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Introductory Text
CHAPTER I GENERAL PROVISIONS
Article 1.Subject matter and scope
Article 2.Definitions
Article 3.Essential requirements
Article 4.Provision of information on the compliance of combinations of radio equipment and software
Article 5.Registration of radio equipment types within some categories
Article 6.Making available on the market
Article 7.Putting into service and use
Article 8.Notification of radio interface specifications and assignment of radio equipment classes
Article 9.Free movement of radio equipment
CHAPTER II OBLIGATIONS OF ECONOMIC OPERATORS
Article 10.Obligations of manufacturers
Article 11.Authorised representatives
Article 12.Obligations of importers
Article 13.Obligations of distributors
Article 14.Cases in which obligations of manufacturers apply to importers and distributors
Article 15.Identification of economic operators
CHAPTER III CONFORMITY OF RADIO EQUIPMENT
Article 16.Presumption of conformity of radio equipment
Article 17.Conformity assessment procedures
Article 18.EU declaration of conformity
Article 19.General principles of the CE marking
Article 20.Rules and conditions for affixing the CE marking and the identification number of the notified body
Article 21.Technical documentation
CHAPTER IV NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
Article 22.Notification
Article 23.Notifying authorities
Article 24.Requirements relating to notifying authorities
Article 25.Information obligation on notifying authorities
Article 26.Requirements relating to notified bodies
Article 27.Presumption of conformity of notified bodies
Article 28.Subsidiaries of and subcontracting by notified bodies
Article 29.Application for notification
Article 30.Notification procedure
Article 31.Identification numbers and lists of notified bodies
Article 32.Changes to notifications
Article 33.Challenge of the competence of notified bodies
Article 34.Operational obligations of notified bodies
Article 35.Appeal against decisions of notified bodies
Article 36.Information obligation on notified bodies
Article 37.Exchange of experience
Article 38.Coordination of notified bodies
CHAPTER V UNION MARKET SURVEILLANCE, CONTROL OF RADIO EQUIPMENT ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE
Article 39.Union market surveillance and control of radio equipment entering the Union market
Article 40.Procedure for dealing with radio equipment presenting a risk at national level
Article 41.Union safeguard procedure
Article 42.Compliant radio equipment which presents a risk
Article 43.Formal non-compliance
CHAPTER VI DELEGATED ACTS AND IMPLEMENTING ACTS AND THE COMMITTEE
Article 44.Exercise of the delegation
Article 45.Committee procedure
CHAPTER VII FINAL AND TRANSITIONAL PROVISIONS
Article 46.Penalties
Article 47.Review and reporting
Article 48.Transitional provisions
Article 49.Transposition
Article 50.Repeal
Article 51.Entry into force
Article 52.Addressees
ANNEX I
EQUIPMENT NOT COVERED BY THIS DIRECTIVE
1. Radio equipment used by radio amateurs within the meaning of...
2. Marine equipment falling within the scope of Council Directive 96/98/EC....
3. The following aviation equipment, where that equipment falls within the...
4. Custom-built evaluation kits destined for professionals to be used solely...
ANNEX II
CONFORMITY ASSESSMENT MODULE A
INTERNAL PRODUCTION CONTROL
1. Internal production control is the conformity assessment procedure whereby the...
2. Technical documentation
3. Manufacturing
4. CE marking and EU declaration of conformity
4.1. The manufacturer shall affix the CE marking in accordance with...
4.2. The manufacturer shall draw up a written EU declaration of...
5. Authorised representative
ANNEX III
CONFORMITY ASSESSMENT MODULES B AND C
EU-TYPE EXAMINATION AND CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION...
Module B EU-type examination
1. EU-type examination is the part of a conformity assessment procedure...
2. EU-type examination shall be carried out by assessment of the...
3. The manufacturer shall lodge an application for EU-type examination with...
4. The notified body shall examine the technical documentation and supporting...
5. The notified body shall draw up an evaluation report that...
6. Where the type meets the requirements of this Directive that...
7. The notified body shall keep itself apprised of any changes...
8. Each notified body shall inform its notifying authority concerning the...
9. The manufacturer shall keep a copy of the EU-type examination...
10. The manufacturer's authorised representative may lodge the application referred to...
Module C Conformity to type based on internal production control
1. Conformity to type based on internal production control is the...
2. Manufacturing
3. CE marking and EU declaration of conformity
3.1. The manufacturer shall affix the CE marking in accordance with...
3.2. The manufacturer shall draw up a written EU declaration of...
4. Authorised representative
ANNEX IV
CONFORMITY ASSESSMENT MODULE H
CONFORMITY BASED ON FULL QUALITY ASSURANCE
1. Conformity based on full quality assurance is the conformity assessment...
2. Manufacturing
3. Quality system
3.1. The manufacturer shall lodge an application for assessment of his...
3.2. The quality system shall ensure compliance of the radio equipment...
3.3. The notified body shall assess the quality system to determine...
3.4. The manufacturer shall undertake to fulfil the obligations arising out...
3.5. The manufacturer shall keep the notified body that has approved...
4. Surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the...
4.2. The manufacturer shall, for assessment purposes, allow the notified body...
4.3. The notified body shall carry out periodic audits to make...
4.4. In addition, the notified body may pay unexpected visits to...
5. CE marking and EU declaration of conformity
5.1. The manufacturer shall affix the CE marking in accordance with...
5.2. The manufacturer shall draw up a written EU declaration of...
6. The manufacturer shall, for a period ending 10 years after...
7. Each notified body shall inform its notifying authority of quality...
8. Authorised representative
ANNEX V
CONTENTS OF TECHNICAL DOCUMENTATION
The technical documentation shall, wherever applicable, contain at least the...
a general description of the radio equipment including: photographs or...
ANNEX VI
EU DECLARATION OF CONFORMITY (No XXX)
1. Radio equipment (product, type, batch or serial number):
2. Name and address of the manufacturer or his authorised representative:...
3. This declaration of conformity is issued under the sole responsibility...
4. Object of the declaration (identification of the radio equipment allowing...
5. The object of the declaration described above is in conformity...
6. References to the relevant harmonised standards used or references to...
7. Where applicable, the notified body … (name, number) … performed...
8. Where applicable, description of accessories and components, including software, which...
9. Additional information:
ANNEX VII
SIMPLIFIED EU DECLARATION OF CONFORMITY
The simplified EU declaration of conformity referred to in Article...
Hereby, [Name of manufacturer] declares that the radio equipment type...
ANNEX VIII
CORRELATION TABLE
ATTACHMENTS
STATEMENT OF THE EUROPEAN PARLIAMENT