S.I. No. 248/2017 - European Union (Radio Equipment) Regulations 2017

Type Statutory Instrument
Publication 2017-06-09
Last updated 2026-01-23
State Repealed superseded text
Text As published
articles 48

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

2 amending acts · 2026-01-23, S.I. No. 14/2026 - European Union (Radio Equipment) Regulations 2026

Reform history JSON API
  • (a) if it appears to the Court that the respondent has placed the radio equipment on the market, an order requiring the respondent to withdraw the radio equipment from the market;
  • (b) if it appears to the Court that the respondent is proposing or continuing to place the radio equipment on the market, an order prohibiting the respondent from doing or continuing to do so.
  • (6) If the High Court makes an order under paragraph (5), it may make such ancillary orders as it considers appropriate.

Inspections and Surveillance

39.

39.

(1) The market surveillance authority shall carry out inspections of radio equipment to which these Regulations apply where appropriate—

  • (a) on its entry into the State (where the State is their place of entry into the Union), or
  • (b) at the storage or manufacturing site of such radio equipment.
  • (2) Without prejudice to the generality of paragraph (1), the market surveillance authority shall organise and perform appropriate surveillance of radio equipment made available on the market or put into service, taking due account of the presumption of the conformity of radio equipment bearing a CE marking, including the requirements arising from Regulation 30 and paragraph (6) of Regulation 31 and the performance of functions in respect of an Article of Regulation (EC) No. 765/2008 referred to in these Regulations.

Appointment of Authorised Officers

40.

40.

(1) The market surveillance authority may appoint such and so many members of staff of the authority, or other person whom the authority considers to be suitably qualified, to be authorised officers for the purpose of these Regulations and the Directive.

  • (2) An authorised officer shall be furnished with a certificate of his or her appointment and shall, when exercising a power conferred on him or her under these Regulations, if requested by a person affected, produce to the person the certificate or a copy of it.
  • (3) The market surveillance authority may terminate the appointment of an authorised officer appointed by the authority whether or not the appointment was for a fixed period.
  • (4) An appointment of an authorised officer ceases—
  • (a) if it is terminated under paragraph (3),
  • (b) if it is for a fixed period, on the expiry of that period, or
  • (c) if the person appointed is a member of staff of the market surveillance authority, upon the person ceasing to be such a member of staff.

Powers of Authorised Officers

41.

41.

(1) An authorised officer shall, for the purposes of all or any of these Regulations and of ensuring compliance with their requirements, have power to do any or all of the following:

