90/2016 Coll.


LAW
Dated 3 March 2016

On conformity assessment of products when made available on the market

Parliament has passed this Act of the Czech Republic:
PART ONE


DELIVERY OF PRODUCTS ON THE MARKET
TITLE
I
GENERAL PROVISIONS


§ 1
Subject Matter


(1) This Act transposes the relevant EU legislation on
common framework for the marketing of products ^ 1), and the procedure
state authorities to protect the market against products which could endanger
life health, property or the environment or other public interest.

(2) This Act incorporates the provisions of the European Union in delivering products to market
^ 2) issued in response to a European Union law on
common framework for the marketing of products ^ 1) and products that are
in accordance with these regulations set by the Government regulates

A) general guidelines for making products available on the market or putting into service of products
,

B) the method of determining product conformity assessment and technical requirements
which products must comply

C) the rights and responsibilities of persons who market or markets supplied,
or put into service products that have to be before placing on the market
conformity with the requirements laid down in legislation | ||
D) conformity assessment of products

E) state administration in state testing and surveillance
market

F) the rights and obligations of persons authorized to carry out activities under this Act
related to State testing,

G) the obligation to provide information related to supplying
products on the market, conformity assessment and market surveillance.

(3) This Act regulates in response to a directly applicable regulation
European Union in the field of accreditation and supervision ^ 3) surveillance relating
the marketing of products and their labeling.

(4) This Act also regulates the exercise of state administration in the products
which is used directly applicable legislation of the European Union in the field
marketing of products related to a common framework for the marketing of products
market, and which are listed in part Two, Title I or
which it provides another law ^ 4) governing conformity assessment and delivery
products on the market.

§ 2

(1) The products covered by the relevant EU regulations
provisions of § 3-15 apply. The provisions of § 23-26, § 50 and 51
these products are used, unless the relevant European Union regulations
otherwise specified.

(2) For products mentioned in Part Two, Title II, § 3 to 15
§ 23-26, § 50 and 51 apply, unless stated in the second part of Title II
otherwise.

§ 3


Concepts
For the purposes of this Act

A) available on the market supply of a product for distribution, consumption or use on
EU market under a commercial activity, whether in return for payment or free of charge
,

B) placing on the market the first delivery of the product to European Union market

C) operator manufacturer, authorized representative, importer and distributor
,

D) the producer of a person who manufactures a product or has such a product designed or manufactured
and the product on the market under his name or trademark
or, if so provided by government decree, it uses
for their own use,

E) means a person established in the territory of a Member State
European Union, which was written mandate from the manufacturer to the extent of its mandate
act on his behalf

F) importer person established in the European Union, which launches the European Union
product from a third country

G) a distributor of a person, with the exception of the manufacturer or importer, which
supply chain product available on the market

H) conformity assessment body of a person or a government department,
that performs conformity assessment activities, including calibration, testing, certification and inspection
,

I) the conformity assessment process demonstrating that the essential
technical requirements relating to a product, process, service, system or
those set by the Government

J) designation CE marking by which the manufacturer indicates that the product is in
accordance with the requirements laid down in the laws that govern
its placement,

K) technical requirements

First the required product characteristics, which are primarily
levels of quality, performance, safety or dimensions,
interoperability, health and the environment, including
product requirements in terms of its trade name, terminology, || | symbols, testing and test methods, packaging, marking and
conformity assessment procedures, as well as production methods and processes
having an impact on product characteristics and

Second other requirements necessary for reasons of protecting

Environment after placing the product on the market or put into service, as
conditions of use, recycling, reuse or disposal
product, where such conditions can significantly influence the composition or
characteristics of the product or its market or put into service

L) recall measure aimed at achieving the return of a product that
already delivered to the end user, the person who
product to the end user, adding

M) withdrawal means any measure aimed at preventing a product
located in the supply chain available on the market.

§ 4

Products intended for conformity assessment and technical requirements that must meet
products at launch or during commissioning
or use, including use for a producer, provides
government regulations in which may further specify

A) methods of conformity assessment

B) the conditions and rules for drawing up the EU declaration of conformity and CE marking
placement or other indications; Government Regulation also for other
marking down its form and method of placement,

C) processes for making products available on the market

D) details of the activities of operators and notified bodies
(§ 17) in conformity assessment.

§ 5

(1) The market may be made only such product that meets the requirements
this law and government regulations issued for its implementation, which will be applicable to
(hereinafter referred to as "specified requirement"), and in which
was assessed a match.

(2) If so provided by government regulations, products can be brought into operation
or used, including the use for his own use
manufacturer only if it meets specified requirements and were assessed for their compliance
.

(3) of Government Regulation may be determined in cases in which the competent
central administrative authority may authorize the placing on the market and put into service the product on
Czech Republic without an assessment of conformity when using the product in
interest of safety, or is intended for experimental purposes.

(4) If the product meets European Union
harmonizing the conditions for the marketing of products (hereinafter
"harmonizing EU") that apply to it, not
public authorities defend the aspects covered by those provisions in its
available on the market in the Czech Republic.

(5) At trade fairs, exhibitions and similar demonstrations can
in cases and under conditions stipulated by the Government and demonstrate products that do not meet the requirements set
.
TITLE II



OPERATORS
§ 6
Producer


(1) The manufacturer shall ensure that products are designed and manufactured
in accordance with specified requirements. For mass-produced
products must ensure compliance with the requirements throughout
production time, even in the event of changes in the structure or
product parameters, or changes in the harmonized standards ^ 5) or changes | || document that prescribes technical requirements that a product, process or service
meet to demonstrate compliance.

(2) The manufacturer shall establish the technical documentation and carry out or
you have carried out the conformity assessment procedure established by government regulation.
The scope and method of preparation of technical documentation can be determined
government regulation. After proving conformity, the manufacturer must
in cases stipulated by the Government to draw up an EU declaration of conformity or another document confirming compliance
(hereinafter the "Declaration of Conformity") and place
CE marking or other prescribed marking.
Technical documentation and declaration of conformity is required to keep the extent and for that
set by Government regulation.

(3) The manufacturer shall indicate on the product identification and information
product data and identification information and contact details relating to his
those set by government regulation. If the size or nature of the product
does not provide these details on the product, and unless the regulations
government otherwise, these data are required on the product packaging or in
document, which is attached to the product. The manufacturer must ensure that
product was accompanied by a clear and understandable instructions and safety information
in the Czech language. If stipulated in Government attaches
manufacturer of each product copy of the declaration of conformity.
Range enclosed instructions and safety information may provide
government regulation.

(4) Manufacturer's cases and to the extent stipulated by the Government
required to perform in order to protect the health and safety of consumers
testing product samples and other necessary investigations concerning products marketed
keep records complaints and non-compliant products and
products withdrawn from circulation, and to inform about these facts
distributors who supplied these products.


(5) A producer who considers or has a reason to believe that
product that the market is not in conformity with the established requirements
shall without undue delay take the necessary and effective measures to
the product into compliance with specified requirements, or download
product from the market or from circulation. If the product poses a risk to
life, health, property or the environment, or else
public interest (hereinafter referred to as "risk"), the manufacturer of this
risk and its nature and causes, as well as received
measures or withdrawal of the product from the market or from the market immediately inform the supervisory authority
(§ 49 par. 1) or the competent authorities of another Member State
European Union, which has supplied a product on the market.

(6) The manufacturer is responsible for the supervisory authority or the competent authority of another
EU Member State in which the product is delivered to the market on its
reasoned request to provide information and documentation necessary to demonstrate the conformity of the product
. Unless otherwise provides the following information and documents
in the official language of the Member State of the European Union.
The manufacturer shall provide those authorities the assistance required to
exercise their responsibility to avoid risks caused by products
placed on the market.

