Slovak republic
Telecommunications Office of the Slovak Republic
Telekomunikačný úrad Slovenskej republiky

ORDER OF THE GOVERNMENT
of the Slovak Republic

of 19 September 2001

setting details of technical requirements and on conformity assessment procedures for radio and telecommunications terminal equipment

According to § 9 clause 3 and § 12 clause 5 of the Act No. 264/1999 Coll. on technical requirements for products and on conformity assessment and on change and amendment of some Acts (hereinafter referred to only as „the Act“), the Government of the Slovak Republic decrees as follows:

§ 1

  1. According to § 9 clause 1 of the Act, the following shall belong to the group of determined products „radio equipment and telecommunications terminal equipment“:
    1. radio equipment,
    2. telecommunications terminal equipment,
    3. equipment, which is at the same time both radio equipment and telecommunications terminal equipment.
  2. Into the group of determined products referred to in clause 1 letter a) up to c) (hereinafter only „apparatus“) do not belong equipment listed in Annex 1 and apparatus exclusively used for the State defence purposes, for the protection of classified materials according to a special regulation,[1]) for fulfilment of responsibilities of the Armed Forces, the Military Intelligence and the Slovak Information Service, and for safety purposes of the Police Corps.

§ 2

For the purpose of this Order it is understood:

  1. radio equipment means a product, or technical part thereof, capable of communication by means of the emission and/or reception of radio waves utilising the spectrum allocated to terrestrial or space radiocommunication,
  2. telecommunications terminal equipment means a product or a technical part thereof enabling communication which is intended to be connected directly or indirectly by any means whatsoever to interfaces of public telecommunications networks,[2])
  3. radio waves means electromagnetic waves of frequencies from 9 kHz to 3 000 GHz propagated in space without artificial guide,
  4. interface means a network termination point which is a physical connection point at which a user is provided with access to public telecommunications network, or an air interface specifying the radio path between radio equipment, and their technical specifications,
  5. equipment class means a class identifying particular types of apparatus which are considered similar and those interfaces for which the apparatus is designed; apparatus may belong to more than one equipment class,
  6. harmful interference means electromagnetic interference which endangers the functioning of a radionavigation service or of other safety services or which otherwise seriously degrades, obstructs or repeatedly interrupts radiocommunications service operated in accordance with a special regulation [3]),
  7. equipment using frequency bands whose use is not harmonised with use within the European Communities means all radio equipment except those which:
    1. do not transmit, or
    2. can transmit only under the control of a network, or
    3. use a frequency band which is allocated to the same radio interface both in the Slovak Republic and in all Member States of the European Communities in the following way:
      1. there is a common frequency allocation,
      2. within this allocation, the allotment and/or assignment of radio frequencies or radio frequency channels follows a common plan or arrangement, and
      3. the equipment satisfies common parameters (e.g. frequency, power, duty cycle, bandwidth, etc.).

§ 3

  1. Apparatus can be placed on the market or put into operation according to intended purpose of use on the proviso that it has been designed and manufactured in such a way, that after correct installation, maintenance and application for intended purpose it does not jeopardise justified concern according to § 1 letter a) of the Act and provided that
    1. without limiting the applied voltage range it satisfies the technical requirements according to a special regulation,[4])
    2. with respect to the electromagnetic compatibility it satisfies the technical requirements according to a special regulation.[5])
  2. Radio equipment shall be produced only in that manner that in addition to the fulfilment of the requirements referred to in clause 1 it effectively uses the spectrum allocated to terrestrial/space radiocommunication and orbital resources so as not to create harmful interference.
  3. At the design of those apparatus, the list of which is published by the Telecommunication Office of the Slovak Republic (hereinafter only „the Office“) in Bulletin of the Ministry of Transport, Posts and Telecommunication of the Slovak Republic (hereinafter only „the Ministry“), the manufacturer shall assure that in addition to the requirements referred to in clauses 1 and 2, the apparatus meets at least one of the following requirements:
    1. it is capable of interworking via networks with other apparatus and it can be connected to interfaces of the appropriate type,
    2. it does not harm the network or its functioning nor misuse network resources, thereby causing unacceptable degradation of service,
    3. it incorporates safeguards to ensure that the personal data and privacy of the user and of the subscriber are protected,
    4. it supports certain features ensuring protection from fraud,
    5. it supports certain features ensuring access to emergency services,
    6. it supports certain features in order to facilitate its use by persons with a disability.

