation Act 2002 ;

“Annex Ia equipment” means:

• (1) Radio equipment falling within the categories or classes of radio equipment referred to in Part I, points 1.1 to 1.12 of Annex Ia to the Directive, and

• (2) from the final transition date, radio equipment referred to in Part I, point 1.13 of Annex Ia to the Directive;

subject to such variation of Annex Ia as may be effected by any delegated act of the European Commission, with effect from the date indicated in any such delegated act;

“authorised officer” means a person appointed under Regulation 41;

“authorised representative” means a person established within the Union who has received a written mandate from a manufacturer to act on the manufacturer’s behalf in relation to specified tasks;

“CE marking” means a marking by which a manufacturer indicates that the radio equipment is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;

“competent authority” means the body designated as the competent authority under Regulation 9;

“conformity assessment” means the process, in accordance with Regulation 20, demonstrating whether the essential requirements have been fulfilled;

“conformity assessment body” means a person who performs conformity assessment procedures laid down in Annex II, III or IV to the Directive;

‘Directive’ means Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014¹ as amended by Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018² , Directive (EU) 2022/2380 of the European Parliament and of the Council of 23 November 2022³ and Commission Delegated Regulation (EU) 2023/1717 of 27 June 2023⁴ ;

“direction” means a direction given by the market surveillance authority under Regulation 8(3)(b), 35(5), 38(1), or 39(1)(a);

“distributor” means any person in the supply chain, other than the manufacturer or importer, who makes radio equipment available on the market;

“economic operator” means a manufacturer, an authorised representative, an importer, distributor or a fulfilment service provider;

“electromagnetic disturbance” has the meaning assigned to it by Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014⁷ on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast);

‘essential requirements’, in relation to radio equipment, means essential requirements set out in Regulation 4(1) or (2) and in relation to a category or class of radio equipment, means the essential requirements applicable to the category or class of radio equipment by virtue of paragraph (5) or (6) of Regulation 4, as the case may be;

“EU declaration of conformity” means a declaration of conformity drawn up in accordance with the requirements of Regulation 21;

“final transition date” means 28 April 2026;

“harmful interference” has the meaning assigned to it by the European Communities (Electronic Communications Networks and Services) (Framework) Regulations 2011 ( S.I. No. 333 of 2011 );

“harmonised standard” means harmonised standard as defined in Article 2 (1)(c) of Regulation (EU) No 1025/2012⁸ ;

“importer” means any person established within the Union who places radio equipment from a third country on the Union market;

“information society service provider” means a provider of a service as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535⁹ of the European Parliament and of the Council;

“making available on the market” means any supply of radio equipment for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

“manufacturer” means a person who manufactures radio equipment or has radio equipment designed or manufactured and markets that equipment under the person’s name or trade mark;

“market surveillance authority” means the body designated as the market surveillance authority under Regulation 34;

‘Member State’ means a Member State of the European Union and, in so far as may be necessary to give effect to the obligations of the State pursuant to the Agreement on the European Economic Area signed in Oporto on 2 May 1992, shall be construed as including a reference to a State (not being a Member State of the European Union) which is a contracting party to that Agreement;

“notified body” means a conformity assessment body whose appointment has been notified to the European Commission—

• (a) by the notifying authority in accordance with Regulation 27, or

• (b) by another Member State,

and whose appointment has been notified to the European Commission and the other Member States pursuant to Article 22 of the Directive;

“notifying authority” means the body designated as the notifying authority under Regulation 24;

“national accreditation body” means the Irish National Accreditation Board;

“placing on the market” means the first making available of radio equipment on the Union market;

“putting into service” means the first use of radio equipment in the Union by its end-user;

“radio communication” means communication by means of radio waves;

“radio determination” means the determination of the position, velocity 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 or receives radio waves for the purpose of radio communication or radiodetermination, or an electrical or electronic product which must be completed with an accessory, such as antenna, so as to intentionally emit or receive radio waves for the purpose of radio communication or radiodetermination;

“radio interface” means the specification of the regulated use of radio spectrum;

“radio waves” means electromagnetic waves of frequencies lower than 3,000GHz (gigahertz) propagated in space without artificial guide;

“recall” means any measure aimed at achieving the return of radio equipment that has already been made available to the end-user;

“Regulations of 2001” means the European Communities (Radio Equipment and Telecommunications Terminal Equipment) Regulations 2001 ( S.I. No. 240 of 2001 );

“Regulations of 2017” means the European Union (Radio Equipment) Regulations 2017 ( S.I. No. 248 of 2017 );

“Regulation (EU) 2019/1020” means Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019⁵ on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No. 765/2008⁶ and (EU) No. 305/2011¹⁰ ;

“technical specification” means a document that prescribes technical requirements to be fulfilled by radio equipment;

“Union” means the European Union within the meaning of the European Communities Act 1972 (No. 27 of 1972);

“Union harmonisation legislation” means any Union legislation harmonising the conditions for the marketing of products;

“withdrawal” in Part 6, means any measure aimed at preventing radio equipment in the supply chain from being made available on the market;

• (2) A word or expression that is used in these Regulations and is also used in Regulation (EU) 2019/1020 or the Directive has, unless the contrary intention appears, the same meaning in these Regulations as it has in Regulation (EU) 2019/1020 and the Directive.

PART 2 SCOPE AND APPLICATION

Application

3.

