426/2016 Sb.
GOVERNMENT REGULATION
of 14 July 1999. December 2016
on conformity assessment of radio equipment on the market when supply
Government orders under section 4, § 6 para. 2 and § 50 para. 5 of law No. 90/2016
Coll., on conformity assessment of specified products when they are making available on the market:
§ 1
The subject of the edit
(1) this regulation incorporates the relevant provision of the European Union ^ 1) and
regulates the technical requirements for radio equipment, which must meet the
When placed on the market and/or put into service, the conditions and procedures for their
making available on the market and the conformity assessment methods.
(2) this regulation does not apply to radio equipment specified in annex
No 1 to this regulation.
(3) The radio equipment not covered by the Decree-Law on conformity assessment
electrical equipment designed for use within certain voltage limits
When they are making available on the market, with the exception of the technical requirements referred to in § 3
paragraph. 1 (b). and).
§ 2
Definition of terms
For the purposes of this regulation, by means of radio equipment labelling
certain categories of radio equipment, which are considered to be similar to, and
radio interface ^ 2) for which they are intended, this radio equipment.
§ 3
Technical requirements
(1) the radio equipment must be constructed in such a way as to ensure the
and) the protection of the health and safety of persons and the protection of domestic animals and
assets in the range of the essential requirements for security policies
electrical equipment designed for use within certain voltage limits,
but with no voltage limit applying, and
(b)) the level of electromagnetic compatibility in the range of requirements for
products in terms of electromagnetic compatibility.
(2) the radio equipment must be constructed in such a way as to effectively
use of the frequency spectrum and promoting the effective use of.
(3) the radio equipment in categories or classes provided for in the implementing
the delegated Act based on article. 44 directive of the European
Parliament and of the Council/53/EU of 16. April 2014 on the harmonisation
the legislation of the Member States relating to the making available of radio
equipment on the market and repealing Directive 1999/5/EC must be Czech
the Telecommunications Authority published in the telecommunications journal form
communication and must be designed so as to
and) coexist with accessories, especially with the uniform
Chargers,
(b)) to work together with other radio equipment through
electronic communications networks,
(c)) is it possible to connect to interfaces of the appropriate type throughout the European
the Union provided for by the implementing Act delegated pursuant to article.
44 directive of the European Parliament and of the Council of the EU 2014/53/,
(d)) did not have an adverse effect on an electronic communications network or its
operation and nezneužívala sources of electronic communications networks,
e) ensure the protection of personal data and privacy of the user and
Subscriber's electronic communications services,
f) ensure the protection against fraud,
(g)) was granted access to emergency calls,
h) facilitate their use for the disabled users and
I) ensure software to upload radio equipment in the case that
He was shown the consistency of this combination of software and radio equipment with
other legislation ^ 3).
§ 4
The delivery of equipment on the market and putting into service
(1) the radio equipment can be supplied on the market or put into service,
only if it is done so that, provided that it is properly installed,
maintained and used for the purposes for which it is intended, shall meet
the requirements of this regulation.
(2) for trade fairs, exhibitions and similar demonstrations can be shown off
the radio equipment, which is not in conformity with this regulation, if it is of
clear, visible sign that this radio equipment is not in conformity, and
may not be delivered on the market or put into service until it is mentioned
into conformity. During demonstrations, measures must be taken to prevent ^ 4)
harmful interference, electromagnetic interference ^ 5) and health hazards
and the safety of persons or domestic animals or a threat to the asset.
The manufacturer of the
§ 5
(1) the manufacturer when placing radio equipment on the market shall ensure that
designed and constructed in accordance with section 3, shall draw up technical documentation
laid down in annex 5 to this Regulation (hereinafter referred to as "the technical
documentation ") and carries out or causes perform the appropriate procedure for assessing the
conformity as set out in section 10.
(2) the manufacturer shall ensure that the radio equipment is designed so that
It was possible to run in at least one Member State of the European Union
(hereinafter referred to as "Member State"), without violating the requirements of the
use of the radio spectrum.
(3) If compliance with the technical requirements of radio equipment
the conformity assessment procedure has been demonstrated, the manufacturer must draw up the EU Declaration of
conformity and affix the CE marking in accordance with § 14.
(4) the manufacturer shall keep the technical documentation and the EU Declaration of conformity
period of 10 years following the placing on the market of radio equipment.
