117/2016 Sb.
GOVERNMENT REGULATION
of 30 March 2004. March 2016
on the assessment of conformity of products in terms of electromagnetic compatibility
When they are making available on the market
The Government directs pursuant to § 4 and § 50 para. 5 of law No. 90/2016 Coll.
conformity assessment of specified products when they are making available on the market (hereinafter
"the Act"):
§ 1
The subject of the edit
(1) this regulation incorporates the relevant provision of the European Union ^ 1) and
regulates the technical product requirements in terms of their
electromagnetic compatibility, which must comply when placing on the market
and/or put into service, the conditions and procedures for their making available on the market and
methods of conformity assessment.
(2) this Regulation shall not apply to
a) radio and telecommunications terminal equipment, which are covered by other
Law ^ 2)
(b)) products, parts and appliances referred to in aviation technology directly
applicable legislation the European Union ^ 3),
c) radio equipment used by radio amateurs within the meaning of the radio
regulations adopted in the framework of the Constitution and Convention of the International Telecommunication
Union ^ 4), if the devices are not supplied on the market; as supplied, the
not a kit with parts intended for radio amateurs and Assembly
on the market, the modified ham radio equipment for its own use and
(d)), which are by their very nature of the physical characteristics that
1. cannot cause the electromagnetic radiation in excess of the level of
to enable the radio, telecommunications, and other devices to operate in
accordance with the intended use, or contribute to such radiation and
2. operate without unacceptable degradation in the presence of
electromagnetic interference that is common when their operation in accordance with the
the intended use,
(e)) the assessment kits tailor-made for professionals designed exclusively
for use in research and development facilities for such purposes.
§ 2
Definition of terms
(1) for the purposes of this regulation, means a
the device or device) and fixed installation,
(b) the finished appliance or appliance) combination supplied on the market
as a single functional unit, intended for the final user, which
can be a source of electromagnetic interference or whose operation can
be affected by such disturbance,
(c) a fixed installation report) several types of apparatus and, where applicable,
the funds, which are assembled, installed and intended to be permanent
use on a given site in advance,
d) electromagnetic compatibility the ability of equipment to satisfactorily
to operate in its electromagnetic environment without causing itself
electromagnetic disturbances to other equipment in that environment,
e) electromagnetic disturbance electromagnetic phenomenon which may degrade the
the function of the device; an electromagnetic disturbance may be electromagnetic
noise, an unwanted signal or a change in the propagation environment,
f) resistance the ability of equipment to function correctly without degradation
in the presence of electromagnetic interference,
g) security to ensure protection of human health, life or
assets,
h) electromagnetic environment all electromagnetic phenomena
observable in a given location.
(2) the device referred to in paragraph 1 (b). (b)) means also
component or subassembly) designed for installation in devices
the end user, which may be a source of electromagnetic interference
or whose functioning can be affected by such disturbance,
(b)) mobile installations are defined as a combination of apparatus or
devices, intended to be moved and operated in different locations.
§ 3
Technical requirements
(1) the device must meet the basic technical requirements, which are
listed in annex 1 to this regulation.
(2) if the basic technical requirements for the equipment referred to in annex
No. 1 laid down in another regulation of the ^ 5), essential requirements referred
in annex 1 to this regulation, shall not apply.
(3) meet the essential technical requirements shall be demonstrated by assessing
of conformity.
§ 4
The delivery of equipment on the market and putting into service
(1) the device may 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) if there is a device which meets the requirements referred to in paragraph 1,
to limit the entry into service or use in accordance with other legal
Regulation in order to
and overcoming existing or anticipated) issue with
electromagnetic compatibility in a particular place, or
(b) protection of public telecommunications networks) or receivers and transmitters,
that are used for safety purposes in well-defined
in the spectrum of situations,
This restriction must be, without undue delay notified to the Office for
standards, metrology and testing (hereinafter referred to as
"The Office"), who inform the European Commission and the other Member States
Of the European Union. This is without prejudice to the procedures under another legal
prescription ^ 6).
