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  1. Introductory Text

  2. PART 1

    1. 1.Citation and commencement

    2. 2.Interpretation

    3. 3.Application

    4. 4.Application of safety legislation

    5. 5.Exhibition at trade fairs

    6. 6.Making available or putting into service

  3. PART 2 Obligations of economic operators

    1. 7.Essential requirements

    2. Manufacturers

      1. 8.Duty to ensure apparatus complies with the essential requirements

      2. 9.Technical documentation and conformity assessment

      3. 10.EU declaration of conformity and CE marking

      4. 11.Retention of technical documentation and EU declaration of conformity

      5. 12.Compliance procedures for series production

      6. 13.Information identifying manufacturer

      7. 14.Instructions and information

      8. 15.Manufacturer's duty to take action in respect of apparatus placed on the market which is considered not to be in conformity

      9. 16.Provision of information and co-operation

    3. Importers

      1. 17.Prohibition on placing apparatus on the market which is not in conformity

      2. 18.Requirements that must be satisfied before an importer places apparatus on the market

      3. 19.Duty not to place non-conforming apparatus on the market

      4. 20.Information identifying importer

      5. 21.Instructions and information

      6. 22.Storage and transport

      7. 23.Importer's duty to take action in respect of apparatus placed on the market which is considered not to be in conformity

      8. 24.Retention of technical documentation and EU declaration of conformity

      9. 25.Provision of information and co-operation

    4. Distributors

      1. 26.Duty to act with due care

      2. 27.Making available on the market

      3. 28.Duty not to make non-conforming apparatus available on the market

      4. 29.Storage and transport

      5. 30.Duty to take action in respect of apparatus placed on the market or made available on the market which is considered not to be in conformity

      6. 31.Provision of information and co-operation

    5. All economic operators

      1. 32.Cases in which the obligations of manufacturers apply to importers and distributors

      2. 33.Identification of economic operators

      3. 34.Translation of EU declaration of conformity

      4. 35.Prohibition on improper use of CE marking

      5. 36.Information concerning the use of apparatus

      6. 37.Fixed installations

    6. Authorised representatives

      1. 38.Appointment of an authorised representative

  4. PART 3 Conformity of apparatus and equipment

    1. 39.Presumption of conformity

    2. 40.Conformity assessment procedures

    3. 41.EU declaration of conformity

    4. 42.CE marking

  5. PART 4 Notification of conformity assessment bodies

    1. 43.Notified bodies

    2. 44.Notification

    3. 45.Contents of notification

    4. 46.Presumption of conformity of notified bodies

    5. 47.Monitoring of notified bodies

    6. 48.United Kingdom Accreditation Service

    7. 49.Changes to notifications

    8. 50.Operational obligations of notified bodies

    9. 51.Subsidiaries and contractors

  6. PART 5 Enforcement and market surveillance

    1. 52.Designation of enforcing authorities

    2. 53.Designation of market surveillance authorities

    3. 54.Enforcement powers

    4. 55.Exercise of enforcement powers

    5. 56.Evaluation of apparatus presenting a risk

    6. 57.Enforcement action in respect of apparatus that is not in conformity and which present a risk

    7. 58.EU safeguard procedure

    8. 59.Enforcement action in respect of formal non-compliance

    9. 60.Restrictive measures

    10. 61.Offences

    11. 62.Penalties

    12. 63.Defence of due diligence

    13. 64.Liability of persons other than the principal offender

    14. 65.Service of documents

    15. 66.Recovery of expenses of enforcement

    16. 67.Action by enforcing authority

    17. 68.Appeals against notices

    18. 69.Appropriate court for appeals against notices

    19. 70.Time limit for prosecution of offences

    20. 71.Compensation

    21. 72.Power of the court to require a matter to be remedied

  7. PART 6 MISCELLANEOUS

    1. 73.Review

    2. 74.Transitional provision

    3. 75.Revocations and savings

    4. 76.Consequential amendments

  8. Signature

  9. SCHEDULES

    1. SCHEDULE 1

      Essential Requirements

      1. 1.General requirements

      2. 2.Specific requirements for fixed installations

    2. SCHEDULE 2

      Module A: internal production control

      1. 1.Internal production control is the conformity assessment procedure whereby the...

      2. 2.Electromagnetic compatibility assessment

      3. 3.The electromagnetic compatibility assessment must take into account all normal...

      4. 4.Technical documentation

      5. 5.The technical documentation must specify the applicable requirements and cover,...

      6. 6.Manufacturing

      7. 7.CE marking and EU declaration of conformity

      8. 8.The manufacturer must draw up a written EU declaration of...

      9. 9.Authorised Representative

    3. SCHEDULE 3

      Applicable conformity assessment procedures

      1. PART 1 Module B: EU-type Examination

        1. 1.EU-type examination is the part of a conformity assessment procedure...

        2. 2.EU-type examination must be carried out by an assessment of...

        3. 3.The manufacturer must lodge an application for EU-type examination with...

        4. 4.The technical documentation referred to in paragraph 3(c) of this...

        5. 5.The notified body must examine the technical documentation to assess...

        6. 6.The notified body must draw up an evaluation report which...

        7. 7.Where the type meets the requirements of these Regulations that...

        8. 8.The EU-type examination certificate, which may be accompanied by one...

        9. 9.The EU-type examination certificate and any annexes to that certificate...

        10. 10.Where the type does not satisfy the applicable requirements of...

        11. 11.The notified body must keep itself apprised of any changes...

        12. 12.The manufacturer must inform the notified body that holds the...

        13. 13.Each notified body must inform its notifying authority of any...

        14. 14.Each notified body must inform the other notified bodies of...

        15. 15.The Commission, the Member States and the other notified bodies...

        16. 16.The manufacturer must keep a copy of the EU-type examination...

        17. 17.The manufacturer's authorised representative may lodge the application referred to...

      2. PART 2 Module C: conformity to type based on internal production control

        1. 18.Conformity to type based on internal production control is the...

        2. 19.Manufacturing

        3. 20.CE marking and EU declaration of conformity

        4. 21.Authorised representative

    4. SCHEDULE 4

      EU declaration of conformity

      1. 1.EU declaration of conformity (No xxxx)

      2. 2.Name and address of manufacturer or the manufacturer's authorised representative:...

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

      4. 4.Object of the declaration (identification of apparatus allowing traceability; it...

      5. 5.The object of the declaration described above is in conformity...

      6. 6.References to the relevant harmonised standards used, including the date...

      7. 7.Where applicable, the notified body … (name, number) performed …...

      8. 8.Additional information: Signed for and on behalf of: (place and...

    5. SCHEDULE 5

      Requirements for notified bodies

      1. 1.A conformity assessment body must be established in the United...

      2. 2.(1) A conformity assessment body must be a third party...

      3. 3.A conformity assessment body, its top level management and the...

      4. 4.Nothing in paragraph 3 of this Schedule precludes the use...

      5. 5.A conformity assessment body, its top level management and the...

      6. 6.A conformity assessment body, its top level management and the...

      7. 7.A conformity assessment body must ensure that the activities of...

      8. 8.A conformity assessment body and its personnel must carry out...

      9. 9.A conformity assessment body must be capable of carrying out...

      10. 10.A conformity assessment body must have at its disposal—

      11. 11.A conformity assessment body must have the means necessary to...

      12. 12.The personnel responsible for carrying out the conformity assessment activities...

      13. 13.A conformity assessment body must be able to demonstrate the...

      14. 14.The remuneration of the top level management and the personnel...

      15. 15.A conformity assessment body must have, and must satisfy the...

      16. 16.A conformity assessment body must ensure that its personnel observe...

      17. 17.Paragraph 16 does not prevent the personnel from providing information...

      18. 18.A conformity assessment body must participate in, or ensure that...

    6. SCHEDULE 6

      Operational obligations of notified bodies

      1. 1.A notified body must carry out conformity assessments in accordance...

      2. 2.A notified body must carry out conformity assessments in a...

      3. 3.Conformity assessment bodies must perform their activities taking due account...

      4. 4.Conformity assessment bodies must respect the degree of rigour and...

      5. 5.Where a notified body finds that the essential requirements or...

      6. 6.Where, in the course of the monitoring of the conformity...

      7. 7.Where corrective measures are not taken or do not have...

      8. 8.Paragraph 9 applies where a notified body is minded to—...

      9. 9.Where this paragraph applies, the notified body must—

      10. 10.A notified body must inform the Secretary of State of—...

      11. 11.A notified body must make provision in its contracts with...

      12. 12.A notified body must provide other bodies notified under the...

      13. 13.A notified body must participate in the work of any...

    7. SCHEDULE 7

      Enforcement and investigatory powers conferred on the enforcing authority and the market surveillance authority

      1. PART 1 ENFORCEMENT AND INVESTIGATORY POWERS

        1. 1.Enforcement powers under the 1987 Act

        2. 2.Modifications to the 1987 Act

        3. 3.Application of Schedule 5 to the Consumer Rights Act 2015

      2. PART 2 COMPLIANCE NOTICES, WITHDRAWAL NOTICES AND RECALL NOTICES

        1. 4.Compliance notice

        2. 5.A compliance notice must— (a) require the relevant economic operator...

        3. 6.A compliance notice may include directions as to the measures...

        4. 7.Subject to paragraph 8, an enforcing authority may revoke or...

        5. 8.An enforcing authority may not vary a compliance notice so...

        6. 9.Withdrawal notice

        7. 10.A withdrawal notice must prohibit the relevant economic operator from...

        8. 11.A withdrawal notice may require the relevant economic operator to...

        9. 12.A withdrawal notice may require the relevant economic operator to...

        10. 13.A consent given by the enforcing authority pursuant to a...

        11. 14.Subject to paragraph 15, an enforcing authority may revoke or...

        12. 15.An enforcing authority may not vary a withdrawal notice so...

        13. 16.A withdrawal notice has effect throughout the United Kingdom.

        14. 17.Recall notice

        15. 18.A recall notice must require the relevant economic operator to...

        16. 19.A recall notice may— (a) require the recall to be...

        17. 20.In determining what requirements to include in a recall notice,...

        18. 21.A recall notice may only be issued by the enforcing...

        19. 22.A relevant economic operator which has received notice from the...

        20. 23.Paragraphs 21(b), (c) and (d) do not apply in the...

        21. 24.Where a relevant economic operator requires the enforcing authority to...

        22. 25.In this Schedule, “Institute” means the charitable organisation with registered...

        23. 26.A recall notice served by the enforcing authority may require...

        24. 27.Subject to paragraph 28, an enforcing authority may revoke or...

        25. 28.An enforcing authority may not vary a recall notice so...

        26. 29.A recall notice has effect throughout the United Kingdom.

        27. 30.Interpretation

  10. Explanatory Note