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

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 9th June, 2017.

I, DENIS NAUGHTEN Minister for Communications, Climate Action and Environment, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972), and for the purpose of giving effect to Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014¹ , and of giving full effect to Regulation (EC) No 765/2008 of 9 July 2008² 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 765/20082;

“authorised officer” means a person appointed under Regulation 40;

“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 6;

“conformity assessment” means the process, in accordance with Regulation 16, demonstrating whether the essential requirements have been fulfilled;

“conformity assessment body” means a person who performs conformity assessment procedures laid down in Schedule 2, 3 or 4;

“Directive” means Directive 2014/53/EU of the European Parliament and of the Council of 16 April 20141;

“direction” means a direction given by the market surveillance authority under Regulation 5(3)(b), 31(4), 34(1), or 35(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 or a distributor;

“electromagnetic disturbance” has the meaning assigned to it by Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014³ 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 specified in Regulation 4(1);

“EU declaration of conformity” means a declaration of conformity drawn up in accordance with the requirements of Regulation 17;

“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 1025/2012⁴ ;

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

“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 30;

“Minister” means Minister for Communications, Climate Action and Environment;

“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 23, 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 20;

“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;

“radiodetermination” 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 (gigaherz) 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 );

“technical documentation” in relation to radio equipment, means technical documentation drawn up in accordance with Regulation 19;

“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 the Directive has, unless the contrary intention appears, the same meaning in these Regulations as it has in the Directive.

PART 2 SCOPE AND APPLICATION

Application

3.

• (2) These Regulations shall not apply to radio equipment used exclusively by the 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 ) shall not apply to radio equipment to which these Regulations apply.

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

4.

• (a) to protect the health and safety of persons and domestic animals and to protect property and so to comply (other than in relation to voltage limits) with the safety requirements of the European Union (Low Voltage Electrical Equipment) Regulations 2016;

• (b) to have an adequate level of electromagnetic compatibility in compliance with the European Communities (Electromagnetic Compatibility) Regulations 2017 ( S.I. No. 69 of 2017 );

• (c) to both effectively use, and support the efficient use of, radio spectrum in a manner that avoids harmful interference.

• (2) A person shall make available on the market radio equipment only if it complies with these Regulations.

• (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.

Free Movement

5.

• (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

6.

Additional Requirements for Putting into Service and Use

7.

• (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

8.

• (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/EC⁶ ;

• (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 Manufacturers

9.

• (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 which shall—

• (i) be clear 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),

• (i) ensure that the radio equipment is accompanied by a copy of the EU declaration of conformity or, in accordance with Regulation 17(3), 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) 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 non-conforming 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

10.

• (2) Subject to paragraph (3), an authorised representative shall only 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 9(1) or subparagraph (a), (b) or (c) of Regulation 9(2).

• (4) The mandate shall permit the authorised representative to perform the following tasks in respect of radio equipment placed on the market by the manufacturer which shall include, but are not limited to:

• (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 representatives mandate.

Obligations of Importers

11.

• (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 16,

• (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 9(2),

• (f) the manufacturer has complied with subparagraphs (d), (f) and (j) of Regulation 9(2),

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

• (h) the importers name, registered trade name or registered trade mark 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 non-conforming 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

12.

• (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 9(1), subparagraphs (d), (f), (g), (h), (i) and (j) of Regulation 9(2) and subparagraphs (h) and (i) of Regulation 11(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

13.

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

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

• (a) a reference in Regulation 9 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

14.

• (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

15.

Conformity Assessment Procedures

16.

• (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 using any of the following conformity assessment procedures:

• (a) Module A (internal production control) set out in Schedule 2;

• (b) Module B (EU-type examination), followed by Module C (conformity to type based on internal production control) set out in Schedule 3;

• (c) Module H (conformity based on full quality assurance) set out in Schedule 4.

• (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 subparagraph (c) of Regulation 4 (1) 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 subparagraph (c) of Regulation 4 (1), shall use the procedures referred to in subparagraph (b) or (c) of paragraph (4).

EU Declaration of Conformity

17.

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

• (b) has the model structure set out in Schedule 6,

• (c) contains the elements set out in Schedule 6,

• (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 Schedule 7,

• (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

18.

• (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 Schedule 4 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.

• (11) A person who affixes a CE marking to radio equipment which is not in conformity with the requirements of these Regulations shall be guilty of an offence.

Technical Documentation

19.

• (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 Schedule 5.

• (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

20.

• (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 paragraphs 16, 17, 18 and 19 of Schedule 8.