§ 4

Providing that the technical requirements referred to in § 3 are concretised by the harmonised technical standards according to § 5 clause 5 of the Act, which apply to them, or by parts thereof, and properties of the apparatus comply with them, in accordance with § 7 clause 2 of the Act the technical requirements are considered to be met.

§ 5

  1. Prior to placing the apparatus on the market the manufacturer or importer shall assess, pursuant to § 12 of the Act, the conformity of apparatus with the technical requirements referred to in § 3 using one of the following procedures:
    1. the compliance of telecommunications terminal equipment which do not make use of the spectrum allocated to terrestrial/space radiocommunication and receiving parts of radio equipment shall be assessed by any one of the procedures described in Annexes 2, 4 or 5,
    2. where a manufacturer has applied the harmonised technical standards, the compliance of radio equipment, except for the radio equipment referred to in letter a) shall be assessed by any one of the procedures described in Annexes 3, 4 or 5,
    3. where a manufacturer has not applied the harmonised technical standards or has applied them only in part, the compliance of radio equipment, except for the radio equipment referred to in letter a) shall be assessed by any one of the procedures described in Annexes 4 or 5.
  2. Where the apparatus is also within the scope of special technical regulations,[6]) the compliance of the apparatus with the requirements referred to in § 3 clause 1 letter a) and b) may be alternatively assessed by means of the procedures according to these regulations.
  3. Documentation relating to the conformity assessment procedure used according to clause 1 shall be kept by the manufacturer or by the importer in the official language [7]) or in the language agreed upon with the authorised body involved.
  4. The manufacturer or importer before placing the apparatus on the market shall draw up the declaration of conformity [8]) according to § 10 and shall affix to each apparatus the Slovak conformity mark.[9]) Provided that the procedures according to Annexes 3, 4 or 5 has been used, the marking shall be accompanied with the identification code of the authorised body involved.
  5. The manufacturer or the importer shall provide the user together with the declaration of conformity 8 ) according to § 10 with information on the intended use of the apparatus. Where it concerns telecommunications terminal equipment, these information shall contain also the identification of interfaces of the public telecommunications networks to which the equipment is intended to be connected. Where it concerns radio equipment, there shall be also information on the packaging and in the instructions for use of the apparatus as to whether the apparatus is intended to be used in the Slovak Republic. On the apparatus for which restricting conditions for operation or requirements for authorisation of operation are imposed pursuant to special regulations,[10]) the marking shall be provided according to Annex 7. For all apparatus such information shall be in the official language 7 ) and shall be displayed at a good visible place.
  6. In the case of radio equipment using frequency bands not in compliance with the technical specification referred to in § 7 clause 2, the manufacturer or importer shall notify the appropriate state administration body performing management of the frequency spectrum [11]) of the intention to place such equipment on the market. This notification shall be given by the manufacturer or importer no less than four weeks in advance of the start of placing on the market. The notification shall contain information about the radio characteristics of the equipment, in particular frequency bands, channel spacing, type of modulation and radiofrequency power as well as the identification code of the authorised body referred to in Annex 4 or 5. The setting of the first sentence does not apply to radio equipment, which does not transmit or which may transmit only under the control of the network.

