Act 90_16_en_working translation

Act No. 90/2016 Coll. as amended by
Act No. 183/2017 Coll.
Act No. 265/2017 Coll.

90/2016 Coll.
Act

of 3 March 2016

on conformity assessment of specified products when made available on the market

The Parliament has adopted this Act of the Czech Republic:

PART ONE

MAKING OF PRODUCTS AVAILABLE ON THE MARKET

TITLE I

GENERAL PROVISIONS

Section 1

Scope

 

(1)           This Act incorporates the relevant legislation of the European Union on a common framework for the marketing of products1) and lays down the action of State bodies when they protect the market against products which could endanger life, health, property or environment or other public interest.

(2)           This Act incorporates the legislation of the European Union published in the field of making of products available on the market2) following provisions of the European Union on a common framework for the marketing of products1) and concerning products that are set by the Government in compliance with those regulations in its Orders, and lays down

      a)      the general guidelines for making of products available on the market or for putting the products into operation;

      b)      the method of determination of products for conformity assessment and of technical requirements that the products must comply with;

      c)      the rights and obligations of persons who are placing the products on the market or making the products available on the market or putting the products into operation which are before being placed on the market subject of the assessment of their conformity with the requirements laid down in the legal regulations;

      d)      the conformity assessment of products;

      e)      the exercise of State administration in the field of State testing and market surveillance;

      f)       the rights and obligations of persons authorised to carry out activities pursuant to this Act relating to State testing;

      g)      the obligations to provide information related to making of products available on the market, conformity assessment and market surveillance.

(3)           This Act furthermore lays down following the directly applicable legislation of the European Union in the field of accreditation and surveillance3) the market surveillance relating to the marketing of products and to their labelling.

 

(4)           This Act lays down also the exercise of the State administration in the area of ​​products for which the directly applicable legislation of the European Union in the field of marketing of products related to a common framework for the marketing of products applies, and which are referred to in Part Two, Title I or for which it provides another Act4) laying down the conformity assessment and making of products available on the market.

Section 2

 

(1)           To the products referred to in relevant Regulation of the European Union the provisions of Sections 3 to 15 shall not apply. The provisions of Sections 23 to 26 and Sections 50 and 51 shall apply to those products, unless the relevant Regulation of the European Union provides otherwise.

(2)           To the products referred to in Part Two Title II, the provisions of Sections 3 to 15, Sections 23 to 26 and Sections 50 and 51 shall apply, unless Part Two Title II provides otherwise.

Section 3

Definitions

For the purposes of this Act the following definitions shall apply

 

a)      ‛making available on the market’ means any supply of a product for the distribution, consumption or use on the market of the European Union in the course of a commercial activity, whether in return for payment or free of charge;

b)      ‛placing on the market’ means the first making available of a product on the market of the European Union;

c)      ‛economic operator’ means the manufacturer, authorised representative, importer and distributor;

d)      ‛manufacturer’ means the person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark or uses it, if so stipulated by the Government in its Order, for his own use;

e)      ‛authorised representative’ means the person established within the territory of a Member State of the European Union, who has received a written mandate from a manufacturer to act, to the extent specified in the mandate, on his behalf;

f)       ‛importer’ means the person established within the European Union, who places a product from a third country on the market of the European Union;

g)      ‛distributor’ means the person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

h)      ‛conformity assessment body’ means the person or the State administration body that performs conformity assessment activities, including calibration, testing, certification and inspection;

i)       ‛conformity assessment’ means the procedure demonstrating whether the essential technical requirements relating to a product, process, service, system or a person set out by the Government in its Order have been fulfilled;

j)       ‛CE marking’ means the marking by which the manufacturer indicates that the product is in conformity with the requirements set out in the legal regulations applicable to its affixing;

k)      ‛technical requirements’ mean

1. the required characteristics of a product, primarily such as level of quality, performance, safety or dimensions, interoperability, health and the environment, including requirements for a product concerning its trade name, terminology, symbols, testing and test methods, packaging, product labelling and conformity assessment procedures, as well as production methods and processes affecting the characteristics of a product; and

2. other requirements necessary for the protection of consumers or the environment after the product has been placed on the market or put into operation, such as the conditions of use, recycling, reuse or disposal of a product, where such conditions may significantly affect the composition or characteristics of a product or its placing on the market or putting it into operation;

l)       ‛recall’ means any measure aimed at achieving the return of a product that has already been made available to the end user to a person who has supplied the product to the end user;

m)     ‛withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market.

 

Section 4

 

The products specified for the conformity assessment and technical requirements that products shall meet when they are placed on the market or put into operation or used, including of use for an own use of the manufacturer, are set out by the Government in its Orders, which may further specify

a)      the methods for conformity assessment;

b)      the conditions and rules for drawing up the EC declaration of conformity and for affixing of the CE marking or another marking; the Governmental Order provides also for such another marking the form and the method of its affixing;

c)      the procedures for making of products available on the market;

d)      the details of activities of operators and notified bodies (Section 17) during the conformity assessment.

 

Section 5

 

(1)           Only such a product shall be placed on the market which is compliant with the requirements laid down in this Act and in the Governmental Orders issued to implement this Act, which relate to it (hereinafter the ‛specified requirement‛) and for which the conformity assessment has been carried out.

(2)           If so stipulated by the Government in its Orders, products shall be put into operation or used, including of use for an own use of the manufacturer, only when they comply with the specified requirements and when the assessment of their conformity has been carried out.

(3)           If a product complies with legislation of the European Union harmonising the conditions for the marketing of products (hereinafter the ‛harmonisation legislation of the European Union’) that apply to the product, the public authorities shall not for aspects laid down in this legislation hinder making it available on the market within the territory of the Czech Republic.

(4)           At the trade fairs, exhibitions and during similar demonstrations the products that do not comply with specified requirements may be demonstrated in the cases and according to the conditions provided by the Government in its Orders.

 

 

TITLE II

ECONOMIC OPERATORS

Section 6

Manufacturer

 

(1)           The manufacturer shall ensure that products are designed and manufactured in accordance with specified requirements. For mass-produced products the manufacturer shall ensure conformity with specified requirements throughout the production, even when it comes to changes of the product design or characteristics of the product or to changes in the harmonised standards5) or to changes of a document that prescribes the technical requirements for the product, process or service to demonstrate their conformity.

(2)           The manufacturer shall establish the technical documentation and carry out or have carried out the conformity assessment procedure established by the Government in its Order. Scope and method of establishment of technical documentation may be determined by the Governmental Order. After demonstrating conformity, the manufacturer shall when it is stipulated by the Government in its Order to draw up an EU declaration of conformity or another document confirming conformity (hereinafter the ‛declaration of conformity’) and affix the CE marking or other prescribed marking. The manufacturer shall keep the technical documentation and declaration of conformity to an extent and for a period of time determined by the Government in its Order.

(3)           The manufacturer shall ensure that the product bears product information and product identification details and identification and contact details relating to his person prescribed by the Government in its Order. When the size or nature of the product does not allow providing these details on the product, and unless stipulated by the Government in its Order otherwise, the manufacturer is required to provide these details on the product packaging or in a document accompanying the product. The manufacturer shall ensure that the product is accompanied by clear and comprehensible instructions and safety information in the Czech language. If prescribed by the Government in its Order, the manufacturer shall accompany each product by a copy of the declaration of conformity. Scope of the instructions and safety information accompanying the product may be prescribed by the Government in its Order.

(4)           In order to protect the health and safety of consumers, the manufacturer shall, in the cases and to the extent set out by the Government in its Order, carry out testing of product samples and other necessary inspections relating to the marketed products, keep records of the complaints and of non-compliant products and of products recalled, and inform the distributors to which he has supplied those products on these facts.

(5)           A manufacturer who considers or has a reason to believe that a product which he has placed on the market is not in conformity with specified requirements shall without undue delay take necessary and effective measures to bring the product into conformity with the specified requirements, or withdraw or recall it. When the product poses a risk to life, health, property or the environment or to another public interest (hereinafter the ‛risk’), the manufacturer shall, without delay, inform the market surveillance authority (Section 49 subsection 1) or the competent authorities of another Member State of the European Union, where he has made the product available on the market, on the risk and on its nature and causes, as well as on the measures he has taken in order to withdraw or recall it.

