Directive 1999/5/EC of the European Parliament and of the Council (3) has been substantially amended several times. Since further amendments are to be made, it should be replaced in the interests of clarity.
(2)
Regulation (EC) No 765/2008 of the European Parliament and of the Council (4) lays down rules on the accreditation of conformity assessment bodies, provides a framework for the market surveillance of products and for controls on products from third countries, and lays down the general principles of the CE marking.
(3)
Decision No 768/2008/EC of the European Parliament and of the Council (5) lays down common principles and reference provisions intended to apply across sectoral legislation in order to provide a coherent basis for revision or recasts of that legislation. Directive 1999/5/EC should therefore be adapted to that Decision.
(4)
The essential requirements laid down in Directive 1999/5/EC which are relevant to fixed-line terminal equipment, i.e. to ensure the protection of health and safety of persons and of domestic animals and the protection of property and an adequate level of electromagnetic compatibility, are appropriately covered by Directive 2014/35/EU of the European Parliament and of the Council (6) and Directive 2014/30/EU of the European Parliament and of the Council (7). This Directive should therefore not apply to fixed-line terminal equipment.
(5)
Competition issues in the market for terminal equipment are appropriately covered by Commission Directive 2008/63/EC (8), in particular through the obligation for national regulatory authorities to ensure the publication of details of technical interface specifications for network access. It is therefore not necessary to include in this Directive requirements facilitating competition in the market for terminal equipment covered by Directive 2008/63/EC.
(6)
Equipment which intentionally emits or receives radio waves for the purpose of radio communication or radiodetermination makes systematic use of radio spectrum. In order to ensure an efficient use of radio spectrum so as to avoid harmful interference, all such equipment should fall within the scope of this Directive.
(7)
The objectives with respect to safety requirements laid down in Directive 2014/35/EU are sufficient to cover radio equipment, and should therefore be the reference and made applicable by virtue of this Directive. In order to avoid unnecessary duplications of provisions other than those concerning such requirements, Directive 2014/35/EU should not apply to radio equipment.
(8)
The essential requirements in the area of electromagnetic compatibility laid down by Directive 2014/30/EU are sufficient to cover radio equipment, and should therefore be the reference and made applicable by virtue of this Directive. In order to avoid unnecessary duplications of provisions other than those concerning essential requirements, Directive 2014/30/EU should not apply to radio equipment.
(9)
This Directive should apply to all forms of supply, including distance selling.
(10)
In order to ensure that radio equipment uses the radio spectrum effectively and supports the efficient use of radio spectrum, radio equipment should be constructed so that: in the case of a transmitter, when the transmitter is properly installed, maintained and used for its intended purpose it generates radio waves emissions that do not create harmful interference, while unwanted radio waves emissions generated by the transmitter (e.g. in adjacent channels) with a potential negative impact on the goals of radio spectrum policy should be limited to such a level that, according to the state of the art, harmful interference is avoided; and, in the case of a receiver, it has a level of performance that allows it to operate as intended and protects it against the risk of harmful interference, in particular from shared or adjacent channels, and, in so doing, supports improvements in the efficient use of shared or adjacent channels.
(11)
Although receivers do not themselves cause harmful interference, reception capabilities are an increasingly important factor in ensuring the efficient use of radio spectrum by way of an increased resilience of receivers against harmful interference and unwanted signals on the basis of the relevant essential requirements of Union harmonisation legislation.
(12)
Interworking via networks with other radio equipment and connection with interfaces of the appropriate type throughout the Union is necessary in some cases. Interoperability between radio equipment and accessories such as chargers simplifies the use of radio equipment and reduces unnecessary waste and costs. A renewed effort to develop a common charger for particular categories or classes of radio equipment is necessary, in particular for the benefit of consumers and other end-users; this Directive should therefore include specific requirements in that area. In particular, mobile phones that are made available on the market should be compatible with a common charger.