• (2) These Regulations shall not apply to radio equipment used exclusively by An Garda Síochána or the Permanent Defence Force, for the purpose of State security (including the economic wellbeing of the State in the case of activities pertaining to State security matters), and in the activities of the State in the enforcement of criminal law.

• (3) Other than as provided by Regulation 4(1)(a), the European Union (Low Voltage Electrical Equipment) Regulations 2016 ( S.I. No. 345 of 2016 ), and 2022 ( S.I. No. 14 of 2022 ) shall not apply to radio equipment to which these Regulations apply.

Making Available on the Market, Putting into Service and Essential Requirements

4.

• (a) the protection of health and safety of persons and of domestic animals and the protection of property, including the objectives with respect to safety requirements set out in Directive 2014/35/EU¹¹ , but with no voltage limit applying;

• (b) an adequate level of electromagnetic compatibility as set out in Directive 2014/30/EU¹² ;

• (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) Subject to Regulation 62(3) a person shall make available on the market radio equipment only if it complies with these Regulations.

• (4) Subject to Regulation 62(3) a person shall put into service radio equipment only if it complies with these Regulations when properly installed, maintained and used in accordance with its intended purpose.

• (5) Radio equipment falling within a class or category specified by a delegated act of the European Commission adopted in accordance with Article 44 of the Directive for the purposes of Article 3(3) of the Directive, shall, while the delegated act is in force, comply with such of the essential requirements referred to in Article 3(3)(a) to (i) of the Directive as the delegated act shall require.

• (6) Annex Ia equipment shall be so constructed that it complies with the applicable specifications relating to charging set out in Annex Ia of the Directive for the relevant category or class of radio equipment.

Possibility for consumers and other end-users to acquire certain categories or classes of radio equipment without a charging device

5.

• (2) Where Annex Ia equipment is offered in accordance with paragraph (1), economic operators shall ensure that information on whether or not a charging device is included with the radio equipment is provided using a pictogram as set out in Part III of Annex Ia to the Directive.

• (3) The pictogram referred to in paragraph (2) shall —

• (a) be printed on the packaging of the radio equipment, or affixed to the packaging of the radio equipment as a sticker,

• (b) be displayed in a visible and legible manner, and

• (c) in the case of distance selling, be displayed close to the indication of the price payable for the radio equipment.

Provision of information on the compliance of combinations of radio equipment and software

6.

• (2) The statement referred to in paragraph (1) shall —

• (a) precisely identify the radio equipment and the software which have been assessed, and

• (b) include the information referred to in Annex VI to the Directive.

• (3) Where a change is made by a manufacturer to radio equipment or software allowing radio equipment to be used as intended such that the statement referred to in paragraph (2) is incorrect, the manufacturer shall provide the competent authority and the European Commission with a further statement regarding the compliance of intended combinations of radio equipment and software with the essential requirements in accordance with paragraph (1).

Registration of radio equipment types within some categories

7.

• (2) When registering a category of radio equipment in the central system under paragraph (1), manufacturers shall provide the applicable elements of the technical documentation specified in paragraphs (a), (d), (e), (f), (g), (h), and (i) of Annex V to the Directive.

• (3) Where the European Commission allocates a registration number to a category of radio equipment registered under paragraph (1), manufacturers shall affix the registration number on radio equipment of that category placed on the market.

Free Movement

8.

• (2) Nothing in these Regulations shall impede the demonstration of radio equipment that does not comply with these Regulations at trade fairs, exhibitions, and similar events provided that a clearly visible sign is displayed at any such trade fair, exhibition or similar event that indicates that the radio equipment concerned—

• (a) does not comply with these Regulations, and

• (b) shall not be made available on the market or put into service until they so comply.

• (3)
• (a) Not less than 6 weeks before a demonstration, a person intending to demonstrate radio equipment under paragraph (2) shall, by notice in writing, provide to the competent authority information regarding the operational and technical characteristics of the radio equipment together with the measures the person intends to take, in carrying out the demonstration, to avoid harmful interference, electromagnetic disturbances and risk to the health or safety of persons or domestic animals or to property.

• (b) Having considered the notice under subparagraph (a) the competent authority may give a direction to the person concerned not to carry out the demonstration or to carry out the demonstration subject to conditions.

• (c) The person shall take the measures notified to the competent authority under subparagraph (a) when carrying out the demonstration where the competent authority does not give a direction to the person in relation to the notice.

• (d) The person shall not carry out the demonstration, or, as the case may be, shall carry out the demonstration in accordance with the direction, where the competent authority gives a direction to the person under subparagraph (b).

• (e) A person who has given a notice in writing under subparagraph (a) may presume that the competent authority does not intend to give a direction under subparagraph (b) if the authority has not given the direction on or by the day that is 14 days before the first of day of the demonstration.

• (f) In this paragraph “demonstration” relates to one trade fair, exhibition or similar event which may be of more than one day’s duration.

Competent Authority

9.

Additional Requirements for Putting into Service and Use

10.

• (a) the effective and efficient use of radio spectrum,

• (b) the avoidance of harmful interference,

• (c) the avoidance of electromagnetic disturbances, or

• (d) public health.

Notification of Radio Interface Specifications

11.

• (2) The requirement to notify the European Commission under paragraph (1) shall not apply to:

• (a) 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/EC⁹ ;

• (b) radio interfaces which, in accordance with implementing acts adopted pursuant to Article 8(2) of the Directive, correspond to radio equipment which can be put into service and used without restrictions within the Union.