(6)           The manufacturer shall, at a reasoned request, provide information and documentation necessary to demonstrate the conformity of the product to the market surveillance authority or to the competent authority of another Member State of the European Union, where he has made the product available on the market. Unless otherwise provided, the manufacturer shall provide information and documentation in the official language of the Member State of the European Union which is concerned. The manufacturer shall be obligated to provide these authorities with assistance necessary for the performance of their competences in order to avoid risks caused by the products which he has placed on the market.

(7)           The manufacturer shall be entitled to appoint an authorised representative. The authorised representative’s mandate shall not include the fulfilment of any of the obligations referred to in subsection 1, nor the obligation to draw up the required technical documentation; it shall however allow him to keep the declaration of conformity and the technical documentation and to provide the assistance to the market surveillance authorities.

 

Section 7

Authorised representative

 

An authorised representative shall perform the tasks in the scope of its mandate and keep the declaration of conformity and the technical documentation for a period of time laid down in the Governmental Order. At the request, the authorised representative shall provide the market surveillance authorities with information and documentation necessary to demonstrate the conformity of the product and with assistance necessary for the performance of their competences in order to avoid risks caused by products which are covered by his mandate.

 

Section 8

Importer

 

(1)           An importer may place on the market only products which are in conformity with specified requirements and shall ensure, when handling the products before they are placed on the market, that this conformity is not jeopardised by the storage and transport conditions.

(2)           The importer shall be obligated

a)      prior to placing the product on the market to ensure that

1. the manufacturer has carried out or has had carried out the respective conformity assessment procedure and has established the technical documentation for the imported product;

2. the product has been affixed by the CE marking or by other prescribed parking;

3. the declaration of conformity is accompanying the product, if so stipulated by the Government in its Order;

4. the product has been provided with clear and comprehensible instructions and safety information in the scope stipulated by the Government in its Order; and

5. manufacturer has complied with the requirements referred to in Section 6 subsection 3; and

b)      to keep a copy of the declaration of conformity for the period of time stipulated by the Government in its Order and, at a reasoned request of the market surveillance authority, to ensure the availability of the technical documentation.

(3)           An importer who considers or has a reason to believe that a product which he intends to place on the market is not in conformity with specified requirements shall not place it on the market until it is in conformity with the specified requirements. When the product poses a risk, the importer shall, without delay, inform the manufacturer and also, including the information on the nature of the risk and its causes, as well as on the measures he has taken or on its withdrawal or recall, the market surveillance authority.

(4)           The importer shall ensure that the product bears identification and contact details relating to his person prescribed by the Government in its Order, or if this is not possible or if so stipulated by the Governmental Order, the importer is required to provide these details on the product packaging or in a document accompanying the product. The importer shall ensure that the product is accompanied by clear and comprehensible instructions and safety information in the Czech language.

(5)           In order to protect the health and safety of consumers, the importer shall, in the cases and to the extent set out by the Government in its Order, carry out testing of product samples and other necessary inspections relating to the marketed products, keep records of non-compliant products and of products recalled, and inform the distributors to which he has supplied those products on these facts.

(6)           The importer shall, at the request, provide information and documentation necessary to demonstrate the conformity of the product to the market surveillance authority or to the competent authority of another Member State of the European Union, where he has made the product available on the market. Unless otherwise provided, the importer shall provide information and documentation in the official language of the Member State of the European Union which is concerned. The importer shall be obligated to provide these authorities with assistance necessary for the performance of their competences in order to avoid risks caused by the products which he has placed on the market.

(7)           An importer who considers or has a reason to believe that a product which he has placed on the market is not in conformity with the established requirements, shall immediately take the necessary measures to bring the product into conformity with those requirements, or to withdraw or recall it. When the product poses a risk, he shall, without delay, inform the manufacturer and the market surveillance authority or the competent authorities of another Member State of the European Union, where he has made the product available on the market, on its nature and causes, as well as on the measures he has taken in order to withdraw or recall it.

 

Section 9

Distributor

 

(1)           A distributor shall act with due care so that products made by him available on the market meet specified requirements and shall ensure, when handling the products before they are made available on the market, that this conformity is not jeopardised by the storage and transport conditions.

(2)           The distributor shall be obligated in the cases and to the extent set out by the Government in its Order to verify prior making the product available on the market whether the product is affixed by the CE marking or other prescribed marking, whether the product is accompanied by the declaration of conformity and by clear and comprehensible instructions and safety information in a scope stipulated by the Government in its Order, whether these instructions and safety information accompanied to the product are in Czech language, and whether the manufacturer and the importer have complied with the requirements referred to in Section 6 subsection 3 and in Section 8 subsection 4.

(3)           A distributor who considers or has a reason to believe that a product is not in conformity with specified requirements shall not make it available on the market until the product is in conformity with those requirements. When the product poses a risk, the importer shall inform the manufacturer or importer and market surveillance authorities.

(4)           The distributor shall, at the request, provide information and documentation necessary to demonstrate the conformity of the product to the market surveillance authority or to the competent authority of another Member State of the European Union, where he has made the product available on the market. The distributor shall, at the request, provide these authorities with assistance necessary for the performance of their competences in order to avoid risks caused by the products which he has made available on the market.

(5)           An distributor who considers or has a reason to believe that the product which he has made available on the market is not in conformity with specified requirements, shall ensure that necessary measures are taken to bring the product into conformity with those requirements, or to withdraw or recall it. When the product poses a risk, the distributor shall, without delay, inform the manufacturer or importer and the market surveillance authority or the competent authorities of another Member State of the European Union, where he has made the product available on the market, on its nature and causes, as well as on the measures he has taken or on the withdrawal or recall.

 

Section 10

 

An importer or distributor shall be, for the purposes of this Act, considered a manufacturer and the obligations referred to in Section 6 shall apply on him, where he places a product on the market under his name or trademark or modifies a product already placed on the market in such a way that conformity with specified requirements may be affected.

 

Section 11

 

For the period of time laid down in Governmental Order, economic operators shall, at the request, identify to market surveillance authorities any economic operator

 

a)      who has supplied them with a product;

b)      to whom they have supplied a product.

 

TITLE III

CONFORMITY ASSESMENT

Section 12

Conformity assessment procedures

 

(1)           The conformity assessment is carried out according to conformity assessment modules, or to a combination thereof, the use of which or a combination thereof is laid down by the Government in its Order for each specified product. A list of conformity assessment modules is set out in Annex I of this Act.

(2)           The individual modules referred to in subsection 1 shall include procedures and practices that are performed in conformity assessment by manufacturers or in the scope of their mandate by authorised representatives, and conformity assessment bodies. Modules specify in particular ways of exchanging information between the manufacturer and the notified body and their scope, scope of product, production or quality system documentation, operations when assessing the suitability of a product design, details on product sampling, scope and methods of testing product samples or prototypes, forms of conformity assessment conclusions, differences in the assessment of serial or piece production and procedures for quality systems audits.

(3)           On the conformity assessment, in cases and to the extent determined by the Government in its Order, an accredited in-house body of a manufacturer may participate, if it meets the following criteria

a)      the manufacturer's in-house body shall be covered by an accreditation granted in accordance with the directly applicable regulation of the European Union in the field of accreditation and market surveillance3);

b)      the manufacturer's in-house body shall constitute a separate organisational unit and its employees shall use such methods of reporting among organisational units of the manufacturer which ensure their impartiality demonstrated to the relevant accreditation body;

c)      neither the manufacturer's in-house body nor its employees shall be involved in the design, manufacture, supply, installation, operation or maintenance of the products they assess, nor shall they engage in any activities that might conflict with their independence of judgment or credibility in relation to their assessment activities;

d)                      the manufacturer's in-house body shall supply its services exclusively to the manufacturer of which it forms a part.