(3) devices that do not meet the requirements of this regulation, may be
exposed to or presented at trade fairs, exhibitions and similar
events, provided that a visible sign clearly, not
be supplied on the market or put into service until it is secured
their conformity with the requirements of this regulation. Demonstrations may be held in
provided that appropriate measures are taken to prevent
electromagnetic interference.
§ 5
The manufacturer of the
(1) the manufacturer when placing on the market shall ensure that these instruments
have been designed and manufactured in accordance with § 3 (1). 1, shall establish the technical
the documentation referred to in annex No. 2 or 3 to this regulation, and performs
or have carried out the conformity assessment procedure referred to in article 10.
(2) if the conformity of the instrument with the essential technical requirements
the conformity assessment procedure, manufacturers shall draw up the EU demonstrated
Declaration of conformity and affix the CE marking.
(3) the manufacturer shall keep the technical documentation and the EU Declaration of conformity
period of 10 years from placing the apparatus on the market.
(4) the manufacturer shall ensure that such procedures were put in place, through the
which mass produced products 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 the device, or to the changes in the harmonised standards or
other technical specifications, on the basis of the conformity of apparatus
declares.
(5) the manufacturer shall ensure that the equipment, which it placed on the market,
the type or the number of the batch or serial number or other element
allowing their identification, or, where the size or
the nature of the instrument does not allow, that the required information is provided on
packaging or in a document accompanying the product. They shall further ensure that the
the device is accompanied by instructions and the information specified in § 13 para. 2 to 4 in
the Czech language. These tutorials, information and any markings shall be
clear, comprehensible and easy to understand.
(6) the manufacturer shall indicate on the product, or, if this is not possible, on its packaging or in
a document accompanying the device your name or business name, if applicable
the trade mark and the address for service, at which he can be contacted.
Delivery address must be the address of the place in which the manufacturer can be
actually reach you. Contact details are given in a language easily
understood by end-users and the supervisory authority.
§ 6
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
apparatus on the market.
§ 7
The importer
(1) the importer before placing the apparatus on the market shall ensure that the manufacturer has made
one of the conformity assessment procedures referred to in section 10, has drawn up a technical
the documentation placed on the machine the CE marking, it set out to
papers and has complied with the requirements set out in § 5 para. 5 and 6.
(2) the importer shall indicate on the product, or, if this is not possible, on its packaging or in
a document accompanying the device your name or business name, if applicable
the trade mark and the address for service, at which he can be contacted.
Contact details are given in language that is easy to understand for the
the final user and the supervisory authority.
(3) the importer shall ensure that the appliance is accompanied by instructions and information
referred to in § 13 para. 2 to 4 in the Czech language.
(4) the importer for a period of 10 years after the apparatus on the market keeps a copy of
EU Declaration of conformity for the purposes of monitoring the market and ensures that the
the supervisory authorities may on request, be submitted to the technical documentation.
§ 8
Distributor
The Distributor before delivery of the apparatus on the market validates that the device carries the
the CE marking, whether it is accompanied by the required documents and tutorials and
the information referred to in section 13(2). 2 to 4 in the English language and that the manufacturer and the
importer met the relevant requirements set out in § 5 para. 5 and 6 and § 7
paragraph. 2.
§ 9
Time to identify the operator
Economic operator for a period of 10 years from the delivery of the apparatus on the market must keep
data that can be used at the request of the supervisory authority to determine the economic
the body, which the device or it to be added.
§ 10
The conformity assessment procedures
(1) the assessment of conformity with the essential requirements referred to in § 3 (1). 1, the
performs
and internal management of production) (module A) set out in annex 2 to this
Regulation, or
(b)) the EU type-examination (module B), after which conformity to type
based on internal production control (module C) referred to in annex 3 to the
application of this regulation.