(5) the manufacturer shall ensure that the radio equipment, which it placed on the market,
the number of the type or series, serial number or other element
allowing for the identification, or in cases where the size or
the nature of the radio equipment does not allow it, that the required information
provided on the packaging or in a document accompanying the radio device.
(6) the manufacturer shall indicate to the radio device, or if this is not possible, on the packaging
or in a document accompanying the radio equipment in a language understood by the
to end users and to the supervisory authority in your name or business name,
where applicable, the trademark, and the address for service. Address for
delivery address must be the place in which the manufacturer can be truly
to reach you.
§ 6
(1) the manufacturer shall ensure that, in language easily understood by consumers and
end-users to radio equipment was accompanied by the instructions and
safety information. Instructions must contain the information necessary to enable the
radio equipment to be used for the intended purpose, with the result that
must also be a description of the accessories or components, including
software that allow you to use the device for its intended purpose.
Instructions, security information and any labelling must be clear,
clear and easy to understand.
(2) in the case of a radio device that intentionally transmits the radio waves
they are part of the instructions and safety information information about
and) of all frequency bands in which the radio equipment works, and
(b) the maximum RF broadcast performance) in the frequency band,
which is operated by a radio device.
(3) the manufacturer shall ensure that each radio device attached
a copy of the EU Declaration of conformity or a simplified EU Declaration of conformity.
Provides only a simplified EU Declaration of conformity, it must
include the address of the website where you can obtain the full text of the
EU Declaration of conformity.
(4) in the event that the radio equipment is its entry into
operation or other requirements for enabling its use, it must be of the
information on the package can detect Member States or geographical area
the Member State where these constraints are putting into service or these
enable the use of requirements in force. This information must be
added to radio device instructions.
(5) the manufacturer shall carry out in order to protect the health and safety of the final
user testing of samples of radio devices that came on the market and other
the investigation, if it is necessary, given the risks that the radio equipment
represents. These tests and the investigation is carried out to the extent necessary for the
the confirmation or refutation of the risk posed by radio equipment
given the intended purpose of the use by the manufacturer. The producer keeps records
complaints, non-conforming radio equipment and radio equipment,
that pulled out of circulation, and these activities will inform the
distributors.
(6) the manufacturer shall ensure that procedures are in place, through which
series-produced radio equipment will remain in conformity with the requirements of
laid down in this regulation and in cases where there are changes to the design
or parameters of radio equipment or to changes in the harmonised standards
or other technical specifications on the basis of the conformity of the
radio equipment declares.
§ 7
Authorized representative
Authorized representative shall keep the EU Declaration of conformity and the technical
documentation for the requirements of a supervisory authority for a period of 10 years after the
radio equipment on the market.
§ 8
The importer
(1) the importer prior to the placing on the market of radio equipment shall ensure that the
the manufacturer has carried out the conformity assessment procedure referred to in article 11 and to
radio device so designed that it can be operated
at least in 1 Member State, without violating the requirements of the
use of the radio spectrum. Furthermore, the importer shall ensure that the manufacturer
has drawn up the technical documentation, placed it on a radio device designation
CE, he put to him the documents required and fulfilled the requirements set out in §
5 (3). 5 and 6 and section 6 (1). 1 to 4.
(2) the importer shall indicate to the radio device, or if this is not possible, on the packaging
or in a document accompanying the radio equipment in a language understood by the
to end users and to the supervisory authority in your name or business name,
where applicable, the trademark, and the address for service.
(3) the importer shall ensure that the radio was accompanied by the instructions and
safety information in Czech language.
(4) the importer for a period of 10 years following the placing on the market of radio equipment
stores a copy of the EU Declaration of conformity at the disposal of the supervisory authority and the
shall ensure that the supervisory authority was at his request, submitted to the technical
documentation.
(5) the importer performs in order to protect the health and safety of the final
user testing of samples of radio devices that came on the market and other
the investigation, if it is necessary, given the risks that the radio equipment
represents. These tests and the investigation is carried out to the extent necessary for the
the confirmation or refutation of the risk posed by radio equipment
given the intended purpose of the use by the manufacturer. The importer keeps records
complaints, non-conforming radio equipment and radio equipment,
that pulled out of circulation, and these activities will inform the
distributors.
(6) the importer shall ensure that the storage and transport conditions
not to disrupt the conformity with the requirements of radio equipment
This regulation.