(4)           The manufacturer of which the in-house body forms a part or accreditation body shall, at the request, provide the Office for Standards, Metrology and Testing (hereinafter the ‛Office’) with information on the accreditation of the manufacturer's in-house body and on the scope of it.

 

Section 13

Presumption of conformity

 

(1)           If a product is in conformity with harmonised standards5) or parts thereof which have been published in the Official Journal of the European Union, it is presumed to comply with the technical requirements set out in the Governmental Order which refer to those standards or parts thereof.

(2)           In the absence of harmonised standards, and if so stipulated by the Government in its Order, the Office shall publish in the Journal of the Office for Standards, Metrology and Testing information on existing Czech standards and technical documents prescribing the technical requirements which are presumed appropriate for a duly conformity assessment.

 

Section 14

Declaration of conformity

 

(1)           In the declaration of conformity, the manufacturer shall state that the fulfilment of the essential technical requirements stipulated in the Governmental Order has been demonstrated.

(2)           The declaration of conformity shall contain details listed in Annex II of this Act which are, based on the respective product in consideration, specified by the Government in its Order; elements covered by relevant conformity assessment modules, and shall be constantly updated. It shall be drawn up in the Czech language and in the languages required by the Member States of the European Union where the product is placed or made available on the market.

(3)           Where more Governmental Orders laying down the declaration of conformity apply to a product, and if so stipulated by those Governmental Orders, a single declaration of conformity shall be drawn up with reference to harmonisation legislation of the European Union related to the product, or to relevant Governmental Orders. The single declaration of conformity may, if so stipulated by the Government in its Order, have a form of a file consisting of respective individual declarations of conformity.

 

Section 15

CE marking and other markings

 

(1)           The CE marking6) may bear only a product for which the affixing of this marking is stipulated by the Government in its Order.

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

(3)           To the CE marking according to a module of conformity assessment including the affixing of the identification number of a notified body the notified body which has participated in the conformity assessment shall affix the identification number assigned to it by the European Commission. In line with the instructions of the notified body, this number may be affixed to the CE marking by the manufacturer or his authorised representative.

(4)           If so stipulated by the Government in its Order, also complementary markings shall be affixed at the CE marking or at the identification number of the notified body or at another specified location. To the markings the pictograms or other marks indicating a special risk or method of use may be affixed.

 

 

TITLE IV

STATE TESTING

Section 16

 

(1)           For the purposes of this Act, the State testing shall mean the activities through which the Office carries out the State administration in the field of conformity assessment of products placed on the market under the common framework of the European Union, and that by

a)      evaluating the competence of conformity assessment bodies for the purposes of their notification to the European Commission and to other Member States of the European Union;

b)      opposing the notifications made by other Member States of the European Union;

c)      deciding in the case of notified bodies on changes in their notification; and

d)      carrying out monitoring of notified bodies.

(2)           The activities carried out in conformity assessment by the bodies notified by the Office are also considered as State testing.

 

Notification and monitoring of notified bodies

Section 17

 

(1)           The notified body shall be only a legal entity based in the Czech Republic, which meets the requirements referred to in Section 23, and it can be expected of it that it will meet these requirements continuously, and which must guarantee compliance with obligations relating to the activity of notified bodies and to the proper exercise of this activity.

(2)           The conformity assessment bodies are notified to the European Commission and to other Member States of the European Union by the Office, which is notifying authority within the meaning of harmonisation legislation of the European Union and relevant Regulations of the European Union. The Office shall notify to the European Commission and to other Member States of the European Union also significant changes relating to notifications. For these purposes, the Office uses an electronic notification tool managed by the European Commission.

(3)           The Office shall inform the European Commission also on the procedures used in the assessment and notification of conformity assessment bodies and in monitoring of bodies notified by the Office, as well as on changes in these procedures.

 

Section 18

 

(1)           The notification procedure is initiated on the basis of an application submitted to the Office by the conformity assessment body.

(2)           The application for notification shall, in addition to general requirements of the Administrative Procedure Code, contain a description of the activities to be performed in conformity assessment that relate to the Governmental Order pursuant to this Act or to the relevant Regulation of the European Union, together with the introduction of conformity assessment procedures or modules and with the introduction of relevant products.

 

Section 19

 

(1)           When assessing the application in terms of the professional competence of a conformity assessment body for notification purposes the Office uses a certificate of accreditation issued by an accreditation body7), where one is attached to the application. Where the applicant fails to submit an accreditation certificate or where the accreditation certificate does not document sufficient competence of the body to comply with all requirements referred to in Section 23, the applicant shall provide the Office with all documentary evidence required by the Office necessary for the assessment, recognition and regular monitoring of the compliance with these requirements.

(2)           In proceedings for notification applications, the Office shall decide within 90 days of the application receipt. In case that the applicant demonstrates his professional competence in another way than through the certificate of accreditation, the time-limit shall be extended by 30 days.

(3)           When the conformity assessment body meets the requirements and conditions pursuant to Section 17 subsection 1, the Office shall make the notification pursuant to Section 17 subsection 2, otherwise the application shall be rejected.

(4)           The notification shall include full details of the conformity assessment activities, the conformity assessment modules and of the product concerned, as well as details of the competence of the conformity assessment body in relation to the relevant harmonisation legislation of the European Union or to the relevant Regulation of the European Union that relate to the product concerned.

(5)           The Office shall inform the applicant on the notification made together with an instruction that the information on the date of the beginning of an authorisation of the notified body can be obtained from the notified bodies’ information system of the European Commission, and shall stay, with a resolution remarked to the file, the proceedings.

 

Section 20

 

(1)           The body concerned may perform the activities of a notified body only where no objections are raised by the European Commission or the other Member States within 2 weeks of notification disclosure where an accreditation certificate has been used or within 2 months of notification disclosure where an accreditation has not been used.

(2)           Where neither the European Commission nor any Member State of the European Union raises any objection to the notification pursuant to the subsection 1, the Office shall remark this fact in the file and inform the notified body. At the same time, without undue delay, the Office shall publish a communication on the authorisation of activities of the notified body in the Journal of the Office, including the scope of its authorisation, the date from which it is authorised to perform the activities of a notified body and the identification number of the notified body. At a request and in an agreed way, the Office shall issue to the notified body a certificate of origin or certificate of duration of its authorisation for the activities in the conformity assessment. A request to issue such a certificate can advance together with the request for notification or can be applied during the proceedings. From the moment of authorisation the notified body is considered to have its request granted.

(3)           Where the European Commission or a Member State of the European Union raises an objection to the notification pursuant to the subsection 1, the Office shall require the applicant to take appropriate measures to eliminate the shortcomings and shall, in that respect, give him a reasonable time-limit for the correction. When the applicant eliminates the shortcomings within the determined time-limit, he shall communicate it to the Office without undue delay. When the Office takes the shortcomings for eliminated, it shall make the re-notification pursuant to Section 17 subsection 2. When the applicant within the determined time-limit fails to eliminate the shortcomings, the Office shall reject the application.

 

Section 21

 

(1)           The Office shall monitor whether the notified bodies comply with the provisions of this Act and whether they follow the Governmental Order or the relevant Regulation of the European Union. At a request, a notified body shall be obligated to prove to the Office the correctness of its conclusions adopted in the conformity assessment and in this respect, without undue delay, to provide in particular the documentary evidence, based on which these conclusions has been adopted. While monitoring the Office is also authorised to establish the evidence relating to the activities in the conformity assessment performed by other bodies, to which a notified body has assigned specific tasks relating to the conformity assessment (hereinafter the ‛subcontractor’).

(2)           When the Office finds that a notified body no longer meets the requirements referred to in Section 23, it shall, depending on the seriousness of the consequences of non-compliance with these requirements, decide to suspend, restrict or withdraw the authorisation to perform the activities of a notified body. On such decisions the Office shall, without delay, inform of the European Commission and other Member States of the European Union.

(3)           In case of non-compliance with requirements referred to in Section 23, in which the Office considers that the non-compliance has no direct impact on the proper performance of the activities of a notified body, the Office shall decide on suspension of the authorisation to perform the activities of a notified body and set a time-limit for the redress. When the notified body informs the Office on redress and the Office finds it sufficient, its decision to suspend the authorisation to perform the activities of a notified body shall be candled. When the notified body within the determined time-limit fails to secure the redress, the Office shall decide on a restriction or a withdrawal of the authorisation to perform the activities of a notified body.