(2) the manufacturer may decide that the procedure referred to in paragraph 1
(a). (b)) only on some aspects of essential requirements, if the
other aspects of essential requirements shall follow the procedures referred to in paragraph
1 (b). and).
§ 11
Presumption of conformity
If the appliance is in conformity with the harmonised standards which are
the appliance cover and links which have been published in the official journal
The European Union, or their parts, it is considered that it is in compliance with
essential requirements set out in annex 1 to this regulation, on the
covered by those standards or parts thereof.
§ 12
EU Declaration of conformity
(1) the EU Declaration of conformity to meet the essential requirements
set out in annex 1 to this regulation.
(2) the EU Declaration of conformity shall be drawn up in accordance with the specimen in annex
No 4 to this regulation. The statement contains the information set out in
relevant modules set out in annexes 2 and 3 to this regulation, and
must still be updated. EU Declaration of conformity shall be translated also into
the language or languages required by the Member State of the European Union, in which
the device is put into operation or made available on the market.
(3) If the device is subject to more rules for harmonisation of the European
the Union providing for the elaboration of EU Declaration of conformity,
a single EU Declaration of conformity with links to all of these provisions, in accordance with
which was considered a match, including links to their publication. This
a single EU Declaration of conformity may take the form of a folder consisting of
declarations of conformity issued to individual regulations.
section 13 of the
The CE marking and other labelling and information
(1) the CE marking visibly, legibly and indelibly placed on
the device or data plate. If this is not possible or cannot be
given the nature of the instrument must be affixed to the
the package if the appliance is delivered, and on the accompanying documents.
(2) to the instrument shall be accompanied by a warning to the special measures, which must
be taken when mounting, installation, maintenance or use of the appliance,
in order to ensure that after the commissioning of the unit will meet
the essential requirements laid down in point 1 of annex 1 to this regulation.
(3) in the case of apparatus for which it is not in its use in residential areas
guarantee compliance with the essential requirements laid down in point 1 of Annex No. 1
This Regulation shall be clearly marked restriction of use
on the device, or even on its packaging.
(4) the information required for the use of the appliance in accordance with the purpose to
which is intended, it must be listed in the instructions accompanying the apparatus.
§ 14
Fixed installation
(1) a device that is intended to be incorporated into a fixed
installation and is not otherwise available on the market separately, may not meet the
the essential requirements referred to in § 3 (1). requirements referred to in § 1, 6 and 12 and section
14 and 15 of the Act, including requirements under § 5 to 13, if the accompanying
the documentation shall indicate to the device
and) data identifying the fixed installation, for which the device is intended,
the characteristics of the electromagnetic compatibility and the measures
to be taken with regard to the incorporation of the apparatus into the fixed installation
in order not to compromise the conformity of the installation, and
(b)) information pursuant to § 5 para. 5 the first sentence, § 5 para. 6 and § 7 (2). 2.
(2) an assessment of the conformity of the installation operator performs a fixed installation or
in the case of a person authorized by the
and fixed installation), signs of inconsistency, especially when
the reference to interference, and
(b) the Czech Telecommunication Office) the procedure under other legal
prescription ^ 7) finds that the documents submitted by the operator of the installation
or his authorised person, which are, in particular, the accompanying documents,
the documentation provided for in point 2 of annex 1 to this regulation,
other documents, if applicable, to conform to the established requirements sufficiently
demonstrate.
§ 15
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 of 9 June. July 2008 laying
sets out the requirements for accreditation and market surveillance relating to the marketing of
products on the market and repealing Regulation (EEC) No 339/93 or section 13 of the
paragraph. 1,
(b)) the CE marking has not been affixed,
c) EU Declaration of conformity has not been drawn up,
d) EU Declaration of conformity has not been drawn up in accordance with this
by regulation,
e) technical documentation is missing or incomplete,
(f)), the information specified in § 5 para. 6 or in article 7 para. 2 are missing or
are incorrect or incomplete, or
g) was not fulfilled other administrative requirement referred to in section 6 (1). 5 and
6 or in § 8 para. 3, 6 and 7 of the Act and in section 5, or section 7.
section 16 of the
Transitional provisions
(1) comply with the requirements laid down by regulation of the Government No. 616/2006
Coll. may continue to be supplied on the market and put into service, if the
placed on the market before the date of 20. April 2016.