  • (a) subject to paragraph (4) or (5), at all reasonable times enter and examine any place at which there are reasonable grounds to believe that radio equipment is being kept or has been manufactured, stored, distributed, supplied, placed on the market, made available on the market or put into service or that records relating to the radio equipment are kept, and search and inspect the place, any process being carried out and any radio equipment or records found at that place;
  • (b) secure for later inspection a place referred to in subparagraph (a) or part of that place, or radio equipment or records kept at that place and require that the place, part thereof, radio equipment or records or any other thing kept at that place as the authorised officer considers appropriate having regard to his or her functions is or are left undisturbed for so long as is reasonably necessary for the purpose of any search, examination, investigation, inspection or inquiry;
  • (c) require any person in charge of, or employed in, a place referred to in subparagraph (a) to produce to the authorised officer such books, documents or records (and in the case of such information in a non-legible form to reproduce it in a permanent legible form) that are in the person’s power, possession or control or to give to the authorised officer such information as the officer may reasonably require in relation to any entries in such records;
  • (d) inspect and take copies of or extracts from any such books, documents or records (including in the case of information in non-legible form a copy of or extract from such information in a permanent legible form) or require that such a copy be provided;
  • (e) require a person at a place referred to in subparagraph (a) by whom or on whose behalf a computer is or has been used to produce or store records or any person having control of, or otherwise concerned with the operation of the computer, to afford the authorised officer access thereto and such reasonable assistance as the authorised officer may require;
  • (f) remove and detain, where the officer has reasonable cause to suspect that there has been a contravention of these Regulations, radio equipment or records (including documents stored in a non-legible form) and any copies taken for such period as the authorised officer considers reasonably to be necessary for further examination or until the conclusion of any legal proceedings;
  • (g) require that records at a place referred to in subparagraph (a) be maintained for such period as the authorised officer considers reasonably to be necessary;
  • (h) require any person to give the authorised officer such information in relation to radio equipment or part thereof or any article or substance or process used in the manufacture of radio equipment as the authorised officer may reasonably require for the purposes of any search, examination, investigation, inspection or inquiry under these Regulations;
  • (i) require by notice, at a time and place specified in the notice, any person (including the person in charge) to give the authorised officer any information that the authorised officer may reasonably require in relation to such place, any radio equipment or part of the place, activity, installation or procedure at such place, and to produce to the authorised officer any records that are in that person’s power, possession or control;
  • (j) examine any person whom the authorised officer reasonably believes to be able to give to the authorised officer information relevant to any search, examination, investigation, inspection or inquiry under these Regulations and require the person to answer such questions as the authorised officer may ask relative to the search, examination, investigation, inspection or inquiry and to sign a declaration of the truth of the answers;
  • (k) where appropriate, install, use and maintain at a place referred to in subparagraph (a) monitoring instruments or systems or take any measurements or photographs or make any tape, electronic or other recordings that the authorised officer considers necessary for the purposes of any search, examination, investigation, inspection or inquiry under these Regulations;
  • (l) as regards any radio equipment or any article or substance used in the manufacture of radio equipment the authorised officer finds at a place referred to in subparagraph (a), require any person in charge of the place, or any person who appears to the authorised officer to be in possession of the radio equipment or the article or substance, to supply without charge or payment, for test, examination or analysis sufficient samples thereof;
  • (m) take possession of and detain any radio equipment or part thereof or any article or substance used in the manufacture of radio equipment kept at a place referred to in subparagraph (a) which appears to the authorised officer to be in contravention of these Regulations for so long as is necessary for all or any of the following purposes, namely:
  • (i) to examine or arrange for the examination, testing or analysis of it under subparagraph (o);
  • (ii) to ensure that it is not tampered with before the examination, testing or analysis of it is completed;
  • (iii) to ensure that it is available for use as evidence in any proceedings;
  • (n) cause any radio equipment or part thereof or any article or substance used in the manufacture of radio equipment found at a place referred to in subparagraph (a) which appears to the authorised officer to be in contravention of these Regulations to be dismantled or subjected to any process, test or analysis (but not so as to damage or destroy it unless this is in the circumstances necessary for the purposes of these Regulations) and where an authorised officer proposes to exercise this power in the case of radio equipment or an article or substance used in the manufacture of radio equipment found at a place referred to in subparagraph (a), the authorised officer shall, if so requested by a person who at the time is present at or in, and has responsibilities in relation to, that place, and if it is practicable and safe to do so, cause anything which is to be done by virtue of that power to be done in the presence of that person;
  • (o) require any person to afford the authorised officer such facilities and assistance within the person’s power, control or responsibilities as are reasonably necessary to enable the authorised officer to exercise any of the powers conferred on him or her by these Regulations.
  • (2) Before exercising the power conferred by subparagraph (m) or (n) of paragraph (1) in respect of any radio equipment, article or substance, an authorised officer shall, in so far as it is reasonably practicable to do so, consult such persons as appear to him or her to be appropriate for the purpose of ascertaining what dangers, if any, there may be in doing anything which he or she proposes to do under that power.
  • (3) Where, under the power conferred by subparagraph (m) or (n) of paragraph (1) an authorised officer takes possession of any radio equipment, article or substance found at or in any place, the authorised officer shall, if it is practicable for him or her to do so, take a sample thereof and give to a responsible person at the place a portion of the sample marked by the authorised officer in a manner sufficient to identify it.
  • (4) An authorised officer shall not, other than with the consent of the occupier, enter a private dwelling unless he or she has obtained a warrant from the District Court under Regulation 42 authorising such entry.
  • (5) Where an authorised officer in the exercise of his or her powers under this Regulation is prevented from entering any place, an application may be made to the District Court under Regulation 42 for a warrant authorising such entry.
  • (6) A statement or admission made by a person pursuant to a requirement under subparagraph (h), (i) or (j) of paragraph (1) shall not be admissible in proceedings brought against that person for an offence (other than an offence under paragraph (2) of Regulation 44).
  • (7) Where any measure has been taken or notice given by the market surveillance authority under this Regulation or Regulation 32, 33, or 35, the costs of any removal, detention, seizure, destruction, rendering inoperable or disposal for the purposes of these Regulations may be charged to the economic operator, the manager of the place where the product was found or the private importer, where known.