(7) The manufacturer is entitled to appoint an authorized representative.
The commission authorized representative must not include any performance of
obligations referred to in paragraph 1 shall not be required to produce the desired
technical documentation, he must not allow
keep the declaration of conformity and the technical documentation, and providing synergy authorities || | supervision.

§ 7
Authorised representative


Authorized representative shall perform the tasks within the scope of its mandate and
stores declaration of conformity and the technical documentation for a period determined
government decree. Upon request, shall provide the supervisory authorities
information and documentation necessary to demonstrate product compliance and interoperability
required for the performance of their responsibilities in order to avoid risks caused
products, which are covered by his mandate.

§ 8
Importer


(1) The importer may be placed on the market only products which are in accordance with
stated requirements, and shall ensure that the period during which
pre-market products handled in storage and not
transport conditions such compliance risk.

(2) The importer is obliged

) Before placing the product on the market to ensure that

First manufacturer with imported product it done or had done
appropriate conformity assessment procedure and drawn up the technical documentation

Second product has been CE marking or other prescribed marking

Third was attached to a product declaration of conformity, if so provided
Government

Fourth product has been provided with clear and comprehensible instructions and safety information in
extent determined by government decree and

Fifth manufacturer has complied with the requirements set out in § 6 para. 3, and

B) keep a copy of the declaration of conformity for a period specified in the Regulation
government and reasoned request by the supervisory authority to ensure his availability
technical documentation.

(3) An importer who believes or has a reason to believe that
product that intends to place on the market is not in accordance with established
requirements, may place the product on the market until the product is not
given the stipulated requirements to comply. If the product poses
risk, the importer shall immediately inform the manufacturer, and
including information on the nature of the risk and its causes, as well as it
measures taken or to withdraw a product from the market or from circulation || | also inform the supervisory authority.

(4) The importer shall indicate on the product identification and contact information
concerning the person specified by Government, or if that is not possible
or if stipulated by government regulations, is obliged to introduce these data
product packaging or in a document that is attached to the product.
Importer is obliged to ensure that the product be accompanied by clear and understandable
instructions and safety information in the Czech language.

(5) The importer in the cases and to the extent stipulated by the Government
required to perform in order to protect the health and safety of consumers
sample testing and other necessary investigations regarding the products placed on the market
keep records of nonconforming products and product recalls, and
informed about these facts distributors which these products
added.

(6) The importer is obliged supervisory body or competent authority of another
EU Member State in which the product is delivered to the market on its
request to provide information and documentation necessary to demonstrate compliance
product. Unless otherwise provides the following information and documents in
official language of the Member State of the European Union. the importer

Obliged to provide these authorities upon request
assistance required to exercise their competence in order to avoid risks caused by products
placed on the market.

(7) An importer considers or has a reason to believe that
product that the market is not in conformity with the established requirements
shall immediately take the necessary measures to bring the product into compliance with those
requirements, or withdraw from the market or from circulation.
If a product presents a risk, it is obliged to notify and its nature and causes, as well
measures taken or to withdraw a product from the market or from circulation
immediately inform the manufacturer and the supervisory authority or the competent authority
another Member State of the European Union, which has supplied a product on the market.

§ 9
Distributor


(1) Distributor act with due care so that products supplied by it to
market meet the specified requirements, and shall ensure that, once
period for which prior to delivery of the products handled, not | || storage and transport conditions products to comply with the set requirements
risk.

(2) Distributor is obligated in the cases and to the extent provided
government regulation before delivering the product to the market to verify whether the product
CE marking or other prescribed marking whether the product is accompanied by a statement
conformity and clear and understandable instructions and safety information
within the range set by the Government that these
instructions and safety information included with the product are
Czech language, and that the manufacturer and the importer have complied with the requirements set out in § 6
paragraph. 3 and § 8. 4th

(3) Where a distributor considers or has a reason to believe that
product does not comply with the set requirements, may
this product available on the market until the product will be given with these requirements by || | line. If the product presents a risk, it is obliged to notify
manufacturer or importer and market surveillance authorities.

(4) The distributor must supervisory body or competent authority of another
EU Member State in which the product is delivered to the market on its
request to provide information and documentation necessary to demonstrate compliance
product. The distributor is obliged to provide these authorities upon request
cooperation needed to exercise their responsibilities in order to avoid risks caused
products supplied to the market.

(5) Where a distributor considers or has a reason to believe that
product, which added to the market is not in accordance with specified requirements
is obliged to ensure that the necessary measures be taken to bring the
product into compliance with those requirements, to withdraw from the market or from circulation
. If the product presents a risk, it is obliged to
and its nature and causes, as well as the measures taken or to download a
product from the market or from circulation immediately inform the manufacturer or importer
and the supervisory authority or the competent authority of another
Member State of the European Union, which has supplied a product on the market.

§ 10

Importer or distributor for the purposes of this Act considered
producer who is subject to the obligations of the manufacturer under § 6 if
places a product on the market under his name or trademark or modifies a product
, which was already listed on the market in such a way that
may affect its compliance with specified requirements.

§ 11

Operators are required for the period stipulated in Government Regulation
at the request of the competent supervisory authorities to identify all the
entities

A) has supplied them with a product or

B) which supplied a product.
TITLE III

ASSESSMENT OF CONFORMITY


§ 12

Conformity assessment procedures

(1) Conformity assessment is carried out by conformity assessment modules
or their combination, the use of which, or a combination thereof
for a particular product set provides for government regulation. List
conformity assessment modules specified in Annex no. 1 hereto.

(2) Individual modules referred to in paragraph 1 shall include procedures and practices that
in conformity assessment provided by the manufacturer, or the scope of its mandate
plenipotentiaries, and conformity assessment bodies.
Modules specify particular ways of exchanging information between the manufacturer and the body and
their scope, extent of product documentation, production, or the system
quality activity when assessing the suitability of the design of the product, details of the sampling
product scope and methods of testing product samples or
prototypes, molds conclusions of conformity assessment, differences in assessing
serial or piece production of products and procedures for audits
quality systems.

(3) assessing compliance with the circumstances and the extent specified in
governments can participate in accredited in-house body manufacturer
if it meets the following criteria:

A) the manufacturer's in-house department covers the accreditation granted in

Accordance with applicable regulations of the European Union in the field of accreditation and supervision
^ 3)

B) in-house department of the manufacturer constitute a separate organizational unit
and his employees use such methods of reporting among departments
manufacturer to ensure their impartiality,
rendered to the accreditation body

C) in-house department of the manufacturer and its employees shall not engage in
design, manufacture, supply, installation, operation or maintenance of products which
assess, and must not engage in any activities that might
compromise their independence of judgment or credibility towards
assessment activities

D) in-house producer department provides services exclusively to manufacturers
which it is part.

(4) The manufacturer, part of which is in-house department or
accreditation body shall provide on request
Office for Standards, Metrology and Testing (hereinafter the "Office")
information about that was accredited in-house body manufacturer,
including the scope of accreditation.

§ 13
Presumption of conformity


(1) If the product is in conformity with harmonized standards ^ 5) or
parts of which have been published in the Official Journal of the European Union,
it is considered that it is in compliance with the technical requirements
listed in government regulation to which these standards or parts thereof concerned.

(2) the absence of harmonized standards, and if so provided by regulation
government, the Office shall publish in the Gazette of the Office for Standards, Metrology and
testing information on existing Czech
technical standards and technical documents prescribing
technical requirements which are considered appropriate for a proper assessment of conformity.