(2) valid certificates and other documents certifying the detected
fact released persons notified pursuant to Decree-Law No.
616/2006 Coll., shall remain in force and shall be deemed the certificates and other
the documents certifying the facts established under this regulation.
§ 17
Regulation (EEC)
Government Regulation No. 616/2006 Coll. on technical requirements for products from
with regard to their electromagnetic compatibility, is hereby repealed.
section 18
The effectiveness of the
This Regulation shall enter into force on 20 March 2004. April 2016.
Prime Minister:
Mgr. Sobotka in r.
Minister of industry and trade:
Ing. Mládek, CSc., r.
Č. 1
BASIC TECHNICAL REQUIREMENTS
1. General requirements
Devices must be designed and constructed so that, taking into account the
achieved the status of the equipment ensure that
a) electromagnetic interference that cause, shall not exceed the level at which
radio and telecommunications equipment or other devices are not capable of
work in accordance with the intended use, and
(b)) are the level of resistance to electromagnetic interference
the expected when their operation in accordance with the intended use, which they
enables you to operate without unacceptable degradation of traffic in accordance with the
the intended use.
2. Specific requirements for fixed installations
Installation and intended use of components
Fixed installation must be installed with the use of codes of good practice
and with regard to the details of the intended use of components in order to meet
the essential requirements laid down in point 1. The rules of practice must be
documented, and the documentation or installation, the operator shall
the designated officer for the operation of the installation to store for the needs of
the supervisory authorities.
Č. 2
THE INTERNAL PRODUCTION CONTROL (MODULE A)
1. Internal production control
Internal production control is the conformity assessment procedure whereby the manufacturer
performs the activities provided for in paragraphs 2, 3, 4 and 5 of this annex and the
own responsibility, ensures and declares that the instruments concerned satisfy the
the requirements of this regulation which apply to them.
2. assessment of electromagnetic compatibility
The manufacturer of the device on the electromagnetic compatibility
the basis of the relevant phenomena in order to meet the essential requirements laid down in
point 1 of annex 1 to this regulation.
When the electromagnetic compatibility assessment shall be taken into account
all normal operating conditions. If the device can have a different
configuration, you must assess the electromagnetic compatibility, confirm
whether the device meets the essential requirements referred to in point 1 of the annex No. 1 in
all of the possible configurations that the manufacturer designates a representative
for the intended use of the device.
3. the technical documentation
The manufacturer shall establish the technical documentation. The documentation must allow
assessment of the conformity of the instrument with the appropriate requirements, and contain
adequate analysis and risk assessment.
The technical documentation shall specify the applicable requirements and to the extent necessary
for the assessment must cover the design, manufacture and operation of the device.
The technical documentation shall contain, where relevant, at least the following
requirements:
and a general description of the device);
b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies,
circuits or any other design documentation;
c) descriptions and explanations necessary for the understanding of those drawings and schemes
and operation of the instrument;
(d)) the list of harmonized standards, references to which have been published in the
The official journal of the European Union and which have been applied in full
or in part, and descriptions of the solutions adopted to meet the essential requirements of the
of this regulation, where those harmonised standards have not been applied, including
list of other relevant technical specifications that were used.
In the event of partly applied harmonised standards, the technical
documentation shall specify the parts which have been applied;
e) results of design calculations, examinations carried out, where appropriate,
For more results of the calculations and checks;
f) test reports.
