Act No. 90/2016 Coll., on Conformity Assessment of Specified Products When Making them Available on the Market (working compiled English version)

Act No. 90/2016 Coll., on Conformity Assessment of Specified Products When Making them Available on the Market (working compiled English version)

Amendment: 183/2017 Coll.

Amendment: 265/2017 Coll.

Amendment: 526/2020 Coll.

Amendment: 299/2021 Coll.

Amendment: 374/2021 Coll.

Amendment: 431/2022 Coll.

Parliament has agreed on this law of the Czech Republic:

PART ONE

SUPPLYING PRODUCTS TO THE MARKET

TITLE I

GENERAL PROVISIONS

Subject of modification

(1) This Act incorporates the relevant European Union regulations on the common framework for the marketing of products1) and regulates the procedure of state authorities in protecting the market from products that could endanger life, health, property or the environment or other public interest.

(2) This Act incorporates the provisions of the European Union in the area of supplying products on the market²⁾ issued in connection with the European Union's regulation on a common framework for the marketing of products¹⁾ and to products which are prescribed by government regulations in accordance with these regulations, shall be governed by

(a) general principles for the placing on the market or putting into service of products,
(b) the method of determining the products to be assessed for conformity and the technical requirements which the products must meet,
(c) the rights and obligations of persons who place on the market or supply on the market, or put into service, products for which conformity with the requirements laid down in legislation is to be assessed before they are placed on the market,
(d) conformity assessment of products,
(e) performance of state administration in the field of state testing and market supervision,
(f) the rights and obligations of persons authorised to carry out activities under this Act that are related to State testing,
(g) obligations to provide information related to the supply of products on the market, conformity assessment and market surveillance.

(3) This Act further regulates, in relation to directly applicable European Union legislation in the field of accreditation and supervision3), market surveillance concerning the placing on the market and labelling of products.

(4) This Act also regulates the exercise of state administration in the field of products to which a directly applicable European Union regulation on the marketing of products relating to the common framework for the marketing of products applies and which are listed in Part Two of Title I or for which another Act4) regulating conformity assessment and the supply of products on the market so provides.

(1) The provisions of Sections 3 to 15 shall not apply to products to which the relevant European Union Regulation applies. The provisions of Sections 17 to 26, 50 and 51 shall apply to such products unless otherwise provided for in the relevant European Union Regulation.

(2) In the case of products referred to in Part Two of Title II, the provisions of Sections 3 to 15, 17 to 26, 50 and 51 shall apply unless otherwise provided in Part Two of Title II.

Concepts

For the purposes of this Act, the following shall mean

(a) the supply on the market of a product for distribution, consumption or use on the market of the European Union in the course of a commercial activity, whether or not for consideration,
(b) by placing on the market, the first supply of the product on the market of the European Union,
(c) the economic operator shall be the manufacturer, the authorised representative, the importer and the distributor,
(d) a manufacturer is a person who manufactures a product or has a product designed or manufactured and markets that product under his own name or trademark or, where a government regulation so provides, uses it for his own use,
(e) an authorised representative is a person established in the territory of a Member State of the European Union who has been authorised in writing by the manufacturer to act on his behalf within the scope of his mandate,
(f) the importer is a person established in the European Union who places a product from a third country on the market of the European Union,
(g) a distributor is a person, other than a manufacturer or importer, who makes a product available on the market in the supply chain,
(h) a conformity assessment body shall be a person or an organisational unit of the State which carries out conformity assessment activities, including calibration, testing, certification and inspection,
(i) conformity assessment, the process of demonstrating that the essential technical requirements relating to a product, process, service, system or person set out in a Government Regulation have been met,
(j) the CE marking, by which the manufacturer indicates that the product complies with the requirements laid down in the legislation governing its affixing,
(k) technical requirements
the required characteristics of the product, which are, in particular, the level of quality, performance characteristics, safety or dimensions, interoperability, health and environmental protection, including the requirements for the product as regards its trade name, nomenclature, symbols, testing and test methods, packaging, product labelling and conformity assessment procedures, as well as manufacturing methods and processes affecting the characteristics of the products; and
other requirements necessary to protect consumers or the environment after the product has been placed on the market or put into service, such as conditions of use, recycling, reuse or disposal of the product, where these conditions may significantly affect the composition or characteristics of the product or its placing on the market or putting into service,
(l) a recall measure aimed at returning a product which has already been supplied to the end user to the person who supplied the product to the end user,
(m) a withdrawal from the market, a measure aimed at preventing a product which is in the supply chain from being made available on the market.

The products to be assessed for conformity and the technical requirements which the products must meet when they are placed on the market or put into service or use, including for the manufacturer's own use, shall be laid down by the Government by regulations, which may further specify

(a) methods of conformity assessment,
(b) the conditions and rules for drawing up the EU declaration of conformity and for affixing the CE marking or any other marking; the Government Regulation shall also lay down the form and method of affixing the other marking,
(c) the procedures for placing products on the market,
(d) details of the conformity assessment activities of economic operators and notified bodies (§ 17).

(1) Only a product may be placed on the market which complies with the requirements of this Act and the Government Regulations issued for its implementation which apply to it (hereinafter referred to as "specified requirement") and for which conformity has been assessed.

(2) Where a government regulation so provides, products may be put into service or used, including for the manufacturer's own use, only if they meet the specified requirements and have been assessed for conformity.

(3) If a product meets the requirements of the European Union regulations harmonising the conditions for the placing of products on the market (hereinafter referred to as "harmonisation regulation of the European Union"), which apply to the product, the public authorities may not prevent the supply of the product on the market in the Czech Republic from the aspects regulated by these regulations.

(4) At trade fairs, exhibitions and similar demonstrations, products which do not meet the requirements may be demonstrated in cases and under the conditions laid down by Government Decree.

TITLE II

ECONOMIC OPERATORS

Producer

(1) The manufacturer shall ensure that products are designed and manufactured in accordance with the specified requirements. In the case of mass-produced products, he shall ensure that the specified requirements are complied with throughout the manufacturing process, even if there are changes in the design or parameters of the product, or if there are changes in the harmonised standards5) or in the document prescribing the technical requirements which the product, process or service has to meet in order to demonstrate conformity.