• (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

21.

• (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,

in relation to which the conformity assessment body claims to have the competence to perform conformity assessment in accordance with these Regulations and relevant harmonised standards, 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 paragraphs 1 to 16 of Schedule 8 for the purposes of a notification.

• (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 documentation attesting that the conformity assessment body meets the requirements specified in paragraphs 1 to 15 of Schedule 8.

• (4) For the purposes of an application under paragraph (1), the certificate of accreditation referred to in paragraph (3) (a) may be issued by the national accreditation body.

• (5) 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

22.

Notification Procedure

23.

• (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 referred to in Regulation 21(3) (a), the notifying authority shall provide the European Commission and the other Member States with documentary evidence which attests to the conformity assessment bodys 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 paragraphs 1 to 15 of Schedule 8.

• (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 a body which meets the criteria set out in paragraphs (1) to (5) shall be considered a notified body for the purposes of these Regulations.

• (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

24.

• (a) no longer meets the requirements specified in paragraphs 1 to 15 of Schedule 8, or

• (b) that it is failing to fulfil its obligations under these Regulations, 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

25.

• (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

26.

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

• (3) A notified 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 notified body shall respect the degree of rigour and the level of protection required to ensure the compliance of the radio equipment with these Regulations.

• (5) Where a notified body finds that the essential requirements 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 is no longer in compliance, 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 paragraphs 17, 18, 19 and 20 of Schedule 8.

Appeal against decision of notified body

Appeal of Decision under Part 5

27.

• (a) a manufacturer is aggrieved by a decision of a notified body under Regulation 26 which affects the manufacturer, or

• (b) a notified body is aggrieved by a decision of the notifying authority under Regulation 24 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

28.

• (a) any refusal, restriction, suspension or withdrawal of an EU-type examination certificate or a quality system approval in accordance with the requirements of Schedules 3 and 4,

• (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 the market surveillance authority or a market surveillance authority of a Member State other than the State 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 Schedules 3 and 4, 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 provide information required under Schedules 3 and 4.

Coordination of Notified Bodies

29.

• (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

30.

• (2) For the purposes of Article 39 of the Directive and the application to radio equipment, of Articles 15(3) and 16 to 29 of Regulation (EC) No. 765/2008, the market surveillance authority shall—

• (a) be the market surveillance authority, within the meaning of Regulation (EC) No. 765/2008, in the State for the purposes of those Articles and in relation to that application,

• (b) perform the functions assigned to a market surveillance authority in those Articles of Regulation (EC) No. 765/2008 and in relation to that application, and

• (c) perform the functions specified in Articles 20, 22 and 23(2) of Regulation (EC) No. 765/2008 in relation to that application.

• (3) Without prejudice to paragraph (2)(b), for the purposes of Article 19 of Regulation (EC) No. 765/2008, where, pursuant to that Article, the market surveillance authority considers it is necessary to do so, the market surveillance authority may destroy or otherwise render inoperable radio equipment presenting a serious risk referred to in that Article.

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

31.

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

• (3) Where, in the course of carrying out the evaluation under paragraph (1), 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.

• (4) Where, in the course of the evaluation under paragraph (1) 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.

• (5) 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 (4).

• (6) Where a direction is given under paragraph (4)—

• (a) without prejudice to Regulation 36, Article 21 of Regulation (EC) No. 765/2008 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 21 of Regulation (EC) No. 765/2008 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 21 of Regulation (EC) No. 765/2008 in respect of the making of those representations.

• (7) 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.

• (8) The economic operator shall, within the time specified in the direction, comply with a direction given to the operator under paragraph (4).

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

32.

• (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 (6) of Regulation 31 shall apply to a notice under this paragraph as it applies to a direction under Regulation 31 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 15 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

33.

• (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 of a Member State other than the State is considered to be unjustified, the market surveillance authority shall withdraw the measure.

Compliant Radio Equipment Presenting Risk

34.

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

• (b) to withdraw the radio equipment from the market in the State;

• (c) to recall the radio equipment from the market in the State;

• (d) to do or refrain from doing anything in order to comply with these Regulations and the Directive.

• (2) The economic operator shall, within the time specified in the direction, comply with a direction given to the operator under paragraph (1).

• (3) The market surveillance authority shall give notice to the European Commission and the other Member States of a direction given under paragraph (1) which shall include all available details, in particular—

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

• (b) the origin and supply chain of the radio equipment,

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

• (d) the nature and duration of the national measures taken.