PART 3 OBLIGATIONS OF ECONOMIC OPERATORS

Obligations of Economic Operators

12.

• (2) An economic operator shall comply with its obligation to cooperate with the market surveillance authority in the State as set out in Article 7(1) of Regulation (EU) 2019/1020.

• (3) An information society service provider shall comply with its obligation to cooperate with the market surveillance authority in the State as set out in Article 7(2) of Regulation (EU) 2019/1020.

• (4) Radio equipment offered for sale online or through means of distance sales shall be deemed to be made available on the market if the offer is targeted at end users in a Member State. An offer for sale shall be considered to be targeted at end users in a Member State if the relevant economic operator directs, by any means, its activities to that Member State.

• (5) Nothing in these Regulations limits or affects any obligations imposed on economic operators or information society service providers to cooperate with any relevant authority designated by a Member State under Article 10 of Regulation (EU) 2019/1020 as responsible for carrying out market surveillance in the territory of that Member State other than the market surveillance authority.

Obligations of Manufacturers

13.

• (a) has been designed and manufactured in accordance with the essential requirements, and

• (b) is so constructed that it can be operated in at least one Member State without infringing requirements applying in that State relating to the use of radio spectrum.

• (2) Before placing radio equipment on the market, the manufacturer of the equipment shall—

• (a) draw up the technical documentation,

• (b) either—

• (i) carry out the conformity assessment applicable to the radio equipment, or

• (ii) have that conformity assessment carried out,

• (c) where compliance of radio equipment with the essential requirements has been demonstrated by the conformity assessment—

• (i) draw up the EU declaration of conformity, and

• (ii) affix the CE marking,

• (d) ensure that the radio equipment bears a type, batch or serial number or other element allowing its identification, or where because of its size or nature that is not possible, on its packaging or in the document accompanying the component,

• (e) ensure that procedures are in place for series production to remain in conformity with these Regulations, having regard to any changes in radio equipment design or characteristics or changes in the harmonised standards or in other technical specifications, by reference to which conformity of radio equipment is declared,

• (f) indicate on the radio equipment or, where that is not possible, on its packaging or a document accompanying the radio equipment—

• (i) the manufacturer’s name, registered trade name or registered trade mark, and

• (ii) the postal address which shall indicate a single point at which the manufacturer can be contacted,

• (g) identify, on the packaging of the radio equipment, the Member State or geographical area within a Member State where restrictions on putting it into service are in place or requirements for authorisation of its use apply,

• (h) ensure that the radio equipment is accompanied by instructions and safety information, as well as any labelling, which shall—

• (i) be clear, understandable, and intelligible,

• (ii) include information required to use the radio equipment in accordance with its intended use,

• (iii) include where applicable, a description of accessories and components, including software, which allow the radio equipment to operate as intended,

• (iv) include, in the case of radio equipment intentionally emitting radio waves, information in relation to:

• (I) the frequency band or bands in which the radio equipment operates;

• (II) the maximum radio-frequency power transmitted in the frequency band or bands in which the radio equipment operates,

• (v) include, in the case of radio equipment referred to in subparagraph (g), supplemental information relating to the restriction or authorisation concerned to that on the packaging referred to in subparagraph (g), and

• (vi) in the case of radio equipment referred to in Part I of Annex Ia to the Directive, include (in accordance with paragraphs (3), (4), (5), and (6)) information on the specifications relating to the radio equipment’s charging capabilities and the compatible charging devices, as specified in Part II of Annex Ia to the Directive,

• (i) ensure that the radio equipment is accompanied by a copy of the EU declaration of conformity or, in accordance with Regulation 21(2), a simplified EU declaration of conformity, and

• (j) ensure that the information required under subparagraphs (f) and (h) is provided in both the Irish and English languages or in the English language only.

• (3) In the case of Annex Ia equipment made available to consumers or other end-users, the information referred to in clause (vi) of paragraph (2)(h) shall be displayed on a label as set out in Part IV of Annex Ia to the Directive —

• (a) in a visible and legible manner, and

• (b) without prejudice to paragraph (4), where the radio equipment is made available by means of distance selling, close to the indication of the price of the radio equipment.

• (4) The label referred to in paragraph (3) shall be —

• (a) printed in the instructions referred to in paragraph (2)(h), and

• (b) subject to paragraphs (5) and (6), printed on the packaging of the radio equipment or affixed to the packaging as a sticker.

• (5) Where the radio equipment referred to in paragraph (3) does not have packaging, a sticker with the label referred to in paragraph (3) shall be affixed to the radio equipment.

• (6) Where the size or nature of the radio equipment does not allow otherwise, the label referred to in paragraph (3) shall be printed and made available as a separate document accompanying the radio equipment.