4. production
The manufacturer shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured instruments with the technical
the documents set out in point 3 and with the essential requirements laid down in
point 1 of annex 1 to this regulation.
5. the CE marking and EU Declaration of conformity
5.1 the manufacturer shall affix the CE marking on each appliance that
complies with the relevant requirements of this regulation.
5.2. the manufacturer shall draw up a written declaration of conformity for the EU model of the device
and for a period of 10 years after the apparatus on the market, together with the technical
documentation at the disposal of the supervisory authority. The EU Declaration of conformity
the device must be provided, for which it has been drawn up.
A copy of the EU Declaration of conformity shall on request provide the supervisory authority.
6. Authorized Representative
The activities of the manufacturer referred to in point 5 may be on its behalf and on its
the responsibility fulfilled by his authorised representative, if the manufacturer in
authorised representative established 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 device and verifies and attests
the technical design of instruments complies with the essential requirements laid down in
point 1 of annex 1 to this regulation.
2. the EU type-examination shall be made of the technical suitability assessment
the design of the instrument through examination of the technical documentation
in accordance with point 3, without examination of the specimen (design type). May be limited to
some aspects of essential requirements, as determined by the manufacturer or his
authorised representative.
3. the manufacturer lodges an application with a single notified body of his choice, the request
the EU type-examination.
The request must specify the aspects of essential requirements, which
review is required. Furthermore, the request shall contain:
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
the notified body;
(c)) the technical documentation. Technical documentation shall enable
the conformity of the instrument with the appropriate requirements of this regulation and
include an adequate analysis and assessment of risks. The technical documentation
shall specify the applicable requirements and to the extent necessary for the assessment,
cover the design, manufacture and operation of the device. The technical documentation
must contain, if applicable, at least the following information:
I) a general description of the device,
II) conceptual design and manufacturing drawings and schemes of components, sub-assemblies,
circuits, etc.,
III) descriptions and explanations necessary for the understanding of the drawings,
schemes and the operation of the device,
IV) list of the harmonized standards, references to which have been published in the
The official journal of the European Union and which have been applied in full
or in part, and descriptions of the solutions adopted to meet the essential requirements of the
laid down in this regulation, where those harmonised standards applied
they were not, including a list of other relevant technical specifications,
that were used. In the event of partly applied harmonised standards
the technical documentation shall indicate only the parts which have been applied,
v) results of design calculations, examinations carried out, where appropriate,
For more results of the calculations or the checks and
vi) test reports.
4. the notified body shall examine the technical documentation with a view to assessing
the adequacy of the technical design of the instrument in relation to aspects
the basic requirements to the review is required.
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 to the authority, the notified body shall publish
the content of this report, in full or in part, only with the consent of the
manufacturer.
6. Where the type meets the requirements of this regulation which shall apply to the
the instrument, the notified body shall issue the EU type-examination certificate to the manufacturer
type. This certificate must contain the name and address of the manufacturer, conclusions of the
review information about aspects of essential requirements, which are
the review covered, conditions for its validity and the necessary data
to identify the approved type. 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 they are produced in conformity with the
přezkoumaným type, and perform a check in operation.
If the type does not satisfy the requirements laid down in this regulation, refuses to
the notified body must issue a type-examination certificate of the EU and shall inform the
applicant accordingly, giving detailed reasons for such denial denial.
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 laid down in this regulation;
If such a situation occurs, shall determine whether such changes require
further investigation and 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 the instruments with the
the essential requirements of this regulation or the conditions of validity of the
the certificate. The notified body shall approve these adjustments in the form of a supplement to the
the original EU type-examination certificate.
8. each notified body shall inform the authority of the EU type-examination certificates
type or additions thereto which it has issued or withdrawn, and shall, periodically or on
request, make available to the Office a list of the certificates and/or additions thereto,
refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies of the
the EU type-examination certificates and/or any additions thereto which it has refused,
withdrawn, suspended or otherwise restricted, and, upon the request of any other notified
subjects also about certificates and/or any additions thereto which it has issued.