Formal Non-Compliance

35.

• (b) The findings referred to in paragraph (a) are:

• (i) the CE marking has been affixed in violation of—

• (I) Article 30 of Regulation (EC) No. 765/2008, or

• (II) Regulation 18;

• (ii) the CE marking has not been affixed;

• (iii) the identification number of the notified body, where the conformity assessment procedure set out in Schedule 4 is applied, has been affixed in contravention of Regulation 18 or has not been affixed;

• (iv) the EU declaration of conformity has not been drawn up;

• (v) the EU declaration of conformity has not been drawn up correctly;

• (vi) the technical documentation is either not available or not complete;

• (vii) the information referred to in subparagraphs (d) and (f) of Regulation 9(2) or subparagraph (h) of Regulation 11(2) is absent, false or incomplete;

• (viii) information on the intended use of radio equipment, the EU declaration of conformity or usage restrictions as set out in subparagraphs (g), (h) and (i) of Regulation 9(2) does not accompany the radio equipment;

• (ix) an economic operator has not complied with Regulation 14.

• (2) The economic operator shall, within the time specified in the direction, comply with a direction given to the operator under paragraph (1).

• (3) Where the relevant economic operator does not take adequate corrective action within the period specified in a direction given under paragraph (1) the market surveillance authority may, in respect of the non-compliance, take all appropriate measures to—

• (a) restrict or prohibit the radio equipment from being made available on the market,

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

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

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

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

• (b) paragraph (6) of Regulation 31 shall apply to a notice under this paragraph as it applies to a direction under Regulation 31 subject to any other necessary modifications.

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

PART 7 ENFORCEMENT

Directions

36.

• (2) A direction under paragraph (1) may be given to one or more than one economic operator to whom the notice relates.

• (3) A direction under paragraph (1) shall—

• (a) state the reason for the opinion referred to in paragraph (1),

• (b) identify the provision of these Regulations in respect of which the opinion is held,

• (c) specify the action to be taken in respect of the radio equipment by the person to whom the direction is given and the period specified in the direction within which the action shall be taken,

• (d) inform the person of the requirement to confirm compliance with the direction in accordance with paragraph (9),

• (e) inform the person of the right to appeal the direction under Regulation 37,

• (f) include an address for service of an appeal,

• (g) be signed and dated by the market surveillance authority, and

• (h) state that if the person to whom it is given fails to comply with the direction the person shall be guilty of an offence and liable on conviction to the penalty referred to in paragraph (15).

• (4) A direction may require that the action required be undertaken—

• (a) immediately because of the urgency of the matter,

• (b) from a specified date,

• (c) by a specified date, or

• (d) between specified dates.

• (5) A direction may include—

• (a) the action to be taken to bring radio equipment into compliance with the requirements of these Regulations,

• (b) a requirement to bring to the attention of any person who may be affected by the non-compliance or to the notice of the public generally.

• (6) A person to whom a direction has been given may appeal the direction under Regulation 37.

• (7) Where, in the opinion of the market surveillance authority—

• (a) urgent action is required which is justified in particular by public health or safety requirements, and

• (b) it is necessary because of the gravity of the non-compliance with the requirements of these Regulations, to immediately give the person a direction,

the authority may, notwithstanding paragraphs (1) and (2), give the person a direction.

• (8) Where paragraph (7) applies, the market surveillance authority shall give the person to whom the direction is given the opportunity to make representations to it in writing as soon as may be after the giving of the direction.

• (9) As soon as practicable after complying, and in any case not later than 7 days after the date specified in the direction by which it is to be complied with, a person to whom a direction has been given shall notify the market surveillance authority in writing that the direction has been complied with.

• (10) Within one month of receiving a notification under paragraph (9), where the market surveillance authority is satisfied that the direction has been complied with, the authority shall give notice to the to the person concerned confirming that compliance.

• (11) The market surveillance authority may, where it considers it appropriate to do so, by notice in writing to the person to whom a direction was given, withdraw a direction.

• (12) A direction shall, subject to paragraphs (4) and (5) of Regulation 37, take effect on the date specified in the direction.

• (13) Where a person fails to comply with a direction the market surveillance authority may apply to the judge of the District Court in whose District Court district the person resides or carries on business for an order requiring the person to comply with the direction and the Court may make an order directing the person to comply with the direction.

• (14) A person to whom a direction has been given shall not—

• (a) pending the determination of any appeal under Regulation 37, deal with radio equipment or other matter to which the direction relates, other than in accordance with the terms of the direction, or

• (b) if the direction is confirmed or varied on appeal under Regulation 37, deal with radio equipment or any other matter to which the direction relates other than in accordance with the terms of the direction as confirmed or varied.