(2) The manufacturer shall be obliged to draw up technical documentation and to carry out or have carried out the conformity assessment procedure laid down in the Government Regulation. The scope and manner of drawing up the technical documentation may be determined by Government Regulation. After having demonstrated conformity, the manufacturer shall, in the cases provided for in the Government Regulation, draw up an EU declaration of conformity or other document attesting conformity (hereinafter referred to as "declaration of conformity") and affix the CE marking or other prescribed marking. The manufacturer shall keep the technical documentation and the declaration of conformity to the extent and for the period laid down in the Government Regulation.

(3) The manufacturer shall indicate on the product the information and identification data on the product and the identification data and contact details relating to his person, as laid down by Government Regulation. If the size or nature of the product does not permit the indication of these particulars on the product, and unless otherwise provided for in a Government Regulation, he shall indicate these particulars on the packaging of the product 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. Where provided for in a Government Regulation, the manufacturer shall attach a copy of the declaration of conformity to each product. The scope of the instructions and safety information to be enclosed may be determined by the Government by regulation.

(4) The manufacturer shall, in cases and to the extent provided for in the Government Regulation, be obliged to carry out tests of product samples and other necessary investigations concerning products placed on the market in order to protect the health and safety of consumers, to keep records of complaints and non-conforming products and products which he has withdrawn from circulation, and to inform distributors to whom he has supplied these products of these facts.

(5) A manufacturer who considers or has reason to believe that a product which he has placed on the market does not comply with the specified requirements shall, without undue delay, take the necessary and effective measures to bring the product into compliance with the specified requirements or withdraw the product from the market or from circulation. Where the product presents a risk to life, health, property or the environment or other public interest (hereinafter referred to as 'the risk'), the manufacturer shall immediately inform the supervisory authority (Article 49(1)) or the competent authorities of another Member State of the European Union in which it has placed the product on the market of that risk and its nature and causes, as well as of the measures taken or of the withdrawal of the product from the market or from circulation.

(6) Upon reasoned request, the manufacturer shall provide the supervisory authority or the competent authority of another Member State of the European Union in which he has made the product available on the market with the information and documents necessary to demonstrate the conformity of the product. Unless they agree otherwise, he shall provide such information and supporting documents in an official language of the relevant Member State of the European Union. The manufacturer shall provide those authorities with the assistance necessary to enable them to exercise their powers with a view to eliminating the risks arising from products which he has placed on the market.

(7) The manufacturer is entitled to appoint his authorised representative. The mandate of the authorised representative shall not include the performance of any of the obligations referred to in paragraph 1, nor the obligation to draw up the required technical documentation, but shall enable him to keep the declaration of conformity and the technical documentation and to provide the supervisory authorities with assistance.

Authorised representative

The authorised representative shall carry out the tasks within the scope of his mandate and shall keep the declaration of conformity and the technical documentation for the period specified in the Government Regulation. He shall, on request, provide the supervisory authorities with the information and documentation necessary to demonstrate the conformity of the product and with the cooperation required to exercise their powers in order to eliminate the risks posed by the products covered by his mandate.

Importer

(1) The importer may place on the market only products which comply with the requirements laid down and shall ensure that, for the period during which he handles the products before placing them on the market, such compliance is not compromised by storage and transport conditions.

(2) The importer shall

(a) before placing the product on the market, ensure that
the manufacturer has carried out or had carried out the relevant conformity assessment procedure and has drawn up the technical documentation for the product imported by him,
the product bears the CE marking or other prescribed marking,
the product is accompanied by a declaration of conformity, if a government regulation so provides,
the product has been provided with clear and comprehensible instructions and safety information to the extent required by government regulation; and
the manufacturer has complied with the requirements set out in Article 6(3), and
(b) keep a copy of the declaration of conformity for the period specified in the Government Regulation and make the technical documentation available to the supervisory authority on reasoned request.

(3) An importer who considers or has reason to believe that a product which he intends to place on the market does not comply with the specified requirements shall not place that product on the market until the product has been brought into compliance with the specified requirements. Where the product presents a risk, the importer shall immediately inform the manufacturer thereof and shall also inform the supervisory authority, including the nature of the risk and its causes, as well as the measures taken by the importer or the withdrawal of the product from the market or from circulation.

(4) The importer shall be obliged to indicate on the product the identification and contact details concerning his person as laid down by Government Regulation, or, if this is not possible or if the Government Regulation so provides, he shall be obliged to indicate these details on the packaging of the product or in the 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) The importer shall, in cases and to the extent provided for in the Government Regulation, be obliged to carry out sample tests and other necessary investigations concerning products placed on the market in order to protect the health and safety of consumers, to keep records of non-conforming products and product recalls, and to inform the distributors to whom he has supplied these products of these facts.

(6) Upon request, the importer shall provide the supervisory authority or the competent authority of another Member State of the European Union in which he has made the product available on the market with the information and documents necessary to demonstrate the conformity of the product. Unless they agree otherwise, he shall provide that information and supporting documents in an official language of the relevant Member State of the European Union. The importer shall, on request, provide those authorities with the assistance necessary for the exercise of their powers in order to eliminate the risks posed by the products he has placed on the market.

(7) An importer who considers or has reason to believe that a product which he has placed on the market does not comply with the requirements laid down shall immediately take the necessary measures to bring the product into compliance with those requirements or withdraw it from the market or from circulation. Where the product presents a risk, he shall immediately inform the manufacturer and the supervisory authority or the competent authority of another Member State of the European Union in which he has placed the product on the market, of the nature and causes of the risk and of the measures taken or of the withdrawal of the product from the market or from circulation.

Distributor

(1) A distributor shall act with due care to ensure that the products he supplies to the market meet the requirements laid down and shall ensure that, during the period of time he handles the products before they are supplied to the market, the compliance of the products with the requirements laid down is not compromised by storage and transport conditions.

(2) The distributor shall, in the cases and to the extent provided for in the Government Regulation, verify, before placing the product on the market, whether the product bears the CE marking or any other prescribed marking, whether the product is accompanied by a declaration of conformity and clear and comprehensible instructions and safety information to the extent provided for in the Government Regulation, whether these instructions and safety information accompanying the product are in the Czech language, and whether the manufacturer and importer have complied with the requirements set out in Section 6(3) and Section 8(4).

(3) A distributor who believes or has reason to believe that a product does not comply with the requirements laid down shall not make that product available on the market until the product has been brought into compliance with those requirements. If the product presents a risk, he shall inform the manufacturer or importer and the market surveillance authorities.