§ 9
Distributor
The distributor prior to delivery of the radio equipment on the market shall verify that
and) radio equipment bears the CE marking, the
(b)) are accompanied by the required documents, the radio equipment, instruction and
safety information in Czech language and
(c) manufacturers and importers meet) the requirements set out in § 5 para. 2, 5 and 6,
§ 6 para. 1 to 4 and § 7 (2). 2.
§ 10
Time to identify the operator
Economic operator for a period of 10 years from the delivery of radio equipment on the market
stores the data that can be used at the request of the supervisory authority to determine
the operator, who had radio equipment added or which
radio equipment, he added.
§ 11
The conformity assessment procedures
(1) the manufacturer shall carry out the conformity assessment of radio equipment with technical
the requirements set out in § 3. The manufacturer shall take into account in the conformity assessment
all the intended conditions of use of the radio equipment and in case of
technical requirement set out in section 3, paragraph 3. 1 (b). and also reasonably)
foreseeable conditions of use. If it can have radio equipment
different configurations, you must confirm whether the conformity assessment of radio equipment
It meets the technical requirements set out in § 3 in all possible
configurations.
(2) the assessment of conformity with the technical requirements provided for in § 3 (1). 1 (b). and)
and (b))
and internal management of production) (module A) set out in annex 2 to this
Regulation,
(b)) the EU type-examination (module B) and conformity to type based on the
internal production control (module C) set out in Appendix 3 to this
Regulation, or
c) happens to be based on full quality assurance (module H)
set out in annex 4 to this regulation.
(3) if the manufacturer Used in the conformity assessment of radio equipment with
technical requirements set out in § 3 (1). 2 and 3 the harmonised
standards to which references have been published in the official journal of the European
the Union, the conformity assessment shall be carried out
and internal management of production) (module A) set out in annex 2 to this
Regulation,
(b)) the EU type-examination (module B) and conformity to type based on the
internal production control (module C) set out in Appendix 3 to this
Regulation, or
c) happens to be based on full quality assurance (module H)
set out in annex 4 to this regulation.
(4) if the manufacturer in the conformity assessment of radio equipment with technical
the requirements set out in § 3 (1). 2 and 3 in part or not at all did not use
the harmonised standards, the references of which have been published in the official journal of the
The European Union, or if the harmonised standards are not established,
conformity assessment shall be carried out
the EU type-examination) (module B) and conformity to type based on the
internal production control (module C) set out in Appendix 3 to this
Regulation, or
(b)) happens to be based on full quality assurance (module H)
set out in annex 4 to this regulation.
§ 12
Presumption of conformity
If the radio device is in conformity with harmonised standards or
parts thereof, the references of which have been published in the official journal of the
The European Union, which will apply to radio equipment, it shall be deemed that the
in conformity with the technical requirements set out in § 3, to which these
standards or parts thereof.
section 13 of the
EU Declaration of conformity
(1) the EU Declaration of conformity certifying that the technical specifications
set out in section 3 and shall prepare, in accordance with the model set out in annex No.
6 to this regulation.
(2) the EU Declaration of conformity shall contain the elements specified in paragraphs 1 to 8
of annex 6 to this regulation or, where appropriate, additional information
set out in point 9 of annex 6 to this regulation, if they are not
likely to cause misleading impression. EU Declaration of conformity must be
updated continuously. EU Declaration of conformity shall be translated into the language or
languages required by the Member State in which the radio shows
or available on the market.
(3) a simplified EU Declaration of conformity shall contain the elements set out in the
Annex 7 to this regulation and shall be continuously updated.
Simplified EU Declaration of conformity must be translated into the language or
languages required by the Member State in which the radio device
placed or made available on the market. Full text of the EU Declaration of conformity is available
on the website, whose address is given in a simplified
EU Declaration of conformity in the language or languages required by the Member
the State, in which the radio device placed or made available on the market.
(4) If the radio device is subject to more Community harmonisation legislation
The European Union, providing for the elaboration of EU Declaration of conformity,
draw up a single EU Declaration of conformity with links to all of these
regulations. This single EU Declaration of conformity may take the form of a folder
consisting of declarations of conformity issued to individual regulations.
§ 14
The CE marking and other labelling
(1) the CE marking is affixed on the radio device before it is placed on the
the market.
