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Red Ec

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Custom Specially designed upon request to meet your business needs. Learn more. Such information shall result from a conformity assessment carried out in accordance with Article 17, and shall be given in the form of a statement of compliance which includes the elements set out in Annex VI.

Depending on the specific combinations of radio equipment and software, the information shall precisely identify the radio equipment and the software which have been assessed, and it shall be continuously updated.

The Commission shall be empowered to adopt delegated acts in accordance with Article 44 specifying which categories or classes of radio equipment are concerned by the requirement set out in paragraph 1 of this Article.

The Commission shall adopt implementing acts laying down the operational rules for making the information on compliance available for the categories and classes specified by the delegated acts adopted pursuant to paragraph 2 of this Article.

As from 12 June , manufacturers shall register radio equipment types within categories of radio equipment affected by a low level of compliance with the essential requirements set out in Article 3 within a central system referred to in paragraph 4 of this Article prior to radio equipment within those categories being placed on the market.

When registering such radio equipment types, manufacturers shall provide some, or where justified all, elements of the technical documentation listed in points a , d , e , f , g , h and i of Annex V.

The Commission shall allocate to each registered radio equipment type a registration number, which manufacturers shall affix on radio equipment placed on the market.

The Commission shall be empowered to adopt delegated acts in accordance with Article 44 specifying which categories of radio equipment are concerned by the requirement set out in paragraph 1 of this Article, and the elements of the technical documentation to be provided, taking into account the information on the compliance of radio equipment provided by Member States in accordance with Article 47 1 and following an evaluation of the risk of non-implementation of the essential requirements.

The Commission shall adopt implementing acts laying down the operational rules for registration and the operational rules for affixing the registration number on radio equipment for the categories specified by the delegated acts adopted pursuant to paragraph 2 of this Article.

The Commission shall make available a central system allowing manufacturers to register the required information. That system shall ensure appropriate control of access to information of confidential nature.

Following the date of application of a delegated act adopted pursuant to paragraph 2 of this Article, the reports prepared in accordance with Article 47 1 and 2 shall evaluate its impacts.

Member States shall take appropriate measures to ensure that radio equipment is made available on the market only if it complies with this Directive.

Member States shall allow the putting into service and use of radio equipment if it complies with this Directive when it is properly installed, maintained and used for its intended purpose.

Notification of radio interface specifications and assignment of radio equipment classes. The Commission shall adopt implementing acts establishing the equivalence between notified radio interfaces and assigning a radio equipment class, details of which shall be published in the Official Journal of the European Union.

Member States shall not impede, for reasons relating to aspects covered by this Directive, the making available on the market in their territory of radio equipment which complies with this Directive.

At trade fairs, exhibitions and similar events, Member States shall not create any obstacles to the display of radio equipment which does not comply with this Directive, provided that a visible sign clearly indicates that such radio equipment may not be made available on the market or put into service until it has been brought into conformity with this Directive.

Demonstration of radio equipment may only take place provided that adequate measures, as prescribed by Member States, have been taken to avoid harmful interference, electromagnetic disturbances and risk to the health or safety of persons or of domestic animals or to property.

When placing their radio equipment on the market, manufacturers shall ensure that it has been designed and manufactured in accordance with the essential requirements set out in Article 3.

Manufacturers shall ensure that radio equipment shall be so constructed that it can be operated in at least one Member State without infringing applicable requirements on the use of radio spectrum.

Manufacturers shall draw up the technical documentation referred to in Article 21 and carry out the relevant conformity assessment procedure referred to in Article 17 or have it carried out.

Where compliance of radio equipment with the applicable requirements has been demonstrated by that conformity assessment procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.

Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the radio equipment has been placed on the market.

Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Directive.

Changes in radio equipment design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which conformity of radio equipment is declared shall be adequately taken into account.