(13)
The protection of personal data and privacy of users and of subscribers of radio equipment and the protection from fraud may be enhanced by particular features of radio equipment. Radio equipment should therefore in appropriate cases be designed in such a way that it supports those features.
(14)
Radio equipment can be instrumental in providing access to emergency services. Radio equipment should therefore in appropriate cases be designed in such a way that it supports the features required for access to those services.
(15)
Radio equipment is important to the well-being and employment of people with disabilities, who represent a substantial and growing proportion of the population of Member States. Radio equipment should therefore in appropriate cases be designed in such a way that people with disabilities may use it without or with only minimal adaptation.
(16)
The compliance of some categories of radio equipment with the essential requirements set out in this Directive may be affected by the inclusion of software or modification of its existing software. The user, the radio equipment or a third party should only be able to load software into the radio equipment where this does not compromise the subsequent compliance of that radio equipment with the applicable essential requirements.
(17)
In order to supplement or amend certain non-essential elements of this Directive, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
(18)
In order to effectively address the needs related to interoperability, protection of personal data and privacy of the user and of the subscriber, protection from fraud, access to emergency services, use by users with a disability or the prevention of non-compliant combinations of radio equipment and software, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the specification of categories or classes of radio equipment that have to comply with one or more of the additional essential requirements set out in this Directive which address those needs.
(19)
Verification by radio equipment of the compliance of its combination with software should not be abused in order to prevent its use with software provided by independent parties. The availability to public authorities, manufacturers and users of information on the compliance of intended combinations of radio equipment and software should contribute to facilitate competition. In order to achieve those objectives, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the specification of categories or classes of radio equipment for which manufacturers have to provide information on the compliance of intended combinations of radio equipment and software with the essential requirements set out in this Directive.
(20)
A requirement to register in a central system radio equipment to be placed on the market may enhance the efficiency and effectiveness of market surveillance and thereby contribute to ensuring a high level of compliance with this Directive. Such a requirement entails additional burden to economic operators and should therefore be introduced only for those categories of radio equipment where a high level of compliance has not been attained. In order to ensure the application of such a requirement, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the specification of the categories of radio equipment which manufacturers have to register within a central system and the elements of the technical documentation to be provided on the basis of the information on the compliance of radio equipment to be provided by Member States and following an evaluation of the risk of non-implementation of the essential requirements.
(21)
Radio equipment which complies with the relevant essential requirements should be allowed to circulate freely. Such equipment should be allowed to be put into service and used for its intended purpose, where applicable in accordance with rules on authorisations for the use of radio spectrum and the provision of the service concerned.
(22)
In order to avoid unnecessary barriers to trade in radio equipment within the internal market, Member States should notify, under Directive 98/34/EC of the European Parliament and of the Council (9), other Member States and the Commission of their projects in the area of technical regulations, such as radio interfaces, unless those technical regulations allow Member States to comply with binding Union acts such as Commission decisions on the harmonised use of radio spectrum adopted under Decision No 676/2002/EC of the European Parliament and of the Council (10), or where they correspond to radio equipment which can be put into service and used without restrictions within the Union.
(23)
The provision of information on the equivalence of regulated radio interfaces and their conditions of use reduces barriers for the access of radio equipment to the internal market. The Commission should therefore assess and establish the equivalence of regulated radio interfaces and make such information available in the form of radio equipment classes.
(24)
In accordance with Commission Decision 2007/344/EC (11), Member States are to use the Frequency Information System (EFIS) of the European Communications Office (ECO) in order to make comparable information regarding the use of radio spectrum in each Member State available to the public via the internet. Manufacturers can search in EFIS frequency information for all Member States prior to the placing on the market of radio equipment and thereby evaluate whether and under which conditions such radio equipment may be used within each Member State. There is therefore no need to include in this Directive additional provisions, such as prior notification, allowing manufacturers to be informed of the conditions of use of radio equipment using non-harmonised frequency bands.
(25)
For the purpose of promotion of research and demonstration activities it should be possible, in the context of trade fairs, exhibitions and similar events, to display radio equipment which does not comply with this Directive and cannot be placed on the market, on the condition that exhibitors ensure that sufficient information is provided to the visiting public.