§ 6

  1. Prior to placing the apparatus on the market the manufacturer or his authorised representative established in the EU Member State or in the Slovak Republic (hereinafter only „authorised representative“) or a person responsible for placing the apparatus on the market shall assess, pursuant to § 12 of the Act, the conformity of apparatus with the requirements referred to in § 3 using one of the following procedures:
    1. the compliance of telecommunications terminal equipment which do not make use of the spectrum allocated to terrestrial/space radiocommunication and receiving parts of radio equipment shall be assessed by any one of the procedures described in Annexes 2, 4, or 5,
    2. where the manufacturer has applied the harmonised technical standards, the compliance of radio equipment, except for the radio equipment referred to in letter a), shall be assessed by any one of the procedures described in Annexes 3, 4 or 5,
    3. where the manufacturer has not applied the harmonised technical standards or has applied them only in part, the compliance of radio equipment, except for the radio equipment referred to in letter a) shall be assessed by any one of the procedures described in Annexes 4 or 5.
  2. Where the apparatus is also within the scope of special technical regulations,6 ) the conformity of the apparatus with the requirements referred to in § 3 clause 1 letter a) and b) may be alternatively assessed by means of the procedures according to these regulations.
  3. Documentation relating to the conformity assessment procedure used according to clause 1 shall be kept by the manufacturer or by his authorised representative, or the person responsible for placing the apparatus on the market in the official language,7 ) in the official language of the EU Member State, in which the conformity assessment procedure is carried out or in the language agreed upon with the appropriate authorised body entrusted with fulfilment of tasks of notified bodies operating within the European Union (hereinafter only „notified body“).
  4. The manufacturer, his authorised representative or the person responsible for placing the apparatus on the market shall draw up a declaration of conformity with the requirements referred to in § 3 and shall affix the CE marking in accordance with Annex 6 on each apparatus. For the identification of the apparatus the data shall be used as follows:
    1. type number,
    2. batch and/or serial numbers,
    3. identification data of the manufacturer or the person responsible for placing the apparatus on the market.
  5. Where the procedures identified in Annex 3, 4 or 5 are used, the CE marking shall be accompanied with the identification number of the appropriate notified body. Radio equipment shall in addition be accompanied by the equipment class identifier in accordance with Annex 7.
  6. The manufacturer, his authorised representative or the person responsible for placing the apparatus on the market shall provide the user together with the declaration of conformity to the requirements referred to in § 3 with information on the intended use of the apparatus. Where it concerns telecommunications terminal equipment these information shall contain also the identification of interfaces of the public telecommunications networks to which the equipment is intended to be connected. Where it concerns radio equipment, there shall be also information on the packaging and in the instructions for use of the apparatus for which EU Member State or the Slovak Republic, or for which geographical territory within the EU Member State or the Slovak Republic is the equipment intended to be used. The marking on the apparatus according to Annex 7 notifies the user on potential restrictions or requirements for permission of use of the radio equipment in some EU Member States or in the Slovak Republic. For all apparatus such information shall be in the official language 7 ) and shall be displayed at a good visible place.
  7. In the case of radio equipment using the frequency band, the use of which is not harmonised with the use within the European Communities, the manufacturer, his authorised representative or the person responsible for placing the apparatus on the market shall notify the appropriate state administration body performing management of the frequency spectrum 11 ) of the intention to place such equipment on the market. This notification shall be given at least four weeks in advance of the start of placing on the market. The notification shall contain information about the radio characteristics of the equipment, in particular frequency bands, channel spacing, type of modulation and radiofrequency power as well as the identification code of the notified body referred to in Annex 4 or 5.
  8. Where the apparatus is subject in addition to the Directive on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity also to other directives of the European Communities, which cover other aspects and at the same time stipulate an affixing of the CE marking, this marking shall indicate that the apparatus also fulfils the provisions of these directives. However, where one or more of these directives enable the manufacturer during the transitional period to make a choice which regime he will apply, then the CE marking shall indicate that the apparatus fulfils the provisions only of those directives, which the manufacturer has applied. In this case information on the directives used shall be given in the documents, reports or the operational instructions required by these directives and attached to the relevant apparatus.

§ 7

  1. Licence holders for the operation of public telecommunications network shall elaborate according to a special regulation [12]) technical specifications of the offered interfaces of the public telecommunications networks, which are in sufficient detail to permit the design of telecommunications terminal equipment capable of utilising all services provided through the corresponding interface. The specifications shall also include all the data needed to carry out the tests, whether the telecommunications terminal equipment meets the applicable requirements referred to in § 3. They shall publish the specifications in advance, before the provision of public telecommunication services through these interfaces is started.
  2. Announcements about the technical specifications of regulated interfaces and on the interfaces referred to in clause 1 shall be published by the Office in the Bulletin of the Ministry; notification shall contain information on the place at which these specifications are available.

§ 8

  1. Apparatus complying with the relevant provisions of this Order and the list of which is published by the Office in the Bulletin of the Ministry are presumed to be selected telecommunication equipment approved in compliance with a special regulation.[13])
  2. Apparatus, which do not satisfy the requirements of this Order may be displayed at trade fairs, exhibitions, presentations and similar undertakings, provided that they are visibly marked by a notice, that such apparatus may not be placed on the market or put into operation until compliance with requirements of this Order is not achieved.