(8)(a) In this Regulation “place” means any structure, premises, land or other location or part thereof and includes any container, railway wagon, vessel, aircraft or other vehicle.

  • (b) In this Regulation—

“person in charge” means, in relation to a place—

  • (i) the person under whose direction and control the activities at that place are being conducted, or
  • (ii) the person whom the authorised officer has reasonable grounds for believing is in control of that place.
  • (c) In this Regulation—

“record” includes any memorandum, book, report, statement, register, plan, chart, map, drawing, specification, diagram, pictorial or graphic work or other document, any photograph, film or recording (whether of sound or images or both), any form in which data (within the meaning of the Data Protection Acts 1988 and 2003) are held, any form (including machine-readable form) or thing in which information is held or stored manually, mechanically or electronically, and anything that is a part or copy, in any form, of any of, or any combination of, the foregoing.

Search Warrant

42.

42.

(1) Without prejudice to the powers conferred on an authorised officer by any provision of these Regulations, an authorised officer may, for the purposes of an investigation into an offence under these Regulation, apply to a judge of the District Court for a warrant in relation to any place.

  • (2) Where, on the hearing of an application under paragraph (5) of Regulation 42 or paragraph (1), a judge of the District Court is satisfied on sworn information of the authorised officer that he or she—
  • (a) has been prevented from entering any place that is not a private dwelling,
  • (b) has reasonable grounds for believing that relevant records are kept at a place that comprises, of forms part of, a private dwelling, or
  • (c) has reasonable grounds for suspecting that evidence of, or relating to the commission of an offence under these Regulations is to be found in any place,

that judge may issue to the authorised officer a warrant under this Regulation authorising one or more than one authorised officer accompanied, if the judge considers it appropriate to so provide, by such number of members of te Garda Síochána as may be specified in the warrant, at any time within 4 weeks from the date of issue of the warrant, to enter, if necessary by force, the place or private dwelling and exercise any of the powers referred to in Regulation 42.

  • (3) An application under paragraph (1) in the case of a place shall be made to the judge of the District Court in whose District Court district the place is situated.
  • (4) In this Regulation “place” has the meaning assigned to it by Regulation 41(8)(a).

PART 8 MISCELLANEOUS

Giving of Direction, Notice or Other Document

43.

43.

(1) Subject to paragraphs (2) and (3), a direction, notice or other document that is required to be given to a person by these Regulations shall be addressed to the person concerned by name and may be given to the person in one of the following ways:

  • (a) by delivering it to the person;
  • (b) by leaving it at the address at which the person carries on business or ordinarily resides or, in the case in which an address for service has been furnished, at that address;
  • (c) by sending it by post in a prepaid registered letter to the address at which the person carries on business or ordinarily resides or, in a case in which an address for service has been furnished, to that address;
  • (d) where there is a facility for receiving the text of the notice by electronic means at the address at which the person carries on business or ordinarily resides, by transmitting the text of the notice by such means to such address, provided that the notice is also delivered in any of the other ways referred to in this paragraph;
  • (e) if the address at which the person ordinarily resides cannot be ascertained by reasonable inquiry and the notice relates to a premises, by delivering to the premises or by affixing it in a conspicuous position on or near the premises.
  • (2) Where a direction is to be given to a person who is the owner or occupier of land or property and the name of the person cannot be ascertained by reasonable inquiry, it may be addressed to the person by using the words “the owner” or, as the case may require, “the occupier”.
  • (3) For the purposes of this Regulation, a company within the meaning of the Companies Act 2014 or an existing company within the meaning of that Act shall be deemed to be ordinarily resident at its registered office, and every other body corporate and every unincorporated body shall be deemed to be ordinarily resident at its principal office or place of business.
  • (4) Where an opinion, finding, statement or decision of the competent authority or market surveillance authority is contained in a document which—
  • (a) purports to have been made by or at the direction of the competent authority or market surveillance authority, as the case may be, and
  • (b) is produced in evidence by an officer of the competent authority or market surveillance authority, as the case may be, or by an authorised officer in any proceedings,