(26)
Economic operators should be responsible for the compliance of radio equipment with this Directive, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of health and safety of persons and of domestic animals, and the protection of property, an adequate level of electromagnetic compatibility, an effective and efficient use of radio spectrum and, where necessary, a high level of protection of other public interests, and to guarantee fair competition on the Union market.
(27)
All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they only make available on the market radio equipment which is in conformity with this Directive. It is necessary to provide for a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution chain.
(28)
In order to facilitate communication between economic operators, market surveillance authorities and consumers, Member States should encourage economic operators to include a website address in addition to the postal address.
(29)
The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure. Conformity assessment should therefore remain solely the obligation of the manufacturer.
(30)
The manufacturer should provide sufficient information on the intended use of the radio equipment so as to allow its use in compliance with the essential requirements. Such information may need to include a description of accessories such as antennas and of components such as software, and specifications of the installation process of the radio equipment.
(31)
The requirement laid down in Directive 1999/5/EC to include an EU declaration of conformity with equipment has been found to simplify and to enhance the information and the efficiency of market surveillance. The possibility to provide a simplified EU declaration of conformity has allowed the burden associated with this requirement to be reduced without reduction of its effectiveness, and should therefore be provided for within this Directive. Furthermore, in order to ensure easy and efficient access to an EU declaration of conformity, including a simplified EU declaration of conformity, it should be possible to affix it to the packaging of the radio equipment concerned.
(32)
It is necessary to ensure that radio equipment from third countries entering the Union market complies with this Directive, and in particular that appropriate conformity assessment procedures have been carried out by manufacturers with regard to that radio equipment. Provision should therefore be made for importers to make sure that the radio equipment they place on the market complies with the requirements of this Directive and that they do not place on the market radio equipment which does not comply with such requirements or presents a risk. Provision should also be made for importers to make sure that conformity assessment procedures have been carried out and that marking of radio equipment and documentation drawn up by manufacturers are available for inspection by the competent national authorities.
(33)
When placing radio equipment on the market, every importer should indicate on the radio equipment his name, registered trade name or registered trade mark and the postal address at which he can be contacted. Exceptions should be provided for in cases where the size or nature of the radio equipment does not allow it. This includes cases where the importer would have to open the packaging in order to put his name and address on the radio equipment.
(34)
The distributor makes radio equipment available on the market after it has been placed on the market by the manufacturer or the importer and should act with due care to ensure that its handling of the radio equipment does not adversely affect the compliance of the radio equipment.
(35)
Any economic operator that either places radio equipment on the market under his own name or trade mark or modifies radio equipment in such a way that compliance with this Directive may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.
(36)
Distributors and importers, being close to the market place, should be involved in market surveillance tasks carried out by the competent national authorities, and should be prepared to participate actively, providing those authorities with all necessary information relating to the radio equipment concerned.
(37)
Ensuring traceability of radio equipment throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities' task of tracing economic operators who made non-compliant radio equipment available on the market. When keeping the information required under this Directive for the identification of other economic operators, economic operators should not be required to update such information in respect of other economic operators who have either supplied them with radio equipment or to whom they have supplied radio equipment.
(38)
This Directive should be limited to the expression of essential requirements. In order to facilitate conformity assessment with those requirements it is necessary to provide for a presumption of conformity for radio equipment which is in conformity with harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council (12) for the purpose of expressing detailed technical specifications of those requirements.
(39)
Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised standards where those standards do not entirely satisfy the requirements of this Directive.
(40)
In order to enable economic operators to demonstrate and the competent authorities to ensure that radio equipment made available on the market conforms to the essential requirements, it is necessary to provide for conformity assessment procedures. Decision No 768/2008/EC establishes modules for conformity assessment procedures, which include procedures from the least to the most stringent, in proportion to the level of risk involved and the level of safety required. In order to ensure inter-sectoral coherence and to avoid ad-hoc variants, conformity assessment procedures should be chosen from among those modules.