§ 9

  1. Where telecommunications terminal equipment meets the relevant requirements referred to in § 3, it is regarded, that for the purpose of concluding a contract between the telecommunication enterprise and the user according to a special regulation [14]) its connection to the corresponding interfaces defined by the manufacturer is technically feasible.
  2. If the Office has determined, that the apparatus declared to be compliant with the requirements of this Order causes serious damage to a network or harmful interference or harm to the network or its operation, with reference to the nature of the subject matter it shall apply the procedure in accordance with special regulations.[15]) The Office shall inform the Ministry about any such a measure.
  3. If the protection of the network requires an immediate disconnection of the equipment, the operator of the public telecommunications network (hereinafter only „operator“) may, on the assumption that he will offer to the user an immediate alternative solution, disconnect the apparatus declared to be compliant with the requirements of this Order. The operator shall inform the Office about each of such a measure without any delay.
  4. If the apparatus enables to keep the data and information transmission secret, the manufacturer, the importer, the distributor or sales person shall supply the entitled authorities [16]) via the Ministry of Interior of the Slovak Republic free of charge with the functional equipment and data about this equipment or other applicable solution enabling the capture of data and information in an intelligible form. If the equipment and data are not supplied, the equipment shall not be placed on the market.

[1]) The Act No 241/2001 Coll. on protection of classified materials and on change and amendment of some Acts.

[2]) § 4 clause 5 of the Act No. 195/2000 Coll. on telecommunications.

[3]) Act No. 195/2000 Coll. on telecommunications as amended by the Act No. 308/2000 Coll.

[4]) § 2 of the Order of the Government No. 392/1999 Coll. setting details of technical requirements and on conformity assessment procedures for electrical equipment used in certain voltage limits.

[5]) § 3 of the Order of the Government No. 394/1999 Coll. setting details of technical requirements for products with regard to electromagnetic compatibility.

[6]) Order of the Government No. 392/1999 Coll. setting details of technical requirements and on conformity assessment procedures for electrical equipment used in certain voltage limits.

Order of the Government No. 394/1999 Coll. setting details of technical requirements for products with regard to electromagnetic compatibility.

[7]) Act of the National Council of the Slovak Republic No. 270/1995 Coll. on Official Language of the Slovak Republic as amended by later regulations. [8]) § 13 of the Act No. 264/1999 Coll. on technical requirements for products and on conformity assessment and on change and amendment of some Acts. [9]) § 18 of the Act No. 264/1999 Coll. [10]) § 36 to 38 of the Act No. 195/2000 Coll. [11]) § 31 of the Act 195/2000 Coll. as amended by the Act No. 308/2000 Coll. [12]) § 17 clause 1 of the Act 195/2000 Coll. [13]) § 34 clause 2 of the Act 195/2000 Coll. [14]) § 39 to 44 of the Act No.195/2000 Coll. [15]) § 48 clause 9 of the Act No. 195/2000 Coll.
§ 31 of the Act No. 264/1999 Coll. [16]) E.g. § 88 of the Penal Code as amended by later regulations, § 35 of the Act of the National Council of the Slovak Republic No. 171/1993 Coll. on Police Corps as amended by the Act No. 353/1997 Coll., § 13 of the Act of the National Council of the Slovak Republic No. 46/1993 Coll. on Slovak Intelligence Service, § 13 of the Act of the National Council of the Slovak Republic No. 198/1994 Coll. on Military Intelligence.

§ 10

Declaration of conformity 8 ) shall be elaborated in the official language and shall contain:

  1. identification data of the manufacturer or importer issuing the declaration of conformity (trade name, name and surname, residence, place of business and the identification number of the natural person or trade name, residence and the identification number of the legal person),
  2. identification data of the apparatus (type number, batch number, serial number, year of production, for radio equipment frequency bands, channel spacing, type of modulation and radiofrequency power),
  3. identification data of the manufacturer, if the declaration of conformity is drawn up by another subject than the manufacturer of the apparatus,
  4. the description of the apparatus and its functions (intended use determined by the manufacturer or, if appropriate, by the importer), further data about the apparatus (data for identification the interfaces of the public telecommunications network, to which the telecommunications terminal equipment is intended to be connected, in the case of radio equipment the data on limiting conditions for the operation or requirements for permission to use that equipment),
  5. the list of technical regulations, to which the equipment is declared to be compliant,
  6. the list of harmonised Slovak technical standards or other technical standards used for conformity assessment,
  7. information about the conformity assessment procedure used according to § 5,
  8.  if an authorised body has participated in the conformity assessment, data on this body (trade name, residence, identification code of the authorised body), number and date of issue of its findings on the apparatus,
  9. the affirmation of the manufacturer or the importer that the properties of the apparatus comply with the requirements referred to in § 3 and, if appropriate, the requirements of other regulations, and that the equipment is safe under the conditions of normal use, eventually of the use determined by the manufacturer or the importer,
  10. the date and place of issue of the declaration of conformity, the name and position of the responsible person of the subject issuing the declaration of conformity and his signature.