(4) The distributor shall, on request, provide the supervisory authority or the competent authority of another Member State of the European Union in which he has made the product available on the market with the information and documents necessary to demonstrate the conformity of the product. The distributor shall, on request, provide those authorities with the assistance necessary for the exercise of their powers with a view to eliminating risks arising from products which he has supplied to the market.

(5) A distributor who considers or has reason to believe that a product which he has made available on the market does not comply with the requirements laid down shall ensure that the necessary measures are taken to bring the product into compliance with those requirements or shall withdraw it from the market or from circulation. Where the product presents a risk, it shall immediately inform the manufacturer or importer and the supervisory authority or the competent authority of another Member State of the European Union in which it has placed the product on the market of that risk and of its nature and causes, as well as of the measures taken or of the withdrawal of the product from the market or from circulation.

For the purposes of this Act, an importer or distributor shall be deemed to be a manufacturer subject to the obligations of a manufacturer under Section 6 if he places a product on the market under his name or trademark or if he modifies a product already placed on the market in such a way as to affect its conformity with the requirements laid down.

Economic operators are obliged to identify all economic operators for a period of time specified in the government regulation upon request of the competent supervisory authorities,

(a) who have supplied them with the product, or
(b) to whom they have supplied the product.

TITLE III

CONFORMITY ASSESSMENT

Conformity assessment procedures

(1) Conformity assessment shall be carried out in accordance with the conformity assessment modules, or combinations thereof, the use of which, or their combination, for the relevant specified product shall be determined by government regulation. The list of conformity assessment modules is set out in Annex 1 to this Act.

(2) The individual modules referred to in paragraph (1) shall include the procedures and acts which are carried out by manufacturers, or by authorised representatives within the scope of their mandate, and conformity assessment bodies in the conformity assessment. In particular, the modules shall specify the means of exchange of information between the manufacturer and the notified body and their scope, the scope of the product, production or quality system documentation, the activities involved in assessing the suitability of the product design, the details of product sampling, the scope and methods of testing samples of products or prototypes thereof, the forms of conformity assessment conclusions, the differences in the assessment of batch or unit production of products and the procedures for quality system audits.

(3) An accredited in-house department of the manufacturer may participate in the conformity assessment in cases and to the extent specified by the Government Regulation, if it meets the following criteria:

(a) the manufacturer's in-house service is subject to accreditation granted in accordance with directly applicable European Union legislation on accreditation and supervision3),
(b) the manufacturer's in-house service shall form an organisationally separate unit and its employees shall use reporting methods between the manufacturer's organisational units which ensure their impartiality as demonstrated to the accreditation body,
(c) the manufacturer's in-house service and its employees shall not be involved in the design, manufacture, supply, installation, operation or maintenance of the products they assess and shall not engage in any activities that could compromise their independent judgement or credibility in relation to the assessment activities,
(d) the manufacturer's in-house unit provides services exclusively to the manufacturer of which it is part.

(4) The manufacturer, of which the in-house unit is a part, or the accreditation body shall be obliged to provide information on request to the Office for Technical Standardization, Metrology and State Testing (hereinafter referred to as "the Office") that the in-house unit of the manufacturer has been accredited, including the scope of this accreditation.

Presumption of conformity

(1) Where a product conforms to harmonised standards⁵⁾ or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the technical requirements set out in the Government Regulation to which those standards or parts thereof relate.

(2) If there are no harmonised standards and if a government regulation so provides, the Office shall publish in the Bulletin of the Office for Technical Standardisation, Metrology and State Testing information on existing Czech technical standards and technical documents prescribing technical requirements that are considered appropriate for proper conformity assessment.

Declaration of conformity

(1) By means of a declaration of conformity, the manufacturer confirms that the conformity assessment has demonstrated compliance with the essential technical requirements laid down in the Government Regulation.

(2) The declaration of conformity shall contain the data listed in Annex 2 to this Act, which are specified by Government Regulation depending on the product under assessment, and the elements set out in the relevant conformity assessment modules, and shall be kept up to date. It shall be drawn up in the Czech language and in the languages required by the Member States of the European Union in which the product is placed or supplied on the market.

(3) Where a product is covered by more than one government regulation governing the drawing up of a declaration of conformity and these government regulations allow it, a single declaration of conformity shall be drawn up, in which references shall be made to the harmonisation regulations of the European Union applicable to the product in question and, where appropriate, to the relevant government regulations. This single declaration of conformity may, where the Government Regulation so permits, take the form of a folder made up of the relevant individual declarations of conformity.

CE marking and other markings

(1) CE marking⁶⁾ may be affixed only to a product for which the affixing of this marking is prescribed by government regulation.

(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. A government regulation may provide for other means of affixing the CE marking, in particular that the CE marking is to be affixed on the product's nameplate or on its packaging or on documents accompanying the product.

(3) The notified body which has participated in the conformity assessment shall affix to the CE marking in the conformity assessment according to the module involving the attachment of the notified body identification number the identification number assigned to it by the European Commission. This number may be affixed to the CE marking by the manufacturer or his authorised representative, as instructed by the notified body.

(4) Where a government regulation so provides, specific markings shall be added after the CE marking or, where appropriate, after the identification number of the notified body or in another specified place. The marking may be accompanied by pictograms or other signs indicating a particular risk or method of use.

TITLE IV

STATE TESTING

(1) For the purposes of this Act, state testing shall mean the activities by which the Office carries out state administration in the field of conformity assessment in the marketing of products in accordance with the common framework of the European Union by

(a) assess the competence of conformity assessment bodies for the purpose of notifying them to the European Commission and other Member States of the European Union,
(b) object to notifications made by other Member States of the European Union,
(c) for notified bodies, decide on changes to their notification; and
(d) carry out inspections of notified bodies.

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

Notification and control of notified bodies

(1) A notified body may only be a legal person established in the Czech Republic, which meets the requirements set out in Section 23 and can be expected to meet these requirements on a permanent basis, and which provides guarantees of compliance with the obligations relating to the activities of notified bodies and the proper performance of these activities.

(2) Conformity assessment bodies shall be notified to the European Commission and to the other Member States of the European Union by the Authority, which is the notifying authority within the meaning of the harmonisation rules of the European Union and the relevant European Union regulations. The Authority shall also notify the European Commission and the other Member States of the European Union of significant changes concerning the notification. For these purposes, it shall use the electronic notification tool managed by the European Commission.