(2) the CE marking visibly, legibly and indelibly to the radio
equipment or to its data plate, unless the nature of the radio
the device does not allow. The CE marking shall also be placed visibly and legibly
on the package, if there is a radio device supplied ^ 6).
(3) the size of the CE marking, which is on the radio equipment is located, you may
due to the nature of the radio equipment, and assuming it remains
visible and readable, less than 5 mm.
(4) if the conformity assessment procedure set out in annex 4 to
of this regulation, the CE marking is followed by the identification number of the
of the notified body. The identification number of the notified body shall have
the same size as the CE mark. The identification number of the notified
operator places the notified body or by the manufacturer's instructions or
his authorised representative.
§ 15
The technical documentation
(1) technical documentation shall contain at least the information set out in
Annex 5 to this regulation.
(2) technical documentation shall be drawn up before placing the radio
equipment on the market and must be continuously updated.
(3) the technical documentation and correspondence relating to the procedures for the EU
type-examination shall be drawn up in the official language of the Member 1
State in which the notified body is established or in a language of the notified
readily understood by the subject.
(4) if the technical documents drawn up in accordance with the requirements of
This regulation, the supervisory authority of the manufacturer or importer may request that in
the prescribed period had done the exam body which is acceptable
for the supervisory authority in order to verify compliance with the technical requirements of the
set out in § 3.
section 16 of the
Formal defects
A formal deficiency is considered when
and) the CE marking was placed in breach of article. 30 of the regulation of the European
Parliament and of the Council (EC) no 765/2008 laying down requirements for the
accreditation and market surveillance relating to the marketing of products on the market and
repealing Regulation (EEC) No 339/93, or with section 14,
(b)) the CE marking has not been affixed,
(c)) identification number of the notified body has not been located or has been
located in contravention of section 14,
d) EU Declaration of conformity has not been drawn up,
e) EU Declaration of conformity has not been drawn up in accordance with this
by regulation,
f) technical documentation is missing or incomplete,
g) to radio devices are accompanied by information on its intended purpose
use, EU Declaration of conformity or for information about restrictions on use,
h) manufacturer does not register the type of radio equipment,
I) the information specified in § 5 para. 5 and 6 or § 8 paragraph. 2 are missing, are
incorrect or incomplete, or
(j)) are not met the requirements set out in section 10.
§ 17
Transitional provision
Radio equipment complying with the requirements of Decree-Law No. 426/2000 Coll.
laying down technical requirements for radio and telecommunication
terminal equipment, in the version in force before the date of entry into force of this
Regulation may continue to be supplied on the market and put into service, if
has been placed on the market before the date of 13. June 2017.
section 18
Regulation (EEC)
Shall be deleted:
1. Government Regulation No. 426/2000 Coll., laying down technical
requirements for radio and telecommunications terminal equipment.
2. Government Regulation No. 484/2002 Coll., amending Decree-Law No.
426/2000 Coll., laying down technical requirements for radio and on
telecommunications terminal equipment.
3. Part of the twelfth Government Regulation No. 251/2003 Coll., amending certain
Government regulations issued in implementation of law No. 22/1997 Coll., on technical
requirements for products and amending and supplementing certain acts, as amended by
amended.
§ 19
The effectiveness of the
This Regulation shall enter into force on the fifteenth day following its publication.
Prime Minister:
Mgr. Sobotka in r.
Minister of industry and trade:
Ing. Mládek, CSc., r.
Č. 1
THE DEVICE TO WHICH THIS REGULATION DOES NOT APPLY
1. Radio equipment used for amateur radio
service ^ 7), if not this device comes on the market. For that do not come on
market shall be:
and kits intended for) the Radio Assembly and the use of radio amateurs,
b) radio equipment adjusted radio amateurs for their own use,
c) device built ham radio, which is used for scientific and
experimental purposes in connection with the amateur service.
2. Devices that are shipping equipment ^ 8).
3. Aircraft equipment, aircraft parts and equipment ^ 9).
4. Tailored development kits intended for professionals only
to be used for these purposes in research and development facilities.
5. Radio equipment exclusively used for activities concerning the
public security, defence, State security and the activities of the State in
the field of criminal law.
Č. 2
THE INTERNAL PRODUCTION CONTROL (MODULE A)
1. Internal production control is the conformity assessment procedure whereby the manufacturer
fulfils the obligations laid down in points 2, 3 and 4 and on their own responsibility
ensures and declares that the device complies with the technical
the requirements set out in § 3.