§ 14

Declaration of Conformity

(1) Statement of compliance manufacturer confirms that the conformity assessment
been shown to meet the basic technical requirements set out in
government regulation.

(2) Declaration of Conformity containing the information listed in Annex no. 2 to this Act
which are depending on the product under consideration concretized
government regulation, and the elements specified in the relevant modules of conformity assessment
, and must be constantly updated. Drawn up in the Czech language and
in the official languages ​​of the Member States of the European Union, in which the product
placed or made available on the market.

(3) Where a product is subject to more government regulation governing
conformity declaration, and government regulations to admit
draw up a single declaration of conformity, in which reference is made to || | harmonization legislation of the European Union, related to the product
or the appropriate government regulation. This single declaration of conformity
may, if permitted by government regulations, form component consisting
relevant individual declarations of conformity.

§ 15

CE and other markings

(1) The CE marking ^ 6) may be provided only product in which it is
location of this designation determined by government decree.

(2) The CE marking is affixed to the product before it is placed on the market;
must be affixed visibly, legibly and indelibly.
Government regulation may determine other ways of placing the CE mark, in particular, that the CE marking has
be placed on the product label or on the packaging or on
documents accompanying the product.

(3) The CE marking of conformity assessment under the module, including
connection identification number of the notified body, connects announced
entity which participated in the conformity assessment, identification number, which is assigned
European Commission . According to the guidelines notified body may
connect this number to the CE marking the manufacturer or his authorized representative
.

(4) If so stipulated by government regulations complement the CE marking,
or the identification number of the notified body or other
given site-specific designation. The designation may be connected
pictograms or other marks indicating a special risk or use
way.
TITLE IV

Testing


§ 16

(1) State testing for the purposes of this Act means activities
which the Office carries out state administration in the field of conformity assessment when
product marketing under a common framework of the European Union, and the fact that


A) evaluate the competence of conformity assessment bodies for their
notification to the European Commission and other Member States of the European Union,

B) in the case of notified bodies decide on changes in their notification and

C) carry out monitoring of notified bodies.

(2) The state testing is also considered to be the activities carried out by the Office
notified bodies in conformity assessment.

Notification and monitoring of Notified Bodies

§ 17

(1) The body can only be a legal entity established in

Czech Republic, which meets the requirements of § 23 and is on her
assume that it will meet this requirement continuously, and which offers
guarantees compliance with the obligations relating to notified bodies
and proper execution of this activity.

(2) Conformity Assessment Bodies notified to the European Commission and other
Member States of the European Union Office, which is notifying authority within the meaning
harmonization of European Union legislation and the related regulations
European Union. The Office shall notify the European Commission and other Member States of the European Union
also significant changes to the notification. These
uses an electronic notification tool
managed by the European Commission.

(3) The Office shall also inform the European Commission about the procedures, which are used by
assessment and notification of conformity assessment bodies and the control it
notified bodies, and of changes in those procedures.

§ 18

(1) Notification procedure is initiated on the basis of an application filed by the Office
conformity assessment body.

(2) The request for notification shall, in addition to general terms, according to the Administrative Procedure
contain a description of the activities in conformity assessment that relate to
government regulation under this Act or the relevant regulation
European Union, together specifying procedures or conformity assessment modules and
assessed products.

§ 19

(1) In considering the request in terms of competence subject
conformity assessment procedures for notification of the Office uses an accreditation certificate issued by the accreditation body
^ 7), if the request is accompanied.
It does not submit an accreditation certificate, or a certificate of accreditation
not documented adequately meet all requirements according to § 23
applicant shall provide the Authority with all required documents by
necessary for assessment, recognition and regular monitoring of performance these requirements.

(2) The notification procedure, the Office will decide within 90 days of receipt of the request
. In the event that the applicant demonstrates its competence
other way than through an accreditation certificate
extend this deadline by 30 days.

(3) If a conformity assessment body meets the requirements and prerequisites
according to § 17 para. 1, the Authority announcement according to § 17 paragraph. 2, in the opposite case
reject the application.

(4) The notification shall include full details of the conformity assessment activities
, conformity assessment modules and the product concerned, and data
a conformity assessment body in relation to the harmonization
European Union law or the relevant regulation
European Union, which relate to the product concerned.

(5) for notification to the Authority shall notify the applicant with instructions that
date information early authorization of the notified body
can be obtained from the information system of the European Commission notified bodies, and management
marked by a resolution to Pat interrupted.

§ 20

(1) Permission to perform activities shall give the body
conformity assessment, if the European Commission nor any Member State
European Union does not object to such notification within 2 weeks
disclosure notification if it has been used certificate accreditation
or within 2 months of the disclosure notification, if the accreditation
applied.

(2) If the European Commission nor any Member State of the European Union
raise any objection against the notice under paragraph 1, the Office of this fact
notes in the file and inform the notified body. At the same time, without undue delay
published in the Bulletin of the Office of Communication of the authorization
activities of the notified body, including the scope of the authorization, data,
from which the entity is authorized to perform the activities of a notified body and
identification number of the notified body . On request, the Office shall issue
notified body of an appointed way confirmation of the occurrence or duration of
authorizations for activities in conformity assessment.
Request the issuance of such a certificate can advance together for a request for notification or
during the proceedings. The emergence of permission to the notified body looks as if
his request was granted.

(3) If the European Commission or a Member State of the European Union
raise an objection against a notice under paragraph 1, the Office will invite the applicant
to take measures to eliminate shortcomings and provide for the reasonable
deadline. If the applicant removes the deficiencies within a specified period
communicate this fact without undue delay of the Authority. If
Office reaches the conclusion that the applicant deficiencies, re-announcement by
§ 17 paragraph. 2. If an applicant within the period specified deficiencies are not removed,
Office rejects the application.

§ 21

(1) The Office shall examine whether it notified bodies comply with the provisions of this Act and
whether they passed by government regulation or relevant
EU regulation. A notified body is obliged to request evidence

Office of the correctness of its conclusions adopted in conformity assessment and for that purpose
without delay and provide the required extent
submit particular documents, based on which these conclusions were adopted
. When checking Office is also authorized to establish the facts
regarding activities in conformity assessment organized by other entities
which a notified body subcontracts specific tasks concerning
Conformity Assessment (the "subcontractor").

(2) If the Office finds that a notified body no longer meets the requirements
according to § 23, with regard to the seriousness of the consequences of failure to meet these requirements
decides to suspend, limit or revoke
carry out activities announced entity. The decisions
Office informs without delay the European Commission and other Member States of the European Union
.

(3) In the case of non-compliance in accordance with § 23, in which the Authority considers that
failing which they have no direct bearing on the proper performance of activities notified
entity, the Office of suspension of authorization to perform the activities of a notified body
and set a deadline for correction. Informs If the notified body
Office of redress and the Office finds sufficient remedy,
decision to suspend the authorization to carry out activities of a notified
entity canceled. If the notified body within a specified period
remedy fails, the Office of the restriction or withdrawal of authorization to carry out the activities
notified.

(4) If the Board finds infringement under § 24-26, which
considers that it is less serious and no evidence of non-compliance pursuant to §
23, invite the notified body within a specified period of time has taken measures
to remedy. If the Office does not consider such action as sufficient, then
adoption of remedial measures within a specified period impose a decision that is
first act in the proceedings for the suspension, limitation or revocation
perform the activities of a notified body.