(4)           When the Office detects an infringement of obligations referred to in Sections 23 to 26 which it considers for less serious and when it does not imply any evidence of non-compliance with requirements referred to in Section 23, the Office shall require the notified body to take appropriate corrective measures within a determined time-limit. When the Office does not consider such an approach to be adequate, then it shall impose the corrective action within a determined time-limit by a decision which is the first act in proceedings for a suspension, restriction or withdrawal of an authorisation to perform the activities of a notified body.

(5)           In the proceedings for a suspension, restriction or withdrawal of an authorisation to perform the activities of a notified body, the Office shall decide also at a request of a notified body. In such a case, the decision shall not be taken by the Office, unless the conditions pursuant to Section 22 subsection 4 are fulfilled.

 

Section 22

 

(1)           A legal entity which authorisation to perform the activities of a notified body has been restricted or withdrawn by a final decision of the Office shall

a)      without undue delay, inform on the decision of the Office all affected economic operators;

b)      at the request of an economic operator which is concern by the consequences of the change in the validity of the notification, transfer the rights and obligations relating to the conformity assessment, including the subsequent verification of the fulfilment of conditions under which the certificate or other document proofing the findings has been issued (hereinafter the ‛certificate’), to a notified body with which the economic operator has entered into an agreement pursuant to Section 24 subsection 1, give him the relevant documentation and inform the Office on the transfer of the rights and obligations, including the transfer of documentation;

c)      ensure that the relevant documentation concerning the activities of a notified body is available, at the request, to the Office or to the market surveillance authority, and that for a period of time which is determined by the Office according to the decision on a restriction or on a withdrawal of authorisation to perform the activities of a notified body.

(2)           The certificates and documents relating to the conformity assessment issued inaccurately by a notified body prior to a restriction or to a withdrawal of authorisation to perform the activities of a notified body and not revoked by this notified body, may be revoked by a notified body which has assumed the rights and obligations pursuant to subsection 1 paragraph b) or by the market surveillance authority if it finds that they have been issued inaccurately during the inspection.

(3)           A notified body which has assumed the rights and obligations pursuant to subsection 1 paragraph b), may use the evidence from the transferring notified body to complete unfinished cases of the conformity assessment, or for a subsequent verification of the fulfilment of conditions under which the certificate or other document proofing the findings has been issued.

(4)           When a notified body intends to terminate or limit its activity without breaching its obligations referred to in Section 23, it shall, before a decision on a restriction or a withdrawal of authorisation to perform the activities of a notified body is taken by the Office, transfer the rights and obligations to another notified body; subsection 1 paragraph b) shall apply mutatis mutandis.

(5)           In case of the termination of a legal entity which is a notified body, this entity shall, before the termination, transfer all relevant documentation concerning the operations of the notified body to the Office.

 

Notified Bodies

Section 23

 

(1)           The following requirements shall apply to notified bodies

a)      the conformity assessment body shall be a third-party body independent from the economic operator whose product it assesses and from the product itself; when not excluded by the Government in its Order, as the conformity assessment body may be considered also a body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses, on condition that its independence and the absence of any conflict of interest are demonstrated;

b)      the conformity assessment body, its top-level management and the personnel responsible for carrying out the third party tasks in the process of conformity assessment (hereinafter the „personnel“) shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of products which it assesses; become directly involved in the design, manufacturing or construction, marketing, installation, use or maintenance of those products; nor represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgment and integrity related to the activities in conformity assessment for which they have been notified, including the provision of advisory services; this shall not preclude the use of assessed products that are necessary for the operations of the conformity assessment body or use of such products for personal purposes;

c)      the conformity assessment body and personnel shall carry out the third party tasks in the process of conformity with the highest degree of professional integrity and requisite technical competence in the specific field and must be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their tasks in the conformity assessment;

d)      the conformity assessment body shall be capable of carrying out all the third party tasks in the process of conformity assessment assigned to it in accordance with the relevant Governmental Orders pursuant to this Act or the relevant Regulation of the European Union, whether those tasks are carried out by the notified body itself or on its behalf and under its own responsibility;

e)      at all times and for each system of assessment and for each kind or category of products, in relation to which it has been notified, the conformity assessment body shall have the following at its disposal

1. the personnel with technical knowledge and appropriate experience to perform the third party tasks in the process of conformity assessment;

2. the description of procedures according to which the conformity assessment is carried out, ensuring the transparency and the ability of reproduction of these procedures; it shall have appropriate policies and procedures in place that distinguish between the tasks it carries out as a notified body and other activities;

3. the procedures to perform its activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process;

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

g)      the personnel involved in conformity assessment shall have the following

1. sound technical and vocational training covering all the third party tasks in the process of the conformity assessment within the relevant scope for which the body has been notified;

2. satisfactory knowledge of the requirements related to the assessment they carry out and adequate authorisation to carry out such operations;

3. appropriate knowledge and understanding of the applicable essential technical requirements, harmonised standards, provisions of harmonisation legislation of the European Union and Governmental Orders, or of the relevant Regulations of the European Union;

4. the ability required to draw up the certificates, records and reports to demonstrate that the assessments have been carried out;

h)      the conformity assessment body shall ensure that activities of its subcontractors do not affect the confidentiality, objectivity and impartiality of its tasks in the process of the conformity assessment;

i)       the conformity assessment body shall ensure that the remuneration of the top-level management and personnel is not dependent on the number of assessments carried out or on the results of such assessments;

j)       the conformity assessment body shall take out liability insurance for a harm caused by the activities of the notified body, with a limit of indemnity in the amount proportionate to the extent of these activities;

k)      the conformity assessment body shall ensure that the personnel is bound to observe professional secrecy with regard to all information gained in carrying out their tasks pursuant to this Act or pursuant to the applicable Regulation of the European Union.

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

(3)           The requirements for notified bodies referred to in subsections 1 and 2 in terms of technical resources and personal capacity may be further specified by the Government in its Orders.

 

Section 24

 

(1)           The notified bodies shall carry out activities in the conformity assessment in accordance with the conformity assessment procedures set out by the Government in its Orders or relevant Regulations of the European Union. They shall act on their behalf and under their own responsibility pursuant to a contract on inspection 8), subject of which are the tasks carried out in the process of the conformity assessment or in monitoring of the subsequent verification of the fulfilment of conditions under which the certificate has been issued. The essential elements of the contract include also indication of the rights and obligations arising from subsections 2 to 5.

 

(2)           The conformity assessment shall be carried out in a proportionate manner, avoiding an unnecessary burden for economic operators. While performing their tasks, the notified bodies shall take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process. These bodies shall ensure such a degree of rigour and level of protection that a product complies with the specified requirements, or the requirements of the relevant Regulation of the European Union.

 

(3)           Where a notified body finds that the manufacturer has not ensured the essential technical requirements set out by the Government in its Order, in the relevant Regulation of the European Union, in the relevant harmonised standards or in a document that prescribes the technical requirements for the product, process or service to demonstrate their conformity, that apply to the product, it shall require the manufacturer to take appropriate corrective measures and shall not issue a certificate.

(4)           Where in the course of monitoring the subsequent verification of the fulfilment of conditions under which the certificate has been issued, a notified body finds that a product no longer meets the requirements applied for issuing the certificate, it shall require the manufacturer to take appropriate corrective measures and may, depending on the nature and seriousness of the non-compliance with these requirements, restrict, suspend or withdraw the validity of the respective certificates in question.

(5)           When the manufacturer fails to take the corrective measures or when these measures do not have the required effect, the notified body shall restrict, suspend or withdraw the validity of the respective certificates in question.

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

 

Section 25

 

(1)           Where a notified body has assigned specific tasks to a subcontractor, it shall ensure that the subcontractor meets the requirements corresponding to the notified bodies and inform the Office.

