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

S.I. No. 248/2017 - European Union (Radio Equipment) Regulations 2017. Skip to content Disclaimer Feedback Helpdesk Gaeilge Léim go dtí an t-ábhar Séanadh Aiseolas Deasc chabhrach English Gaeilge Engl

Article 3of the Directive.

  1. The manufacturer shall establish the technical documentation in accordance with Article 21 of the Directive.
  2. 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

Article 3of the Directive.

4. (

  1. 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. (
  2. 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

Article 3of 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: (

  1. a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (
  2. b)a written declaration that the same application has not been lodged with any other notified body; (
  3. 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; (
  4. 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.
  1. 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
  2. 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.
  3. 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: (
  1. a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well; (
  2. b)the technical documentation for each radio equipment type intended to be manufactured. The technical documentation shall contain, wherever applicable, the elements set out in Schedule 5; (
  3. c)the documentation concerning the quality system; and (
  4. d)a written declaration that the same application has not been lodged with any other notified body.
(2)The quality system shall ensure compliance of the radio equipment with the requirements of 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: (
  1. a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality; (
  2. 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; (
  3. 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; (
  4. d)the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; (
  5. 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; (
  6. f)the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel, etc.; (
  7. 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: (
  1. a)the quality system documentation; (
  2. b)the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.; (
  3. c)the quality records as provided for by the manufacturing part of the 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.
  1. Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.
  2. 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: (
  1. a)a general description of the radio equipment including: (
  2. i)photographs or illustrations showing external features, marking and internal layout; (
  3. ii)versions of software or firmware affecting compliance with essential requirements; (iii) user information and installation instructions; (
  4. b)conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits and other relevant similar elements; (
  5. c)descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the radio equipment; (
  6. d)a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the

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; (

  1. e)copy of the EU declaration of conformity; (
  2. 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; (
  3. g)results of design calculations made, examinations carried out, and other relevant similar elements; (
  4. h)test reports; (
  5. 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: (
  1. a)Directive 2014/53/EU (
  2. 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 en

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