Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (Text with EEA relevance) (c. 53)

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1. Introductory Text

2. CHAPTER I GENERAL PROVISIONS

   1. Article 1. Subject matter and scope

   2. Article 2. Definitions

   3. Article 3. Essential requirements

   4. Article 4. Provision of information on the compliance of combinations of radio equipment and software

   5. Article 5. Registration of radio equipment types within some categories

   6. Article 6. Making available on the market

   7. Article 7. Putting into service and use

   8. Article 8. Notification of radio interface specifications and assignment of radio equipment classes

   9. Article 9. Free movement of radio equipment

3. CHAPTER II OBLIGATIONS OF ECONOMIC OPERATORS

   1. Article 10. Obligations of manufacturers

   2. Article 11. Authorised representatives

   3. Article 12. Obligations of importers

   4. Article 13. Obligations of distributors

   5. Article 14. Cases in which obligations of manufacturers apply to importers and distributors

   6. Article 15. Identification of economic operators

4. CHAPTER III CONFORMITY OF RADIO EQUIPMENT

   1. Article 16. Presumption of conformity of radio equipment

   2. Article 17. Conformity assessment procedures

   3. Article 18. EU declaration of conformity

   4. Article 19. General principles of the CE marking

   5. Article 20. Rules and conditions for affixing the CE marking and the identification number of the notified body

   6. Article 21. Technical documentation

5. CHAPTER IV NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

   1. Article 22. Notification

   2. Article 23. Notifying authorities

   3. Article 24. Requirements relating to notifying authorities

   4. Article 25. Information obligation on notifying authorities

   5. Article 26. Requirements relating to notified bodies

   6. Article 27. Presumption of conformity of notified bodies

   7. Article 28. Subsidiaries of and subcontracting by notified bodies

   8. Article 29. Application for notification

   9. Article 30. Notification procedure

   10. Article 31. Identification numbers and lists of notified bodies

   11. Article 32. Changes to notifications

   12. Article 33. Challenge of the competence of notified bodies

   13. Article 34. Operational obligations of notified bodies

   14. Article 35. Appeal against decisions of notified bodies

   15. Article 36. Information obligation on notified bodies

   16. Article 37. Exchange of experience

   17. Article 38. Coordination of notified bodies

6. CHAPTER V UNION MARKET SURVEILLANCE, CONTROL OF RADIO EQUIPMENT ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE

   1. Article 39. Union market surveillance and control of radio equipment entering the Union market

   2. Article 40. Procedure for dealing with radio equipment presenting a risk at national level

   3. Article 41. Union safeguard procedure

   4. Article 42. Compliant radio equipment which presents a risk

   5. Article 43. Formal non-compliance

7. CHAPTER VI DELEGATED ACTS AND IMPLEMENTING ACTS AND THE COMMITTEE

   1. Article 44. Exercise of the delegation

   2. Article 45. Committee procedure

8. CHAPTER VII FINAL AND TRANSITIONAL PROVISIONS

   1. Article 46. Penalties

   2. Article 47. Review and reporting

   3. Article 48. Transitional provisions

   4. Article 49. Transposition

   5. Article 50. Repeal

   6. Article 51. Entry into force

   7. Article 52. Addressees

9. 1. ANNEX I

      EQUIPMENT NOT COVERED BY THIS DIRECTIVE

      1. 1. Radio equipment used by radio amateurs within the meaning of...

      2. 2. Marine equipment falling within the scope of Council Directive 96/98/EC....

      3. 3. The following aviation equipment, where that equipment falls within the...

      4. 4. Custom-built evaluation kits destined for professionals to be used solely...

   2. ANNEX II

      CONFORMITY ASSESSMENT MODULE A

      1. INTERNAL PRODUCTION CONTROL

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

         2. 2. Technical documentation

         3. 3. Manufacturing

         4. 4. CE marking and EU declaration of conformity

            1. 4.1. The manufacturer shall affix the CE marking in accordance with...

            2. 4.2. The manufacturer shall draw up a written EU declaration of...

         5. 5. Authorised representative

   3. ANNEX III

      CONFORMITY ASSESSMENT MODULES B AND C

      1. EU-TYPE EXAMINATION AND CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION...

         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 and supporting...

            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. 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 in accordance with...

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

            4. 4. Authorised representative

   4. ANNEX IV

      CONFORMITY ASSESSMENT MODULE H

      1. 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

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

            2. 3.2. The quality system shall ensure compliance of the radio equipment...

            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. CE marking and EU declaration of conformity

            1. 5.1. The manufacturer shall affix the CE marking in accordance with...

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

         6. 6. The manufacturer shall, for a period ending 10 years after...

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

         8. 8. Authorised representative

   5. ANNEX V

      CONTENTS OF TECHNICAL DOCUMENTATION

      1. The technical documentation shall, wherever applicable, contain at least the...

      2. a general description of the radio equipment including: photographs or...

   6. ANNEX VI

      EU DECLARATION OF CONFORMITY (No XXX)

      1. 1. Radio equipment (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 the radio equipment allowing...

      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. Where applicable, description of accessories and components, including software, which...

      9. 9. Additional information:

   7. ANNEX VII

      SIMPLIFIED EU DECLARATION OF CONFORMITY

      1. The simplified EU declaration of conformity referred to in Article...

      2. Hereby, [Name of manufacturer] declares that the radio equipment type...

   8. ANNEX VIII

      CORRELATION TABLE

10. ATTACHMENTS

    1. STATEMENT OF THE EUROPEAN PARLIAMENT