• (7) A manufacturer of radio equipment which the manufacturer has placed on the market shall—

• (a) retain the technical documentation and a copy of the EU declaration of conformity for 10 years after the radio equipment has been placed on the market,

• (b) when deemed appropriate with regard to a risk presented by radio equipment and to protect the health and safety of consumers, carry out sample testing of the radio equipment which has been made available on the market,

• (c) investigate, and, if necessary, keep a register of complaints of nonconforming radio equipment and recalls of radio equipment,

• (d) keep distributors informed of monitoring referred to in subparagraphs (b) and (c),

• (e) in respect of radio equipment which the manufacturer considers or has reason to believe is not in conformity with the requirements of these Regulations—

• (i) immediately take any corrective measures necessary to bring the radio equipment into conformity including the withdrawal or recall of the radio equipment if appropriate, and

• (ii) where the radio equipment presents a risk, immediately inform the competent authority to that effect, giving details of—

• (I) the non-compliance, and

• (II) any corrective measures taken and the results of such measures,

• (f) further to a request in a notice given to the manufacturer by the competent authority, giving reasons for the request, provide the competent authority with all the information and documentation in paper or electronic form, in both the Irish and English languages or the English language only, necessary to demonstrate the conformity of radio equipment with these regulations, and

• (g) co-operate with the competent authority, on receipt of a request in that behalf from it, on any action taken to eliminate a risk posed by radio equipment which the manufacturer has placed on the market.

Authorised Representatives

14.

• (2) Subject to paragraph (3), an authorised representative shall perform the tasks specified in the mandate received from the manufacturer.

• (3) The mandate referred to in paragraph (1) shall not include the obligations laid down in subparagraph (a) of Regulation 13(1) or subparagraph (a), (b) or (c) of Regulation 13(2).

• (4) The mandate referred to in paragraph (1) shall, at a minimum permit the authorised representative to perform the following tasks:

• (a) retaining a copy of the EU declaration of conformity and the technical documentation at the disposal of the market surveillance authority for 10 years after the radio equipment has been placed on the market;

• (b) further to a request in a notice given to the authorised representative by the competent authority, giving reasons for the request, provide the competent authority with all the information and documentation necessary to demonstrate the conformity of radio equipment;

• (c) co-operating with the competent authority, 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

15.

• (2) Before placing radio equipment on the market an importer shall ensure that—

• (a) the conformity assessment procedure has been complied with by the manufacturer in accordance with Regulation 20,

• (b) the radio equipment is so constructed that it can be operated in at least one Member State without infringing requirements applying in that State relating to the use of the radio spectrum,

• (c) the manufacturer has drawn up the technical documentation,

• (d) the radio equipment bears the CE marking,

• (e) the radio equipment is accompanied by documents and information required under subparagraphs (g), (h) and (i) of Regulation 13(2),

• (f) the manufacturer has complied with subparagraphs (d), (f) and (j) of Regulation 13(2),

• (g) the radio equipment is accompanied by instructions and safety information,

• (h) the importers name, registered trade name or registered trademark and the postal address at which the importer can be contacted are indicated—

• (i) on the radio equipment, or

• (ii) if, for reasons including the size of the radio equipment or that it would require opening its packaging, compliance with clause (i) is not possible, on the packaging of, or in a document accompanying, the radio equipment, and,

• (i) the information required under paragraphs (g) and (h) is provided in both the Irish and English languages or in the English language only.

• (3) Where, before placing radio equipment on the market, an importer considers or has reason to believe that radio equipment is not in conformity with the essential requirements, the importer—

• (a) shall not place the radio equipment on the market until it has been brought into conformity, and

• (b) where the radio equipment presents a risk, shall inform the manufacturer and the market surveillance authority of the risk.

• (4) An importer shall ensure that, while radio equipment is under the responsibility of the importer, the storage of the radio equipment or the conditions under which it is transported do not jeopardise its compliance with the essential requirements.

• (5) An importer of radio equipment who has placed radio equipment on the market shall—

• (a) for a period of 10 years after the radio equipment has been placed on the market, retain a copy of the EU declaration of conformity and the technical documentation at the disposal of the market surveillance authority, and make it available upon request,

• (b) carry out, as required, when deemed appropriate with regard to a risk presented by radio equipment and to protect the health and safety of consumers, sample testing of the radio equipment which has been made available on the market,

• (c) investigate and, if necessary, keep a register of complaints of nonconforming radio equipment and recalls of radio equipment,

• (d) keep distributors informed of monitoring referred to in subparagraphs (b) and (c),

• (e) in respect of radio equipment which the importer considers or has reason to believe is not in conformity with the requirements of these Regulations—

• (i) immediately take any corrective measures necessary to bring the radio equipment into conformity including withdrawal or recall of the radio equipment, if appropriate, and

• (ii) where the radio equipment presents a risk, immediately inform the competent authority to that effect, giving details of—

• (I) the non-compliance, and

• (II) any corrective measures taken,

• (f) further to a request in a notice given to the importer by the competent authority, giving reasons for the request, provide the competent authority with all the information and documentation, in paper or electronic form, in both the Irish and English languages or the English language only, necessary to demonstrate the conformity of radio equipment, and

• (g) co-operate with the competent authority on receipt of a reasoned request from it on any action taken to eliminate a risk posed by radio equipment which the importer has placed on the market.

Obligations of Distributors

16.

• (2) Before making radio equipment available on the market a distributor shall verify that—

• (a) the radio equipment bears the CE marking,

• (b) the radio equipment is accompanied by the documents required by these Regulations,

• (c) the radio equipment is accompanied by the instructions and safety information in both the Irish and English languages or the English language only, and

• (d) the manufacturer and the importer have complied with the requirements set out in subparagraph (b) of Regulation 13(1), subparagraphs (d), (f), (g), (h), (i) and (j) of Regulation 13(2) and subparagraphs (e), (h) and (i) of Regulation 15(2) respectively.