• (15) A person who fails to comply with paragraph (14) shall be guilty of an offence and shall be liable on summary conviction to a class A fine.

• (16) This Regulation shall not operate to prevent or restrict—

• (a) the entitlement of any person to bring proceedings for the purpose of securing compliance with these Regulations or Regulation (EC) No. 765/2008, or

• (b) the bringing or prosecuting of any proceedings for an offence under these Regulations.

Right of Appeal Against a Direction, Notice or Measure of Market Surveillance Authority

37.

• (a) a direction given by the market surveillance authority,

• (b) a notice given by the market surveillance authority under Regulation 32(3) or 35(4), or

• (c) a measure taken under Regulation 32(1) or 35(3) by the market surveillance authority,

may appeal to the appropriate court against the direction or notice given or the measure taken.

• (2) A notice of an appeal shall contain a statement of the grounds on which the appeal is made and be made by written notice, which shall be lodged with the appropriate office of the court by the appellant not later than 14 days from the date upon which the direction or notice concerned was given to him or her or the measure was taken.

• (3) A copy of the notice by which a person makes an appeal under this Regulation shall be given by him or her to the market surveillance authority not less than 48 hours before the hearing of the appeal and the authority shall be entitled to appear, be heard and adduce evidence on the hearing of the appeal and at the hearing of any application referred to it under paragraph (4).

• (4) The bringing of an appeal shall not have the effect of suspending the operation of the direction, notice or measure as the case may be, but the appropriate court to which the appeal has been made, may, on application to it by the appellant, suspend its operation until the appeal is determined or withdrawn.

• (5) On the hearing of an appeal the appropriate court may confirm, vary or revoke the direction, notice or measure as the case may be.

• (6) In this Regulation “the appropriate court” means—

• (a) in case the estimated value of the radio equipment to which the direction or notice given or measure taken relates does not exceed €15,000 or such amount as may stand specified for the time being by law as that Courts jurisdiction in tort, the District Court,

• (b) in case the estimated value of the radio equipment to which the direction or notice given or measure taken relates does not exceed €75,000 or such amount as may stand specified for the time being by law as that Courts jurisdiction in tort, the Circuit Court, and

• (c) in any other case, the High Court.

• (7) If, in relation to an appeal under this Regulation to the District Court, that court becomes of the opinion during the hearing of the appeal that the value of the radio equipment, the subject of the appeal, exceeds that courts jurisdiction in tort, it may, if it so thinks fit, transfer the appeal to the Circuit Court or the High Court, whichever it considers appropriate having regard to its opinion of the value of the radio equipment.

• (8) If, in relation to an appeal under this Regulation to the Circuit Court, that court becomes of the opinion during the hearing of the appeal that the value of the radio equipment, the subject of the appeal, exceeds that courts jurisdiction in tort, it may, if it so thinks fit, transfer the appeal to the High Court.

• (9) Paragraphs (7) and (8) are without prejudice to the jurisdiction of a court (being either the District Court or the Circuit Court) to determine an appeal under this Regulation in relation to which it was, at the time of the hearing of the appeal, the appropriate court.

• (10) An appeal under this Regulation to the District Court shall be determined by the judge of the District Court for the District Court district in which the radio equipment concerned was placed on the market or the appellant ordinarily resides.

• (11) An appeal under this Regulation to the Circuit Court shall be determined by the judge of the Circuit Court for the circuit in which the radio equipment concerned was placed on the market or the appellant ordinarily resides.

Power to Make Applications to High Court.

38.

• (a) is being or may be placed on the market, and

• (b) is likely to cause serious injury or damage to property or harmful interference,

the market surveillance authority may apply to the High Court for an order under paragraph (5).

• (2) An application under paragraph (1) shall be made by way of motion.

• (3) The High Court may hear the application only if it is satisfied that a copy of the application has been served on the person alleged to be responsible for placing or proposing to place the radio equipment on the market and on being served with such a copy, the person becomes the respondent to the application.

• (4) The High Court may make such interim or interlocutory order as it considers appropriate pending determination of an application made under paragraph (1) and the Court may not refuse interim or interlocutory relief merely because the market surveillance authority may not suffer damage if relief were not granted pending determination of the application.

• (5) On hearing an application under paragraph (1), the High Court may, if it considers it appropriate to do so, make either or both of the following orders: