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  1. Introductory Text

  2. CHAPTER 1 GENERAL PROVISIONS

    1. Article 1.Subject matter

    2. Article 2.Scope

    3. Article 3.Definitions

    4. Article 4.Making available on the market and/or putting into service

    5. Article 5.Free movement of equipment

    6. Article 6.Essential requirements

  3. CHAPTER 2 OBLIGATIONS OF ECONOMIC OPERATORS

    1. Article 7.Obligations of manufacturers

    2. Article 8.Authorised representatives

    3. Article 9.Obligations of importers

    4. Article 10.Obligations of distributors

    5. Article 11.Cases in which obligations of manufacturers apply to importers and distributors

    6. Article 12.Identification of economic operators

  4. CHAPTER 3 CONFORMITY OF EQUIPMENT

    1. Article 13.Presumption of conformity of equipment

    2. Article 14.Conformity assessment procedures for apparatus

    3. Article 15.EU declaration of conformity

    4. Article 16.General principles of the CE marking

    5. Article 17.Rules and conditions for affixing the CE marking

    6. Article 18.Information concerning the use of apparatus

    7. Article 19.Fixed installations

  5. CHAPTER 4 NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

    1. Article 20.Notification

    2. Article 21.Notifying authorities

    3. Article 22.Requirements relating to notifying authorities

    4. Article 23.Information obligation on notifying authorities

    5. Article 24.Requirements relating to notified bodies

    6. Article 25.Presumption of conformity of notified bodies

    7. Article 26.Subsidiaries of and subcontracting by notified bodies

    8. Article 27.Application for notification

    9. Article 28.Notification procedure

    10. Article 29.Identification numbers and lists of notified bodies

    11. Article 30.Changes to notifications

    12. Article 31.Challenge of the competence of notified bodies

    13. Article 32.Operational obligations of notified bodies

    14. Article 33.Appeal against decisions of notified bodies

    15. Article 34.Information obligation on notified bodies

    16. Article 35.Exchange of experience

    17. Article 36.Coordination of notified bodies

  6. CHAPTER 5 UNION MARKET SURVEILLANCE AND CONTROL OF APPARATUS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE

    1. Article 37.Union market surveillance and control of apparatus entering the Union market

    2. Article 38.Procedure for dealing with apparatus presenting a risk at national level

    3. Article 39.Union safeguard procedure

    4. Article 40.Formal non-compliance

  7. CHAPTER 6 COMMITTEE, TRANSITIONAL AND FINAL PROVISIONS

    1. Article 41.Committee procedure

    2. Article 42.Penalties

    3. Article 43.Transitional provisions

    4. Article 44.Transposition

    5. Article 45.Repeal

    6. Article 46.Entry into force and application

    7. Article 47.Addressees

    1. ANNEX I

      ESSENTIAL REQUIREMENTS

      1. 1. General requirements

      2. 2. Specific requirements for fixed installations

    2. ANNEX II

      MODULE A: INTERNAL PRODUCTION CONTROL

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

      2. 2. Electromagnetic compatibility assessment

      3. 3. Technical documentation

      4. 4. Manufacturing

      5. 5. CE marking and EU declaration of conformity

        1. 5.1. The manufacturer shall affix the CE marking to each individual...

        2. 5.2. The manufacturer shall draw up a written EU declaration of...

      6. 6. Authorised representative

    3. ANNEX III

      1. PART A

        1. Module B: EU-type examination

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

          2. 2. EU-type examination shall be carried out by assessment of the...

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

          4. 4. The notified body shall examine the technical documentation to assess...

          5. 5. The notified body shall draw up an evaluation report that...

          6. 6. Where the type meets the requirements of this Directive that...

          7. 7. The notified body shall keep itself apprised of any changes...

          8. 8. Each notified body shall inform its notifying authority concerning the...

          9. 9. The manufacturer shall keep a copy of the EU-type examination...

          10. 10. The manufacturer’s authorised representative may lodge the application referred to...

      2. PART B

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

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

          2. 2. Manufacturing

          3. 3. CE marking and EU declaration of conformity

            1. 3.1. The manufacturer shall affix the CE marking to each individual...

            2. 3.2. The manufacturer shall draw up a written EU declaration of...

          4. 4. Authorised representative

    4. ANNEX IV

      EU declaration of conformity (No Xxxx)

      1. 1. Apparatus model/Product (product, type, batch or serial number):

      2. 2. Name and address of the manufacturer or his 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:

    5. ANNEX V

    6. ANNEX VI

  8. ATTACHMENTS

    1. STATEMENT OF THE EUROPEAN PARLIAMENT