When deemed appropriate with regard to the risks presented by radio equipment, manufacturers shall, to protect the health and safety of end-users, carry out sample testing of radio equipment made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming radio equipment and radio equipment recalls, and shall keep distributors informed of any such monitoring.

Manufacturers shall ensure that radio equipment which they have placed on the market bears a type, batch or serial number or other element allowing its identification, or, where the size or nature of the radio equipment does not allow it, that the required information is provided on the packaging, or in a document accompanying the radio equipment.

Manufacturers shall indicate on the radio equipment their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where the size or nature of radio equipment does not allow it, on its packaging, or in a document accompanying the radio equipment.

The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and market surveillance authorities.

Manufacturers shall ensure that the radio equipment is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

Instructions shall include the information required to use radio equipment in accordance with its intended use.

Such information shall include, where applicable, a description of accessories and components, including software, which allow the radio equipment to operate as intended.

Such instructions and safety information, as well as any labelling, shall be clear, understandable and intelligible. The following information shall also be included in the case of radio equipment intentionally emitting radio waves:.

Manufacturers shall ensure that each item of radio equipment is accompanied by a copy of the EU declaration of conformity or by a simplified EU declaration of conformity.

Where a simplified EU declaration of conformity is provided, it shall contain the exact internet address where the full text of the EU declaration of conformity can be obtained.

In cases of restrictions on putting into service or of requirements for authorisation of use, information available on the packaging shall allow the identification of the Member States or the geographical area within a Member State where restrictions on putting into service or requirements for authorisation of use exist.

Such information shall be completed in the instructions accompanying the radio equipment. The Commission may adopt implementing acts specifying how to present that information.

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 45 2.

Manufacturers who consider or have reason to believe that radio equipment which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that radio equipment into conformity, to withdraw it or recall it, if appropriate.

Furthermore, where the radio equipment presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the radio equipment available on the market to that effect, giving details, in particular, of the non-compliance, of any corrective measures taken and of the results thereof.

Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the radio equipment with this Directive, in a language which can be easily understood by that authority.

They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by radio equipment which they have placed on the market.

A manufacturer may, by a written mandate, appoint an authorised representative. The obligations laid down in Article 10 1 and the obligation to draw up technical documentation laid down in Article 10 3 shall not form part of the authorised representative's mandate.

An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:.

Before placing radio equipment on the market importers shall ensure that the appropriate conformity assessment procedure referred to in Article 17 has been carried out by the manufacturer and that the radio equipment is so constructed that it can be operated in at least one Member State without infringing applicable requirements on the use of radio spectrum.

They shall ensure that the manufacturer has drawn up the technical documentation, that the radio equipment bears the CE marking and is accompanied by the information and documents referred to in Article 10 8 , 9 and 10 , and that the manufacturer has complied with the requirements set out in Article 10 6 and 7.

Where an importer considers or has reason to believe that radio equipment is not in conformity with the essential requirements set out in Article 3, he shall not place the radio equipment on the market until it has been brought into conformity.

Furthermore, where the radio equipment presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect.

Importers shall indicate on the radio equipment their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the radio equipment.

This includes cases where the size of radio equipment does not allow it, or where importers would have to open the packaging in order to indicate their name and address on the radio equipment.

Importers shall ensure that the radio equipment is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

Importers shall ensure that, while radio equipment is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential requirements set out in Article 3.

When deemed appropriate with regard to the risks presented by radio equipment, importers shall, to protect the health and safety of end-users, carry out sample testing of radio equipment made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming radio equipment and radio equipment recalls, and shall keep distributors informed of any such monitoring.

Importers who consider or have reason to believe that radio equipment which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that radio equipment into conformity, to withdraw it or recall it, if appropriate.

Furthermore, where the radio equipment presents a risk, importers shall immediately inform the competent national authorities of the Member States in which they made the radio equipment available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

Importers shall, for 10 years after the radio equipment has been placed on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.

Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of radio equipment in a language which can be easily understood by that authority.