• (3) Where, before making radio equipment available on the market a distributor considers or has reason to believe that the radio equipment is not in conformity with the essential requirements, the distributor—

• (a) shall not make the radio equipment available on the market until it has been brought into conformity, and

• (b) where the radio equipment presents a risk, shall inform the manufacturer or importer and the market surveillance authority.

• (4) While radio equipment is under the responsibility of a distributor, that distributor shall ensure that the storage of the radio equipment or the conditions under which it is transported do not jeopardise its compliance with the essential requirements.

• (5) A distributor who has made radio equipment available on the market shall—

• (a) in respect of radio equipment which the distributor considers or has reason to believe is not in conformity with these Regulations—

• (i) ensure that any corrective measures necessary to bring that radio equipment into conformity are taken, including withdrawal or recall of the radio equipment, if appropriate, and

• (ii) where the radio equipment presents a risk, immediately inform the competent authority to that effect, giving details of—

• (I) the non-compliance, and

• (II) any corrective measures taken,

• (b) further to a request in a notice given to the distributor by the competent authority, giving reasons for the request, provide the competent authority with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the radio equipment with these Regulations, and

• (c) co-operate with the competent authority on receipt of a reasoned request from it on any action taken to eliminate a risk posed by radio equipment which the distributor has made available on the market.

Cases Where Obligations of Manufacturers Apply to Importer or Distributor

17.

• (a) the importer places radio equipment on the market under the importer’s name or trademark;

• (b) the distributor places radio equipment on the market under the distributor’s name or trademark;

• (c) the importer or distributor modifies radio equipment already placed on the market in such a way that compliance with these Regulations may be affected.

• (2) Regulation 13 applies where an importer or distributor is considered to be a manufacturer under paragraph (1), subject to the following:

• (a) a reference in Regulation 13 to a manufacturer shall be construed as a reference, as the case may be, to an importer or distributor;

• (b) any other necessary modifications.

Identification of Economic Operators

18.

• (a) any other economic operator who has supplied the first economic operator with radio equipment;

• (b) any other economic operator to whom the first economic operator has supplied radio equipment.

• (2) An economic operator is required to be able to present the information referred to in paragraph (1) for a period of 10 years after the economic operator has been supplied with, or has supplied, the radio equipment.

PART 4 CONFORMITY OF RADIO EQUIPMENT

Presumption of Compliance with Conformity Assessment Procedures

19.

Conformity Assessment Procedures

20.

• (2) The conformity assessment shall—

• (a) take into account all operating conditions under which the radio equipment is intended to be operated, and,

• (b) for the essential requirements referred to in Regulation 4(1)(a), also take into account reasonably foreseeable conditions under which the radio equipment could be operated.

• (3) Where the radio equipment is capable of taking different configurations, the conformity assessment shall confirm whether the radio equipment meets the essential requirements in all possible configurations.

• (4) A manufacturer of radio equipment shall demonstrate compliance of the radio equipment with the essential requirements applicable by virtue of subparagraphs (a) and (b) of Regulation 4(1) and Regulation 4 (6) using any of the following conformity assessment procedures:

• (a) Module A (internal production control) set out in Annex II to the Directive;

• (b) Module B (EU-type examination), followed by Module C (conformity to type based on internal production control) set out in Annex III to the Directive;

• (c) Module H (conformity based on full quality assurance) set out in Annex IV to the Directive.

• (5) The manufacturer of radio equipment who has applied harmonised standards, the references of which have been published in the Official Journal of the European Union, in assessing the compliance of the radio equipment with the essential requirements referred to in Regulation 4(2) and in paragraph (5) of Regulation 4 shall use any of the procedures referred to in subparagraph (a), (b) or (c) of paragraph (4).

• (6) The manufacturer of radio equipment who has not applied or has partly applied harmonised standards the references of which have been published in the Official Journal of the European Union, or in respect of whose radio equipment no harmonised standard exists, in assessing the compliance of the radio equipment with the essential requirements referred to in Regulation 4(2) and in paragraph (5) of Regulation 4, shall use the procedures referred to in subparagraph (b) or (c) of paragraph (4).

EU Declaration of Conformity

21.

• (a) states that the fulfilment of the essential requirements has been demonstrated,

• (b) has the model structure set out in Annex VI to the Directive,

• (c) contains the elements set out in Annex VI to the Directive,

• (d) is continuously updated, and

• (e) when the radio equipment is placed or made available on the market in the State, is translated into—

• (i) both the Irish and English languages, or

• (ii) the English language only.

• (2) The manufacturer when drawing up a simplified EU declaration of conformity, or having one drawn up by an authorised representative, in respect of the radio equipment shall ensure that the simplified declaration—

• (a) contains the elements set out in Annex VII to the Directive,

• (b) is continuously updated,

• (c) when the radio equipment is placed or made available on the market in the State, is translated into—

• (i) both the Irish and English languages, or

• (ii) the English language only,

and

• (d) contains the exact internet address at which the full text of the EU declaration of conformity shall be available in both the Irish and English languages or the English language only.

• (3) A manufacturer of radio equipment, when drawing up an EU declaration of conformity or having one drawn up by an authorised representative, in respect of the radio equipment which is subject to more than one Union act requiring an EU declaration of conformity, shall ensure that—

• (a) a single EU declaration of conformity relating to the radio equipment shall be drawn up in respect of all such Union acts, and

• (b) the EU declaration of conformity referred to in subparagraph (a) shall identify the Union acts concerned including their publication references.