2.
The technical documentation
The manufacturer shall draw up technical documentation in accordance with § 15.
3.
Production
The manufacturer shall take steps to ensure that the manufacturing process and its monitoring ensure
compliance of the manufactured equipment with the technical documentation and with the
technical requirements set out in § 3.
4.
CE marking and Declaration of conformity EU
4.1. The manufacturer shall affix the CE marking in accordance with § 14 on each radio equipment,
that meets the requirements of this regulation.
4.2. the manufacturer shall draw up for each type of radio equipment written EU
Declaration of conformity, and for a period of 10 years after the radio on
the market is, together with the technical documentation at the disposal of the body
supervision. The EU Declaration of conformity is provided radio equipment for which
It was drawn up. A copy of the EU Declaration of conformity shall on request provide
the supervisory authority.
5.
Authorized representative
The manufacturer's obligations set out in point 4 may be on its behalf and on its
the responsibility fulfilled by his authorised representative, if they are listed in the
credentials.
Č. 3
PART AND
THE EU TYPE-EXAMINATION (MODULE B)
1. the EU type-examination is the part of a conformity assessment procedure in which
the notified body examines the technical design of the radio devices and verifies and
confirms that the technical design meets the technical radio equipment
the requirements set out in § 3.
2. the EU type-examination shall be made of the technical suitability assessment
design of radio equipment, and that an examination of the technical documentation and
supporting evidence referred to in point 3, without examination of the specimen (design type).
3. the manufacturer must lodge with the notified body of his choice, the request for the EU
type-examination. The application must include:
and the name and address of the manufacturer), and if the application is lodged by the authorised representative,
his name and address,
(b)) a written declaration that the same application has not been lodged with any other
a notified body,
(c)) the technical documentation. Technical documentation shall enable
conformity assessment of radio equipment with the requirements of this regulation and
contains an adequate analysis and assessment of the risk. The technical documentation
shall specify the requirements, and to the extent necessary for the assessment must apply to
design, manufacture and operation of the radio equipment. If it is relevant, it must
the technical documentation must contain the elements set out in annex 5 of this
Regulation,
(d)) the support evidence for the adequacy of the technical design solution. These
the supporting evidence shall mention any relevant documents that
have been applied, in particular where the relevant harmonised standards have not been
used or have not been applied in full. Supporting evidence in the case
appropriate, include the results of the tests carried out in accordance with other
the relevant technical specifications by the appropriate laboratory of the manufacturer or
another testing laboratory on his behalf and under his responsibility.
4. the notified body shall examine the technical documentation and supporting evidence
in order to assess the adequacy of the technical design of the radio device.
5. the notified body shall draw up an evaluation report that records the
the activities undertaken in accordance with paragraph 4 and their outcomes. Without prejudice to the
obligations of the notified body referred to in paragraph 8, the notified body
contents of this report shall be published, in full or in part, only with the
the consent of the manufacturer.
6. Where the type meets the requirements of this regulation on the
radio equipment is subject, the notified body shall issue a certificate to the manufacturer of the EU
type-examination. This certificate must contain the name and address of the
the manufacturer, conclusions of the examination, information about the basic technical
requirements to which the review covered, the conditions of validity
certificate and the particulars necessary to identify the type under consideration. To
the EU type-examination certificate may be accompanied by 1 or more of the annexes.
The EU type-examination certificate and its annexes shall contain all
information to allow evaluation of whether it is produced by the radio equipment in the
conformity with the examined type to perform its check.
If the type does not satisfy the requirements of this regulation, the notified body
refuses to issue EU type-examination certificate and shall inform the applicant
that refusal refusal.
7. the notified body shall ensure that it is kept informed of any changes
the generally acknowledged State of the art which indicate that the approved
type may no longer comply with the requirements of this regulation and decide,
whether such changes require further investigation. If the investigation so require,
the notified body shall inform the manufacturer.
The manufacturer shall inform the notified body that holds the technical
the documentation concerning the EU type-examination certificate of all
modifications to the approved type that may affect the conformity of this radio
device with the essential requirements or the conditions for validity of
of this certificate. Such modifications require additional approval in the form of
addition to the original EU type-examination certificate.
8. the notified body shall inform its notifying authority of EU certificates
type-examination or additions thereto which it has issued or withdrawn, and
periodically or upon request, make available to its notifying authority list
These certificates and/or additions thereto refused, suspended or
otherwise restricted.