§ 11

Apparatus approved in accordance with § 35 of the Act No 195/2000 Coll. on telecommunications may be placed on the market until 31 December 2002 at the latest, unless the validity of the approval decision expires earlier.

§ 12

  1. On the day of entering into force the international treaty by which is the Slovak Republic bound, the provisions of § 5 and § 10 shall be repealed.
  2. This Order shall enter into force on 1 January 2002 with the exception of the provisions of § 6, which shall become effective on the day of entering into force the international treaty by which is the Slovak Republic bound.

Annex No. 1
to the Order of the Government No. 443/2001 Coll.

Equipment not covered by this Order

  1. Radio equipment used by radio amateurs, unless this equipment is commercially available.
    Kits of components intended to be assembled by radio amateurs and commercial equipment modified by and for the use of radio amateurs are not regarded as commercially available equipment.
  2. Determined products for which particulars on technical requirements are laid down by generally binding legal regulation [1]).
  3. Cables and wires.
  4. Radio equipment intended to be used solely for the reception of sound and television broadcasting services.
  5. Products, appliances and components in the field of civil aviation:
    1. products - civil aircraft, engines, propellers or appliances,
    2. appliances - instruments, equipment, mechanisms, apparatus or accessories used or intended to be used in operating an aircraft in flight, whether installed in, intended to be installed in, or attached to a civil aircraft, but not forming part of the frame, engine or propeller,
    3. components - materials, parts or subassemblies not included under letter a) or b) and intended to be used in civil aircraft, engines, propellers or appliances.
  6. 6. Air-traffic-management equipment and systems, in particular:
    1. communication systems,
    2. surveillance systems,
    3. systems providing automated assistance to air-traffic control,
    4. navigation systems.

Annex No. 2
to the Order of the Government No. 443/2001 Coll.

Internal production control

  1. At the procedure referred to in § 5 clause 1:
    1. the manufacturer or the importer shall carry out, or have carried out the product performance tests and shall asses the conformity on the base of technical documentation described in point 3,
    2. the manufacturer or the importer ensures and declares, that the products concerned satisfy the requirements of this Order that apply to them. The manufacturer or the importer shall affix to each product the Slovak conformity mark and shall draw up the written declaration of conformity.
  2. At the procedure referred to in § 6 clause 1:
    1. the manufacturer or his authorised representative assures and declares that the products concerned satisfy the requirements of this Order that apply to them. The manufacturer or his authorised representative shall affix to each product the CE marking and shall draw up the written declaration on conformity,
    2. the manufacturer shall elaborate the technical documentation described in point 3. The manufacturer or his authorised representative shall keep this documentation for a period ending 10 years after the last equipment has been manufactured, in order it would be available to the surveillance bodies for inspection purposes,
    3. where neither the manufacturer nor his authorised representative is established in the EU Member State or in the Slovak Republic, this documentation shall be submitted to the surveillance bodies by the person, who places the product on the market in the European Community or in the Slovak Republic,
    4. the manufacturer or his authorised representative shall keep with the technical documentation a copy of the declaration of conformity,
    5. the manufacturer shall take all measures necessary in order that the manufacturing process ensures compliance of the manufactured products with the technical documentation referred to in point 3 and with requirements of this Order that apply to the product.
  3. Technical documentation shall enable the conformity of the product with the requirements referred to in § 3 to be assessed. It shall cover the design, manufacture and operation of the product, in particular:
    1. a general description of the product,
    2. conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
    3. descriptions and explanations needed for the understanding of the inscribed drawings and schemes and the function of the product,
    4. a list of the standards referred to in § 4 applied in full or in part; descriptions and explanations of the solutions adopted to meet the requirements referred to in § 3, where the standards referred to in § 4 have not been applied or such standards do not exist,
    5. results of design calculations, examinations carried out, etc.,
    6. test reports.

Annex No. 3
to the Order of the Government No. 443/2001 Coll.