such document shall be admissible in evidence and shall be evidence of any such opinion, finding, statement or decision in such proceedings without further proof.

Offences and Penalties

44.

44.

(1) A person who contravenes or fails to comply with any of the following shall be guilty of an offence:

  • (a) paragraph (2) or (3) of Regulation 4;
  • (b) subparagraph (a), (b) or (c) of Regulation 5 (3);
  • (c) Regulation 9;
  • (d) paragraph (2) of Regulation 10;
  • (e) Regulation 11, 12, 14, 16, or 17;
  • (f) paragraph (1), (3) or (4) of Regulation 18;
  • (g) paragraph (2) or (5) of Regulation 19;
  • (h) paragraph (6) of Regulation 23;
  • (i) paragraph (3) of Regulation 25;
  • (j) paragraph (1), (5), (6) or (7) of Regulation 26;
  • (j) Regulation 28;
  • (k) paragraph (2) or (8) of Regulation 31;
  • (l) paragraph (4) of Regulation 32;
  • (m) paragraph (2) or (5) of Regulation 35;
  • (n) paragraph (2) of Regulation 34.
  • (2) A person shall be guilty of an offence who—
  • (a) obstructs or impedes an authorised officer in the exercise of his or her powers under these Regulations,
  • (b) refuses to produce any radio equipment, article, substance, book, record or other document or to answer any question that an authorised officer lawfully requires him or her to produce or to answer,
  • (c) produces or causes to be produced any book, record or other document to an authorised officer which is false or misleading in any material respect knowing it to be so false or misleading, or
  • (d) gives to an authorised officer any information, which is false or misleading in any material respect knowing it to be so false or misleading.
  • (3) A person who falsely represents himself or herself to be an authorised officer shall be guilty of an offence.
  • (4) A person guilty of an offence under this Regulation shall be liable on summary conviction to a class A fine.
  • (5) Summary proceedings for an offence under this Regulation may be brought and prosecuted by the market surveillance authority.
  • (6) Where an offence under these Regulations is committed by a body corporate and is proved to have been so committed with the consent or connivance of or to be attributable to any neglect on the part of any person, being a director, manager, secretary, or other officer of the body corporate, or a person who was purporting to act in such capacity, that person shall, as well as the body corporate, be guilty of an offence and shall be liable to be proceeded against and punished as if he or she were guilty of the first-mentioned offence.
  • (7) Where the affairs of a body corporate are managed by its members, paragraph (6) applies in relation to the acts and defaults of a member in connection with his or her functions of management as if he or she were a director or manager of the body corporate.
  • (8) In this Regulation “record” has the meaning assigned to it by Regulation 41 (8) (c).

Review and Reporting

45.

45.

(1) The market surveillance authority shall submit to the European Commission regular reports on the application of the Directive by 12 June 2017 and at least every two years thereafter.

  • (2) The reports prepared and submitted in accordance with paragraph (1) shall contain a presentation of the market surveillance activities performed by the market surveillance authority and provide information on whether and to what extent compliance with the requirements of the Directive has been attained, including in particular requirements on identification of economic operators.

Application of the Wireless Telegraphy Act, 1926

46.

46.

(1) Notwithstanding section 3 (1) of the Wireless Telegraphy Act, 1926 , a person shall not be required to hold a licence under that Act to keep or have in his or her possession any apparatus for wireless telegraphy solely for the purpose of placing that apparatus on the market, within the meaning of the Directive.