(5) In the case of suspension, limitation or revocation
perform activities shall be decided Authority also where all the
notified body requests. The condition for the decision of the authorities in this case
conditions pursuant to § 22 paragraph. 4th

§ 22

(1) A legal entity that has been established by a final decision of the Office
limited or eliminated valid authorization to perform activities of a notified
entity is obliged

A) of this decision Office without delay inform all
operators concerned

B) at the request of the operator, which concern the consequences of changes
validity of the notification, transfer the rights and obligations associated with
conformity assessment, including the subsequent verification of the fulfillment of the preconditions under which it was delivered
certificate or other document
certifying established facts (the "certificate") to the notified body with which the
this trader entered into an agreement pursuant to § 24 para. 1, pass him
related documentation and advise the Authority on the transfer of rights
and obligations, including the transfer of documentation,

C) ensure that the relevant documentation concerning the activities of the notified body
available on request to the Office or to the supervisory authority, and
it over to him to the decision to restrict or revoke authorization
perform activities shall Authority established.

(2) Certificates and documents relating to the conformity assessment
erroneously issued by the notified body before the restriction or revocation of
perform the activities of a notified body and not canceled it is entitled to cancel
notified body which assumed the rights and obligations pursuant to paragraph 1
. b) or supervisory authority if it finds them wrong
issue of market surveillance.

(3) The body which took over the rights and obligations under paragraph 1
point. b) the right to use documents from the donor notified
subject to the completion of unfinished cases conformity assessment or
subsequent verification of the fulfillment of the preconditions under which it was issued
certificate.

(4) In case the notified body intends to terminate or reduce their
activities without breaching its obligations under the requirements of the provisions
§ 23, is required before a decision of the Office of limitation or revocation of authorization
perform activities shall transfer the rights and obligations
to another notified body; paragraph 1 point. b) shall apply mutatis mutandis.

(5) To cause termination of a legal entity which is a notified body
this is required, before the demise of the relevant documentation regarding
activities shall submit to the Office.
Notified bodies


§ 23

(1) Requirements for notified bodies are:

A) the conformity assessment body must be independent of the management
entity whose product it assesses and of the product;
if this regulation does not preclude the government, it may also be a conformity assessment body
belonging to a business association or professional federation sdružujícímu persons who

Involved in the design, manufacture, assembly, use or maintenance
products that conformity assessment body assesses if it proves
its independence and the absence of any conflict of interest

B) the conformity assessment body, its leadership and people who are involved in the
carrying out the conformity assessment (hereinafter "staff")
not design, produce, deliver, install, buy, possess ,
use or maintain the products they assess;
not directly involved in the design, manufacture or construction, marketing,
installation, use or maintenance of those products;
not even represent the parties engaged in those activities.
They shall not engage in any activity that could jeopardize their independence of judgment and
credibility in relation to the activities in conformity to which the notice relates
, including the provision of advisory services;
It does not preclude the use of assessed products necessary for the operation
conformity assessment body or the use of such products for personal
need

C) the conformity assessment body and staff must carry out conformity assessment
at the highest level of professional integrity and requisite technical
competence in the specific field and must not be exposed to any
pressures and inducements, particularly financial, which would
might influence their judgment or the results of conformity assessment,

D) the conformity assessment body must be able to perform all activities
conformity assessment by a notified body by the
appropriate government regulation under this Act or appropriate regulation
European Union, whether done by himself announced entity or
on its behalf and under his responsibility,

E) the conformity assessment body must always be ensured for each procedure
conformity assessment and each kind or category of products to which the notice relates
needed:

First personnel with technical knowledge and experience to perform the tasks
conformity assessment,

Second descriptions of procedures according to which conformity assessment is carried out,
ensuring the transparency of these procedures and the ability of reproduction;
To apply appropriate policies and procedures that distinguish between tasks that are performed
notified body and other activities

Third procedures for the performance of activities which take due account of the size,
industry structure, the degree of complexity of the product technology
and the mass or serial nature of the production

F) conformity assessment body shall have the means necessary to carry
technical and administrative tasks connected with the conformity assessment
have access to all necessary equipment or facilities

G) staff involved in conformity assessment must

First have technical and vocational training covering all activities
conformity assessment to which the notice relates,

Second have knowledge of the requirements of the assessments they carry out and
appropriate permissions to perform this assessment,

Third have knowledge of relevant basic technical requirements
harmonized standards, the provisions of harmonizing regulations
European Union, government regulations, or the relevant regulations of the European Union, and
understand them,

Fourth the ability to draw up certificates, records and reports demonstrating that assessments have been
performed

H) conformity assessment body shall ensure that activities of its
subcontractors do not affect the confidentiality, objectivity and impartiality of its activities
conformity assessment

I) the conformity assessment body must ensure that the remuneration of members of management and employees
so that rewards depend on the number of assessments
or on the results,

J) the conformity assessment body shall have liability insurance for damage caused
activities of the notified body, the limit of the insurance
compensation in the amount proportionate to the extent of these activities

K) conformity assessment body must ensure that staff are required
maintain secrecy regarding any information they obtain
while performing their duties under this Act or under the applicable
EU regulation.

(2) If a conformity assessment body can demonstrate that it meets the criteria laid down
relevant harmonized standards or parts thereof
which have been published in the Official Journal of the European Union,
assumed that meets requirements notified bodies on the extent to which
harmonized standards cover these requirements.

(3) Requirements for notified bodies under paragraphs 1 and 2 regarding
technical resources and staffing, can be concretised in
government regulations.

§ 24

(1) Notified bodies carry out activities in conformity assessment in accordance
with the procedures set out in government regulations or in

Relevant regulations of the European Union. While acting on its own behalf and on their responsibility
under contract ^ 8), whose activities are subject
in conformity assessment and reviewing the implementation of the assumptions under which the certificate was issued
. The essential elements of the contract also includes
concretization of rights and obligations under paragraphs 2 to 5

(2) Conformity assessment is carried out in such a way as to avoid
disproportionate burden on operators. Notified bodies shall perform their activities
take account of the size of
economic entity, the sector in which it operates, the degree of complexity of the
product technology and the mass or serial nature of the production process.
These entities must comply with a degree of rigor and level of protection
that the product is in compliance with specified requirements, or the requirements
relevant European Union regulations.

(3) Where a notified body finds that the manufacturer does not
basic technical requirements set out in government regulations in the relevant regulations of the European Union
, corresponding harmonized standards or in a document that prescribes technical requirements
, by a product, process or service
meet to demonstrate conformity to the product it shall invite
manufacturer to take corrective measures and certificates issued.

(4) If in the course of monitoring compliance with the preconditions under which it was issued
certificate, a notified body finds that a product no longer meets the requirements
applied when issuing the certificate, it prompts the manufacturer to take corrective measures
, and the nature and severity of non-compliance with these requirements may
validity of the certificate in question to restrict or suspend or revoke the certificate
.

(5) If a manufacturer fails to take corrective action, or if such measures
not have the required effect, the notified body shall restrict or suspend
in question the validity of the certificate or certificates withdrawn.

(6) At the request of the manufacturer the notified body shall communicate to the limit
indemnity stipulated in the insurance of liability for harm caused by activities
notified.

§ 25

(1) Where a notified body subcontracts specific tasks subcontractors, ensuring
subcontractor to meet the requirements corresponding to
notified bodies and inform the Office.

(2) The body shall take full responsibility for the tasks performed by subcontractors
regardless of where they are established.

(3) Tasks may be subcontracted only with the consent of a person who
execution of activities relating to conformity assessment notified body
asked.

(4) The body stores and on request provide the Office
relevant documents concerning the assessment of the qualifications of the subcontractor and
activities carried out by the subcontractor.

