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  1. Introductory Text

  2. CHAPTER 1 GENERAL PROVISIONS

    1. Article 1.Objective

    2. Article 2.Definitions

    3. Article 3.Scope

    4. Article 4.Requirements for marine equipment

    5. Article 5.Application

    6. Article 6.Functioning of the internal market

    7. Article 7.Transfer of a ship to the flag of a Member State

    8. Article 8.Standards for marine equipment

  3. CHAPTER 2 THE WHEEL MARK

    1. Article 9.The wheel mark

    2. Article 10.Rules and conditions for affixing the wheel mark

    3. Article 11.Electronic tag

  4. CHAPTER 3 OBLIGATIONS OF ECONOMIC OPERATORS

    1. Article 12.Obligations of manufacturers

    2. Article 13.Authorised representatives

    3. Article 14.Other economic operators

  5. CHAPTER 4 CONFORMITY ASSESSMENT AND NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

    1. Article 15.Conformity assessment procedures

    2. Article 16.EU declaration of conformity

    3. Article 17.Notification of conformity assessment bodies

    4. Article 18.Notifying authorities

    5. Article 19.Information obligation on notifying authorities

    6. Article 20.Subsidiaries of, and subcontracting by, notified bodies

    7. Article 21.Changes to notifications

    8. Article 22.Challenges to the competence of notified bodies

    9. Article 23.Operational obligations of notified bodies

    10. Article 24.Obligation of notified bodies to provide information

  6. CHAPTER 5 UNION MARKET SURVEILLANCE, CONTROL OF PRODUCTS, SAFEGUARD PROVISIONS

    1. Article 25.EU market surveillance framework

    2. Article 26.Procedure for dealing with marine equipment presenting a risk at national level

    3. Article 27.EU safeguard procedure

    4. Article 28.Compliant products which present a risk to maritime safety, to health or to the environment

    5. Article 29.Formal non-compliance

    6. Article 30.Exemptions based on technical innovation

    7. Article 31.Exemptions for testing or evaluation

    8. Article 32.Exemptions in exceptional circumstances

  7. CHAPTER 6 FINAL PROVISIONS

    1. Article 33.Exchange of experience

    2. Article 34.Coordination of notified bodies

    3. Article 35.Implementing measures

    4. Article 36.Amendments

    5. Article 37.Exercise of the delegation

    6. Article 38.Committee

    7. Article 39.Transposition

    8. Article 40.Repeal

    9. Article 41.Entry into force

    10. Article 42.Addressees

    1. ANNEX I

      WHEEL MARK

      1. The mark of conformity must take the following form:

      2. If the wheel mark is reduced or enlarged the proportions...

      3. The various components of the wheel mark must have substantially...

      4. That minimum dimension may be waived for small devices.

    2. ANNEX II

      CONFORMITY ASSESSMENT PROCEDURES

      1. I. MODULE B: EC TYPE-EXAMINATION

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

        2. 2. EC type-examination may be carried out in either of the...

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

        4. 4. The notified body shall:

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

        6. 6. Where the type meets the requirements of the specific international...

        7. 7. If the approved type no longer complies with the applicable...

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

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

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

      2. II. MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF...

        1. 1. Conformity to type based on quality assurance of the production...

        2. 2. Manufacturing

        3. 3. Quality system

          1. 3.1. The manufacturer shall lodge an application for assessment of its...

          2. 3.2. The quality system shall ensure that the products are in...

          3. 3.3. The notified body shall assess the quality system to determine...

          4. 3.4. The manufacturer shall undertake to fulfil the obligations arising out...

          5. 3.5. The manufacturer shall keep the notified body that has approved...

        4. 4. Surveillance under the responsibility of the notified body

          1. 4.1. The purpose of surveillance is to make sure that the...

          2. 4.2. The manufacturer shall, for assessment purposes, allow the notified body...

          3. 4.3. The notified body shall carry out periodic audits to make...

          4. 4.4. In addition, the notified body may pay unexpected visits to...

        5. 5. Conformity marking and declaration of conformity

          1. 5.1. The manufacturer shall affix the wheel mark referred to in...

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

        6. 6. The manufacturer shall keep at the disposal of the competent...

        7. 7. Each notified body shall inform its notifying authorities of quality...

        8. 8. Authorised representative

      3. III. MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE...

        1. 1. Conformity to type based on product quality assurance is that...

        2. 2. Manufacturing

        3. 3. Quality system

          1. 3.1. The manufacturer shall lodge an application for assessment of its...

          2. 3.2. The quality system shall ensure compliance of the products with...

          3. 3.3. The notified body shall assess the quality system to determine...

          4. 3.4. The manufacturer shall undertake to fulfil the obligations arising out...

          5. 3.5. The manufacturer shall keep the notified body that has approved...