The notified body shall inform the other notified bodies of the EU certificates
type-examination or additions thereto which it has refused, withdrawn,
suspended or otherwise restricted, and, upon request, about the certificates
or additions thereto which it has issued.
The notified body shall inform the competent authorities of the Member States on the
the EU type-examination certificates which it has issued, or additions thereto in
where the harmonised standards, the references of which have been published in the
The official journal of the European Union, have not been applied or not applied in
full. The competent authorities of the Member States, the Commission and the other
notified bodies may, on request, obtain a copy of the certificates of the EU
type-examination or additions thereto. The competent authorities of the Member States and
The Commission may, on request, obtain a copy of the technical documentation and the results of the
the review carried out by the notified body. For a period of 10 years from the
assessment of the radio device, or to the expiry of the
the EU type-examination certificate, the notified body shall keep a copy of this
certificate, its annexes and additions, as well as the technical file
documentation including the documentation submitted by the manufacturer.
9. after a period of 10 years following the placing on the market of radio equipment manufacturer
for a copy of the certificate of the national authorities of the EU type-examination
type, its annexes and additions with the technical documentation.
10. the manufacturer's authorised representative may lodge the application referred to in point 3 and
to fulfil the obligations laid down in points 7 and 9, if they are listed in the
credentials.
PART (B)
CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL (MODULE C)
1. conformity to type based on internal production control is the part of the procedure
conformity assessment, the manufacturer fulfils the obligations laid down in points 2 and
3, and ensures and declares that the radio equipment is in conformity with the type
as described in the EU type-examination certificate and satisfies the requirements of this
the regulation, which is applicable to it.
2.
Production
The manufacturer shall take steps to ensure that the manufacturing process and its monitoring ensure
compliance of the manufactured equipment with the approved type described in the
the EU type-examination certificate and with the requirements of this regulation which is
to them.
3.
CE marking and Declaration of conformity EU
3.1. The manufacturer shall affix the CE marking in accordance with § 14 on each radio equipment,
that is in conformity with the type as described in the EU type-examination certificate and
meets the requirements of this regulation of the Government.
3.2. the manufacturer shall draw up a written EU Declaration of conformity for each type of
radio equipment and for a period of 10 years after the radio on
the market is at the disposal of the competent authorities. The EU Declaration of conformity
indicates the type of radio equipment for which it was drawn up. Copy Of The EU
the Declaration of conformity on request provide the supervisory authority.
4.
Authorized representative
The manufacturer's obligations set out in point 3 may be on its behalf and on its
the responsibility fulfilled by his authorised representative, if they are listed in the
credentials.
Č. 4
CONFORMITY BASED ON FULL QUALITY ASSURANCE (MODULE H)
1. conformity based on full quality assurance is the procedure
conformity assessment, whereby the manufacturer fulfils the obligations laid down in points 2 and
5 and on his own responsibility, ensures and declares that the radio equipment
meet the requirements of this regulation which apply to them.
2.
Production
The manufacturer must operate an approved quality system for design, manufacture,
final inspection of radio equipment and radio equipment testing
provided for in point 3 and shall be subject to surveillance as provided for in section 4.
3.
The quality system
3.1 the manufacturer lodges an application with a notified body which he has chosen, the application for
assessment of his quality system for the radio equipment. The application must
include:
and the name and address of the manufacturer), and if the application is lodged by the authorised representative,
his name and address,
(b)) the technical documentation for each type of radio equipment, which has
produce. If possible, the technical documentation contains the elements set out
in annex 5,
(c)) the documentation concerning the quality system, and
(d)) a written declaration that the same application has not been lodged with any other
of the notified body.
3.2. The quality system shall ensure compliance of the radio equipment with
the requirements of this regulation which apply to them. All the elements,
requirements and provisions adopted by the manufacturer must be systematically
documented in the form of written measures, procedures and instructions.
