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Decision No 768/2008/EC of the European Parliament and of the CouncilShow full title

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (Text with EEA relevance) (revoked)

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  1. Introductory Text

  2. Article 1.General principles

  3. Article 2.Subject matter and scope

  4. Article 3.Level of protection of public interests

  5. Article 4.Conformity assessment procedures

  6. Article 5.EC declaration of conformity

  7. Article 6.Conformity assessment

  8. Article 7.Reference provisions

  9. Article 8.Repeal

  10. Signature

    1. Expand +/Collapse -

      ANNEX I

      REFERENCE PROVISIONS FOR COMMUNITY HARMONISATION LEGISLATION FOR PRODUCTS

      1. Chapter R1 Definitions

        1. Article R1.Definitions

      2. Chapter R2 Obligations of economic operators

        1. Article R2.Obligations of manufacturers

        2. Article R3.Authorised representatives

        3. Article R4.Obligations of importers

        4. Article R5.Obligations of distributors

        5. Article R6.Cases in which obligations of manufacturers apply to importers and distributors

        6. Article R7.Identification of economic operators

      3. Chapter R3 Conformity of the product

        1. Article R8.Presumption of conformity

        2. Article R9.Formal objection to a harmonised standard

        3. Article R10.EC declaration of conformity

        4. Article R11.General principles of the CE marking

        5. Article R12.Rules and conditions for affixing the CE marking

      4. Chapter R4 Notification of conformity assessment bodies

        1. Article R13.Notification

        2. Article R14.Notifying authorities

        3. Article R15.Requirements relating to notifying authorities

        4. Article R16.Information obligation on notifying authorities

        5. Article R17.Requirements relating to notified bodies

        6. Article R18.Presumption of conformity

        7. Article R19.Formal objection to a harmonised standard

        8. Article R20.Subsidiaries of and subcontracting by notified bodies

        9. Article R21.Accredited in-house bodies

        10. Article R22.Application for notification

        11. Article R23.Notification procedure

        12. Article R24.Identification numbers and lists of notified bodies

        13. Article R25.Changes to notifications

        14. Article R26.Challenge of the competence of notified bodies

        15. Article R27.Operational obligations of notified bodies

        16. Article R28.Information obligation on notified bodies

        17. Article R29.Exchange of experience

        18. Article R30.Coordination of notified bodies

      5. Chapter R5 Safeguard procedures

        1. Article R31.Procedure for dealing with products presenting a risk at national level

        2. Article R32.Community safeguard procedure

        3. Article R33.Compliant products which present a risk to health and safety

        4. Article R34.Formal non-compliance

    2. Expand +/Collapse -

      ANNEX II

      CONFORMITY ASSESSMENT PROCEDURES

      1. Module A Internal production control

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

        2. 2. Technical documentation

        3. 3. Manufacturing

        4. 4. Conformity marking and declaration of conformity

        5. 4.1. The manufacturer shall affix the required conformity marking set out ...

        6. 4.2. The manufacturer shall draw up a written declaration of conformity...

        7. 5. Authorised representative

      2. Module A1 Internal production control plus supervised product testing

        1. 1. Internal production control plus supervised product testing is the conformity ...

        2. 2. Technical documentation

        3. 3. Manufacturing

        4. 4. Product checks

        5. 5. Conformity marking and declaration of conformity

        6. 5.1. The manufacturer shall affix the required conformity marking set out ...

        7. 5.2. The manufacturer shall draw up a written declaration of conformity...

        8. 6. Authorised representative

      3. Module A2 Internal production control plus supervised product checks at random intervals...

        1. 1. Internal production control plus supervised product checks at random intervals ...

        2. 2. Technical documentation

        3. 3. Manufacturing

        4. 4. Product checks

        5. 5. Conformity marking and declaration of conformity

        6. 5.1. The manufacturer shall affix the required conformity marking set out ...

        7. 5.2. The manufacturer shall draw up a written declaration of conformity...

        8. 6. Authorised representative

      4. 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. 4.1. examine the technical documentation and supporting evidence to assess the...

        6. 4.2. verify that the specimen(s) have been manufactured in conformity with ...

        7. 4.3. carry out appropriate examinations and tests, or have them carried ...

        8. 4.4. carry out appropriate examinations and tests, or have them carried ...

        9. 4.5. agree with the manufacturer on a location where the examinations ...

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

        11. 6. Where the type meets the requirements of the specific legislative...

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

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

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

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

      5. 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. Conformity marking and declaration of conformity

        4. 3.1. The manufacturer shall affix the required conformity marking set out ...

        5. 3.2. The manufacturer shall draw up a written declaration of conformity...

        6. 4. Authorised representative

      6. Module C1 Conformity to type based on internal production control plus supervised...

        1. 1. Conformity to type based on internal production control plus supervised ...

        2. 2. Manufacturing

        3. 3. Product checks

        4. 4. Conformity marking and declaration of conformity

        5. 4.1. The manufacturer shall affix the required conformity marking set out ...

        6. 4.2. The manufacturer shall draw up a written declaration of conformity...