  • (2) Nothing in the Wireless Telegraphy Acts, 1926 to 1988, shall operate to restrict or prevent any person from working or using an apparatus for wireless telegraphy, which is lawfully in their possession, or which is otherwise in compliance with the licensing requirements of those Acts for its intended purpose where it complies with the provisions of the Directive, save where such restriction or prevention is related to the effective and appropriate use of the radio frequency spectrum, avoidance of harmful interference or matters relating to public health.

Revocation

47.

47.

The Regulations of 2001 are revoked.

Transitional Provisions and Continuation of Regulations of 2001

48.

48.

(1) A person may, before 13 June 2017, place on the market or put into service radio equipment to which the Regulations of 2001 apply.

  • (2) A person may, at any time, make available on the market radio equipment referred to in paragraph (1).
  • (3) Notwithstanding their revocation under Regulation 47, the Regulations of 2001 shall continue to apply to a product specified in the Regulations of 2001 which is—
  • (a) placed on the market or put into service in accordance with paragraph (1), or
  • (b) made available on the market in accordance with paragraph (2).
  • (4) A person who, immediately before the coming into operation of these Regulations, was an authorised officer under the Regulations of 2001 shall be deemed to be an authorised officer appointed under these Regulations and, accordingly, paragraph (4) of Regulation 41 shall apply in respect of that person.

SCHEDULE 1 Equipment to Which These Regulations Do Not Apply

1.

Radio equipment used by radio amateurs within the meaning of Article 1, definition 56, of the International Telecommunications Union (ITU) Radio Regulations, unless the equipment is made available on the market.

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

  • (a) radio kits for assembly and use by radio amateurs;
  • (b) radio equipment modified by and for the use of radio amateurs;
  • (c) equipment constructed by individual radio amateurs for experimental and scientific purposes related to amateur radio.
2.

Marine equipment falling within the scope of Council Directive the European Union (Marine Equipment) Regulations 2014 ( S.I. No. 540 of 2014 ). Airborne products, parts and appliances falling within the scope of Article 3 of Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC.

3.

Custom-built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.

SCHEDULE 2 Conformity Assessment Module A

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 Article 3 of the Directive.

2.

The manufacturer shall establish the technical documentation in accordance with Article 21 of the Directive.

3.

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 Article 3 of the Directive.

4.

(a) The manufacturer shall affix the CE marking in accordance with Articles 19 and 20 of the Directive to each item of radio equipment that satisfies the applicable requirements of the Directive.

  • (b) 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 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 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.

5.

The manufacturers obligations set out in point 4 of this Schedule may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

SCHEDULE 3 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 Article 3 of the Directive.

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 of this Module B Schedule, without examination of a specimen (design type).

3.

The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice.

The application shall include:

  • (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
  • (b) a written declaration that the same application has not been lodged with any other notified body;
  • (c) the technical documentation. The technical documentation shall make it possible to assess the radio equipments conformity with the applicable requirements of the Directive 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 5;
  • (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 of this Schedule and their outcomes. Without prejudice to its obligations as provided in point 8 of this Module B Schedule, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

6.

Where the type meets the requirements of this Directive that apply to the radio equipment concerned, the notified body shall issue an EU-type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the aspects of the essential requirements covered by the examination, the conditions (if any) for its validity and the necessary data for identification of the assessed type. The EU-type examination certificate may have one or more annexes attached.

The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured radio equipment with the examined type to be evaluated and to allow for in-service control.

Where the type does not satisfy the applicable requirements of the Directive, 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.

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 the Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

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 the Directive 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.

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.

Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.

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 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 manufacturers authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9 of this Module B Schedule, 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 of this Module C Schedule, 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 the Directive that apply to it.

2.

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 the Directive that apply to it.

3.

(1) The manufacturer shall affix the CE marking in accordance with Articles 19 and 20 of the Directive 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 the Directive.

  • (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.

4.

The manufacturers obligations set out in point 3 of this Module C Schedule may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

SCHEDULE 4 Conformity Assessment Module

MODULE H

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 of this Schedule, and ensures and declares on his sole responsibility that the radio equipment concerned satisfies the requirements of the Directive that apply to it.

