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S.I. No. 145/2016 - European Communities (Electromagnetic Compatibility) Regulations 2016.

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the making

this Statutory Instrument was published in “Iris Oifigiúil”

30th March, 2016. The Minister for Jobs, Enterprise and Innovation, in exercise

the powers conferred on him by section 3

the European Communities Act 1972 (No. 27

1972), and for the purpose

giving effect to Directive 2014/30/EU

the European Parliament and

the Council

26 February 20141 , hereby make the following regulations: Citation and commencement 1.

(1)These Regulations may be cited as the European Communities (Electromagnetic Compatibility) Regulations 2016.
(2)These Regulations shall, subject to paragraph
(3), come into operation on 20 April 2016.
(3)The following Regulations come into operation on the day these Regulations are made— (
  1. a)Regulations 2, 3, 4, 5, 6, 7, 8, 9, 10 and 13, (
  2. b)Regulation 14 in so far as it relates to Regulation 13, and (
  3. c)Regulations 15, 16
(1), 18 and 19. Interpretation 2.
(1)In these Regulations— “Directive” means Directive 2014/30/EU

the European Parliament and

the Council

26 February 2014 on the harmonisation

the laws

the Member States relating to electromagnetic compatibility (recast)1; “market surveillance authority” has the meaning assigned to it by Regulation (EC) No. 765/2008; “notifying authority” means the Regulator designated under Regulation 5; “notified body” means a body— (a) which has been notified in accordance with these Regulations, and (b) in respect

which, pursuant to that notification, Regulation 10

(3)has been satisfied; “Regulation (EC) No. 765/2008” means Regulation (EC) No. 765/2008

the European Parliament and

the Council

9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing

products and repealing Regulation (EEC) No. 339/932 ; “Regulations

2007” means the European Communities (Electromagnetic Compatibility) Regulations 2007 ( S.I. No. 109

2007 ); “Regulator” means the Commission for Communications Regulation.

(2)A word or an expression which is used in these Regulations and is also used in the Directive has, unless the context otherwise requires, the same meaning in these Regulations as it has in the Directive. Application 3.
(1)These Regulations shall apply to equipment as specified in Article 3

the Directive.

(2)These Regulations shall not apply to the equipment and other matters specified in Article 2
(2)

the Directive. Notification

bodies authorised to carry out third-party conformity assessment tasks 4. The Regulator shall notify the Commission and other Member States

bodies authorised to carry out third-party conformity assessment tasks under the Directive. Designation

Regulator as notifying authority 5.

(1)The Regulator is designated as the notifying authority for the purposes

Article 21

the Directive.

(2)The Regulator shall— (
  1. a)set up the necessary procedures for— (
  2. i)the assessment and notification

conformity assessment bodies, and (ii) the monitoring

notified bodies, including the monitoring

compliance by a notified body with Regulation 8, and (b) carry out the procedures referred to in subparagraph (a). Information obligation

Regulator 6. The Regulator shall inform the Commission

its procedures for the assessment and notification

conformity assessment bodies and the monitoring

notified bodies and

any changes to those procedures. Requirements for notified bodies 7.

(1)A conformity assessment body shall meet the requirements laid down in paragraphs
(2)to
(11)

Article 24

the Directive for the purposes

notification.

(2)For the purposes

paragraph

(1), the presumption, referred to in Article 25

the Directive,

compliance with the requirements laid down in paragraphs

(2)to
(11)

Article 24

the Directive, shall apply— (a) where, as required by Article 25

the Directive, a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards, or parts

such standards, referred to in that Article, and (b) in so far as the applicable harmonised standards, referred to in subparagraph (a), cover those requirements. Subsidiaries

, and subcontracting by, notified bodies 8. Where a notified body subcontracts specific tasks connected with conformity assessment, or has recourse to a subsidiary, the notified body shall comply with Article 26

the Directive. Application for notification 9.

(1)An application for notification shall be made in accordance with Article 27

the Directive.

(2)For the purposes

an application for notification referred to in paragraph

(1)and Article 27
(2)

the Directive, the accreditation certificate that is to accompany the application may be an accreditation certificate issued by the Irish National Accreditation Board.