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

(3)           The tasks shall be subcontracted only with the consent of a person who has asked the notified body for the performance of activities relating to the conformity assessment.

(4)           The notified body shall keep all relevant documents concerning the assessment of the qualifications of the subcontractor and of the activities carried out by the subcontractor and, at the request; it shall provide the Office with the evidence.

 

Section 26

 

(1)           The notified body shall provide the Office with following information

a)      on any case where it has refused to issue a certificate as well as on certificates which it has issued, suspended or withdrawn;

b)      on any circumstances affecting either the scope of the notification or the conditions for the notification,

c)      at any request for information on activities carried out in the process of the conformity assessment it has received from the market surveillance authorities,

d)      at the request, on conformity assessment activities carried out within the scope of their notification and on any other activity carried out.

(2)           Depending on the nature of a product, the Government may lay down in its Order another scope for the provision of information.

(3)           The notified body shall provide the other notified bodies including the notified bodies in other Member States of the European Union which carry out similar activities in the process of the conformity assessment and cover the same products with relevant information on issues relating to negative conformity assessment results, and, at the request, on issues relating also to positive assessment results.

(4)           The notified body shall participate in the standardisation activities related to the scope of its notification and in the activities of the coordination groups of the notified bodies established pursuant to the harmonisation legislation of European Union or relevant Regulations of the European Union or ensure that its personnel has been informed on these activities and it shall follow the decisions and the documents, which are the result of the work of such a group.

PART TWO

SPECIAL PROVISIONS FOR CERTAIN PRODUCTS

TITLE I

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

Division 1

Personal protective equipment

Section 27

 

(1)           Where the directly applicable regulation of the European Union in the area of personal protective equipment11) referrers to a national competent authority, this authority shall be in the Czech Republic the market surveillance authority.

(2)           Where the directly applicable regulation of the European Union in the area of personal protective equipment referrers to the language determined or required by the Member State, this language shall be in the Czech Republic the Czech language.

 

Division 2

Appliances burning gaseous fuels

Section 27a

 

(1)           Where the directly applicable regulation of the European Union in the area of appliances burning gaseous fuels12) referrers to a national competent authority, this authority shall be in the Czech Republic the market surveillance authority.

(2)           Where the directly applicable regulation of the European Union in the area of appliances burning gaseous fuels referrers to the language determined or required by the Member State, this language shall be in the Czech Republic the Czech language.

 

Division 3

Cableway installations

Section 27b

 

(1)           Where the directly applicable regulation of the European Union in the area of cableway installations13) referrers to a national competent authority, this authority shall be in the Czech Republic the market surveillance authority.

(2)           Where the directly applicable regulation of the European Union in the area of cableway installations referrers to the language determined or required by the Member State, this language shall be in the Czech Republic the Czech language.

 

TITLE II

SPECIAL PROVISIONS FOR CERTAIN OTHER PRODUCTS

Division 1

Lifts and safety components for lifts

Section 28

 

For the purposes of the conformity assessment of lifts and safety components for lifts the following definitions shall apply

 

a)      ‛lift’ means the lifting appliance serving specific levels, having a carrier moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal, or a lifting appliance moving along a fixed course even where it does not move along rigid guides;

b)      ‛installer’ means the person who takes the responsible for the design, manufacture, and installation and placing on the market;

c)      ‛making available on the market’ means any supply of a safety component for lifts for distribution or use on the market of the European Union in the course of a commercial activity, whether in return for payment or free of charge;

d)                      ‛placing on the market’ means

1. the first making available on the market of a safety component for lifts; or

2. the supply of a lift for use on the market of the European Union in the course of a commercial activity, whether in return for payment or free of charge;

e)      ‛manufacturer’ means any person who manufactures a safety component for lifts or has a safety component for lifts designed or manufactured, and markets it under his name or trade mark;

f)       ‛authorised representative’ means any person established within the territory of the European Union who has received a written mandate from an installer or a manufacturer to act on his behalf in relation to specified tasks;

g)      ‛importer’ means any person established within the territory of the European Union who places a safety component for lifts from a third country on the market of the European Union;

h)      ‛distributor’ means any person in the supply chain, other than the manufacturer or the importer, who makes a safety component for lifts available on the market;

i)       ‛economic operators’ means the installer, the manufacturer, the authorised representative, the importer and the distributor;

j)       ‛recall’ in relation to a lift means any measure aimed at achieving the dismantling and safe disposal of a lift, and in relation to a safety component for lifts means any measure aimed at achieving the return of a safety component for lifts that has already been made available to the installer or to the end-user;

k)      ‛withdrawal’ means any measure aimed at preventing a safety component for lifts in the supply chain from being made available on the market.

 

Section 29

 

When placing a lift on the market, the installer

 

a)      shall ensure that it has been designed, manufactured, installed and tested in accordance with the essential technical requirements for health and safety;

b)      shall draw up the technical documentation and carry out the relevant conformity assessment procedure or have it carried out;

c)      where the compliance of the lift with the applicable essential requirements for health and safety has been demonstrated by that procedure, he shall draw up an EU declaration of conformity, ensure that it accompanies the lift, and affix the CE marking;

d)      shall keep the technical documentation, the EU declaration of conformity and, where applicable, the approval decisions for 10 years after the lift has been placed on the market;

e)      when deemed appropriate with regard to the risks presented by a lift, he shall, to protect the health and safety of consumers, investigate, and, if necessary, keep a register of complaints, and of non-conforming lifts;

f)       shall ensure that lifts bear a type, batch or serial number or other element allowing their identification;

g)      shall indicate, on the lift, his name or registered trade mark and the postal address at which he can be contacted; the address shall indicate a single point at which the installer can be contacted; the contact details shall be indicate in the Czech language;

h)      shall ensure that the lift is accompanied by the instructions in the Czech language; such instructions, as well as any labelling, shall be clear and understandable.

(2)           The installer who consider or have a reason to believe that a lift which he has placed on the market is not in conformity with the technical requirements laid down in the Governmental Order shall immediately take the corrective measures necessary to bring that lift into conformity. Furthermore, where the lift presents a risk, the installer shall immediately inform the market surveillance authority or the competent authority of the Member States in which he has placed the lift on the market, giving details, in particular, of the non-conformity and of corrective measures he has taken.

(3)           The installer shall be entitled to appoint an authorised representative.

 

(4)           The installer shall, at a reasoned request of the market surveillance authority or a competent authority of the other Member State of the European Union, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the lift with the technical requirements laid down in the Governmental Order, in the Czech language.

 

(5)           The installer shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by lifts which he has placed on the market.

 

(6)           In line with the instructions of the notified body, the identification number of the notified body affixed to the CE marking pursuant to Section 15 subsection 3 may be affixed to the lift by the manufacturer or by his authorised representative.

 

Section 30

 

The builder9) and the installer shall provide each other the necessary information and makes appropriate steps to ensure the proper operation and safe use of the lift.

 

Division 2

Fixed installations in terms of the electromagnetic compatibility

Section 31

 

For the purposes of the conformity assessment of fixed installations in terms of the electromagnetic compatibility the following definitions shall apply

 

a)      ‛apparatus’ means any finished appliance or combination thereof made available on the market as a single functional unit; intended for the end-user and liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance;

b)      ‛fixed installation’ means a particular combination of several types of apparatus and, where applicable, other devices, which are assembled, installed and intended to be used permanently at a predefined location.

 

Section 32

 

(1)           Where there are indications of non-compliance of a fixed installation with the essential requirements laid down in the Governmental Order, the operator of the fixed installation or a person authorised by him shall ensure that the conformity assessment of the fixed installation is carried out in line with the requirements set out in the Governmental Order.

 

(2)           The conformity of a fixed installation with the essential requirements shall be ensured by the operator of the fixed installation.