(3) The Authority shall also inform the European Commission of the procedures it uses for the assessment and notification of conformity assessment bodies and for the control of bodies notified by it, and of changes to those procedures.

(1) The notification procedure shall be 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 the general particulars under the Administrative Procedure Code, contain a description of the conformity assessment activities relating to the Government Regulation under this Act or to the relevant European Union Regulation, together with an indication of the conformity assessment procedures or modules and the products assessed.

(1) When assessing the application in terms of the professional competence of the conformity assessment body for the purposes of notification, the Office shall use the certificate of accreditation issued by the accreditation body7), if it was attached to the application. If the applicant does not submit a certificate of accreditation, or if the certificate of accreditation does not sufficiently document compliance with all the requirements pursuant to Section 23, the applicant shall provide the Authority with all documents required by the Authority necessary for the assessment, recognition and periodic monitoring of compliance with those requirements.

(2) The Office shall decide on the notification procedure within 90 days from the date of receipt of the request. Where the applicant proves his/her competence by means other than the accreditation certificate, this period shall be extended by 30 days.

(3) If the conformity assessment body meets the requirements and prerequisites pursuant to Section 17(1), the Office shall carry out the notification pursuant to Section 17(2), otherwise it shall reject the application.

(4) The notification shall contain full details of the conformity assessment activities, the conformity assessment module and the product concerned, and information on the competence of the conformity assessment body in relation to the relevant harmonisation regulation of the European Union or the relevant regulation of the European Union that applies to the product concerned.

(5) The Office shall notify the applicant of the notification and shall inform him that information on the date of commencement of the notified body's authorisation to operate may be obtained from the European Commission's information system on notified bodies, and shall suspend the proceedings by a resolution noted in the file.

(1) Authorisation to carry out the activities of a notified body shall vest in the conformity assessment body if neither the European Commission nor any Member State of the European Union objects to the notification within 2 weeks of the notification being made available if accreditation has been used, or within 2 months of the notification being made available if accreditation has not been used.

(2) If neither the European Commission nor any Member State of the European Union objects to the notification pursuant to paragraph 1, the Authority shall note this fact in the file and inform the notified body thereof. At the same time, without undue delay, it shall publish in the Bulletin of the Authority a notice of the authorisation to carry out the activities of the notified body, including the scope of that authorisation, the date from which the body is authorised to carry out the activities of the notified body and the identification number of the notified body. Upon request, the Office shall issue to the notified body, in an agreed manner, a confirmation of the origin or duration of the authorisation for conformity assessment activities. Such a certificate may be requested in advance with the request for notification or during the procedure. The notified body shall be considered as having been granted the authorisation.

(3) If the European Commission or a Member State of the European Union objects to the notification pursuant to paragraph (1), the Office shall invite the applicant to take measures to remedy the deficiencies and shall give it a reasonable period of time to do so. If the applicant remedies the deficiencies within the time limit, it shall communicate that fact to the Office without undue delay. If the Authority concludes that the applicant has remedied the deficiencies, it shall re-notify the applicant in accordance with Section 17(2). If the applicant fails to remedy the deficiencies within the specified period, the Office shall reject the application.

(1) The Authority shall check whether the entities notified by it comply with the provisions of this Act and whether they proceed in accordance with the Government Regulation or the relevant European Union Regulation. The notified body shall, upon request, provide the Office with evidence of the correctness of its conclusions adopted in the conformity assessment and, for this purpose, shall provide without undue delay and to the extent required, in particular the documentation on the basis of which these conclusions were adopted. In the course of the inspection, the Authority shall also be entitled to ascertain the facts relating to conformity assessment activities carried out by other bodies to which the notified body entrusts specific conformity assessment tasks (hereinafter referred to as 'subcontractor').

(2) If the Office finds that the notified body no longer meets the requirements under Section 23, it shall decide, taking into account the seriousness of the consequences of non-compliance, to suspend, restrict or revoke the authorisation to carry out the activities of the notified body. The Authority shall immediately inform the European Commission and the other Member States of the European Union of these decisions.

(3) In the case of non-compliance with the requirements referred to in Section 23, where the Authority considers that the non-compliance does not have a direct consequence on the proper performance of the notified body's activities, the Authority shall decide on the suspension of the authorisation to carry out the activities of the notified body and shall set a deadline for correction. If the notified body informs the Authority of the remedy and the Authority finds the remedy sufficient, it shall revoke the decision to suspend the notified body's authorisation to carry out the activities of the notified body. If the notified body fails to remedy the situation within the time limit, the Authority shall decide to restrict or withdraw the authorisation to carry out the activities of the notified body.

(4) If the Authority finds a breach of an obligation under Sections 24 to 26 which it considers to be minor and does not indicate a failure to comply with the requirements under Section 23, it shall request the notified body to take remedial action within a specified time limit. If the Authority does not consider such action to be sufficient, it shall impose the adoption of corrective measures within the time limit by a decision which shall be the first act in the procedure for the suspension, restriction or revocation of the notified body's authorisation to carry out its activities.

(5) The Office shall also decide on the suspension, limitation or revocation of the authorisation to carry out the activities of a notified body if the notified body so requests. In this case, the conditions pursuant to Section 22(4) shall be fulfilled as a condition for the Authority's decision.

(1) A legal person whose valid authorisation to carry out the activities of a notified body has been restricted or revoked pursuant to a final decision of the Authority shall

(a) inform all affected economic operators of the Authority's decision without undue delay,
(b) at the request of the economic operator affected by the consequences of the change in the validity of the notification, transfer the rights and obligations related to the conformity assessment, including the subsequent verification of the fulfilment of the requirements under which the certificate or other document attesting to the established facts (hereinafter referred to as "certificate") was issued, to the notified body with which the economic operator has concluded a contract pursuant to § 24(1), transfer the related documentation to it, and inform the Authority of the transfer of rights and obligations, including the transfer of documentation,
(c) ensure that the relevant documentation relating to the notified body's activities is made available to the Authority or the supervisory authority on request for the period of time specified by the Authority in the decision to restrict or withdraw the notified body's authorisation to carry out its activities.