• (4) A manufacturer of radio equipment who has drawn up an EU declaration of conformity in accordance with this Regulation shall be responsible for compliance of the radio equipment in respect of which the declaration has been drawn up with these Regulations.

CE Marking

22.

• (2) The CE marking referred to in paragraph (1) shall be the only marking which attests to the conformity of radio equipment with the applicable requirements of the relevant EU harmonisation legislation providing for its affixing.

• (3) Unless it is not possible or warranted because of the nature of the radio equipment, the CE marking shall be affixed visibly, legibly and indelibly to the radio equipment or its data plate.

• (4) The manufacturer of radio equipment or the authorised representative of that manufacturer shall also affix the CE marking visibly and legibly to the packaging of radio equipment.

• (5) The CE marking affixed to radio equipment may be lower than 5 mm in height, provided that it remains visible and legible.

• (6) The CE marking shall be followed by the identification number of the notified body, where the conformity assessment procedure set out in Annex IV to the Directive is applied, which number shall have the same height as the CE marking.

• (7) The identification number of the notified body shall be affixed—

• (a) by the notified body itself or,

• (b) where instructed to do so by the notified body, by—

• (i) the manufacturer, or

• (ii) the authorised representative of the manufacturer.

• (8) The market surveillance authority shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.

• (9) A person shall not affix a sign, marking or inscription to radio equipment that is likely to mislead third parties as to the meaning or form of the CE marking.

• (10) A person shall not affix a marking to radio equipment if it is likely to impair the visibility, legibility or meaning of the CE marking.

Technical Documentation

23.

• (a) all relevant data or details of the means used by the manufacturer of radio equipment to ensure that the radio equipment complies with the essential requirements, and

• (b) at a minimum, the elements set out in Annex V to the Directive.

• (2) The manufacturer shall continuously update the technical documentation drawn up by the manufacturer.

• (3) The technical documentation and correspondence relating to any EU-type examination procedure concerning radio equipment shall be drawn up by the manufacturer of the radio equipment in—

• (a) both the Irish and English languages, or

• (b) the English language only.

• (4) Where the technical documentation does not comply with paragraph (1), (2) or (3) and in so doing fails to present sufficient relevant data or means used to ensure compliance of radio equipment with the essential requirements, the market surveillance authority may give notice to the manufacturer or importer concerned requiring that manufacturer or importer to have a test performed by a body acceptable to the market surveillance authority at the expense of the manufacturer or importer, within a specified period, and to furnish the results of the test to the market surveillance authority in order that it may verify compliance of the radio equipment with the essential requirements.

• (5) The manufacturer or importer shall have the test referred to in paragraph (4) performed and furnish the results of that test to the market surveillance authority as required by the authority under paragraph (4).

PART 5 NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Notifying Authority

24.

• (2) The notifying authority shall—

• (a) set up and carry out the necessary procedures for the assessment and notification of conformity assessment bodies, and

• (b) carry out the monitoring of notified bodies, including compliance by a notified body with Article 28 of the Directive.

• (3) The notifying authority shall inform the European Commission of its procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies and any changes thereto.

• (4) The notifying authority shall comply with the requirements of Article 24 of the Directive.

Application for Notification

25.

• (2) The application under paragraph (1) shall be accompanied by—

• (a) a description of—

• (i) the conformity assessment activities,

• (ii) the conformity assessment module or modules, and

• (iii) the radio equipment,

for which the conformity assessment body claims to be competent, and

• (b) such other information and documentation as the notifying authority may require to satisfy itself that the conformity assessment body complies with the requirements specified in Article 26 of the Directive.

• (3) The application under paragraph (1) shall also be accompanied by—

• (a) where one exists, a certificate of accreditation,

• (b) where no certificate of accreditation exists, all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements set down in Article 26 of the Directive

• (4) Without prejudice to any other enactment, the national accreditation body may issue a certificate of accreditation for the purposes of an application under this Regulation.

Presumption of Conformity of Notified Bodies

26.

Notification Procedure

27.

• (2) The notifying authority shall notify the European Commission and the other Member States using the electronic notification tool developed and managed by the European Commission.

• (3) The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and the radio equipment concerned and the relevant attestation of competence.

• (4) Where a notification is not based on an accreditation certificate, the notifying authority shall provide the European Commission and the other Member States with documentary evidence which attests to the conformity assessment body’s competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 26 of the Directive.

• (5) The conformity assessment 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.

• (6) Only such a body shall be considered a notified body for the purposes of these Regulations and the Directive.

• (7) The notifying authority shall notify the European Commission and the other Member States of changes to the notification under this Regulation as it considers relevant.

Restriction, Suspension or Withdrawal of Notification

28.

• (a) no longer meets the requirements laid down in Article 26 of the Directive, or

• (b) that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw notification, as it considers appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations.

• (2) The notifying authority shall immediately inform the European Commission and the other Member States of the matters referred to in paragraph (1).

• (3) The notifying authority shall—

• (a) give notice to the notified body advising the body of the restriction, suspension or withdrawal of a notification under paragraph (1) as soon as possible, and

• (b) advise the notified body concerned that it may make representations to the authority in respect of the restriction, suspension or withdrawal, as the case may be, of a notification.