2.

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 of this Schedule and shall be subject to surveillance as specified in point 4 of this Schedule.

3.

(1) The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the radio equipment concerned.

The application shall include:

  • (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
  • (b) the technical documentation for each radio equipment type intended to be manufactured. The technical documentation shall contain, wherever applicable, the elements set out in Schedule 5;
  • (c) the documentation concerning the quality system; and
  • (d) a written declaration that the same application has not been lodged with any other notified body.
  • (2) The quality system shall ensure compliance of the radio equipment with the requirements of the Directive 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:

  • (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality;
  • (b) 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 this Directive that apply to the radio equipment will be met;
  • (c) 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;
  • (d) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
  • (e) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;
  • (f) the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel, etc.;
  • (g) the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.
  • (3) The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3(2) of this Schedule.

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.

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 the Directive. The audit shall include an assessment visit to the manufacturers premises. The auditing team shall review the technical documentation referred to in point 3(1)(b) of this Schedule to verify the manufacturers ability to identify the applicable requirements of the Directive and to carry out the necessary examinations with a view to ensuring compliance of the radio equipment with those requirements.

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.

  • (4) 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.
  • (5) 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) of this Schedule or whether a reassessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

4.

(1) The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

  • (2) The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
  • (a) the quality system documentation;
  • (b) the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.;
  • (c) the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel, etc.
  • (3) The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.
  • (4) In addition, the notified body may pay unexpected visits to the manufacturer. During such visits, the notified body may, if necessary, carry out radio equipment tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
5.

(1) The manufacturer shall affix the CE marking in accordance with Articles 19 and 20 of the Directive and, under the responsibility of the notified body referred to in point 3(1) if this Schedule, the latters identification number to each item of radio equipment that satisfies the applicable requirements set out in Article 3 of the Directive.

  • (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.

(1) 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) of this Schedule;
  • (b) the documentation concerning the quality system referred to in point 3(1) of this Schedule;
  • (c) the change referred to in point 3(5), as approved;
  • (d) the decisions and reports of the notified body referred to in points 3(5), 4(3) and 4(4) of this Schedule.
7.

Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.

8.

The manufacturers obligations set out in points 3(1), 3(5), 5 and 6 of this Schedule may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

SCHEDULE 5 Contents of Technical Documentation

The technical documentation shall, wherever applicable, contain at least the following elements:

  • (a) a general description of the radio equipment including:
  • (i) photographs or illustrations showing external features, marking and internal layout;
  • (ii) versions of software or firmware affecting compliance with essential requirements;
  • (iii) user information and installation instructions;
  • (b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits and other relevant similar elements;
  • (c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the radio equipment;
  • (d) a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements set out in Article 3 of the Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;
  • (e) copy of the EU declaration of conformity;
  • (f) where the conformity assessment module in Schedule 3 has been applied, copy of the EU-type examination certificate and its annexes as delivered by the notified body involved;
  • (g) results of design calculations made, examinations carried out, and other relevant similar elements;
  • (h) test reports;
  • (i) an explanation of the compliance with the requirement of Article 10(2) of the Directive and of the inclusion or not of information on the packaging in accordance with Article 10(10) of the Directive.

SCHEDULE 6 EU Declaration of Conformity (No. )

1.

Radio equipment (product, type, batch or serial number):

2.

Name and address of the manufacturer or his authorised representative:

3.

This declaration of conformity is issued under the sole responsibility of the manufacturer.

4.

Object of the declaration (identification of the radio equipment allowing traceability; it may include a colour image of sufficient clarity where necessary for the identification of the radio equipment):

5.

The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:

  • (a) Directive 2014/53/EU
  • (b) 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):

SCHEDULE 7 Simplified EU Declaration of Conformity

The simplified EU declaration of conformity referred to in Article 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:

SCHEDULE 8 Minimum Criteria for Notification as a Notified Body in the State

1.

A conformity assessment body shall be a third-party body independent of the organisation or the product it assesses. 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 it can demonstrate independence and the absence of any conflict of interest, be considered such a body.