(2) Certificates and documents relating to conformity assessment, erroneously issued by a notified body before the restriction or revocation of the authorisation to carry out the activities of the notified body, and not revoked by it, shall be revoked by the notified body which has assumed the rights and obligations under paragraph (1)(b), or by the supervisory authority if their erroneous issue is found during market surveillance.

(3) A notified body which has taken over the rights and obligations referred to in paragraph (1)(b) shall be entitled to use the documentation from the transferring notified body to complete the pending conformity assessment cases or to verify subsequently the fulfilment of the conditions under which the certificate was issued.

(4) Where a notified body intends to terminate or restrict its activities without breaching its obligations arising from the requirements of Section 23, it shall, before the Authority decides to restrict or withdraw the authorisation to carry out the activities of a notified body, transfer the rights and obligations to another notified body; paragraph (1)(b) shall apply mutatis mutandis.

(5) If a legal person which is a notified body is to be dissolved, it shall, before dissolution, be obliged to submit the relevant documentation concerning the activities of the notified body to the Office.

Notified entities

(1) The requirements for a notified body are:

(a) the conformity assessment body shall be independent of the economic operator whose product it assesses and of that product; it may also be a conformity assessment body belonging to an economic association or a trade association of persons involved in the design, manufacture, supply, assembly, use or maintenance of the products which it assesses, provided that it demonstrates its independence and the absence of any conflict of interest, unless this is excluded by a Government Regulation,
(b) the conformity assessment body, its management and the persons involved in carrying out the conformity assessment tasks (hereinafter referred to as 'personnel') shall not design, manufacture, supply, install, purchase, own, use or maintain the products they assess; they shall not be directly involved in the design, manufacture or construction, placing on the market, installation, use or maintenance of those products; nor shall they represent persons engaged in those activities. They shall not carry out any activity that could compromise their independent judgement and credibility in relation to the conformity assessment activities covered by the notification, including the provision of consultancy services; this shall not preclude the use of the products under assessment necessary for the conformity assessment body's activities, nor the use of such products for their own use,
(c) the conformity assessment body and its personnel shall carry out the conformity assessment to the highest level of professional integrity and required technical competence in the specific field and shall not be subject to any pressures and inducements, in particular financial, which might influence their judgement or the results of the conformity assessment activity,
(d) the conformity assessment body shall be able to carry out all the conformity assessment activities required of the notified body by the relevant Government Regulations under this Act or the relevant European Union Regulation, whether carried out by the notified body itself or on its behalf and under its responsibility,
(e) the conformity assessment body shall have in place for each conformity assessment procedure and for each type or category of products covered by the notification the necessary:
personnel with the expertise and experience needed to perform tasks related to conformity assessment,
descriptions of the procedures under which conformity assessment is carried out and which ensure the transparency of those procedures and the possibility of re-initiating them; they shall apply appropriate rules and procedures to distinguish between the tasks carried out by the notified body and other activities,
procedures for carrying out activities which take due account of the size, sector, structure of enterprises, the degree of complexity of the product technology and the mass or serial production of the product,
(f) the conformity assessment body shall have the necessary means to carry out the technical and administrative tasks associated with the conformity assessment and shall have access to any necessary equipment or facilities,

(g) personnel involved in conformity assessment shall
have technical and professional training in all the conformity assessment activities covered by the notification,
have knowledge of the requirements related to the assessments they carry out and the appropriate authorisation to carry out those assessments,
Have knowledge and understanding of the relevant basic technical requirements, harmonised standards, provisions of European Union harmonisation regulations, government regulations or relevant European Union regulations,
be able to produce certificates, reports and reports demonstrating that assessments have been carried out,

(h) the conformity assessment body shall ensure that the activities of its subcontractors do not compromise the confidentiality, objectivity and impartiality of its conformity assessment activities,
(i) the conformity assessment body shall ensure that the remuneration of management and staff is not dependent on the number of assessments carried out or the results thereof,
(j) the conformity assessment body shall have insurance against liability for damage caused by the activities of the notified body, with a limit of indemnity appropriate to the scope of those activities,
(k) a conformity assessment body shall ensure that its personnel are bound to maintain confidentiality in respect of any information they obtain in the performance of their duties under this Act or under the relevant European Union Regulation.

(2) Where a conformity assessment body can demonstrate that it complies with the criteria set out in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements for notified bodies to the extent that the harmonised standards refer to those requirements.

(3) The requirements for notified bodies referred to in paragraphs 1 and 2 in terms of technical means and staffing may be specified in Government Regulations.

(1) Notified bodies shall carry out conformity assessment activities in accordance with the conformity assessment procedures laid down in Government Regulations or in the relevant European Union Regulations. In doing so, they shall act on their own behalf and under their own responsibility on the basis of a contract 8), the subject matter of which is conformity assessment activities or control of the fulfilment of the conditions under which the certificate was issued. The essential elements of the contract shall also include the specification of the rights and obligations arising from paragraphs 2 to 5.

(2) Conformity assessment shall be carried out in such a way as to avoid a disproportionate burden on economic operators. Notified bodies shall, in carrying out their activities, take into account the size and structure of the economic operator concerned, the sector in which it operates, the degree of complexity of the product technology concerned and the mass or serial nature of the production process. They shall maintain a level of rigour and protection such that the product complies with the requirements laid down or with the requirements of the relevant European Union Regulation.

(3) Where a notified body finds that a manufacturer does not comply with the essential technical requirements set out in a Government Regulation, in the relevant European Union Regulation, in the relevant harmonised standards or in a document prescribing the technical requirements to be met by a product, process or service in order to demonstrate the conformity of that product, it shall require the manufacturer to take corrective measures and shall not issue a certificate.

(4) Where, in the course of verifying compliance with the conditions under which the certificate was issued, the notified body finds that the product no longer meets the requirements applied when the certificate was issued, it shall require the manufacturer to take corrective measures and may, depending on the nature and seriousness of the non-compliance, restrict or suspend the validity of the certificates in question or withdraw the certificate.

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

(6) At the request of the manufacturer, the notified body shall be obliged to disclose the amount of the limit of the insurance claim under the insurance against liability for damage caused by the notified body's activities.

(1) Where a notified body subcontracts specific tasks to a subcontractor, it shall ensure that the subcontractor complies with the requirements corresponding to the requirements for notified bodies and shall inform the Authority thereof.

(2) The notified body shall be fully responsible for the tasks carried out by subcontractors wherever they are established.