 

Division 3

Recreational craft and personal watercraft

Section 33

 

For the purposes of the conformity assessment of recreational craft and personal watercraft the following definitions shall apply

 

a)      ‛recreational craft’ means any watercraft of any type, excluding personal watercraft, intended for sports and leisure purposes of hull length from 2,5 m to 24 m, regardless of the means of propulsion;

b)      ‛personal watercraft’ means the watercraft of less than 4 m in hull length which uses a propulsion engine having a water jet pump as its primary source of propulsion and designed to be operated by a person or persons sitting, standing or kneeling on, rather than within the confines of, a hull;

c)      ‛propulsion engine’ means any spark or compression ignition, internal combustion engine used directly or indirectly for propulsion purposes;

d)      ‛major engine modification’ means the modification of a propulsion engine which increases the rated power of the engine by more than 15 % or could potentially cause the engine to exceed the specified requirements for the emission limits;

e)      ‛major craft conversion’ means the conversion of a watercraft which changes the means of propulsion of the watercraft, involves a major engine modification, or alters the watercraft to such an extent that it may not meet the specified requirements;

f)       ‛putting into operation’ means the first use of a product by its end-user in a Member State of the European Union;

g)      ‛private importer’ means any person established within the territory of the European Union who imports for his own use and in the course of a non-commercial activity a product from a third country into the Member State of the European Union.

 

Section 34

 

(1)           The product shall be put into operation only when it meets the specified requirements; the conformity assessment has been carried out and is maintained and used in a manner not to endanger its compliance with the specified requirements, as the following are concerned

a)      recreational craft and personal watercraft (hereinafter the ‛watercraft’);

b)      component of the watercraft;

c)      propulsion engine.

 

(2)           A watercraft or a propulsion engine after a major conversion or modification thereof shall be, after such a conversion or modification, placed on the market or put into operation only when its conformity has been re-assessed. The appropriate procedure of the conformity assessment laid down by the Government in its Order shall be ensured by the person who is, after the conversion or modification, placing the product on the market or into operation.

 

(3)           The appropriate procedure of the conformity assessment laid down by the Government in its Order of a watercraft, which becomes a product stipulated by the Government in its Order for conformity assessment, when changes in the purpose of its use occur or when it is placed on the market before the date set by the Government in its Order, shall be ensured by the person who is placing the product on the market or into operation.

(4)           The appropriate procedure of the conformity assessment laid down by the Government in its Order of a product, which is placed on the market by a private importer as a watercraft, its component or a propulsion engine and conformity assessment of which has not been ensured by the manufacturer, shall be ensured by the private importer.

(5)           The persons referred to in subsections 2 to 4 shall affix to the product, before it is placed on the market or put into operation, the CE marking. The notified body, which has carried out the conformity assessment, shall affix to the CE marking its identification number, or it shall be, in line with the instructions of the notified body, affixed by the person referred to in subsections 2 to 4.

 

Section 35

(1)           For the product which is the watercraft, its component or propulsion engine, the private importer before putting it into operation

a)      shall ensure its compliance with the requirements referred to in Section 6 subsection 1 first sentence, Section 6 subsections 2 and 3 third sentence and Section 6 subsection 6, if the responsibility has not been fulfilled by the manufacturer;

b)      shall ensure that the name and address of the notified body which has carried out the conformity assessment of the product is marked on the product; and

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

(2)           The private importer shall for the period of time stipulated by the Government in its Order identify, at the request of the competent market surveillance authorities, the operator who has supplied him with the product.

 

Section 36

 

(1)           The Office shall assign an identification code to a notified body authorised to carry out conformity assessment according to Section 34 subsections 2 to 4.

(2)           Where the conformity assessment is carried out according to Section 34 subsection 4, the procedure of the notified body referred to in Section 24 subsections 2 and 3 shall apply mutatis mutandis also to the private importer.

 

Section 37

 

(1)           A partly completed watercraft may be made available on the market only when

a)      its manufacturer or importer has accompanied the partly completed watercraft with a declaration that it is intended to be completed by another manufacturer; and

b)      the partly completed watercraft complies with the essential requirements to the extent appropriate to the stage of its completion.

(2)           The declaration referred to in subsection 1 paragraph a) shall be issued in the Czech language and in the official languages ​​of the Member States of the European Union, where the partly completed watercraft is made available on the market. Particular elements of the declaration shall be set out by the Government in its Order.

 

Division 4

Marine equipment

Section 38

 

For the purposes of the conformity assessment of marine equipment the ship shall mean the seagoing vessel self-propelled intended for maritime sailing for the transport of cargo or passengers or cargo and passengers flying the flag of the Czech Republic or another Member State of the European Union.

 

Section 39

 

(1)           The product, which is marine equipment, shall be placed on the ship only when it meets specified requirements effective on the date of its location and when the assessment of its conformity has been carried out. Where the product meets these requirements, public authorities should not hinder its location on the ship.

(2)           A producer who is not established within the territory of the European Union shall be obligated to appoint his authorised representative by written mandate. The mandate of the authorised representative shall include the address at which he may be contacted.

(3)           An importer or distributor, for the purposes of this Act, shall be considered a manufacturer also when he places a product on a ship which is the marine equipment.

 

Section 40

 

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

(2)           A copy of the EU declaration of conformity shall be provided to the operator of the ship on which the marine equipment is or has to be placed and to the notified body which has carried out the conformity assessment.

 

Section 41

 

(1)           Instead of the CE marking, for the marine equipment a conformity marking shall be used whose graphical form provides the Government in its Order.

(2)           The provisions of Section 15 subsections 2 to 4 apply to this conformity marking accordingly.

(3)           The conformity marking can be replaced or accompanied by an electronic identifier, when the conditions set out in the laws and regulations of the European Union are met.

 

Sections 42

 

(1)           In the case of the notified bodies authorised to carry out conformity assessment of the marine equipment, the Office shall carry out its inspections according to Section 21 at least every two years.

(2)           The notified bodies authorised to carry out conformity assessment of the marine equipment shall, at the request, provide the European Commission or the competent authority of another Member State of the European Union without undue delay with information on positive and negative results of the conformity assessment.

 

Division 5

Pressure equipment

Section 43

 

For the purposes of the conformity assessment of pressure equipment the following definitions shall apply

a)      ‛the assembly‛ means the several pieces of pressure equipment assembled by the manufacturer to constitute an integrated functional unit;

b)      ‛putting into operation’ means the first use of the pressure equipment or assembly by the user.

 

Section 44

 

(1)           Pressure equipment or assemblies shall be placed on the market and put into operation by users only when its conformity with the essential requirements set out in the Governmental Order has been assessed by an inspectorate notified pursuant to Section 45 subsection 2.

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

(3)           The pressure equipment or assemblies referred to in subsection 1 may be used only in business establishments operated by the group which applies a common safety policy as regards the technical specifications for the design, manufacture, inspection, maintenance and use of pressure equipment and assemblies and of which the inspectorate is part.

 

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

 

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

(6)           The procedures applicable to conformity assessment by the user inspectorate are modules A2, C2, F and G, set out in Annex I to this Act.

 

Section 45

 

(1)           Where in Part One, Title IV and in Part Four the notified bodies are mentioned, it is understood, for the purposes of the Governmental Order relating to making the pressure equipment available on the market, that also recognised third-party organisations and users inspectorates are covered.

(2)           For the notification of recognised third-party organisations and user’s inspectorates, the Sections 16 to 26 shall apply mutatis mutandis, with the exception of Section 23 subsection 1 paragraph a) after the semicolon which shall not apply for the users’ inspectorates.

(3)           For the user inspectorate, the notification pursuant to Section 17 subsection 2 shall, except of data pursuant to Section 19 subsection 4, contain also the list of business establishments complying with the provisions of Section 44 subsection 3.

Section 45a

The Office may, at a reasoned request, authorise the placing on the market or putting into operation of a pressure equipment or assembly for which the conformity has not been assessed it this pressure equipment or assembly is to be used for experimental purposes.

 

Division 6

Radio equipment

Section 46

 

For the purposes of the conformity assessment of radio equipment the following definitions shall apply

 

a)      ‛radio equipment’ means the electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radio determination, or an electrical or electronic product which must be completed with an accessory, such as antenna, so as to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radio determination;

b)      ‛radio communication’ means the communication by means of radio waves;

c)      ‛radio waves’ means the electromagnetic waves of frequencies lower than 3 000 GHz, propagated in space without artificial guide;

d)      ‛radio determination’ means the determination of the position, velocity and/or other characteristics of an object, or the obtaining of information relating to those parameters, by means of the propagation properties of radio waves;

e)      ‛putting into operation’ means the first use of the radio equipment by the end-user.