When making radio equipment available on the market distributors shall act with due care in relation to the requirements of this Directive.

Before making radio equipment available on the market distributors shall verify that the radio equipment bears the CE marking, that it is accompanied by the documents required by this Directive and by the instructions and safety information in a language which can be easily understood by consumers and other end-users in the Member State in which the radio equipment is to be made available on the market, and that the manufacturer and the importer have complied with the requirements set out in Article 10 2 and 6 to 10 and Article 12 3 respectively.

Where a distributor considers or has reason to believe that radio equipment is not in conformity with the essential requirements set out in Article 3, he shall not make the radio equipment available on the market until it has been brought into conformity.

Furthermore, where the radio equipment presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities.

Distributors shall ensure that, while radio equipment is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential requirements set out in Article 3.

Distributors who consider or have reason to believe that radio equipment which they have made available on the market is not in conformity with this Directive shall make sure that the corrective measures necessary to bring that radio equipment into conformity, to withdraw it or recall it, if appropriate, are taken.

Furthermore, where the radio equipment presents a risk, distributors shall immediately inform the competent national authorities of the Member States in which they made the radio equipment available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of radio equipment.

They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by radio equipment which they have made available on the market.

An importer or distributor shall be considered a manufacturer for the purposes of this Directive and he shall be subject to the obligations of the manufacturer under Article 10, where he places radio equipment on the market under his name or trade mark or modifies radio equipment already placed on the market in such a way that compliance with this Directive may be affected.

Economic operators shall, on request, identify the following to the market surveillance authorities:. Economic operators shall be able to present the information referred to in the first paragraph for 10 years after they have been supplied with the radio equipment and for 10 years after they have supplied the radio equipment.

Radio equipment which is in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential requirements set out in Article 3 covered by those standards or parts thereof.

The manufacturer shall perform a conformity assessment of the radio equipment with a view to meeting the essential requirements set out in Article 3.

The conformity assessment shall take into account all intended operating conditions and, for the essential requirement set out in point a of Article 3 1 , the assessment shall also take into account the reasonably foreseeable conditions.

Where the radio equipment is capable of taking different configurations, the conformity assessment shall confirm whether the radio equipment meets the essential requirements set out in Article 3 in all possible configurations.

Manufacturers shall demonstrate compliance of radio equipment with the essential requirements set out in Article 3 1 using any of the following conformity assessment procedures:.

EU-type examination that is followed by the conformity to type based on internal production control set out in Annex III;. The EU declaration of conformity shall state that the fulfilment of the essential requirements set out in Article 3 has been demonstrated.

The EU declaration of conformity shall have the model structure set out in Annex VI, shall contain the elements set out in that Annex and shall be continuously updated.

It shall be translated into the language or languages required by the Member State in which the radio equipment is placed or made available on the market.

The simplified EU declaration of conformity referred to in Article 10 9 shall contain the elements set out in Annex VII and shall be continuously updated.

The full text of the EU declaration of conformity shall be available at the internet address referred to in the simplified EU declaration of conformity, in a language or languages required by the Member State in which the radio equipment is placed or made available on the market.

Where radio equipment is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts.

That declaration shall contain the identification of the Union acts concerned including their publication references.

By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the radio equipment with the requirements laid down in this Directive.

On account of the nature of radio equipment, the height of the CE marking affixed to radio equipment may be lower than 5 mm, provided that it remains visible and legible.

Rules and conditions for affixing the CE marking and the identification number of the notified body. The CE marking shall be affixed visibly, legibly and indelibly to the radio equipment or to its data plate, unless that is not possible or not warranted on account of the nature of radio equipment.

The CE marking shall also be affixed visibly and legibly to the packaging. The CE marking shall be affixed before the radio equipment is placed on the market.

The CE marking shall be followed by the identification number of the notified body where the conformity assessment procedure set out in Annex IV is applied.