Internal production control plus specific apparatus tests

The procedure according to Annex 2 shall be used, supplemented by the following requirements:

  1. For each type of apparatus, all essential radio test suites shall be carried out by the manufacturer or on his behalf. The identification of the test suites that are considered to be essential is the responsibility of an authorised body (notified body) chosen by the manufacturer except where the test suites are defined in the harmonised standards. The authorised body (notified body) shall take due account of previous decisions made by authorised bodies (notified bodies) acting together. At the procedure according to § 5 an authorised body may be chosen and the test may be performed or may have to be performed by the importer instead of the manufacturer.
  2. The manufacturer or importer at the procedure according to § 5, or the manufacturer, his authorised representative or the person responsible for placing the apparatus on the market at the procedure according to § 6 shall draw up a declaration that these tests have been carried out and that the apparatus complies with the requirements referred to in § 3. Prior to placing on the market the identification code of the authorised body (notified body) shall be affixed to the apparatus.
  3. Procedures according to points 1 and 2 in relation to notified bodies shall be applied from the day when the international agreement by which is the Slovak Republic bound will come into effect.

Annex No. 4
to the Order of the Government No. 443/2001 Coll.

Technical construction file

The procedure according to Annex 3 shall be used, supplemented by the following requirements:

  1. The technical documentation described in Annex 2 and the declaration of conformity to specific radio test suites described in Annex 3 shall form a technical construction file.
  2. The manufacturer or importer at the procedure according to § 5, or the manufacturer, his authorised representative or the person responsible for placing the apparatus on the market at the procedure according to § 6 shall submit this file to one or more authorised bodies (notified bodies), notifying each of them of others who have received the file.
  3. The authorised body (notified body) shall review the technical construction file and if it is considered that it has not been properly demonstrated that the requirements of this Order have been met, the authorised body (notified body) may issue an opinion to the manufacturer or to the importer at the procedure according to § 5, or to the manufacturer, his authorised representative or the person responsible for placing the apparatus on the market at the procedure according to § 6 and shall accordingly inform in these sense the other authorised bodies (notified bodies) who have received the file. The opinion shall be given within four weeks of receipt of the file by the authorised body (notified body). On receipt of this opinion, or after the end of the four-week period, the apparatus may be placed on the market, without prejudice to the provisions of § 5 clause 6, § 6 clause 6 and special regulations [2]).
  4. Procedures according to points 2 and 3 in relation to notified bodies shall be applied from the day when the international agreement by which is the Slovak Republic bound will come into effect.

Annex No. 5
to the Order of the Government No. 443/2001 Coll.