        7. 5. Authorised representative

      7. Module C2 Conformity to type based on internal production control plus supervised...

        1. 1. Conformity to type based on internal production control plus supervised ...

        2. 2. Manufacturing

        3. 3. Product checks

        4. 4. Conformity marking and declaration of conformity

        5. 4.1. The manufacturer shall affix the required conformity marking set out ...

        6. 4.2. The manufacturer shall draw up a written declaration of conformity...

        7. 5. Authorised representative

      8. Module D Conformity to type based on quality assurance of the production...

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

        2. 2. Manufacturing

        3. 3. Quality system

        4. 3.1. The manufacturer shall lodge an application for assessment of his...

        5. 3.2. The quality system shall ensure that the products are in...

        6. 3.3. The notified body shall assess the quality system to determine...

        7. 3.4. The manufacturer shall undertake to fulfil the obligations arising out ...

        8. 3.5. The manufacturer shall keep the notified body that has approved...

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

        10. 4.1. The purpose of surveillance is to make sure that the ...

        11. 4.2. The manufacturer shall, for assessment purposes, allow the notified body...

        12. 4.3. The notified body shall carry out periodic audits to make ...

        13. 4.4. In addition, the notified body may pay unexpected visits to ...

        14. 5. Conformity marking and declaration of conformity

        15. 5.1. The manufacturer shall affix the required conformity marking set out ...

        16. 5.2. The manufacturer shall draw up a written declaration of conformity...

        17. 6. The manufacturer shall, for a period ending at least 10...

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

        19. 8. Authorised representative

      9. Module D1 Quality assurance of the production process

        1. 1. Quality assurance of the production process is the conformity assessment ...

        2. 2. Technical documentation

        3. 3. The manufacturer shall keep the technical documentation at the disposal ...

        4. 4. Manufacturing

        5. 5. Quality system

        6. 5.1. The manufacturer shall lodge an application for assessment of his...

        7. 5.2. The quality system shall ensure compliance of the products with...

        8. 5.3. The notified body shall assess the quality system to determine...

        9. 5.4. The manufacturer shall undertake to fulfil the obligations arising out ...

        10. 5.5. The manufacturer shall keep the notified body that has approved...

        11. 6. Surveillance under the responsibility of the notified body

        12. 6.1. The purpose of surveillance is to make sure that the ...

        13. 6.2. The manufacturer shall, for assessment purposes, allow the notified body...

        14. 6.3. The notified body shall carry out periodic audits to make ...

        15. 6.4. In addition, the notified body may pay unexpected visits to ...

        16. 7. Conformity marking and declaration of conformity

        17. 7.1. The manufacturer shall affix the required conformity marking set out ...

        18. 7.2. The manufacturer shall draw up a written declaration of conformity...

        19. 8. The manufacturer shall, for a period ending at least 10...

        20. 9. Each notified body shall inform its notifying authorities of quality...

        21. 10. Authorised representative

      10. 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

        4. 3.1. The manufacturer shall lodge an application for assessment of his...

        5. 3.2. The quality system shall ensure compliance of the products with...

        6. 3.3. The notified body shall assess the quality system to determine...

        7. 3.4. The manufacturer shall undertake to fulfil the obligations arising out ...

        8. 3.5. The manufacturer shall keep the notified body that has approved...

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

        10. 4.1. The purpose of surveillance is to make sure that the ...

        11. 4.2. The manufacturer shall, for assessment purposes, allow the notified body...

        12. 4.3. The notified body shall carry out periodic audits to make ...

        13. 4.4. In addition, the notified body may pay unexpected visits to ...

        14. 5. Conformity marking and declaration of conformity

        15. 5.1. The manufacturer shall affix the required conformity marking set out ...

        16. 5.2. The manufacturer shall draw up a written declaration of conformity...

        17. 6. The manufacturer shall, for a period ending at least 10...

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

        19. 8. Authorised representative

      11. Module E1 Quality assurance of final product inspection and testing

        1. 1. Quality assurance of final product inspection and testing is the ...

        2. 2. Technical documentation

        3. 3. The manufacturer shall keep the technical documentation at the disposal ...

        4. 4. Manufacturing

        5. 5. Quality system

        6. 5.1. The manufacturer shall lodge an application for assessment of his...

        7. 5.2. The quality system shall ensure compliance of the products with...

        8. 5.3. The notified body shall assess the quality system to determine...

        9. 5.4. The manufacturer shall undertake to fulfil the obligations arising out ...

        10. 5.5. The manufacturer shall keep the notified body that has approved...

        11. 6. Surveillance under the responsibility of the notified body

        12. 6.1. The purpose of surveillance is to make sure that the ...

        13. 6.2. The manufacturer shall, for assessment purposes, allow the notified body...

        14. 6.3. The notified body shall carry out periodic audits to make ...

        15. 6.4. In addition, the notified body may pay unexpected visits to ...

        16. 7. Conformity marking and declaration of conformity

        17. 7.1. The manufacturer shall affix the required conformity marking set out ...

        18. 7.2. The manufacturer shall draw up a written declaration of conformity...

        19. 8. The manufacturer shall, for a period ending at least 10...

        20. 9. Each notified body shall inform its notifying authorities of quality...