The identification number of the notified body shall have the same height as the CE marking. The identification number of the notified body shall be affixed by the notified body itself or, under its instructions, by the manufacturer or his authorised representative.

Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.

The technical documentation shall contain all relevant data or details of the means used by the manufacturer to ensure that radio equipment complies with the essential requirements set out in Article 3.

It shall, at least, contain the elements set out in Annex V. The technical documentation shall be drawn up before radio equipment is placed on the market and shall be continuously updated.

The technical documentation and correspondence relating to any EU-type examination procedure shall be drawn up in an official language of the Member State in which the notified body is established or in a language acceptable to that body.

Where the technical documentation does not comply with paragraphs 1, 2 or 3 of this Article, and in so doing fails to present sufficient relevant data or means used to ensure compliance of radio equipment with the essential requirements set out in Article 3, the market surveillance authority may ask the manufacturer or the importer to have a test performed by a body acceptable to the market surveillance authority at the expense of the manufacturer or the importer within a specified period in order to verify compliance with the essential requirements set out in Article 3.

Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Directive.

Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with Article Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 to a body which is not a governmental entity, that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article In addition it shall have arrangements to cover liabilities arising out of its activities.

A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs.

A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.

A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment.

A notifying authority shall not offer or provide any activities that conformity assessment bodies perform or consultancy services on a commercial or competitive basis.

A notifying authority shall safeguard the confidentiality of the information it obtains. A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.

Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.

For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to A conformity assessment body shall be established under national law of a Member State and have legal personality.

A conformity assessment body shall be a third-party body independent of the organisation or the radio equipment it assesses. A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of radio equipment which it assesses may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.

A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the radio equipment which they assess, nor the representative of any of those parties.

This shall not preclude the use of assessed radio equipment that is necessary for the operations of the conformity assessment body or the use of such radio equipment for personal purposes.

A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of that radio equipment, or represent the parties engaged in those activities.

They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified.

This shall in particular apply to consultancy services. Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.

A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Annexes III and IV in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.

At all times and for each conformity assessment procedure and each kind or category of radio equipment in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:.

It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;.

A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner.

The personnel responsible for carrying out conformity assessment tasks shall have the following:. The impartiality of the conformity assessment bodies, their top level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.

The remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.

Conformity assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.

The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annexes III and IV or any provision of national law giving effect to them, except in relation to the competent authorities of the Member State in which its activities are carried out.

Proprietary rights shall be protected. Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities, the regulatory activities in the area of radio equipment and frequency planning, and the activities of the notified body coordination group established under the relevant Union harmonisation legislation and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.

Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union it shall be presumed to comply with the requirements set out in Article 26 in so far as the applicable harmonised standards cover those requirements.

Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 26 and shall inform the notifying authority accordingly.

Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.

Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client. Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annexes III and IV.

A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established.

The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the radio equipment for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article They shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission.

The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and the radio equipment concerned and the relevant attestation of competence.

Where a notification is not based on an accreditation certificate as referred to in Article 29 2 , the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body's competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used.

Only such a body shall be considered a notified body for the purposes of this Directive. The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the notification.

It shall assign a single such number even where the body is notified under several Union acts. The Commission shall make publicly available the list of the bodies notified under this Directive, including the identification numbers that have been assigned to them and the activities for which they have been notified.

Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 26, or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations.

It shall immediately inform the Commission and the other Member States accordingly. In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.

The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject.

The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned.

The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.

Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requesting the notifying Member State to take the necessary corrective measures, including withdrawal of notification if necessary.

That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 45 2. Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annexes III and IV.

Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators.

Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the radio equipment technology in question and the mass or serial nature of the production process.

In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the radio equipment with this Directive.

Where a notified body finds that the essential requirements set out in Article 3 or corresponding harmonised standards or other technical specifications have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue an EU-type examination certificate or a quality system approval.