The quality system documentation must permit a consistent interpretation of the programs,
plans, manuals and records relating to the quality. System documentation
quality must contain, in particular, a description of:
and) the objectives in terms of quality and the organisational structure, responsibilities and
powers of the management with regard to design and product quality,
(b)) of the specifications relating to the technical design, including standards, that
will be used, and in the case that the relevant harmonised standards
not apply in full, the means that will be used to
ensure that the technical requirements, which are on the radio
equipment is subject to,
c) inspection and design verification techniques, processes and measures that
used in the design of radio equipment, which belongs to the
type of radio equipment,
(d)) of the respective methods, procedures and activities that shall be used when
production, control and quality assurance,
(e)) of the examination and tests that will be carried out before, during
and after manufacture, the frequency with which,
(f)) the quality records, such as inspection reports and records of the
tests carried out, records of calibration reports
qualifications of the staff
g) the means of monitoring the achievement of the required quality
the design and the product and the efficient operation of the quality system.
3.3 the notified body shall assess the quality system to determine whether it satisfies
the requirements referred to in 3.2. The elements of the quality system that conform to the
the relevant specifications of the relevant harmonised standards, compliance with these
the requirements of the standard. Persons who, on behalf of the notified body
assessment of the quality system, (hereinafter referred to as "audit team") must
have experience with quality management systems, and at least one of them must have
experience of assessments of the relevant field of radio equipment and the
the technology of radio equipment and the knowledge of the requirements of this regulation.
The audit includes an assessment visit to the manufacturer's premises.
The auditing team shall review the technical documentation referred to in point 3.1.
(b)), to verify the manufacturer's ability to identify the relevant requirements of this
Regulation and carry out the necessary examination to ensure compliance of the radio
devices with these requirements. The conclusions of the audit, including the reasons therefor,
notified to the manufacturer or to his authorised representative.
3.4. the manufacturer is obliged to fulfil the obligations arising from the approved
the quality system as approved and to maintain it so that it remains
adequate and efficient.
3.5. The manufacturer shall inform the notified body that has approved the quality system,
of any intended change of the quality system. The notified body of the proposed
amendments to consider and decide whether the modified quality system will continue to be
comply with the requirements referred to in point 3.2 or whether a re-assessment is necessary.
The notified body shall notify the manufacturer, the conclusions of his review, including their
justification.
4.
The surveillance of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations
arising out of the approved quality system.
4.2. the manufacturer must allow the notified body in order to assess access to
the places of design, manufacture, inspection, testing and storage
and shall provide it with all necessary information, in particular:
and quality system documentation)
(b)) the quality records provided for in part of the quality system relating to
the design, such as results of analyses, calculations, tests,
(c)) the quality records provided for in the manufacturing part of the quality system,
for example, the reports of the inspections, the records of the tests carried out,
records of the calibration, qualification reports of the personnel concerned.
4.3. the notified body shall carry out periodic audits to make sure that
manufacturer maintains and applies the quality system and provide the manufacturer detail about
audit.
4.4. the notified body may make unannounced to the manufacturer
visits. During such visits the notified body may
If necessary, carry out or have carried out tests of radio equipment,
to verify that the quality system is functioning correctly. The notified body
provide the manufacturer with a visit report and, if they were
the tests carried out.
5.
CE marking and Declaration of conformity EU
5.1 On every radio device that meets the requirements set out in section 3,
the manufacturer shall affix the CE marking in accordance with section 14, and the identification number of the notified
entity.
5.2. the manufacturer shall draw up a written EU Declaration of conformity for each type of
radio equipment and for a period of 10 years after the radio on
the market is kept at the disposal of the supervisory authorities. The EU Declaration of conformity
given the type of radio equipment, for which it has been drawn up. Copy Of The EU
the Declaration of conformity on request provide the supervisory authority.
6. The manufacturer shall keep at the disposal of the competent authorities for a period of 10 years from the
the placing on the market of radio equipment:
and) the technical documentation referred to in point 3.1,
(b)) the documentation concerning the quality system referred to in point 3.1,
c) information about the change referred to in point 3.5, as approved,
d) conclusions and reports from the notified body referred to in points 3.5, 4.3, and
4.4.
7. each notified body shall inform its notifying authority approvals
quality systems, which has issued or withdrawn, and shall, periodically or upon request,
make available to its notifying authority the list of quality system approvals
which it has refused, suspended or otherwise restricted. Each notified body must
It shall inform the other notified bodies of quality system approvals
which it has refused, suspended or withdrawn, and, on request, the system approvals
the quality which it has issued.
8.
Authorized representative
The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be
behalf and under his responsibility fulfilled by his authorised representative,
If they are specified in the mandate.