(3)Without prejudice to any other enactment, the Irish National Accreditation Board may issue an accreditation certificate for the purposes

an application referred to in paragraph

(1). Notification procedure 10.
(1)Where the Regulator is satisfied that the conformity assessment body, which has made an application referred in accordance with Regulation 9, satisfies the requirements laid down in Article 24

the Directive, the Regulator may notify that conformity assessment body.

(2)The Regulator shall— (a) make the notification in accordance with paragraphs
(2),
(3)and
(4)

Article 28

the Directive, and (b) shall comply with paragraph

(6)

Article 28

the Directive.

(3)A conformity assessment body which has been, in accordance with this Regulation, notified by the Regulator, may perform the activities

a notified body only where no objections are raised by the Commission or the other Member States within— (a) 2weeks

a notification where an accreditation certificate is used in the notification, or (b) 2months

a notification where accreditation is not used in the notification.

(4)A body referred to in paragraph
(3)which complies with that paragraph shall be considered to be a notified body for the purposes

the Directive and these Regulations. Changes to notifications 11.

(1)Where the Regulator has ascertained, or has been informed, that a notified body— (a) no longer meets the requirements laid down in Article 24

the Directive, or (b) is failing to fulfil its obligations under these Regulations, the Regulator shall restrict, suspend or withdraw notification, as appropriate, depending on the seriousness

the failure to meet those requirements or fulfil those obligations.

(2)The Regulator shall immediately inform the Commission and the other Member States

the matters referred to in paragraph

(1).
(3)The Regulator shall— (a) inform the notified body concerned

a restriction, suspension or withdrawal

a notification under paragraph

(1)as soon as possible, and (b) request the notified body concerned to make representations to it in respect

the restriction, suspension or withdrawal, as the case may be,

a notification.

(4)Where a notified body is aggrieved by a decision

the Regulator to restrict, suspend or withdraw its notification the notified body may appeal the decision to the District Court.

(5)Where— (a) a restriction, suspension or withdrawal

a notification, is made, or (

  1. b)the notified body concerned has ceased its activity, the Regulator shall take appropriate steps— (
  2. i)to ensure that the files

that notified body are processed by another notified body, or (ii) to keep those files in a manner that will permit the Regulator to have access to them for the performance by it

its functions under these Regulations. Obligation on Regulator for purposes

Article 31

Directive 12.

(1)The Regulator shall comply with paragraph
(2)

Article 31

the Directive.

(2)The Regulator may request the notified body concerned provides it with information or documents relating to or connected with the performance by it

its functions under paragraph

(1).
(3)A notified body shall comply with a request referred to in paragraph
(2). Operational obligations

notified bodies 13.

(1)A notified body shall carry out a conformity assessment— (
  1. a)in accordance with the conformity assessment procedures provided for in Annex III to the Directive, and (
  2. b)in a proportional manner, avoiding unnecessary burdens for economic operators.
(2)A conformity assessment body shall— (a) perform its activities taking due account

— (i) the size

an undertaking, (

  1. ii)the sector in which it operates, (iii) its structure, (
  2. iv)the degree

complexity

the apparatus technology concerned, and (v) the mass or serial nature

the production process, and (b) in performing its activities pursuant to paragraph (a), shall respect the degree

rigour and the level

protection required for the compliance

the apparatus with the Directive.

(3)Where a notified body finds that the essential requirements set out in Annex 1 to the Directive or corresponding harmonised standards or other technical specifications have not been met by a manufacturer, the notified body shall— (a) require that manufacturer to take appropriate corrective measures, and (b) not issue a certificate.
(4)Where, in the course

the monitoring

conformity following the issue

a certificate, a notified body finds that an apparatus no longer complies, it shall— (

  1. a)require the manufacturer to take appropriate corrective measures, and (
  2. b)suspend or withdraw the certificate if necessary.