§ 26

(1) The body shall notify the Office

A) any cases where extradition was refused a certificate and
certificates issued, suspended or withdrawn,

B) any circumstances affecting the scope of and conditions for notification

C) any request for information on assessment activities
conformity received from market surveillance authorities,

D) on request, conformity assessment activities performed within
scope of their notification and any other activity performed.

(2) The other range information may provide a government decree
according to the nature of the product.

(3) It shall provide the other notified bodies including
notified bodies in other Member States of the European Union, which
out similar conformity assessment activities covering the same
products with relevant information on issues relating to negative
conformity assessment results, and, upon request, information on issues relating to
positive conformity assessment results.

(4) The body is obliged to participate in standardization activities
relating to the scope of its notification and coordination activities
groups of notified bodies established by harmonizing regulations
European Union or relevant regulations of the European Union or
ensure that its employees informed of these activities, and
is obliged to follow the decisions and documents, which are the result
work of this group.
PART TWO


SPECIAL PROVISIONS FOR CERTAIN PRODUCTS
TITLE
I

SPECIAL PROVISIONS FOR PRODUCTS PREPARED BY APPLICABLE REGULATIONS OF THE EUROPEAN UNION

Section 1

Personal protective equipment


§ 27

Reference is directly applicable legislation in the field of personal protective
funds to the national competent authority is that authority in the Czech Republic
supervisory authority.
TITLE II


SPECIAL PROVISIONS FOR CERTAIN OTHER PRODUCTS
Section 1


Lifts and safety components for lifts

§ 28


For the purposes of conformity assessment of lifts and safety components for lifts means


A) lift lifting appliance serving specific levels, having a carrier
moving between guides which are rigid and inclined from the horizontal
plane at an angle greater than 15 degrees, or lifting devices intended path of movement
although they do not move between fixed guides

B) a supplier of a person who is responsible for the design, manufacture, installation and
placing on the market,

C) available on the market supply of a safety component for lifts for
distribution or use on the EU market under the trade
activity, whether in return for payment or free of charge

D) placing on the market

First first making a safety component for lifts on the market, or

Second supply of a lift for use on the EU market under the trade
activity, whether in return for payment or free of charge

E) the producer of a person who manufactures a safety component for lifts or
keeps safety component for lifts designed or manufactured and
this component is placed on the market under his name or trademark,

F) means a person established in the European Union, which was
authorized in writing by the supplier or manufacturer to act on his behalf in
specific tasks,

G) importer person established in the European Union, which launches the European Union
safety component for lifts from a third country

H) a distributor of a person in the supply chain, other than the manufacturer or importer
, which provides a safety component for lifts on the market

I) operators supplier, manufacturer, authorized representative, importer and distributor
,

J) withdrawal and recall in connection with elevator
any measure aimed at dismantling and safe disposal of the elevator, and in the context of
safety component for lifts any measure
aimed at restoration safety component for lifts that has already been made available
contractor or end user

K) withdrawal of measures aimed at preventing a
safety component for lifts that are already in the distribution chain
made available on the market.

§ 29

(1) When placing on the market of the lift contractor

A) ensure that this elevator was designed, manufactured, installed and tested in accordance
basic technical requirements for protection
health and safety

B) establish the technical documentation and carry out or perform
appropriate conformity assessment procedure

C) in the event that the compliance of the lift with the relevant essential requirements
health and safety demonstrated by such procedure,
draw up an EU declaration of conformity, ensure that it accompanies the lift, and placed
CE marking

D) holds the technical documentation and the EU declaration of conformity and if
approval decision for a period of 10 years from the placing on the market,

E) where it is appropriate with regard to the risks elevator
represents done to protect the health and safety of consumers
investigation and, if necessary, hold a register of complaints and
substandard elevators | ||
F) ensure that the elevator to bear a type or batch or serial
number or other element allowing its identification,

G) state to lift its name or registered trade mark and
mailing address at which he can be contacted;
address must contain only place where you can contact the vendor;
contact information is provided in the Czech language

H) ensure that the lift is accompanied by instructions in the Czech language;
this manual and all other markings must be clear and understandable.

(2) A supplier who believes or has reason to believe that a lift
who said the market is not in conformity with the technical requirements laid down
Government Regulation shall immediately take the corrective measures that are necessary to
putting this lift into conformity. Furthermore, if the elevator is a risk
contractor shall immediately inform the supervisory authority or the competent authority
another EU Member State in which the lift in the market, and
giving details, in particular the non-compliance and any corrective | || measures.

(3) The Contractor shall be entitled to appoint an authorized representative.

(4) The Contractor shall provide the supervisory authority or the competent authority of another
EU member state on the basis of a reasoned request
all information and documentation in paper or electronic form,
that are necessary to demonstrate compliance with a lift
technical requirements established by government decree, in the Czech language.

(5) The Contractor is obligated to cooperate with the authority pursuant to paragraph 4
at its request, on any action taken to eliminate the risks posed
elevators, which he marketed.

(6) identification number of the notified body, connected to denote

CE according to § 15 para. 3, according to the instructions of the notified body to connect
also lift contractor or his authorized representative.

§ 30

Builder ^ 9) and the contractor shall provide each other information and
makes appropriate steps to ensure the proper operation and safe use of the lift
.
Section 2


Fixed installations for electromagnetic compatibility

§ 31

For the purposes of assessing compliance of fixed installations in terms
electromagnetic compatibility means

A) unit finished appliance or combination thereof
available on the market as a single functional unit, intended for the end user who
may cause electromagnetic interference or whose operation can be
electromagnetic interference effect, || |
B) fixed installations particular combination of several types of apparatus and, where
funds, which are assembled, installed and intended for permanent
use at a predefined location.

§ 32

(1) In the event that the fixed installation, signs of non-compliance with the essential requirements set
government regulation ensures
operator of a fixed installation or a person authorized by the conformity assessment
fixed installation in accordance with these requirements Government Regulation.

(2) The conformity of the fixed installation with the essential requirements
operator provides fixed installations.
Section 3


Recreational craft and personal watercraft

§ 33

For the purposes of conformity assessment of recreational craft and personal watercraft will mean


A) recreational craft boat of any type intended for sports or recreational purposes
hull length from 2.5 m to 24 m, whatever kind
drive, with the exception of personal watercraft,

B) personal watercraft vessel of less than 4 m, using as a primary source of propulsion
combustion engine with a water jet pump propulsion system and
designed to be operated by a person or persons sitting, standing or kneeling on
hull, rather than within,

C) driving engine spark or compression ignition internal combustion engine used
directly or indirectly for propulsion purposes,

D) greater adjusting drive motor such an adjustment that increases
rated engine power by more than 15% or as a result may be exceeded
set requirements for emission limit values ​​

E) major craft such an arrangement, involving a change in the type of drive
vessels greater adjusting drive motor vessel or
that can jeopardize compliance with the prescribed requirements

F) putting into operation the first use of the product by the end user in
EU Member State,

G) importer private person established in the European Union, which
for their own needs and in its non-trading activities, imports the product from a third country
to a Member State of the European Union.

§ 34

(1) The product may only be commissioned if it meets the requirements set
was with him and conformity assessment is maintained and used
no way endanger its compliance with specified requirements, if it is a

A) recreational craft or personal watercraft (hereinafter the "vessel")

B) part of the vessel and

C) drive motor.

(2) The product is a vessel or a drive motor and which has been
a major modification, may be placed on the market or put into service after
an adjustment if there was reassessed consensus.
Performing appropriate conformity assessment procedure laid down in Regulation
governments to ensure a person who has an adjustment places the product on the market or put into service
.

(3) The vessel, which will become a product intended for government regulation
conformity assessment of changes in the purpose of its use or launch
before the expiry of the period set by the Government ensure the implementation of relevant
conformity assessment procedure set out Government Regulation person who places
product on the market or put into service.