Č. 5
THE CONTENT OF THE TECHNICAL DOCUMENTATION
The technical documentation shall contain at least the following elements:
and a general description of the radio equipment), including:
1. photographs or drawings that show external signs, markings and
the internal layout,
2. the version of the software or firmware, that have an impact on compliance with the
the technical requirements,
3. the instructions and safety information for the user and installation instructions,
b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies,
circuits, and other similar elements,
c) descriptions and explanations necessary for the understanding of said drawings and
schemes and the operation of the radio equipment,
(d)) the list of harmonised standards which have been applied in full or in part and
the references of which have been published in the official journal of the European Union, and
a description of the solutions adopted to meet the essential safety requirements
laid down in section 3, where those harmonised standards have not been applied,
including a list of other relevant technical specifications. In the case of
partially applied harmonised standards, the technical documentation
shall specify the parts which have been applied,
e) copy of the EU Declaration of conformity,
(f)) was used a conformity assessment module set out in annex 3,
the EU type-examination certificate copy with attachments, as it issued a
the competent notified body,
g) results of design calculations made, examinations and other
Similarly, important elements,
h) test reports,
I) explanation consistent with the requirement of § 5 para. 2 and an explanation of the entry
the information on the packaging in accordance with § 6 para. 4.
Č. 6
EU Declaration of conformity (no XXX) ^ 10)
1. Radio equipment (product number, type or series or serial
number).
2. the name and address of the manufacturer or his authorised representative.
3. this Declaration of conformity is issued under the sole responsibility of the manufacturer.
4. Object of the Declaration (identification of radio equipment that allows the
the tracing; may include a sufficiently clear color
the representation, if it is necessary to identify the radio equipment).
5. Object of the Declaration is in accordance with the relevant harmonised
the legislation of the European Union: directive 2014/53/EU. In the appropriate
cases for more harmonisation of laws of the Union.
6. References to the relevant harmonised standards used or references to the
other technical specifications on the basis of conformity declares.
References shall be given with their identification number and version and in the relevant
cases, also with the date of issue.
7. If necessary, the notified body must: ... (name, number) ... carried out ... (description
measures) ... and issued certificate of EU type examination: ....
8. where appropriate, a description of the accessories and components, including software, which
allow the intended operation of the radio equipment in accordance with the EU
Declaration of conformity.
9. Additional information:
Signed for and on behalf of: ...
(place and date of issue):
(name, function) (signature):
Č. 7
SIMPLIFIED EU DECLARATION OF CONFORMITY
Simplified EU Declaration of conformity referred to in section 6 (1). 3 has this form:
This [name of manufacturer] declares that the type of radio devices [markings
Radio type] is in accordance with Directive 2014/53/EU. Full
the text of the EU Declaration of conformity is available at the following Internet
pages. ...
1) directive of the European Parliament and of the Council/53/EU of 16. April
2014 on the harmonisation of the laws of the Member States relating to the
the supply of radio equipment on the market and repealing Directive 1999/5/EC.
section 2 (b) 2). l) Act No. 127/2005 Coll., on electronic communications and
amending some related laws (Act on electronic
communications), as amended.
3) for example, Act No. 181/2014 Coll., on cyber security and
change related laws (law on Cyber Security), law No.
101/2000 Coll., on the protection of personal data and on amendments to certain laws, as
as amended.
4 for example, section 19b), 25, and 100 of Act No. 127/2005 Coll. as amended
regulations.
5) § 2 (2). 1 (b). e) Government Regulation No. 117/2016 Coll., on the assessment of
conformity of the products in terms of electromagnetic compatibility in their
making available on the market.
6) article 30 of the European Parliament and Council Regulation (EC) no 765/2008 of the
on 9 April. July 2008 setting out the requirements for accreditation and supervision
market surveillance relating to the marketing of products and repealing
Regulation (EEC) No 339/93 (Text with EEA relevance).
7) § 1 (b). and) Decree No. 156/2005 Coll., on technical and operational
conditions of the amateur radio services.
8) of Decree-Law No 345/2016 Coll., on the ship's rigging.
9) European Parliament and Council Regulation (EC) No 216/2008 of 20 December.
February 2008 on common rules in the field of civil aviation and
establishment of the European Aviation Safety Agency, which the masses
Council Directive 91/670 EC, Regulation (EC) No 1592/2002 and directive
2004/36/EC.
10) a manufacturer may give the EU Declaration of conformity number.