• (4) Where—

• (a) a restriction, suspension or withdrawal of a notification is made, or

• (b) the notified body concerned has ceased its activity, the notifying authority shall take appropriate steps to ensure—

• (i) that the files of that notified body are processed by another notified body, or

• (ii) that those files are kept in a manner that will permit the notifying authority to have access to them for the performance by the authority of its functions under these Regulations.

Challenge of the Competence of Notified Bodies

29.

• (2) The notifying authority may give notice to the notified body concerned requesting the body to provide the authority with information or documents relating to or connected with the performance by the authority of its functions under paragraph (1).

• (3) A notified body shall comply with a notice referred to in paragraph (2).

Operational Obligations of Notified Bodies

30.

• (2) Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators.

• (3) A conformity assessment body shall perform its activities taking 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.

• (4) In performing its activities under paragraph (3), a conformity assessment body shall nevertheless respect the degree of rigour and the level of protection required to ensure the compliance of the radio equipment with the Directive and these Regulations.

• (5) Where a notified body finds that the essential requirements set out in Article 3 of the Directive or corresponding harmonised standards or other technical specifications have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue an EU-type examination certificate or a quality system approval.

• (6) Where, in the course of the monitoring of conformity following the issue of an EU-type examination certificate or a quality system approval, a notified body finds that radio equipment no longer complies, it shall give notice to the manufacturer requiring the manufacturer to take appropriate corrective measures and shall suspend or withdraw the EU-type examination certificate or the quality system approval if necessary.

• (7) Where corrective measures referred to in paragraph (6) are not taken or do not have the required effect, the notified body shall, having considered any representations made to it by the manufacturer, restrict, suspend or withdraw any EU-type examination certificate or quality system approval, as appropriate.

• (8) A notified body who has subcontracted specific tasks or has recourse to a subsidiary shall comply with Article 28 of the Directive.

Appeal of Decision under Part 5

31.

• (a) a manufacturer is aggrieved by a decision of a notified body under Regulation 30 which affects the manufacturer, or

• (b) a notified body is aggrieved by a decision of the notifying authority under Regulation 28 to restrict, suspend or withdraw its notification, the manufacturer, or as the case may be, notified body concerned may, within the period of 7 days beginning on the day on which the decision is taken or communicated to the manufacturer, or as the case may be, notified body, appeal to a judge of the District Court in the District Court District in which the manufacturer, or as the case may be, notified body, carries on business, against the decision and in determining the appeal the judge may—

• (i) affirm the decision with or without modification, or

• (ii) quash the decision.

• (2) The judge of the District Court determining the appeal under paragraph (1) may make such order as to the payment of costs of the appeal as he or she considers appropriate.

Information Obligation of Notified Bodies

32.

• (a) any refusal, restriction, suspension or withdrawal of an EU-type examination certificate or a quality system approval in accordance with the requirements of Annexes III and IV to the Directive,

• (b) any circumstances affecting the scope of or conditions for notification,

• (c) any request for information which it has received in a notice given by market surveillance authorities regarding conformity assessment activities, or

• (d) on receipt of a notice given by the notifying authority containing a request in that behalf, conformity assessment activities performed within the scope of the body’s notification and any other conformity assessment activity performed, including cross-border activities and subcontracting.

• (2) A notified body shall, in accordance with the requirements of Annexes III and IV to the Directive, provide other bodies notified under the Directive or these Regulations which perform conformity assessment activities of a similar nature in respect of radio equipment of the same class or categories with relevant information on matters relating to negative and, on request, positive conformity assessment results.

• (3) A notified body shall fulfil the information obligations under Annexes III and IV to the Directive.

Coordination of Notified Bodies

33.

• (2) A notified body shall participate in the work of a sectoral group under paragraph (1) either directly or by means of a designated representative.

• (3) A notified body shall, on receipt of a notice given by the notifying authority containing a request in that behalf, provide information to the notifying authority concerning compliance by the notified body with its obligations under this Regulation.

PART 6 UNION MARKET SURVEILLANCE, CONTROL OF RADIO EQUIPMENT ENTERING UNION MARKET AND SAFEGUARD PROCEDURE

Union Market Surveillance, Control of Radio Equipment Entering Union Market and Market Surveillance Authority

34.

• (2) For the purposes of Article 39 of the Directive and the application to radio equipment, of Articles 2(3), 10 - 14, 16 - 20, 22 - 28, 30 – 32 and 34 of Regulation (EU) 2019/1020 and Regulation (EC) No. 765/2008⁶ and Regulation (EU) 2023/988¹⁵ , the market surveillance authority shall—

• (a) without prejudice to its existing powers, for the purpose of its role as a market surveillance authority under any related enactment, have the powers set out in Article 14(4) of Regulation (EU) 2019/1020.

• (b) be the market surveillance authority, within the meaning of Article 10(2) of Regulation (EU) 2019/1020, in the State for the purposes of those Articles and in relation to that application,

• (c) perform the functions assigned to a market surveillance authority in those Articles of Regulation (EU) 2019/1020 and in relation to that application, and

• (d) perform the functions specified in Articles 19, 20 and 34(4) of Regulation (EU) 2019/1020 in relation to that application.

Procedure for Dealing with Radio Equipment Presenting a Risk at National Level

35.