(3) Tasks may be subcontracted only with the consent of the person who has requested the notified body to carry out the conformity assessment activities.

(4) The notified body shall keep and make available to the Authority on request the relevant documents relating to the assessment of the qualifications of the subcontractor and the activities carried out by the subcontractor.

(1) The notified body shall inform the Authority

(a) all cases where the issue of a certificate has been refused and certificates issued, suspended or withdrawn by him,
(b) any circumstances affecting the scope and terms of the notification,
(c) all requests for information on conformity assessment activities carried out received from market surveillance authorities,
(d) on request, the conformity assessment activities carried out within the scope of their notification and any other activities carried out.

(2) The Government may by regulation determine a different scope of information provision according to the nature of the product.

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

(4) A notified body shall participate in, or ensure that its employees are informed of, standardisation activities related to the scope of its notification and the activities of the coordination groups of notified bodies set up under European Union harmonisation rules or under the relevant European Union regulations, and shall comply with the decisions and documents resulting from the work of that group.

PART TWO

SPECIAL PROVISIONS FOR CERTAIN PRODUCTS

TITLE I

SPECIAL PROVISIONS FOR PRODUCTS COVERED BY THE RELEVANT EUROPEAN UNION REGULATIONS

Section 1

Personal protective equipment

(1) Where a directly applicable European Union regulation in the field of personal protective equipment refers to¹¹⁾ to the competent national authority, this authority is the supervisory authority in the Czech Republic.

(2) Where a directly applicable regulation of the European Union in the field of personal protective equipment refers to a language designated or required by a Member State, that language in the Czech Republic shall be the Czech language.

Section 2

Gas appliances

(1) Where directly applicable European Union legislation in the field of gaseous fuel appliances refers to¹²⁾ to the competent national authority, this authority is the supervisory authority in the Czech Republic.

(2) Where a directly applicable regulation of the European Union in the field of gaseous fuel appliances refers to a language designated or required by a Member State, that language in the Czech Republic shall be the Czech language.

Section 3

Ropeways

(1) Where a directly applicable regulation of the European Union in the field of cableways refers to¹³⁾ to the competent national authority, this authority is the supervisory authority in the Czech Republic.

(2) If a directly applicable regulation of the European Union in the field of cableways refers to a language designated or required by a Member State, this language in the Czech Republic is the Czech language.

Section 4

Medical devices

(1) The Office is the authority responsible in the Czech Republic for notified bodies under directly applicable European Union legislation in the field of medical devices¹⁴⁾.

(2) Where a directly applicable regulation of the European Union in the field of medical devices refers to a language designated or required by a Member State for documents submitted to the authority under paragraph 1 for the purpose of appointing conformity assessment bodies, that language shall be the Czech language in the Czech Republic.

(3) In the notification procedure, the time limit referred to in section 19(2) shall be extended by the time limits laid down in the directly applicable European Union regulation in the field of medical devices¹⁵⁾.

Section 5

In vitro diagnostic medical devices

(1) The Office is the authority responsible in the Czech Republic for notified bodies under directly applicable European Union legislation in the field of in vitro diagnostic medical devices¹⁶⁾.

(2) Where a directly applicable regulation of the European Union in the field of in vitro diagnostic medical devices refers to a language designated or required by a Member State for documents submitted to the authority under paragraph 1 for the purpose of appointing conformity assessment bodies, that language shall be the Czech language in the Czech Republic.

(3) In notification proceedings, the time limit referred to in section 19(2) shall be extended by the time limits laid down in the directly applicable European Union regulation in the field of in vitro diagnostic medical devices¹⁷⁾.

Section 6

EU fertiliser products

(1) The Authority is the authority responsible in the Czech Republic for notified bodies within the meaning of directly applicable European Union legislation in the field of EU fertiliser products.¹⁸⁾.

(2) Where a directly applicable European Union regulation in the field of EU fertiliser products refers to a language designated or required by a Member State, that language in the Czech Republic shall be the Czech language.

Section 7

Unmanned systems

(1) Where a directly applicable regulation of the European Union governing unmanned systems refers to¹⁹⁾to a national authority, this authority is the supervisory authority in the Czech Republic.

(2) Where a directly applicable regulation of the European Union governing unmanned systems refers to a language designated or required by a Member State, that language in the Czech Republic shall be the Czech language.

TITLE II

SPECIAL PROVISIONS FOR CERTAIN OTHER PRODUCTS

Section 1

Lifts and safety components for lifts

For the purposes of conformity assessment of lifts and safety components for lifts, the following shall mean

(a) a lifting device serving different levels with the supporting part moving between guides which are fixed and deflected from the horizontal at an angle greater than 15°, or lifting devices with a defined path of movement even if they do not move between fixed guides,
(b) the supplier is the person responsible for the design, manufacture, installation and placing on the market of the lift,
(c) supplying on the market the supply of a safety component for lifts for distribution or use on the European Union market in the course of a commercial activity, whether in return for payment or free of charge,
(d) placing on the market
the first delivery of a safety component for lifts to the market, or
the supply of a lift for use on the European Union market in the course of a commercial activity, whether in return for payment or free of charge,
(e) a manufacturer is a person who manufactures a safety component for lifts or has a safety component for lifts designed or manufactured and markets that component under his name or trademark,
(f) an authorised representative, a person established in the European Union who has been authorised in writing by the supplier or manufacturer to act on his behalf in the performance of specific tasks,
(g) the importer is a person established in the European Union who places on the market of the European Union a safety component for lifts from a third country,
(h) the distributor is a person in the supply chain, other than the manufacturer or importer, who supplies a safety component for lifts to the market,
(i) economic operators supplier, manufacturer, authorised representative, importer and distributor,
(j) withdrawal and recall, in relation to a lift, any measure aimed at the dismantling and safe disposal of the lift and, in relation to a safety component for lifts, any measure aimed at the return of a safety component for lifts which has already been made available to the supplier or end user,
(k) withdrawal from the market of a measure aimed at preventing a safety component for lifts already in the distribution chain from being made available on the market.