The European Commission, European Union Member States and the other notified bodies
the notified body may request a copy of the EU type-examination certificate
or additions to them. The European Commission and the Member States of the European Union
the notified body may ask for a copy of the technical documentation and the results of the
the review carried out by it. The certificate expires, the EU
type-examination, the notified body shall keep a copy of this certificate,
its annexes and additions, as well as the technical file including the
the documentation submitted by the manufacturer.
9. For a period of 10 years after the apparatus on the market, the manufacturer for
the need for the supervisory authority a copy of the EU type-examination certificate, its
annexes and additions together with the technical documentation.
10. the manufacturer's authorised representative may lodge the application referred to in point 3 and
to carry out the activities provided for in paragraphs 7 and 9, where the manufacturer in the mandate
authorised representative established.
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 performs the activities provided for in points 2
and 3, and ensures and declares that the appliances are in conformity with the type
as described in the EU type-examination certificate and satisfy the requirements of
laid down in this regulation that apply to them.
2. production
The manufacturer shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured instruments with the approved type
as described in the EU type-examination certificate and with the requirements of this
the regulation, which applies to them.
3. the CE marking and EU Declaration of conformity
3.1. The manufacturer shall affix the CE marking to each individual unit that is
in conformity with the type as described in the EU type-examination certificate and satisfies the
the relevant requirements of this regulation.
3.2. the manufacturer shall draw up for each machine model written EU Declaration of
conformity and for a period of 10 years after the apparatus on the market is a must, for
the need for the supervisory authority. The manufacturer shall provide, on request, a copy of the EU Declaration of
conformity to the supervisory authority.
4. Authorized Representative
The activities of the manufacturer referred to in point 3 may be on its behalf and on its
responsibility carried out by his authorised representative, if the manufacturer in
authorised representative established the credentials.
Č. 4
EU Declaration of conformity (# XXXX) ^ 8)
1. the Model of the device/product (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 the device allowing to reverse
trace; If it is necessary for the identification of the instrument, can
include a sufficiently clear colour image):
5. object of the Declaration described above is in conformity with the relevant Community harmonisation
regulations of the European Union:
6. references to the relevant harmonised standards used, including data
standards or other technical specifications, including specifications, data on
which conformity is declared:
7. If necessary, the notified body must: ... (name, number) performed ... (description of intervention) and
issued the certificate:
8. other information:
Signed for and on behalf of:
(place and date of issue):
(name, function) (signature):
1) directive of the European Parliament and of the Council of 30/EU of 26 March. February
2014 on the harmonisation of the laws of the Member States relating to the
electromagnetic compatibility.
2) Government Regulation No. 426/2000 Coll. laying down technical
requirements for radio and telecommunications terminal equipment, as amended by
amended.
3) European Parliament and Council Regulation (EC) No 216/2008 of 20 October.
February 2008 on common rules in the field of civil aviation and
establishment of the European Aviation Safety Agency, repealing
Council Directive 91/670 EC, Regulation (EC) No 1592/2002 and directive
2004/36/EC, as amended.
4) Constitution and the International Telecommunication Union Convention, adopted at the
additional Conference of Plenipotentiaries (Geneva, 1992), as amended by
Government Plenipotentiaries Conference (Kyoto, 1994).
5) for example, the Government order No. 120/2016 Coll. on the conformity assessment of measuring instruments
When they are making available on the market, Government Regulation No. 54/2015 Coll.
technical requirements for medical devices.
6) Government Regulation No. 339/2002 Coll., on the procedures for the provision of
information in the field of technical regulations, technical documents and
technical standards, as amended.
7) Act 127/2005 Coll., on electronic communications and amending
some related laws (Act on electronic communications),
in the wording of later regulations.
8) the manufacturer may give the number of the Declaration of conformity.