(41)
Manufacturers should draw up an EU declaration of conformity to provide information required under this Directive on the conformity of radio equipment with the requirements of this Directive and of the other relevant Union harmonisation legislation.
(42)
To ensure effective access to information for market surveillance purposes, the information required to identify all applicable Union acts should be available in a single EU declaration of conformity. In order to reduce the administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up of relevant individual declarations of conformity.
(43)
The CE marking, indicating the conformity of radio equipment, is the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking are set out in Regulation (EC) No 765/2008. Rules governing the affixing of the CE marking should be laid down in this Directive.
(44)
The requirement to affix the CE marking on products is important for the information of consumers and public authorities. The possibility laid down in Directive 1999/5/EC to affix a reduced CE mark on small-sized equipment, provided that it remains visible and legible, has allowed the application of that requirement to be simplified without reducing its effectiveness, and should therefore be included in this Directive.
(45)
The requirement laid down in Directive 1999/5/EC to affix the CE marking on the packaging of equipment has been found to simplify the task of market surveillance, and should therefore be included in this Directive.
(46)
Member States should take appropriate measures to ensure that radio equipment may be made available on the market only if, when properly installed and maintained and used for its intended purpose, it complies with the essential requirements set out in this Directive, and, in the case of the essential requirement to ensure the protection of the health and safety of persons and of domestic animals and the protection of property, also under conditions of use which can be reasonably foreseen. Radio equipment should be considered as non-compliant with that essential requirement only under conditions of use which can be reasonably foreseen, that is when such use could result from lawful and readily predictable human behaviour.
(47)
In view of the rapid pace of technological change towards a paperless environment, where radio equipment is fitted with an integral screen, the Commission should examine, as part of a review of the operation of this Directive, the feasibility of replacing the requirements for affixing: the manufacturer's name, registered trade name or registered trade mark and a single point or postal address at which they can be contacted, CE marking and EU declaration of conformity with either a function whereby such information is automatically displayed upon starting up the radio equipment, or a function allowing the end-user to select the display of the relevant information. Furthermore, as part of that examination of feasibility, where radio equipment fitted with an integral screen operates from an integral battery which does not hold an initial charge, the Commission should also consider the use of removable transparent integral screen covering labels which would display the same information.
(48)
Certain conformity assessment procedures set out in this Directive require the intervention of conformity assessment bodies, which are notified by the Member States to the Commission.
(49)
Experience has shown that the criteria set out in Directive 1999/5/EC that conformity assessment bodies have to fulfil to be notified to the Commission are not sufficient to ensure a uniformly high level of performance of notified bodies throughout the Union. It is, however, essential that all notified bodies perform their functions to the same level and under conditions of fair competition. That requires the setting of obligatory requirements for conformity assessment bodies wishing to be notified in order to provide conformity assessment services.
(50)
If a conformity assessment body demonstrates conformity with the criteria laid down in harmonised standards, it should be presumed to comply with the corresponding requirements set out in this Directive.
(51)
In order to ensure a consistent level of conformity assessment quality it is also necessary to set requirements for notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies.
(52)
The system set out in this Directive should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008. Since accreditation is an essential means of verifying the competence of conformity assessment bodies, it should also be used for the purposes of notification.
(53)
Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in conformity certificates, should be considered by the national public authorities throughout the Union as the preferred means of demonstrating the technical competence of conformity assessment bodies. However, national authorities may consider that they possess the appropriate means of carrying out that evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements.
(54)
Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for radio equipment to be placed on the Union market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment of the competence and the performance of bodies to be notified and the monitoring of bodies already notified cover also activities carried out by subcontractors and subsidiaries.
(55)
It is necessary to increase the efficiency and transparency of the notification procedure and, in particular, to adapt it to new technologies so as to enable online notification.
(56)
Since notified bodies may offer their services throughout the Union, it is appropriate to give the other Member States and the Commission the opportunity to raise objections concerning a notified body. It is therefore important to provide for a period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before they start operating as notified bodies.