(1) When placing a lift on the market, the supplier shall

(a) ensure that the lift is designed, manufactured, installed and tested in accordance with the essential health and safety technical requirements,
(b) draw up the technical documentation and carry out or have carried out the relevant conformity assessment procedure,
(c) where compliance of the lift with the relevant essential health and safety requirements has been demonstrated by such a procedure, draw up an EU declaration of conformity, ensure that it is affixed to the lift and affix the CE marking,
(d) keep the technical documentation and the EU declaration of conformity and, where applicable, the approval decision for 10 years after the lift has been placed on the market,
(e) where appropriate in view of the risks posed by the lift, carry out investigations to protect the health and safety of consumers and, where necessary, keep a register of complaints and non-compliant lifts,
(f) ensure that the lift bears a type or batch number or serial number or other element enabling it to be identified,
(g) indicate on the lift his name or registered trade mark and a delivery address at which he can be contacted; the address must contain a single point at which the supplier can be contacted; the contact details shall be given in the Czech language,

(h) ensure that the lift is accompanied by instructions in the Czech language; these instructions and any other markings shall be clear and comprehensible.

(2) A supplier who considers or has reason to believe that a lift which he has placed on the market is not in conformity with the technical requirements laid down in a Government Regulation shall immediately take the corrective measures necessary to bring that lift into conformity. Furthermore, where the lift presents a risk, the supplier shall immediately inform the supervisory authority or the competent authority of another Member State of the European Union in which he has placed the lift on the market to that effect, giving details, in particular, of the non-compliance and of the corrective measures taken.

(3) The Supplier is entitled to appoint an authorised representative.

(4) The supplier shall provide the supervisory authority or the competent authority of another Member State of the European Union, upon its reasoned request, with all information and documentation in paper or electronic form necessary to demonstrate the conformity of the lift with the technical requirements set out in the Government Regulation, in the Czech language.

(5) The supplier shall cooperate with the authority referred to in paragraph 4, at its request, in activities aimed at eliminating risks caused by lifts which it has placed on the market.

(6) The notified body's identification number, affixed to the CE marking referred to in Section 15(3), may also be affixed to the lift by the supplier or his authorised representative, as instructed by the notified body.

Builder ⁹⁾ and the supplier shall provide each other with the necessary information and take appropriate steps to ensure the proper operation and safe use of the lift.

Section 2

Fixed installations in terms of electromagnetic compatibility

For the purposes of assessing the conformity of fixed installations with regard to electromagnetic compatibility, the following shall mean

(a) apparatus, a complete apparatus or assembly of apparatus supplied on the market as a single functional unit intended for the end user, which may be a source of electromagnetic interference or the operation of which may be affected by electromagnetic interference,
(b) a fixed installation, a specific assembly of several types of apparatus or devices which are assembled, installed and intended for permanent use at a predetermined location.

(1) In the event that a fixed installation shows signs of non-compliance with the essential requirements set out in the Government Regulation, the fixed installation operator or a person authorised by him shall ensure that the fixed installation is assessed for compliance in accordance with those requirements of the Government Regulation.

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

Section 3

Recreational boats and jet skis

For the purposes of assessing the conformity of recreational craft and jet skis, the following shall mean

(a) recreational craft a craft of any type intended for sporting or recreational purposes with a hull length of between 2,5 m and 24 m, irrespective of the type of propulsion, excluding jet skis,
(b) a watercraft of less than 4 m in length, using as its main source of propulsion an internal combustion engine with a hydro-reactive propulsion system and designed to be steered by a person or persons sitting, standing or kneeling on the hull rather than inside it,
(c) propulsion engine a diesel or petrol internal combustion engine used directly or indirectly for propulsion purposes,
(d) a major modification to the propulsion engine which increases the rated engine power by more than 15% or which may result in the specified emission limit values being exceeded,
(e) a major modification of a vessel which involves a change in the type of propulsion of the vessel, a major modification of the propulsion engine of the vessel or which may compromise compliance with the specified requirements,
(f) the first use of the product by the end user in a Member State of the European Union,
(g) a private importer is a person established in the European Union who, for his own use and in the course of his non-commercial activities, imports a product from a third country into a Member State of the European Union.

(1) A product may be put into service if it meets the specified requirements, has been assessed for conformity and is maintained and used in a manner that does not jeopardise its compliance with the specified requirements, provided that it is

(a) a recreational craft or watercraft (hereinafter referred to as "craft"),
(b) part of a vessel; and
c) the drive motor.

(2) A product which is a vessel or propulsion engine and on which a major modification has been carried out may be placed on the market or put into service after such modification has been carried out if it has been reassessed for conformity. The person who places the product on the market or into service after the modification has been carried out shall ensure that the relevant conformity assessment procedure laid down in the Government Regulation is carried out.

(3) In the case of a vessel which becomes a product designated by a Government Regulation for conformity assessment by changing its intended use or by being placed on the market before the expiry of the period specified in the Government Regulation, the person placing the product on the market or in service shall ensure that the relevant conformity assessment procedure specified in the Government Regulation is carried out.

(4) In the case of a product which is a vessel, a component thereof or a propulsion engine, which is put into service by a private importer and for which conformity has not been assessed by the manufacturer, the private importer shall ensure that the relevant conformity assessment procedure set out in the Government Regulation is carried out.

(5) The persons referred to in paragraphs 2 to 4 shall affix the CE marking to the product before it is placed on the market or put into service. The notified body which has carried out the conformity assessment shall affix its identification number to the CE marking or, where instructed by it, the person referred to in paragraphs 2 to 4.

(1) In the case of a product which is a vessel, a part thereof or a propulsion engine, the private importer shall, before putting into service

(a) ensure compliance with the requirements referred to in the first sentence of Section 6(1), the third sentence of Section 6(2) and (3) and Section 6(6) where the manufacturer has not complied with them,
(b) ensure that the name and address of the registered office of the notified body that carried out the conformity assessment are indicated on the product; and
c) draw up an EU declaration of conformity in the Czech language.

(2) A private importer shall, for a period of time specified in the Government Regulation, identify the economic operator who has supplied him with the product at the request of the competent supervisory authorities.

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

(2) The procedure of the notified body pursuant to Section 24(2) and (3) shall apply mutatis mutandis to a private importer where conformity is assessed pursuant to Section 34(4).

(1) A partially completed vessel may be placed on the market if

(a) its manufacturer or importer has attached to the partially completed vessel a declaration that it is intended to be completed by another manufacturer; and
(b) meets the essential requirements to the extent appropriate to its stage of completion.

(2) The declaration referred to in paragraph 1(a) shall be drawn up in the Czech language and in the official languages of the Member States of the European Union in which the partially completed vessel is placed on the market. The particulars of the declaration shall be laid down by Government Regulation.