2.

A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or person undertaking maintenance 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 is necessary for the operations of the conformity assessment body or the use of such radio equipment for personal purposes.

3.

A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture, marketing, installation, use or maintenance of that 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 also apply to consultancy services provided by the conformity assessment body.

4.

A conformity assessment body shall ensure that the activities of a subsidiary of the body or a subcontractor undertaking activities under the responsibility of the body, if any, do not affect the confidentiality, objectivity or impartiality of its conformity assessment activities.

5.

A conformity assessment body and its personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, including financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.

6.

A conformity assessment body shall be capable of carrying out the conformity assessment tasks required of it under Schedule 3 or 4, and in relation to which it has been notified under Part 5, whether those tasks are carried out by the conformity assessment body itself or on its behalf or under its responsibility.

7.

A conformity assessment body shall have at its disposal, at all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified, the necessary—

  • (a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks, and
  • (b) descriptions of procedures in accordance with which conformity assessment is carried out ensuring the transparency and ability of reproduction of those procedures.
8.

A conformity assessment body shall have appropriate policies and procedures in place that distinguish between the tasks carried out as a notified body and other activities.

9.

A conformity assessment body shall have at its disposal, 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, the necessary 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 technology of the radio equipment in question and the mass or serial nature of the production process.

10.

A conformity assessment body shall 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.

11.

The personnel responsible for carrying out the conformity assessment activities shall have—

  • (a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified,
  • (b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments,
  • (c) appropriate knowledge and understanding of the essential requirements, the applicable harmonised standards, the relevant Union harmonisation legislation and enactments within the meaning of section 2 of the Interpretation Act, implementing those requirements, and
  • (d) the ability to draw up EU-type certificates, or quality system approvals, records and reports demonstrating that assessments have been carried out.
12.

A conformity assessment body shall ensure that it is impartial and shall ensure the impartiality of its top level management and assessment personnel. The remuneration of the top level management and assessment personnel of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.

13.

A conformity assessment body shall take out a contract of, or make another arrangement in respect of, insurance against liability for damages or costs that may be incurred in respect of any act done or omitted to be done in the performance or purported performance of conformity assessment activities by it.

14.

The personnel of a conformity assessment body shall be bound to observe professional secrecy with regard to all information obtained in carrying out tasks required of it under Schedule 3 or 4, and in relation to which it has been notified under Part 5, except as regards information provided to the competent authority or the competent authorities of other Member States in which it carries out its activities and proprietary rights shall be protected.

15.

A conformity assessment body shall participate in, or ensure that their assessment personnel are informed of, the relevant standardisation activities, the regulatory activities in the area of radio equipment and frequency planning, and the activities of any notified body coordination group established by the Commission under the relevant harmonisation legislation and shall apply, as general guidance, the administrative decisions and documents produced as a result of the work of that group.

16.

Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for the purpose of carrying out conformity assessment tasks, it shall ensure that the subcontractor or the subsidiary, as the case may be, meets the requirements specified in paragraphs 1 to 15, and shall inform the notifying authority accordingly.

17.

A notified body shall take full responsibility for the tasks connected with conformity assessment performed by a subcontractor or a subsidiary, as the case may be, wherever such a subcontractor or subsidiary is established.

18.

Conformity assessment activities may be subcontracted to a subcontractor or carried out by a subsidiary only with the agreement of the client of the notified body.

19.

A notified body shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of a subcontractor or a subsidiary and the work carried out by such entity under Regulations 19 to 24.

GIVEN under my official Seal,

6 June 2017.

DENIS NAUGHTEN,

Minister for Communications, Climate Action and Environment.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to a legal interpretation.)

The purpose of these Regulations is to give legal effect to Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and of giving full effect to Regulation (EC) No 765/2008 of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products.

Footnotes

1

OJ No. L153, 22.5.2014, p. 62

2

OJ No. L218, 13.8.2008, p 30

3

OJ No. L96, 29.3.2014, p.79

4

OJ No. L316, 14.11.2012, p. 12

6

O.J. No. L108,24.2.2002 p. 1

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