Where, in the course of the monitoring of conformity following the issue of an EU-type examination certificate or a quality system approval, a notified body finds that radio equipment no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the EU-type examination certificate or the quality system approval if necessary.

Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any EU-type examination certificates or quality system approvals, as appropriate.

Member States shall ensure that an appeal procedure against decisions of the notified bodies is available. Notified bodies shall, in accordance with the requirements of Annexes III and IV, provide the other bodies notified under this Directive carrying out similar conformity assessment activities covering the same categories of radio equipment with relevant information on issues relating to negative and, on request, positive conformity assessment results.

The Commission shall provide for the organisation of exchange of experience between the Member States' national authorities responsible for notification policy.

The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Directive are put in place and properly operated in the form of a sectoral group of notified bodies.

Member States shall ensure that the bodies notified by them participate in the work of that group, directly or by means of designated representatives.

Union market surveillance and control of radio equipment entering the Union market. Where the market surveillance authorities of one Member State have sufficient reason to believe that radio equipment covered by this Directive presents a risk to the health or safety of persons or to other aspects of public interest protection covered by this Directive, they shall carry out an evaluation in relation to the radio equipment concerned covering all relevant requirements laid down in this Directive.

The relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose.

Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the radio equipment does not comply with the requirements laid down in this Directive, they shall without delay require the relevant economic operator to take all appropriate corrective actions to bring the radio equipment into compliance with those requirements, to withdraw the radio equipment from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe.

The market surveillance authorities shall inform the relevant notified body accordingly. Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.

The economic operator shall ensure that all appropriate corrective action is taken in respect of all radio equipment concerned that it has made available on the market throughout the Union.

Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the radio equipment being made available on their national market, to withdraw the radio equipment from that market or to recall it.

The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures. The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant radio equipment, the origin of the radio equipment, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.

In particular, the market surveillance authorities shall indicate whether the non-compliance is due to either of the following:.

Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the radio equipment concerned, and, in the event of disagreement with the adopted national measure, of their objections.

Where, within three months of receipt of the information referred to in the second subparagraph of paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.

Member States shall ensure that appropriate restrictive measures, such as withdrawal of the radio equipment from the market, are taken in respect of the radio equipment concerned without delay.

Where, on completion of the procedure set out in Article 40 3 and 4 , objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure.

On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified or not.

The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.

If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant radio equipment is withdrawn or recalled from their market, and shall inform the Commission accordingly.

If the national measure is considered unjustified, the Member State concerned shall withdraw that measure. Where, having carried out an evaluation under Article 40 1 , a Member State finds that although radio equipment is in compliance with this Directive, it presents a risk to the health or safety of persons or to other aspects of public interest protection covered by this Directive, it shall require the relevant economic operator to take all appropriate measures to ensure that the radio equipment concerned, when placed on the market, no longer presents that risk, to withdraw the radio equipment from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe.

The economic operator shall ensure that corrective action is taken in respect of all the radio equipment concerned that he has made available on the market throughout the Union.

That information shall include all available details, in particular the data necessary for the identification of the radio equipment concerned, the origin and the supply chain of radio equipment, the nature of the risk involved and the nature and duration of the national measures taken.

The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken.

On the basis of the results of that evaluation, the Commission shall decide by means of implementing acts whether the national measure is justified or not and, where necessary, propose appropriate measures.

The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 45 3.

On duly justified imperative grounds of urgency relating to the protection of health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 45 4.

Without prejudice to Article 40, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:.

Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit corresponding radio equipment being made available on the market or ensure that it is withdrawn or recalled from the market.

The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. The power to adopt delegated acts referred to in the second subparagraph of Articles 3 3 , 4 2 and 5 2 shall be conferred on the Commission for a period of five years from 11 June The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period.

The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

The delegation of power referred to in the second subparagraph of Articles 3 3 , 4 2 and 5 2 may be revoked at any time by the European Parliament or by the Council.

A decision to revoke shall put an end to the delegation of the power specified in that decision.