• (a) all radio equipment from the final transition date; and

• (b) until the final transition date, all radio equipment except equipment referred to in Part I, point 1.13 of Annex Ia to the Directive

where the market surveillance authority has sufficient reason to believe that such radio equipment presents a risk to the health and safety of persons or to other aspects of protection of the public interest or does not comply with at least one of the applicable essential requirements, the authority shall, without delay, carry out an evaluation in relation to the radio equipment concerned in respect of all relevant requirements of these Regulations.

• (2) In respect of radio equipment referred to in Part I, point 1.13 of Annex Ia to the Directive, until the final transition date, where the market surveillance authority has sufficient reason to believe that such radio equipment presents a risk to the health or safety of persons or to other aspects of public interest protection covered by the Directive, the authority shall, without delay, shall carry out an evaluation in relation to the radio equipment concerned in respect of all relevant requirements of these Regulations.

• (3) The relevant economic operators shall co-operate as necessary with the market surveillance authority for the purpose of an evaluation carried out under paragraphs (1) or (2).

• (4) Where, in the course of carrying out the evaluation under paragraphs (1) or (2), the market surveillance authority finds that the radio equipment does not comply with the requirements of these Regulations, it shall give notice without delay to the economic operator concerned informing the operator of its finding.

• (5) Where, in the course of the evaluation under paragraphs (1) or (2) the market surveillance authority has reason to believe that action is required to prevent a risk to the health and safety of persons or protection of the public interest, it may, having regard to the nature of the risk, give a direction, giving the reasons for the direction, to the economic operator requiring the economic operator to, within such period specified in the direction as the market surveillance authority considers reasonable—

• (a) take all appropriate corrective action to bring the radio equipment into compliance with the requirements of these Regulations,

• (b) withdraw the radio equipment from the market or from service, or

• (c) recall the radio equipment.

• (6) The market surveillance authority shall give notice to the notified body which carried out the conformity assessment of the product informing the body of the giving of the direction under paragraph (5).

• (7) Where a direction is given under paragraph (5)—

• (a) Article 18 of Regulation (EU) 2019/1020 shall apply to the measures specified in the direction, and

• (b) the market surveillance authority shall ensure that any measure specified in that direction complies with Article 18 of Regulation (EU) 2019/1020 and without prejudice to the generality of the foregoing, for the purposes of making representations, the market surveillance authority shall have regard to the period specified in Article 18 of Regulation (EU) 2019/1020 in respect of the making of those representations.

• (8) Where the market surveillance authority considers that non-compliance is not restricted to the State, the authority shall inform the European Commission and the other Member States of the results of the evaluation and of the giving of the direction to take action.

• (9) The economic operator shall, within the time specified in the direction, comply with a direction given to the operator under paragraph (5).

Procedures Where Radio Equipment Continues to Present a Risk at National Level

36.

• (2) The provisional measures which the market surveillance authority may take under paragraph (1) are—

• (a) the prohibition or restriction of the radio equipment from being made available on the market,

• (b) the withdrawal of the radio equipment from the market in the State, or

• (c) the recall of the radio equipment from the market in the State.

• (3) Where the market surveillance authority takes a measure specified in paragraph (2)—

• (a) the authority shall give notice to the economic operator informing the operator of the measure concerned, and

• (b) paragraph (7) of Regulation 35 shall apply to a notice under this paragraph as it applies to a direction under Regulation 35 subject to any other necessary modifications.

• (4) An economic operator shall comply with a measure taken under paragraph (2) and a notice given under paragraph (3).

• (5) The market surveillance authority shall inform the European Commission and other Member States, without delay, of a measure which the authority has taken under paragraph (2).

• (6) The information provided under paragraph (5) shall—

• (a) include all available details,

• (b) without prejudice to the generality of subparagraph (a), include details of—

• (i) the data necessary for the identification of the non-compliant radio equipment,

• (ii) the origin of the radio equipment,

• (iii) the nature of the non-compliance alleged, and the risk involved,

• (iv) the nature and duration of the measure taken, and

• (v) the arguments put forward by the relevant economic operator,

and

• (c) indicate, in the information, whether the non-compliance is due to either—

• (i) the failure of the radio equipment to meet the relevant essential requirements or

• (ii) shortcomings in the harmonised standards referred to in Regulation 19 conferring a presumption of conformity.

• (7) Where another Member State initiates the procedure under Article 40 of the Directive—

• (a) the market surveillance authority shall without delay inform the European Commission and the other Member States of—

• (i) any measures adopted, and

• (ii) any additional information at the disposal of the market surveillance authority relating to the non-compliance of the radio equipment concerned,

and

• (b) where the market surveillance authority disagrees with the adopted national measure, the objections of the market surveillance authority.

• (8) Where, within 3 months of the market surveillance authority informing, under paragraph (5), the European Commission and other Member States of a provisional measure taken, no objection has been raised by the European Commission or a Member State in respect of the measure, the provisional measure shall be deemed to be justified.

Union Safeguard Procedure

37.

• (a) take the necessary measures to ensure that the non-compliant radio equipment is withdrawn or recalled from the market in the State, and

• (b) inform the European Commission accordingly.

• (2) Where, pursuant to Article 41 of the Directive a national measure taken by the market surveillance authority is considered to be unjustified, the market surveillance authority shall withdraw the measure.

Compliant Radio Equipment Presenting Risk

38.

• (a) to take all appropriate measures to ensure that the radio equipment concerned, when placed on the market, no longer presents that risk;