Full quality assurance

  1. The manufacturer who satisfies the obligations according to point 2 ensures and declares that the products concerned satisfy the requirements of this Order that apply to them. The manufacturer shall affix the marks referred to in § 5 or § 6, respectively to each product and shall draw up a written declaration of conformity.
  2. The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing as specified in point 3, and shall be subject to surveillance as specified in point 4.
  3. Quality system
    1. A manufacturer shall lodge an application for assessment (evaluation and approval) of his quality system with an authorised body (notified body). The application shall include:
      1. all relevant information for the products envisaged,
      2. the quality system documentation.
    2. The quality system shall ensure compliance of the products with the requirements of this Order that apply to them. All elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall ensure a common understanding of the quality policies and procedures such as programmes, plans, manuals and quality records.
    3. Documentation of the quality system shall contain in particular a description of:
      1. the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality,
      2. the technical specifications, including the harmonised standards and technical regulations as well as relevant test specifications that will be applied and, where the standards referred to in § 4 will not be applied in full, the description of means that will be used to ensure that the requirements referred to in § 3 of this Order that apply to the products will be met,
      3. the design control and design verification techniques, processes and systemic actions that will be used when designing the products pertaining to the product category covered,
      4. the corresponding manufacturing, quality control and quality assurance techniques, processes and systemic actions that will be applied;
      5. the examinations and tests that will be carried out before, during and after manufacture; the frequency with which they will be carried out, as well as the results of tests carried out before manufacture where appropriate,
      6. the means by which it is ensured that the test and examination facilities respect the appropriate requirements for performance of the necessary tests,
      7. the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,
      8. the means enabling to monitor the achievement of the required product quality and its constructional design and the effective operation of the quality system.
      The authorised body (notified body) shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. The compliance with these requirements shall be presumed for quality systems implemented according to the relevant harmonised standard.
      The authorised body (notified body) shall assess in particular whether the quality control system ensures conformity of the products with the requirements of this Order in the light of the relevant documentation supplied in accordance with points 3.1 and 3.2 including, if appropriate, also the test results supplied by the manufacturer.
      The auditing team shall have at least one member experienced as an assessor in the product technology concerned. The evaluation procedure must include an assessment visit to the manufacturer's premises.
      The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the evaluation and the reasoned assessment decision.
    4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and efficient.
      The manufacturer or his authorised representative shall keep the authorised body (notified body) that has approved the quality system informed of any intended updating of the quality system.
      The authorised body (notified body) shall evaluate the modifications proposed and decide whether the amended quality system will still satisfy the requirements referred to in point 3.2 or whether a reassessment is required.
      It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
  4. Surveillance under the responsibility of the authorised body (notified body)
    1. The aim of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
    2. The manufacturer shall allow the authorised body (notified body) access for inspection purposes to the locations of design, manufacture, inspection, testing and storage, and shall provide it with all necessary information, in particular:
      1. the quality system documentation,
      2. the quality records as foreseen by the design part of the quality system, such as results of analyses, calculations, tests, etc.,
      3. the quality records as foreseen by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
    3. The authorised body (notified body) shall carry out audits at reasonable intervals to make sure that the manufacturer maintains and applies the quality system. The manufacturer shall be provided with an audit report.
    4. In addition, the authorised body (notified body) may pay unexpected visits to the manufacturer. At the time of such visits, the authorised body (notified body) may carry out tests or have them carried out in order to check the proper functioning of the quality system where necessary. The authorised body (notified body) shall provide the manufacturer with a visit report and, if a test has been carried out, with a test report.
  5. The documents kept by the manufacturer available for the surveillance bodies according to § 13 clause 3 of the Act shall contain:
    1. the documentation referred to in point 3.1 letter b),
    2. the updating referred to in the second clause of point 3.4,
    3. the decisions and reports from the authorised body (notified body) which are referred to in the final clause of point 3.4 and in points 4.3 and 4.4.
  6. Each authorised body (notified body) shall make available to the other authorised bodies (notified bodies) the relevant information concerning quality system approvals, including references to the products concerned, issued and withdrawn.
  7. Procedures in relation to notified bodies shall be applied from the day when the international agreement by which is the Slovak Republic bound will come into effect.

Annex No. 6
to the Order of the Government No. 443/2001 Coll.

CE Marking

  1. The graphic form of the CE marking is specified by a special regulation.[3]) If the CE marking is reduced or enlarged, the proportions of the CE marking given by the auxiliary grid shall be respected.
  2. The CE marking shall have a height at least 5 mm except the cases, where this is not possible on account of the nature of the apparatus.
  3. The CE marking shall be affixed to the product or to its identification label. Additionally it shall be affixed to the packaging (if any) and to the accompanying documentation.
  4. The CE marking shall be positioned on a visible place, legibly and indelibly.

Annex No. 7
to the Order of the Government No. 443/2001 Coll.

Initial classification of radio equipment and telecommunications terminal equipment and associated identifiers

  1. Radio equipment and telecommunications terminal equipment which can be placed on the market and be put into operation without restrictions shall constitute a class. This class shall be referred to as „Class 1“. An Equipment Class Identifier shall not be assigned to this class of equipment.
  2. Radio equipment for which apply restrictions to their operation in the Slovak Republic 10 ) or within the countries of the European Union, shall constitute a class. This class shall be referred to as „Class 2“. The following Equipment Class Identifier shall be assigned to equipment within this class:
  3. An informative list of equipment falling within the above mentioned classes will be published by the EC Commission on the internet website containing information about the Directive 1999/5/EC (http://europa.eu.int/comm/enterprise/rtte)http://www.teleoff.gov.sk . Radio equipment for which apply restrictions to their operation in the Slovak Republic are publicised by the Office in the Bulletin of the Ministry and on the web site at the address http://www.teleoff.gov.sk/.
[1]) Order of the Government of the Slovak Republic No. 243/2001 Coll. setting details of technical requirements and on conformity assessment procedures for marine equipment. [2]) § 31 of the Act No. 264/1999 Coll. on technical requirements for products and on conformity assessment and on change and amendment of some Acts.

§ 48 of the Act No. 195/2000 Coll.

[3]) Annex to the Act No 264/1999 Coll.
Last updates: 13. February 2006 09:04:01
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