(4) The product, which is the vessel, its components, or driving force, is
commissioned private importer and which has not undergone conformity assessment
manufacturer, arrange appropriate conformity assessment procedure laid down by government decree
private importer.

(5) The persons referred to in paragraphs 2-4 placed on a product before it is placed on
market or the use of CE marking. A notified body which has
conformity assessment and CE marking join its identification number, or
him according to his instructions connects the person referred to in paragraphs 2 to 4

§ 35

(1) For a product that is a vessel or part of the driving force,
private importer before commissioning

A) ensure compliance in accordance with § 6 para. 1 first sentence, § 6.
2 and 3 and the third sentence of § 6 par. 6, has not fulfilled if the manufacturer

B) provide to the name and registered office address of the notified body
carried out conformity assessment on the product and

C) draw up an EU declaration of conformity in the Czech language.


(2) Private importer is obliged for the period stipulated in Government Regulation on
request of the competent supervisory authorities identify the operator
which he has supplied a product.

§ 36

(1) The Office shall assign an identification code to the notified body
authorized to carry out conformity assessment according to § 34 para. 2 to 4

(2) procedure notified body in accordance with § 24 para. 2 and 3 shall apply mutatis mutandis to the
private importers where conformity is assessed according to § 34 paragraph
.
Fourth
§ 37

(1) Semi-finished vessel may be delivered to the market if

A) the manufacturer or importer to put the finished vessel partly
statement that is intended to be completed by another manufacturer, and

B) satisfies the basic requirements to the extent appropriate to the level of his
completion.

(2) The declaration under paragraph 1. a) be issued in the Czech language
and the official languages ​​of the Member States of the European Union, which is
partly completed craft available on the market. Particulars statement
set by Government regulation.
Section 4

Rigging


§ 38

For the purposes of conformity assessment rigging the ship means a seagoing vessel
self-propelled intended for maritime navigation for the transport
costs or passengers or cargo and passengers
flying the flag of the Czech Republic or another Member State European Union.

§ 39

(1) The product is rigging, may be placed on the ship if
meets the specified requirements effective on the date of its location and it was subjected
conformity assessment. If a product meets these requirements, may
bodies of public administration to defend its position on the ship.

(2) A producer who is not established in the European Union is obliged to appoint an authorized representative
.

(3) An importer or distributor for the purposes of this Act considered
producer also, if placed on a ship a product that is rigging.

§ 40

(1) the EU declaration of conformity be drawn up also in English.

(2) A copy of the EU declaration of conformity to provide the operator with the ship on which
or to be placed in the appropriate rigging and notified body
who carried out conformity assessment.

§ 41

(1) Instead of the CE mark is used for rigging conformity mark,
whose graphical form provides government regulation.

(2) The provisions of § 15 para. 2-4 applies to the conformity mark accordingly.

(3) Mark of conformity can be replaced by an electronic identifier
subject to the conditions of the legislation of the European Union.

§ 42

(1) In the case of notified bodies authorized to carry out conformity assessment shipping kits
Office carries out inspection according to § 21 at least every two years.

(2) Notified bodies authorized to carry out conformity assessment shipping kits
communicate to the European Commission or the competent authority of another
EU Member State without undue delay, information concerning
positive and negative results of conformity assessment.
Section 5

Pressure equipment


§ 43

For the purposes of conformity assessment of pressure equipment assembly
means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional
.

§ 44

(1) marketing and user put into operation can be
pressure equipment or assemblies of which conformity with the essential requirements set out
government regulation has been assessed by
notified in accordance with § 45 para. second

(2) Pressure equipment and assemblies the conformity of which has been assessed
users shall not bear the CE marking.

(3) Pressure equipment and assemblies referred to in paragraph 1
can be used only in commercial factories controlled business corporations
which apply a common safety policy as regards the
technical requirements for the design, manufacture, inspection, maintenance, and use
pressure equipment and assemblies, and which the inspectorate is part of the user.

(4) The user inspectorate operates exclusively for the group of business establishments
which are part of the same business corporations.

(5) The user inspectorate must be organizationally identifiable and must
reporting methods within the group of business establishments
which it is part which ensure and demonstrate its impartiality
assessment.

(6) The procedures applicable to conformity assessment service users are
modules A2, C2, F and G, set out in Annex no. 1 hereto.

§ 45

(1) Where in Part One and Title IV of Part Four
speaks of notified bodies, it is understood that for the purposes of government regulation concerning
supply pressure equipment on the market has also been recognized by an independent organization and testing
users.

(2) for reporting the recognized independent testing organizations and users
shall apply mutatis mutandis § 16-26 with the exception of § 23 para. 1

Point. a) after the semicolon, which for test users
apply.

(3) Notification pursuant to § 17 par. 2 for testing user
also contains statements pursuant to § 19 paragraph. 4 is also a list of business events
complying with the provisions of § 44 para. 3rd
Section 6

Radio equipment


§ 46

For the purposes of conformity assessment of radio equipment means

A) radio equipment electrical and electronic products, which
deliberately transmits or receives radio waves for radio communications or radio
determination, or electrical or electronic product,
which should be added accessories like antenna that could
intentionally transmit or receive radio waves for radio communications or
radiodetermination

B) radio communication communications using radio waves,

C) radio waves electromagnetic waves with a frequency of less than 3,000
GHz propagated in space without artificial guide,

D) determining a radio positioning, velocity or other
properties of a volume or obtaining information about these
parameters using the propagation properties of radio waves.

§ 47

(1) The manufacturer of the radio equipment and software, which makes radio
can use the device for its intended purpose, provide Member States and the European Commission
information about the compliance of the proposed combination of radio
equipment and software are essential requirements. This information is based on
conformity assessment carried out by the procedure set out in government regulations and
serves as a declaration of conformity. According to the specific combination
radio equipment and software this information to accurately identify what
radio equipment and software have been assessed, and are constantly updated
.

(2) The producer registers type of radio equipment belonging to the category to which they belong
devices, which are largely
do not meet the basic requirements, the central system
made available by the Commission, even before the radio equipment such category
market. When you register these types of radio equipment manufacturer
provide some of the technical documentation specified by Government or in justified cases
full documentation. Manufacturer
placed on radio equipment marketed registration number, which the European Commission
assign to each registered type of radio equipment.
Section 7

Gauges


§ 48

(1) The importer is obliged to ensure that the manufacturer has carried out the acts set out in
§ 8 paragraph. 2 point. a) well before putting the instrument into operation.

(2) In the procedure pursuant to § 8. 3 first sentence importer may indicate
meter is not in operation.

(3) In the procedure pursuant to § 9. 1 is a distributor diligent
gauges also put it into operation. The distributor is obliged to verify whether
gauge meets the requirements specified in § 9. 2
well before its commissioning.

(4) In the procedure pursuant to § 9. 3 first sentence distributor must bring
meter is not in operation.

(5) In the procedure pursuant to § 9. 4, the distributor's obligation extends
gauges, which put into operation.
PART THREE



SURVEILLANCE
§ 49
Supervision


(1) Supervision over whether products are available on the market, put into service or used
manufacturer for its own account in accordance with established
requirements or the requirements of the relevant European Union regulation that economic
entities fulfill their obligations under this Act and whether
products are not illegally procured CE marking or other prescribed marking
under this Act or under the applicable
EU regulations, performs supervisory authority, which is the Czech business
inspections, or other administrative body, unless another law provides so.