 

Section 47

 

(1)           The manufacturer of radio equipment and of software allowing radio equipment to be used as intended shall provide the Member States and the Commission with information on the compliance of intended combinations of radio equipment and software with the essential requirements. Such information shall result from a conformity assessment carried out in accordance with the procedure set out in the Governmental Order, and shall be given in the form of a statement of compliance. Depending on the specific combinations of radio equipment and software, the information shall precisely identify the radio equipment and the software which have been assessed, and it shall be continuously updated.

 

(2)           The manufacturer shall register radio equipment type within categories of radio equipment affected by a low level of compliance with the essential requirements within a central system made available by the European Commission prior to radio equipment within those categories being placed on the market. When registering such radio equipment types, the manufacturer shall provide some, or where justified all, elements of the technical documentation set out in the Governmental Order. The manufacturers shall affix on radio equipment placed on the market a registration number which is allocated by the European Commission to each registered radio equipment type.

 

Division 7

Measuring instruments

Section 48

For the purposes of conformity assessment of a measuring instrument, the putting into operation shall mean the first use of a measuring instrument intended for the end-user for the purposes for which it was determined.

Section 48a

 

(1)          The importer shall be obligated to ensure that the manufacturer has performed the acts specified in Section 8 subsection 2 paragraph a) also before putting the measuring instrument into operation.

(2)           In the course of an action pursuant to Section 8 subsection 3 first sentence, the importer shall even not place the measuring instrument into operation.

(3)           In the course of an action pursuant to Section 9 subsection 1, the distributor shall also act with due care when he puts a measuring instrument into operation. The distributor shall be obligated to verify that the measuring instrument complies with the requirements specified in Section 9 subsection 2 also before putting it into operation.

(4)           In the course of an action pursuant to Section 9 subsection 3 first sentence, the distributor shall even not place the measuring instrument into operation.

(5)           In the course of an action pursuant to Section 9 subsection 4, the obligation of the distributor shall be extended also to those measuring instruments, which he has put into operation.

 

Division 8

Non-automatic weighing instruments

Section 48b

 

The Ministry shall establish by its Decree the gravity zones on the territory of the Czech Republic for the purposes of the conformity assessment of a non-automatic weighing instrument.

 

Division 9

Equipment and protective systems intended for use in potentially explosive atmospheres

Section 48c

 

The Office may authorise, if this is in the interest of the safety, at a reasoned request the placing on the market or putting into operation without the conformity assessment of

a)      an equipment or protective system intended for use in potentially explosive atmospheres; or

b)      a safety, control and regulation device which is intended to be used outside a potentially explosive environment, but which is necessary for the safe operation of the products referred to in paragraph a) or which contributes to their functioning.

 

PART THREE

MARKET SURVEILLANCE

Section 49

Market surveillance

 

(1)           The surveillance to ascertain, whether the products are made available on the market, put into operation or used by the manufacturer for own use in accordance with the specified requirements or the requirements of the relevant Regulation of the European Union, whether the economic operators fulfill their obligations stipulated by this Act and whether the products are not unduly affixed with the CE marking or other prescribed marking according to this Act or according to the applicable Regulation of the European Union, shall be carried out by a market surveillance authority, which is the Czech Trade Inspection Authority or other administrative authority, if so stipulated by another Act.

 

(2)           The market surveillance authorities shall be entitled to

 

a)      carry out the analysis or ensure that such analysis are carried out in order to verify that the products meet the specified requirements or the requirements of the relevant Regulation of the European Union; the analysis shall be performed by the competent authorities or bodies; where the analysis shows that the product fails to meet the specified requirements or the requirements of the relevant Regulation of the European Union any costs of the analysis shall be borne by the economic operator concerned;

b)      impose corrective measures on economic operators to eliminate, within the determined time-limit, detected shortcomings, its causes and harmful consequences or to take, without undue delay, necessary corrective actions;

c)      impose an obligation on economic operator to inform without delay the persons who could be a subject to a risk related to the product.

(3)                           Where the market surveillance authority has a sufficient reason to believe that a product fails to meet the specified requirements or the requirements of the relevant Regulation of the European Union, it shall be entitled to require from the notified body information and documents relating to the conformity assessment of the product, including certificates, technical documentation and test reports. In addition, where the market surveillance authority demonstrates that the product does not meet the specified requirements or the requirements of the relevant Regulation of the European Union, it shall notify this fact to the notified body which has issued the certificate, and shall be entitled also to impose on this notified body to withdraw this certificate from the economic operator.

 

Section 50

Safeguard measures

 

(1)           Where the market surveillance authority has a sufficient reason to believe that a product fails to meet the specified requirements or the requirements of the relevant Regulation of the European Union, it shall prohibit the making of the product available on the market, putting it into operation or using of it by the manufacturer for his own use, if it is justified by the nature of the risk

 

(2)           The market surveillance authority shall notify the imposition of measures pursuant to subsection 1 orally to the economic operator and shall make, without undue delay, a written record. If the economic operator does not agree with the measure imposed, he may raise objections, which shall be stated in the record, or he may raise his objections in writing no later than 10 days after the date of receiving the record. The written decision on consideration of the objections shall be delivered to the concerned economic operator. No appeal lies against this decision.

 

(3)           Where the market surveillance authority finds that a product presents a risk, or that the detected shortcomings have not been during the time-limit pursuant to Section 49 subsection 2 paragraph b) eliminated, it shall decide on the prohibition of making the product available on the market, putting it into operation or using of it by the manufacturer for his own use, or it shall decide on the withdrawal or recall of the product from the market. If the reasons for the decision on prohibition are no longer applicable, the market surveillance authority shall decide on its amendment or withdrawal. An appeal against the decision pursuant to the first sentence shall not have a suspense effect.

(4)           The market surveillance authority shall decide on the prohibition of making the product available on the market, putting it into operation or using of it by the manufacturer for his own use, or on withdrawal or recall of the product from the market, also when the economic operator concerned fails, at the request of market surveillance authority the pursuant to Section 49 subsection 2 paragraph b), to eliminate the shortcomings consisting in the fact that

a)                      the CE marking or other prescribed marking has been placed in violation of the provisions of this Act;

b)                      the CE marking or other prescribed marking has not been affixed;

c)                      the conformity declaration has not been drawn up in accordance with the Governmental Order; or

d)                      technical documentation is either not available or not complete.

(5)           The formal shortcomings, the failure to eliminate of which allows the market surveillance authority to decide pursuant to subsection 4, may be further specified by the Government in its Order. An appeal against the decision pursuant to subsection 4 shall not have a suspense effect.

 

Section 51

Products posing a risk despite of compliance with the requirements

 

(1)           Where the market surveillance authority after the analysis pursuant to Section 49 subsection 2 paragraph a) or after the detection pursuant to Section 50 subsection 1 finds out that the product meets the specified requirements or the requirements of the relevant Regulation of the European Union, nevertheless presents a risk, it shall impose on the economic operator to take all appropriate measures and to ensure, within a time-limit adequate to the nature of the risk, that product concerned, when it has been placed on the market, no longer presents that risk and/or its subsequent withdrawal or recall. An appeal against this decision shall not have a suspense effect.

(2)           The economic operator shall ensure that the corrective action is taken in respect of all products concerned and in all Member States of the European Union on the territory of which he has made those products available.

(3)           The economic operator shall, without undue delay, notify the corrective action to the market surveillance authority.

 

Section 52

Notification

 

(1)           The market surveillance authorities shall be obligated to notify to the Ministry of Industry and Trade (hereinafter the „Ministry“) adoption of any measure relating to a product or product series where the product poses a risk. This shall apply also in case where the measure has been taken by the economic operator on his own initiative and the market surveillance authority has been notified thereof.