        4. 4. Surveillance under the responsibility of the notified body

          1. 4.1. The purpose of surveillance is to make sure that the...

          2. 4.2. The manufacturer shall, for assessment purposes, allow the notified body...

          3. 4.3. The notified body shall carry out periodic audits to make...

          4. 4.4. In addition, the notified body may pay unexpected visits to...

        5. 5. Conformity marking and declaration of conformity

          1. 5.1. The manufacturer shall affix the wheel mark referred to in...

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

        6. 6. The manufacturer shall keep at the disposal of the competent...

        7. 7. Each notified body shall inform its notifying authorities of quality...

        8. 8. Authorised representative

      4. IV. MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION

        1. 1. Conformity to type based on product verification is the part...

        2. 2. Manufacturing

        3. 3. Verification

        4. 4. Verification of conformity by examination and testing of every product...

          1. 4.1. All products shall be individually examined and tested in accordance...

          2. 4.2. The notified body shall issue a certificate of conformity in...

        5. 5. Statistical verification of conformity

          1. 5.1. The manufacturer shall take all measures necessary so that the...

          2. 5.2. A random sample shall be taken from each lot. All...

          3. 5.3. If a lot is accepted, all products of the lot...

          4. 5.4. If a lot is rejected, the notified body or the...

        6. 6. Conformity marking and declaration of conformity

          1. 6.1. The manufacturer shall affix the wheel mark referred to in...

          2. 6.2. The manufacturer shall draw up a written declaration of conformity...

        7. 7. If the notified body agrees and under its responsibility, the...

        8. 8. Authorised representative

      5. V. MODULE G: CONFORMITY BASED ON UNIT VERIFICATION

        1. 1. Conformity based on unit verification is the conformity assessment procedure...

        2. 2. Technical documentation

        3. 3. Manufacturing

        4. 4. Verification

        5. 5. Conformity marking and declaration of conformity

          1. 5.1. The manufacturer shall affix the wheel mark referred to in...

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

        6. 6. Authorised representative

    3. ANNEX III

      REQUIREMENTS TO BE MET BY CONFORMITY ASSESSMENT BODIES IN ORDER TO BECOME NOTIFIED BODIES

      1. 1. For the purposes of notification, a conformity assessment body shall...

      2. 2. A conformity assessment body shall be established under national law...

      3. 3. A conformity assessment body shall be a third-party body independent...

      4. 4. A body belonging to a business association or professional federation...

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

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

      7. 7. Conformity assessment bodies shall ensure that the activities of their...

      8. 8. Conformity assessment bodies and their personnel shall carry out the...

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

      10. 10. At all times and for each conformity assessment procedure and...

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

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

      13. 13. The impartiality of the conformity assessment bodies, of their top-level...

      14. 14. The remuneration of the top-level management and of the assessment...

      15. 15. Conformity assessment bodies shall take out liability insurance unless liability...

      16. 16. The personnel of a conformity assessment body shall observe professional...

      17. 17. Conformity assessment bodies shall participate in, or ensure that their...

      18. 18. Conformity assessment bodies shall meet the requirements of standard EN...

      19. 19. Conformity assessment bodies shall ensure that testing laboratories used for...

    4. ANNEX IV

      NOTIFICATION PROCEDURE

      1. 1. Application for notification

        1. 1.1. A conformity assessment body shall submit an application for notification...

        2. 1.2. That application shall be accompanied by a description of the...

        3. 1.3. Where the conformity assessment body concerned cannot provide an accreditation...

      2. 2. Notification procedure

        1. 2.1. Notifying authorities may notify only conformity assessment bodies which have...

        2. 2.2. They shall notify the Commission and the other Member States...

        3. 2.3. The notification shall include full details of the conformity assessment...

        4. 2.4. Where a notification is not based on an accreditation certificate...

        5. 2.5. The body concerned may perform the activities of a notified...

        6. 2.6. Only a body referred to in point 2.5 shall be...

        7. 2.7. The Commission and the other Member States shall be notified...

      3. 3. Identification numbers and lists of notified bodies

        1. 3.1. The Commission shall assign an identification number to a notified...

        2. 3.2. It shall assign a single such number even where the...

        3. 3.3. The Commission shall make publicly available the list of the...

        4. 3.4. The Commission shall ensure that that list is kept up...

    5. ANNEX V

      REQUIREMENTS TO BE MET BY NOTIFYING AUTHORITIES

      1. 1. A notifying authority shall be established in such a way...

      2. 2. A notifying authority shall be organised and operated in such...

      3. 3. A notifying authority shall be organised in such a way...

      4. 4. A notifying authority shall not offer or provide, on a...

      5. 5. A notifying authority shall safeguard the confidentiality of the information...

      6. 6. A notifying authority shall have a sufficient number of competent...