(2) Supervisors may

A) perform analyzes or provide for analysis to verify whether
products meet the specified requirements or the requirements of the regulation
European Union; these analyzes are provided in relevant
bodies or persons; if the analysis found that the product does not meet
specified requirements or the requirements of the relevant EU regulations
cover the costs of an analysis by the operator concerned,

B) store operator corrective measures within a specified period
rectify the deficiencies, their causes and harmful effects or
order to remove them promptly undertake the necessary remedial measures
, || |
C) store operator remedial measures to urgently
informed about the risk of persons who could be exposed to the risk
resulting from the product.

(3) The supervisory authority may, if it has reasonable doubt that the product does not meet
specified requirements or the requirements of the relevant EU regulations
request from the notified body information and documents relating to

Conformity assessment of the product, including certificates, technical
documentation and test reports. In addition, the supervisory authority may give
notified body to review the incentive certificate. In the event that the supervisory authority
demonstrates that the product does not meet the specified requirements, or
relevant regulations of the European Union shall notify
notified body that issued the certificate; it can also save notified
subject to the certificate operator withdrew.

§ 50
Protective measures


(1) If the supervisory authority has reasonable suspicion that a product does not meet
specified requirements or the requirements of the relevant EU regulations
prohibit the product on the market, putting into operation or use of the product
producer's own the need for the time necessary to perform
needed to determine if this is justified by the nature of risk.

(2) The supervisory authority shall notify the imposition of measures pursuant to paragraph 1
operator orally and without delay, a written record
. If he disagrees operator with the measure may
against him to file objections, which are specified in the record, or he may lodge
writing within 10 days from the day he was acquainted with the record.
The supervisory authority shall decide on objections submitted promptly.
A written copy of the decision on objections shall be delivered to the economic
entity. A decision on objections no appeal.

(3) If the supervisory authority finds that a product presents a risk, or that the
period according to § 49 par. 2 point. b) have not been eliminated
identified deficiencies on the prohibition of making a product available on the market, placing
operation or use of the product by the manufacturer for his own use, or
decides to withdraw the product from the market or from circulation.
Ignoring the reasons for imposing the ban, the supervisory authority will decide on the amendment or repeal
. An appeal against the decision in the first sentence does not have suspensive effect
.

(4) The supervisory authority decides to ban the supply of product on the market, putting into
operation or use of the product by the manufacturer for his own use, or for
product withdrawal or recall also in the event that a competent || | operator to challenge the supervisory authority pursuant to § 49 para. 2 point. b)
not eliminate drawbacks, consisting in the fact that

) The CE marking or other prescribed marking was placed
contrary to the provisions of this Act

B) the CE marking or other prescribed marking has not been placed,

C) declaration of conformity has not been drawn up in accordance with the Government, or


D) technical documentation is not available or not complete.

(5) The formal shortcomings, the failure to remove the supervisory authority allows
decide in accordance with paragraph 4, may be closer government regulation
specified. An appeal against the decision under paragraph 4 does not have suspensive effect
.

§ 51

The products pose a risk despite compliance with the requirements

(1) If the supervisory authority after analysis according to § 49 par. 2 point. a)
or discovery pursuant to § 50 par. 1 finds that a product which satisfies
specified requirements or the requirements of the relevant EU regulations
still poses a risk, saves the relevant economic operator to take
all appropriate measures within a reasonable period of risk
ensure that the product concerned, when placed on the market, this risk
longer presents, or to withdraw the product from the market or from circulation.
Appeal against this decision has no suspensive effect.

(2) The operator shall ensure that corrective action is taken
for all the products concerned that in all Member States of the European Union
added to the market.

(3) The remedies operator without undue delay
inform the supervisory authority.

§ 52
Notification requirements


(1) The supervisory authorities are required to notify the Ministry of Industry and Trade
(hereinafter the "Ministry") action related to the product or product batch
where the product presents a risk. This is true even in the case
action taken by the operator concerned on their own initiative and
supervisory authority will receive information on this measure.

(2) Information provided by the Ministry
include all available details, in particular the data necessary for identifying the product, its
origin, supply chain risk presented by a product,
data about the nature and duration of measures taken by the
supervision and appropriate information about the voluntary measures taken by the producers in question
body.

(3) If the risk exceeds the territory of the Czech Republic, Ministry
is obliged to immediately inform about the existence of the product
European Commission and other Member States.

(4) is received by the Ministry from the European Commission information on adoption
measures against product představujícímu risk transmit this information without

Delay supervisory authorities for further action.

(5) To ensure that the information exchange system referred to in paragraphs 1 to 3
apply mutatis mutandis to other legislation governing the procedures
content and form of information on the occurrence of dangerous non-food products ^ 10).
PART FOUR



ADMINISTRATIVE OFFENCES
§ 53
Offences


(1) A person who commits an offense that

A) improperly used the CE marking, other specified labeling according
implementing regulation issued for implementation of this law or
designation under the Regulation of the European Union, or

B) falsifies or alters a certificate or other document issued by
implementing legal regulations issued to implement this Act or
under the relevant EU regulations

C) as the builder of its obligations under § 30.

(2) An offense under paragraph 1 may be fined up to 20 million CZK.

§ 54

Administrative offenses of legal entities and individuals

(1) A legal or natural person commits an administrative offense
that

A) improperly used the CE marking, other specified labeling according
implementing regulation issued for implementation of this law or
designation under the relevant EU regulations

B) falsifies or alters a certificate or other document issued by
implementing legal regulations issued to implement this Act or
under the relevant EU regulations

C) carry out activities in conformity assessment reserved for the purposes of this Act
notified body without authorization under § 20 para. 1

D) fails to comply with one of the safeguard measures issued pursuant to § 50 para. 1, 3 or 4
or

E) fails to comply with any of the measures imposed pursuant to § 49 para. 2 point. b)
or c).

(2) The body commits an administrative offense by

A) in contravention of § 20 para. 1 performs the action of the notified body
without appropriate authorization, or

B) fails to comply with any of the obligations pursuant to § 22 paragraph. 1 or 4, § 24, § 25 paragraph
. 1, 3 or 4 or § 26th

(3) A legal or natural person who is
economic entity or person under the relevant regulations of the European Union
is a manufacturer, importer, distributor or authorized representative, the
commits an administrative offense that, contrary to its obligations to deliver
market, put into operation or uses for its own product

A) without CE marking or other prescribed marking
by implementing legal regulation issued for implementation of this law or no document specified
government regulation or relevant regulations of the European Union, or


B) the CE marking or other prescribed marking
by implementing legal regulation issued for implementation of this Act or any document
which are in conflict with § 14 or § 15 or with relevant regulations of the European Union
.

(4) A legal or natural person commits an administrative offense
that as

A) the operator fails to fulfill any of its obligations under § 6-9 and §
11 or any of the obligations pursuant to § 29, 30, 32, 34, 35, 37, 39, 40,
41 44 , 47 and 48, or

B) a person who according to the relevant regulations of the European Union is a manufacturer
authorized representative, importer or distributor
fulfill any of the obligations under the relevant European Union regulations.

(5) An administrative offense shall be fined up

A) 50,000,000 CZK, for an administrative offense under paragraph 3 or
paragraph 1 point. d) or e)

B) 20,000,000 CZK, for an administrative offense under paragraph 1. a), b) or c
) or paragraph 2. a)

C) 1,000,000 CZK, for an administrative offense pursuant to paragraph 2. b)

D) 500,000 CZK, for an administrative offense under paragraph 4.

§ 55

Joint provisions on administrative offenses

(1) A legal person for an administrative delict if it proves that
made every effort that could be required to breach
legal obligations prevented.