        21. 10. Authorised representative

      12. 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

        5. 4.1. All products shall be individually examined and appropriate tests set ...

        6. 4.2. The notified body shall issue a certificate of conformity in...

        7. 5. Statistical verification of conformity

        8. 5.1. The manufacturer shall take all measures necessary so that the ...

        9. 5.2. A random sample shall be taken from each lot according ...

        10. 5.3. If a lot is accepted, all products of the lot...

        11. 5.4. If a lot is rejected, the notified body or the ...

        12. 6. Conformity marking and declaration of conformity

        13. 6.1. The manufacturer shall affix the required conformity marking set out ...

        14. 6.2. The manufacturer shall draw up a written declaration of conformity...

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

        16. 8. Authorised representative

      13. Module F1 Conformity based on product verification

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

        2. 2. Technical documentation

        3. 3. Manufacturing

        4. 4. Verification

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

        6. 5.1. All products shall be individually examined and appropriate tests, set ...

        7. 5.2. The notified body shall issue a certificate of conformity in...

        8. 6. Statistical verification of conformity

        9. 6.1. The manufacturer shall take all measures necessary so that the ...

        10. 6.2. A random sample shall be taken from each lot according ...

        11. 6.3. If a lot is accepted, all products of the lot...

        12. 7. Conformity marking and declaration of conformity

        13. 7.1. The manufacturer shall affix the conformity marking set out in ...

        14. 7.2. The manufacturer shall draw up a written declaration of conformity...

        15. 8. If the notified body agrees and under its responsibility, the ...

        16. 9. Authorised representative

      14. 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

        6. 5.1. The manufacturer shall affix the required conformity marking set out ...

        7. 5.2. The manufacturer shall draw up a written declaration of conformity...

        8. 6. Authorised representative

      15. Module H Conformity based on full quality assurance

        1. 1. Conformity based on full quality assurance is the conformity assessment ...

        2. 2. Manufacturing

        3. 3. Quality system

        4. 3.1. The manufacturer shall lodge an application for assessment of his...

        5. 3.2. The quality system shall ensure compliance of the products with...

        6. 3.3. The notified body shall assess the quality system to determine...

        7. 3.4. The manufacturer shall undertake to fulfil the obligations arising out ...

        8. 3.5. The manufacturer shall keep the notified body that has approved...

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

        10. 4.1. The purpose of surveillance is to make sure that the ...

        11. 4.2. The manufacturer shall, for assessment purposes, allow the notified body...

        12. 4.3. The notified body shall carry out periodic audits to make ...

        13. 4.4. In addition, the notified body may pay unexpected visits to ...

        14. 5. Conformity marking and declaration of conformity

        15. 5.1. The manufacturer shall affix the required conformity marking set out ...

        16. 5.2. The manufacturer shall draw up a written declaration of conformity...

        17. 6. The manufacturer shall, for a period ending at least 10...

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

        19. 8. Authorised representative

      16. Module H1 Conformity based on full quality assurance plus design examination

        1. 1. Conformity based on full quality assurance plus design examination is ...

        2. 2. Manufacturing

        3. 3. Quality system

        4. 3.1. The manufacturer shall lodge an application for assessment of his...

        5. 3.2. The quality system shall ensure compliance of the products with...

        6. 3.3. The notified body shall assess the quality system to determine...

        7. 3.4. The manufacturer shall undertake to fulfil the obligations arising out ...

        8. 3.5. The manufacturer shall keep the notified body that has approved...

        9. 3.6. Each notified body shall inform its notifying authorities of quality...

        10. 4. Design examination

        11. 4.1. The manufacturer shall lodge an application for examination of the ...

        12. 4.2. The application shall make it possible to understand the design,...

        13. 4.3. The notified body shall examine the application, and where the...

        14. 4.4. The notified body shall keep itself apprised of any changes...

        15. 4.5. Each notified body shall inform its notifying authorities of the...

        16. 4.6. The manufacturer shall keep a copy of the EC design ...

        17. 5. Surveillance under the responsibility of the notified body

        18. 5.1. The purpose of surveillance is to make sure that the ...

        19. 5.2. The manufacturer shall, for assessment purposes, allow the notified body...

        20. 5.3. The notified body shall carry out periodic audits to make ...

        21. 5.4. In addition, the notified body may pay unexpected visits to ...

        22. 6. Conformity marking and declaration of conformity

        23. 6.1. The manufacturer shall affix the required conformity marking set out ...

        24. 6.2. The manufacturer shall draw up a written declaration of conformity...

        25. 7. The manufacturer shall, for a period ending at least 10...

        26. 8. Authorised representative

      17. TABLE: CONFORMITY ASSESSMENT PROCEDURES IN COMMUNITY LEGISLATION

    3. Expand +/Collapse -

      ANNEX III

      EC DECLARATION OF CONFORMITY

      1. 1. No … (unique identification of the product):

      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 product allowing traceability. It...

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

      6. 6. References to the relevant harmonised standards used or references to...

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

      8. 8. Additional information:

      9. Signed for and on behalf of: …………………………………

      10. (place and date of issue):

      11. (name, function) (signature):

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