It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein.

It shall not affect the validity of any delegated acts already in force. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

A delegated act adopted pursuant to the second subparagraph of Articles 3 3 , 4 2 and 5 2 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.

That period shall be extended by two months at the initiative of the European Parliament or of the Council.

The committee may furthermore examine any other matter concerning the application of this Directive raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.

Member States shall lay down rules on penalties applicable to infringements by economic operators of the provisions of national law adopted pursuant to this Directive and shall take all measures necessary to ensure that they are enforced.

Such rules may include criminal penalties for serious infringements. Member States shall submit to the Commission regular reports on the application of this Directive by 12 June and at least every two years thereafter.

The reports shall contain a presentation of the market surveillance activities performed by the Member States and provide information on whether and to what extent compliance with the requirements of this Directive has been attained, including in particular requirements on identification of economic operators.

The Commission shall review the operation of this Directive and report thereon to the European Parliament and to the Council, by 12 June and every five years thereafter.

The report shall cover progress on drawing up the relevant standards, as well as any problems that have arisen in the course of implementation.

The report shall also outline the activities of the Telecommunication Conformity Assessment and Market Surveillance Committee, assess progress in achieving an open competitive market for radio equipment at Union level and examine how the regulatory framework for the making available on the market and putting into service of radio equipment should be developed in order to achieve the following:.

Member States shall not impede, for the aspects covered by this Directive, the making available on the market or putting into service of radio equipment covered by this Directive which is in conformity with the relevant Union harmonisation legislation applicable before 13 June and which was placed on the market before 13 June Member States shall adopt and publish, by 12 June , the laws, regulations and administrative provisions necessary to comply with this Directive.

They shall forthwith communicate the text of those measures to the Commission. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication.

They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directive repealed by this Directive shall be construed as references to this Directive.

Member States shall determine how such reference is to be made and how that statement is to be formulated. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex VIII.

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Radio equipment used by radio amateurs within the meaning of Article 1, definition 56, of the International Telecommunications Union ITU Radio Regulations, unless the equipment is made available on the market.

Custom-built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.

Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4 of this Annex, and ensures and declares on his sole responsibility that the radio equipment concerned satisfies the essential requirements set out in Article 3.

The manufacturer shall establish the technical documentation in accordance with Article The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured radio equipment with the technical documentation referred to in point 2 of this Annex and with the relevant essential requirements set out in Article 3.

CE marking and EU declaration of conformity. The manufacturer shall affix the CE marking in accordance with Articles 19 and 20 to each item of radio equipment that satisfies the applicable requirements of this Directive.

The manufacturer shall draw up a written EU declaration of conformity for each radio equipment type and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the radio equipment has been placed on the market.

The EU declaration of conformity shall identify the radio equipment for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

The manufacturer's obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

When reference is made to this Annex, the conformity assessment procedure shall follow Modules B EU-type examination and C Conformity to type based on internal production control of this Annex.

EU-type examination. EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of the radio equipment and verifies and attests that the technical design of the radio equipment meets the essential requirements set out in Article 3.

EU-type examination shall be carried out by assessment of the adequacy of the technical design of the radio equipment through examination of the technical documentation and supporting evidence referred to in point 3, without examination of a specimen design type.

The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice. The technical documentation shall make it possible to assess the radio equipment's conformity with the applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk s.

The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the radio equipment.

The technical documentation shall contain, wherever applicable, the elements set out in Annex V;. That supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards have not been applied or have not been fully applied.

The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

The notified body shall examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the radio equipment.

The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations as provided in point 8, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

Where the type meets the requirements of this Directive that apply to the radio equipment concerned, the notified body shall issue an EU-type examination certificate to the manufacturer.

That certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the aspects of the essential requirements covered by the examination, the conditions if any for its validity and the necessary data for identification of the assessed type.

The EU-type examination certificate may have one or more annexes attached.

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