(2) In determining the amount of the fine takes into account the seriousness of the administrative offense, especially the manner
committed and its consequences and the circumstances under which it was committed
.

(3) The liability of a legal person for an administrative tort shall expire if
administrative authority did not commence proceedings within 3 years from the date when it became
but no later than 5 years from the date when it was committed .

(4) The liability for conduct that occurred in entrepreneurial
natural person or in direct connection therewith, shall be subject to the provisions of this
Act on liability and sanctions to legal persons.

(5) Administrative offenses under § 53 and § 54 para. 1 point. a), b) and d), para. 3 and 4
discusses supervisory authority, with the exception of administrative offenses pursuant to § 54 paragraph
. 1 point. c) and § 54 para. 2, which discusses Office.


(6) Fines collected by the body that imposed them.

(7) Income from fines is the income of the state budget.
PART FIVE


COMMON, TRANSITIONAL AND POWERS OF
Common provisions


§ 56

The provisions of the Act concerning relations to the Member States of the European
Union concern also relations to the countries of the European Economic
space and the Swiss Confederation.

§ 57

The notified bodies, with the exception of the first Title IV, Part Three and
Fourth, consider also those bodies which have been notified to the European Commission and
EU Member States to other Member States of the European Union
or entities that are considered as
under international agreements by which the Czech Republic is bound.
Transitional provisions


§ 58

Bodies which have been notified to the European Commission and other Member States of the European Union
according to § 11b of the Act no. 22/1997 Coll., As amended
effective prior to the effective date of this Act, and shall be entitled to || | relevant activities of the European Parliament and of the Council (EU)
No. 305/2011 of 9 March 2011 laying down harmonized
conditions for the marketing of construction products on the market and repealing
Council Directive 89/106 / EEC, shall be considered as notified under this Act.

§ 59

Notification procedure initiated under § 11b of the Act no. 22/1997 Coll., As amended
effective prior to the effective date of this Act, and
still open before the effective date of this Act shall be completed in accordance with Law no. 22/1997 Coll., as amended
effective prior to the effective date of this Act.
PART SIX



EFFICIENCY
§ 60

This Act shall take effect on the fifteenth day after its publication, with the exception
provisions of § 47 para. 2, which takes effect on 12 June 2018.



Hamáček vr Zeman

Sobotka



Příl.1 Conformity assessment modules


When assessing compliance with the use of so called modules:

A) Module A: Internal production control,

B) Module A1: Internal production control along with testing of products under
supervision

C) Module A2 Internal production control plus product inspections under the supervision
at random intervals

D) Module B: EU type examination

E) Module C: Conformity to type based on internal production control

F) Module C1: Conformity to type based on internal production control along with
testing products under supervision

G) Module C2: Conformity to type based on internal production control plus
controls products under supervision at random intervals

H) Module D: Conformity to type based on quality assurance of the production process
,

I) Module D1: Quality assurance of the production process

J) Module E: Conformity to type based on quality assurance of products

K) E1 Module: Quality assurance of final inspection and testing of products

L) Module F: Conformity to type based on product verification,

M) Module F1: Conformity based on product verification,

N) Module G: Conformity based on unit verification,

O) Module H Conformity based on full quality assurance

P) Module H1 Conformity based on full quality assurance along with
examine this proposal.


Příl.2
Declaration of Conformity includes the following information:


EU declaration of conformity

First NO. Xxxxxx (unique identification of the product):

Second Name and address of the manufacturer or authorized representative:

Third This declaration of conformity issued under the sole responsibility of the manufacturer
(or the person responsible for the installation)

Fourth Object of the declaration (identification of product allowing traceability
may optionally include a photo)

Fifth The above described object of the declaration is in conformity with harmonization legislation
EU regulations: xxxxxxxx

6th References to the relevant harmonized standards used or references to the specifications
under which conformity is declared:

7th Alternatively, the notified body ... (name, number) ... performed ... (description of intervention) ... and issued the certificate
:
....
8th Further information:



Signed for and on behalf of: ...................
(place and date of issue)
(name, function) (signature) | ||


Note:
The information contained herein may be considered depending on the product concretized government regulation



1) Decision of the European Parliament and the Council no. 768/2008 / EC on a common
framework for the marketing of products and repealing Council Decision
93/465 / EEC.

2) Directive of the European Parliament and Council Directive 2013/53 / EU of 20 November 2013
on recreational craft and personal watercraft
repealing Directive 94/25 / EC.

Directive of the European Parliament and Council Directive 2014/28 / EU of 26 February 2014
harmonization of the laws of the Member States relating to making available

Explosives for civilian use on the market and supervision.

Directive of the European Parliament and Council Directive 2014/29 / EU of 26 February 2014
harmonization of the laws of the Member States relating to making
simple pressure vessels on the market.

Directive of the European Parliament and Council Directive 2014/30 / EU of 26 February 2014
harmonization of the laws of the Member States relating to electromagnetic compatibility
.

Directive of the European Parliament and Council Directive 2014/31 / EU of 26 February 2014
harmonization of the laws of the Member States relating to making
NAWIs market.

Directive of the European Parliament and Council Directive 2014/32 / EU of 26 February 2014
harmonization of the laws of the Member States relating to making
gauges on the market.

Directive of the European Parliament and Council Directive 2014/33 / EU of 26 February 2014
harmonization of the laws of the Member States relating to lifts and
safety components for lifts.

Directive of the European Parliament and Council Directive 2014/34 / EU of 26 February 2014
harmonization of the laws of the Member States concerning equipment
and protective systems intended for use in potentially explosive atmospheres
.

Directive of the European Parliament and Council Directive 2014/35 / EU of 26 February 2014
harmonization of the laws of the Member States relating to making
electrical equipment designed for use within certain voltage limits
market.

Directive 2014/53 / EU of the European Parliament and of the Council of 16 April 2014
harmonization of the laws of the Member States relating to making
radio equipment on the market and repealing Directive 1999/5 / EC.

Directive of the European Parliament and Council Directive 2014/68 / EU of 15 May 2014
harmonization of the laws of the Member States relating to making
pressure equipment on the market.

Directive of the European Parliament and Council Directive 2014/90 / EU of 23 July 2014 on
rigging and repealing Council Directive 96/98 / EC.

3) Regulation of the European Parliament and Council Regulation (EC) no. 765/2008 of 9
July 2008 setting out the requirements for accreditation and market surveillance
relating to the marketing of products and laying
repealing Regulation (EEC) no. 339/93.

4) Act no. 22/1997 Coll., On technical requirements for products and amending
and supplementing certain acts, as amended.

5) Article 2, point 1, letter. c) Regulation of the European Parliament and of the Council (EU)
No. 1025/2012 of 25 October 2012 on European standardization, change
Council Directives 89/686 / EEC and 93/15 / EEC and Directives of the European Parliament and the Council
94/9 / EC, 94/25 / EC 95/16 / EC, 97/23 / EC, 98/34 / EC, 2004/22 / EC
2007/23 / EC, 2009/23 / EC and 2009/105 / EC and repealing
Council decision 87/95 / EEC and decision of the European Parliament and the Council no. 1673/2006 / EC.

6) Article 30 and Annex II of the Regulation of the European Parliament and Council Regulation (EC) No.
. 765/2008.

7) Article 5, paragraph 1 of the European Parliament and Council Regulation (EC) no. 765/2008
.

8) § 2652 et seq. Law no. 89/2012 Coll., Civil Code.

9) § 2 para. 2 point. c) of the Act no. 183/2006 Coll., on territorial planning and
Building Code (Building Act).

10) Decree no. 396/2004 Coll., On procedures, content and form
information about the presence of dangerous non-food products, as amended
.