(57)
In the interests of competitiveness, it is crucial that notified bodies apply the conformity assessment procedures without creating unnecessary burdens for economic operators. For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That can best be achieved through appropriate coordination and cooperation between notified bodies.
(58)
In order to ensure legal certainty, it is necessary to clarify that rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to radio equipment covered by this Directive. This Directive should not prevent Member States from choosing the competent authorities to carry out those tasks.
(59)
Directive 1999/5/EC already provides for a safeguard procedure which applies only in the event of disagreement between Member States over measures taken by a Member State. In order to increase transparency and to reduce processing time, it is necessary to improve the existing safeguard procedure, with a view to making it more efficient and drawing on the expertise available in Member States.
(60)
The decisions of the Commission adopted under Decision No 676/2002/EC may include conditions for the availability and efficient use of radio spectrum which may have as a consequence the limitation of the total number of items of radio equipment put into service, such as a ‘sunset’ date, a maximum penetration rate or a maximum number of items of radio equipment in each Member State or throughout the Union. Those conditions enable the market to be opened up to new radio equipment while limiting the risk of harmful interference by accumulation of an excessive number of items of radio equipment put into service, even though that equipment individually complies with the essential requirements set out in this Directive. Infringing such conditions may create a risk to the essential requirements, particularly a risk of harmful interference.
(61)
The existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to radio equipment presenting a risk to the health or safety of persons or to other aspects of public interest protection covered by this Directive. It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an earlier stage in respect of such equipment.
(62)
Where the Member States and the Commission agree as to the justification of a measure taken by a Member State, no further involvement of the Commission should be required, except where non-compliance can be attributed to shortcomings of a harmonised standard.
(63)
In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (13).
(64)
The advisory procedure should be used for the adoption of implementing acts specifying how to present information in cases of restrictions on putting into service or of existing requirements for authorisation of use; and requesting the notifying Member State to take the necessary corrective measures in respect of a notified body that does not meet or no longer meets the requirements for its notification.
(65)
The examination procedure should be used for the adoption of implementing acts: determining whether certain categories of electrical or electronic products meet the definition of ‘radio equipment’; laying down the operational rules for making the information on compliance available; laying down the operational rules for registration and the operational rules for affixing the registration number on radio equipment; and establishing the equivalence between notified radio interfaces and assigning a radio equipment class. It should also be used with respect to compliant radio equipment which presents a risk to the health or safety of persons or to other aspects of public interest protection.
(66)
The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to compliant radio equipment which presents a risk to the health or safety of persons, imperative grounds of urgency so require.
(67)
In line with established practice, the committee set up by this Directive can play a useful role in examining matters 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.
(68)
When matters relating to this Directive, other than its implementation or infringements, are being examined, i.e. in a Commission expert group, the European Parliament should in line with existing practice receive full information and documentation and, where appropriate, an invitation to attend such meetings.
(69)
The Commission should, by means of implementing acts and, given their special nature, acting without the application of Regulation (EU) No 182/2011, determine whether measures taken by Member States in respect of non-compliant radio equipment are justified or not.
(70)
The Member States should lay down rules on penalties applicable to infringements of the provisions of national law adopted pursuant to this Directive and ensure that those rules are enforced. The penalties provided for should be effective, proportionate and dissuasive.
(71)
It is necessary to provide for transitional arrangements that allow the making available on the market and putting into service of radio equipment that has already been placed on the market in accordance with Directive 1999/5/EC.
(72)
The European Data Protection Supervisor has been consulted.
(73)
Since the objective of this Directive, namely to ensure that radio equipment made available on the market fulfils requirements providing a high level of protection of health and safety, adequate level of electromagnetic compatibility and an effective and efficient use of radio spectrum so as to avoid harmful interference while guaranteeing the proper functioning of the internal market, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.
(74)
Directive 1999/5/EC should be repealed.
(75)
In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (14), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified,