 

(2)           The information provided to the Ministry shall contain all available details, especially data necessary for the identification of the product, its origin, supply chain, risk posed by the product, details on nature and duration of the measure taken by the market surveillance authority and eventually information on voluntary measures taken by the economic operator.

 

(3)           Where the risk is to cross the territory of the Czech Republic, the Ministry shall be obligated to notify, without delay, the presence of such a product to the European Commission and the other Member States of the European Union.

 

(4)           When the Ministry receives information on adoption of measures against a product or product series that pose a risk from the European Commission, it shall forward, without delay, such information to the market surveillance authorities for further proceedings.

 

(5)           To ensure that the system for the exchange of information pursuant to subsections 1 to 3 would be functioning, the special legal regulation laying down procedures, content and form of information on the presence of dangerous non-food products shall be used mutatis mutandis10).

 

PART FOUR

OFFENCES

Section 53

Offences of natural persons

 

(1)           A natural person will commit an offence when

 

a)      unduly uses the CE marking or other marking specified in the legal regulation issued to implement this Act, or a marking specified in the relevant Regulation of the European Union;

b)      falsifies or alters the certificate or another document drawn up pursuant to the legal regulation issued to implement this Act or to the relevant Regulation of the European Union;

c)                      as a builder fails to comply with the obligations pursuant to Section 30.

(2)           In case of an offence pursuant to subsection 1, a penalty may be imposed up to 20 million CZK.

 

Section 54

 

Offences of legal entities and natural persons doing business

 

(1)           A legal person or natural person doing business will commit an offence when

 

a)      unduly uses the CE marking or other marking specified in the legal regulation issued to implement this Act, or a marking specified in the relevant Regulation of the European Union;

b)      falsifies or alters the certificate or another document drawn up pursuant to the legal regulation issued to implement this Act or to the relevant Regulation of the European Union;

c)      without authorisation pursuant Section 20 subsection 1 carries out an activity in the process of the conformity assessment reserved, for the purposes of this Act, to the notified body;

d)                      fails to comply with one of the safeguard measures issued pursuant to Section 50 subsections 1, 3 or 4; or

e)                      fails to comply with one of the measures imposed pursuant to Section 49 subsection 2 paragraphs b) or c).

 

(2)           A notified body will commit an offence when

 

a)                      contrary to Section 20 subsection 1 performs the action of the notified body without an appropriate authorisation; or

b)      fails to comply with one of the obligations pursuant to Section 22 subsections 1 or 4, Section 24, Section 25 subsections 1, 3 or 4 or Section 26.

(3)           A legal person or natural person doing business who is a economic operator or a person who is pursuant to the relevant Regulation of the European Union a manufacturer, importer, authorised representative or distributor, will commit an offence, when contrary to the obligations makes a product available on the market, puts it into operation or uses it for own use

a)      without the CE marking or other marking specified in the legal regulation issued to implement this Act, or without a document stipulated by the Government in its Order or by the relevant Regulation of the European Union;

b)      with the CE marking or other marking specified in the legal regulation issued to implement this Act or with a document, which are affixed or drawn up contrary to Section 14 or Section 15 or to the relevant Regulation of the European Union.

(4)          A legal person or natural person doing business will commit an offence when as

a)      a economic operator fails to comply with one of the obligations pursuant Sections 6 to 9 and Section 11 or one of the obligations pursuant Sections 29, 30, 32, 34, 35, 37, 39, 40, 41, 44, 47 and 49; or

b)      a person who is pursuant to the relevant Regulation of the European Union a manufacturer authorised representative, importer or distributor fails to comply with one of the obligations arising from the relevant Regulation of the European Union.

(5)           In case of an offence, a penalty may be imposed up to

 

a)      50 million CZK, in case of an offence pursuant to subsection 3 or subsection 1 paragraphs d) or e);

b)      20 million CZK, in case of an offence pursuant to subsection 1 paragraph a), b) or c) or subsection 2 paragraph a);

c)      1 million CZK, in case of an offence pursuant to subsection 2 paragraph b);

d)      500,000 CZK, in case of an offence pursuant to subsection 4.

 

Section 55

Common provisions for offences

 

(1)           The offences pursuant to Sections 53 and 54 shall be under consideration of the market surveillance authority, with the exception of offenses pursuant to Section 54 subsection 1 paragraph c) and Section 54 subsection 2 which shall be under consideration of the Office.

 

(2)           The penalties shall be collected by the body which has imposed them.

(3)           In the case of offences pursuant to Section 54 subsection 1 paragraphs d) and e) and to Section 54 subsection 3, the administrative penalty cannot be waived.

 

PART FIVE

COMMON, TRANSITIONAL PROVISIONS AND POWERS

Common provisions

Section 56

 

The provisions of this Act concerning relations to the Member States of the European Union shall apply also to relations to the countries forming the European Economic Area and to the Swiss Confederation.

Section 57

 

As notified bodies, with the exception of the Part One, Title IV, Part Three and Part Four, shall be considered also those bodies which have been notified to the European Commission and to the other Member States of the European Union by other Member States of the European Union, or entities that are considered as notified bodies pursuant to the international agreements which are binding for the Czech Republic.

Section 57a

Powers

 

The Ministry shall issue a Decree pursuant to the Section 48b.

 

 

Transitional provisions

Section 58

 

The entities which have been notified to the European Commission and to other Member States pursuant to Section 11b of the Act No. 22/1997 Coll., in the wording in force before the date of entry into force of this Act, and which are authorised to the relevant activities according to the Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC are considered to have been notified according to this Act.

 

Section 59

 

The proceedings on notifications which have been started pursuant to Section 11b of the Act No. 22/1997 Coll., in the wording in force before the date of entry into force of this Act, and which have not been finished before the date of entry into force of this Act, shall be finished according to the Act No. 22/1997 Coll., in the wording in force before the date of entry into force of this Act.

 

PART SIX

ENTRY INTO FORCE

Section 60

 

This Act shall enter into force on the fifteenth day following the day of its promulgation, except of the provision of Section 47 subsection 2 which shall enter into force on the 12 June 2018.

 

 

 

Hamáèek (signed)

Zeman (signed)

Sobotka (signed)

 

Annex I

 

Conformity assessment modules

 

When assessing the conformity, modules marked in the following way shall be used

 

a) Module A: Internal production control,

b) Module A1: Internal production control plus supervised product testing

c) Module A2: Internal production control plus supervised product checks at random intervals,

d) Module B: EC-type examination

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

f) Module C1: Conformity to type based on internal production control plus supervised product testing

g) Module C2: Conformity to type based on internal production control plus supervised product checks 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) Module E1: Quality assurance of final product inspection and testing,

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 plus design examination.

 

Annex II

 

The declaration of conformity shall include following information:

 

EU DECLARATION OF CONFORMITY

 

1.     No … (unique identification of the product)

2.     Name and address of the manufacturer or his authorised representative

3.     This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer)

4.     Object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate)

5.     The object of the declaration described above is in conformity with the relevant Community harmonisation legislation xxxxx

6.     References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared

7.     Where applicable, the notified body ... (name, number) … performed … (description of intervention) … and issued the certificate ….

8.     Additional information

 

Signed for and on behalf of …………………………………

(place and date of issue)

(name, function), (signature)

 

Note:

Depending on the product, the information herein may be concretized in the Order laid down by the Government.

 

1)              Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC.

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

Directive 2014/28/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses.

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

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

Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments.

Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments.

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

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

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

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

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

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

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

4)              Act No. 22/1997 Coll., on Technical Requirements for Products and on Changes and Amendments to some Acts, as amended

5)              Article 2 (1) (b) of Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 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 of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council

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

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

8)              Section 2652 and following of Act No. 89/2012 Coll., Civil Code.

9)              Section 2 subsection 2 paragraph c) of Act No. 183/2006 Coll., on Territorial Planning and Building Code (Building Act).

10)             Governmental Order No. 396/2004 Coll., on Procedures, content and form of information about the presence of dangerous non-food products, as amended.

11)             Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing the Council Directive 89/686/EEC

12)             Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing the Council Directive 2009/142/EC

13)             Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing the Council Directive 2000/9/EC

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