(5)Where— (a) a manufacturer does not take the corrective measures referred to in subparagraph
(3)or
(4), or (b) the corrective measures referred to in subparagraph
(3)or
(4)are taken but do not have the required effect, the notified body shall restrict, suspend or withdraw any certificate, as it considers appropriate, having regard to all the circumstances. Appeal to District Court 14.
(1)Where— (
  1. a)an economic operator is aggrieved by a decision by a notified body pursuant to Regulation 13 which affects the economic operator, or (
  2. b)a notified body is aggrieved by a decision

the Regulator referred to in Regulation 11, the economic operator concerned, or as the case may be the notified body concerned, may, within the period

7 days beginning on the day on which the decision is taken or communicated to the economic operator, or as the case may be the notified body, appeal to a judge

the District Court in the District Court District in which the economic operator, or as the case may be the notified body, carries on business against the decision and, in determining the appeal, the judge may— (i) if he or she is satisfied that in the circumstances

the case it is reasonable to do so, confirm the decision, with or without modification, or (ii) direct that the decision be cancelled.

(2)The judge

the District Court determining an appeal under paragraph

(1)may make such order as to the payment

costs in respect

the appeal as he or she considers appropriate. Information to be provided by notified body 15.

(1)A notified body shall inform the Regulator

all or any

the following: (a) any refusal, restriction, suspension or withdrawal

a certificate; (b) any circumstances affecting the scope

, or conditions for, notification; (

  1. c)any request for information which the notified body has received from a market surveillance authority regarding conformity assessment activities; (
  2. d)on request, conformity assessment activities performed within the scope

their notification and any other activity performed, including cross-border activities and subcontracting.

(2)A notified body shall provide the other bodies notified under the Directive carrying out similar conformity assessment activities covering the same apparatus with relevant information on issues relating to negative and, on request, positive conformity assessment results. Notified bodies and Annex III

Directive 16.

(1)A notified body shall comply with Annex III

the Directive.

(2)A manufacturer shall comply with the obligation for a manufacturer set out in paragraph 7

Part A

Annex III

the Directive. Coordination

notified bodies 17.

(1)A notified body shall participate in the work

a sectoral group

notified bodies that operates pursuant to Article 36

the Directive.

(2)Participation under paragraph
(1)may be— (
  1. a)directly, or (
  2. b)by means

designated representatives. Service

notices 18.

(1)Subject to paragraphs
(2)and
(3), a notification under Regulation 11 or 13 shall be addressed to the person concerned by name and may be given to the person in one

the following ways— (

  1. a)by delivering it to the person, (
  2. 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, (
  3. 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, (
  4. d)where there is a facility for receiving the text

the notice by electronic means at the address at which the person carries on business or ordinarily resides, by transmitting the text

the notice by such means to such address, provided that the notice is also delivered in any

the other ways referred to in this paragraph, or (e) if the address at which the person ordinarily resides cannot be ascertained by reasonable enquiry and the compliance notice relates to a premises, by delivering it to the premises or by affixing it in a conspicuous position on or near the premises.

(2)Where a notification under Regulation 11 or 13 is to be given to a person who is the owner or occupier

land or property and the name

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

this Regulation, a company within the meaning

the Companies Act 2014 shall be deemed to be ordinarily resident at its registered

fice, and every other body corporate and every unincorporated body shall be deemed to be ordinarily resident at its principal

fice or place

business. Status

notification to Commission under 2007 Regulations. 19. Without prejudice to the repeal

Directive 2004/108/EC3 pursuant to Article 45

the Directive on 20 April 2016, nothing in these Regulations shall affect a notification made in respect

a person notified to the Commission under Regulation 14

the Regulations

2007. GIVEN under the

ficial Seal

the Minister for Jobs, Enterprise and Innovation, 23 March 2016. RICHARD BRUTON, Minister for Jobs, Enterprise and Innovation. EXPLANATORY NOTE (This note is not part

the Instrument and does not purport to be a legal interpretation.) The purpose

these Regulations is to give legal effect to Directive 2014/30/EU

the European Parliament and

the Council

26 February 2014 on the harmonisation

the laws

the Member States relating to electromagnetic compatibility (recast). The Regulations transpose the provisions

the Directive in so far as they relate to the notification

conformity assessment bodies. The Regulations, with the exception

Regulations 2, 3, 4, 5, 6, 7, 8, 9, 10, 13, Regulation 14 in so far as it relates to Regulation 13, Regulations 15, 16

(1), 18 and 19 which take effect on the making

the Regulations, come into operation on 20 April

  1. 1 OJ No. L.96, 29.3.2014, p.
  2. 2 OJ No. L.218, 13.8.2008, p.
  3. 3 OJ No. L 390, 31.12.04, p.
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