Section 4

Boat equipment

For the purposes of assessing the conformity of marine equipment, a ship means a self-propelled seagoing vessel intended for sea navigation for the purpose of carrying cargo or passengers or for the carriage of cargo and passengers flying the flag of the Czech Republic or of another Member State of the European Union.

(1) A product which is marine equipment may be placed on a ship if it complies with the specified requirements in force on the date of its placement and has been assessed for conformity. If the product complies with those requirements, the public authorities shall not prevent it from being placed on a ship.

(2) A manufacturer who is not established in the European Union shall appoint an authorised representative by written mandate. The mandate of the authorised representative shall include an address at which he may be contacted.

(3) For the purposes of this Act, an importer or distributor shall also be deemed to be a manufacturer if he places on board a ship a product which is marine equipment.

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

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

(1) Instead of the CE marking, a conformity marking shall be used for marine equipment, the graphic form of which shall be determined by Government Regulation.

(2) The provisions of Section 15 (2) to (4) shall apply mutatis mutandis to the mark of conformity.

(3) The mark of conformity may be replaced or supplemented by an electronic identifier if the conditions of European Union legislation are met.

(1) For notified bodies authorised to carry out conformity assessment of marine equipment, the Authority shall carry out an inspection pursuant to Section 21 at least every 2 years.

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

Section 5

Pressure equipment

For the purposes of conformity assessment of pressure equipment, the following shall mean

(a) an assembly of several pressure equipment assembled by the manufacturer so as to constitute a complete functional unit,
(b) the first use of the pressure equipment or assembly by its user.'.

(1) Pressure equipment or assemblies may be placed on the market and put into service by users if their conformity with the essential requirements laid down in the Government Regulation has been assessed by a user testing laboratory notified in accordance with Section 45(2).

(2) Pressure equipment and assemblies the conformity of which has been assessed by the user's testing laboratory shall not bear the CE marking.

(3) Pressure equipment or assemblies referred to in paragraph (1) may be used only in commercial establishments controlled by a commercial corporation which applies a uniform safety concept as regards the technical requirements for the design, manufacture, inspection, maintenance and use of pressure equipment and assemblies and of which the user's test facility is a part.

(4) The user's testing room shall work exclusively for a group of business plants that are part of the same business corporation.

(5) The user's testing facility shall be organizationally identifiable and shall use methods of communicating information within the group of commercial establishments of which it is a part that ensure and demonstrate the impartiality of its assessment.

(6) The procedures applicable to the assessment of conformity by a user tester are Modules A2, C2, F and G set out in Annex 1 to this Act.

(1) Where reference is made to notified bodies in Part One of Title IV and Part Four, for the purposes of the Government Regulation relating to the supply of pressure equipment to the market this also includes recognised independent organisations and user testing institutes.

(2) Sections 16 to 26 shall apply mutatis mutandis to the notification of recognised independent organisations and user testing laboratories, with the exception of Section 23(1)(a) of the part of the sentence after the semicolon, which shall not apply to user testing laboratories.

(3) The notification referred to in section 17(2) in respect of a user testing laboratory shall, in addition to the information referred to in section 19(4), also include a list of commercial establishments complying with the provisions of section 44(3).

The Authority may, upon reasoned application, authorise the placing on the market or putting into service of a pressure equipment or assembly for which conformity has not been assessed, if the pressure equipment or assembly is intended for experimental purposes.

Section 6

Radio equipment

For the purposes of conformity assessment of radio equipment, the following shall mean

(a) radio equipment, an electrical or electronic product that intentionally transmits or receives radio waves for the purpose of radio communication or radio direction finding, or an electrical or electronic product that needs to be equipped with accessories, such as an antenna, in order to intentionally transmit or receive radio waves for the purpose of radio communication or radio direction finding,
b) radio communication communication by means of radio waves,
(c) radio waves, electromagnetic waves of a frequency below 3 000 GHz propagating through space without artificial conduction,
(d) radio-determination, the determination of the position, speed of movement or other properties of a volume, or the acquisition of information about these parameters by means of the propagation properties of radio waves,
(e) the first use of the radio equipment by the end user.

(1) The manufacturer of the radio equipment and software which enables the radio equipment to be used for its intended purpose shall provide information to the Member States and the European Commission on the compliance of the intended combinations of radio equipment and software with the essential requirements. This information shall be based on a conformity assessment carried out in accordance with the procedure laid down in the Government Regulation and shall be given in the form of a declaration of conformity. Depending on the specific combinations of radio equipment and software, this information shall indicate precisely which radio equipment and software have been assessed and shall be kept up to date.

(2) A manufacturer shall register a type of radio equipment belonging to a category which includes equipment which does not comply to a significant extent with the essential requirements in a central system made available by the European Commission before placing radio equipment of that category on the market. When registering these types of radio equipment, the manufacturer shall provide certain parts of the technical documentation provided for in the Government Regulation or, where justified, the entire documentation. The manufacturer shall affix to the radio equipment placed on the market a registration number which the European Commission shall assign to each type of radio equipment registered.

Interoperability of automotive radio equipment and digital television equipment

(1) All digital television equipment intended for consumers shall

(a) enable signals to be decoded according to a common European coding algorithm administered by a recognised European standardisation organisation,
b) reproduce signals that have been freely transmitted.

(2) Every digital television equipment with an integrated screen with a visible diagonal of more than 30 cm shall be equipped with at least one open-interface socket which allows easy connection of peripheral devices and can transmit all relevant elements of the digital television signal, including information relating to interactive and conditional access services.

(3) Any automotive radio equipment incorporated in a new category M vehicle shall be capable of receiving and reproducing radio services provided by means of both analogue terrestrial radio broadcasting and digital terrestrial radio broadcasting.

Section 7

Gauges

For the purposes of conformity assessment of measuring instruments, putting into service means the first use of a measuring instrument intended for the end user for the purposes for which it was intended.

(1) The importer shall ensure that the manufacturer also carries out the actions set out in Section 8(2)(a) before putting the measuring instrument into operation.

(2) In the case of the procedure referred to in the first sentence of Section 8(3), the importer may not even put the meter into operation.

(3) In the procedure referred to in Section 9(1), the distributor shall act with due care also in respect of meters put into service by him. The distributor shall also be obliged to verify that the meter complies with the requirements referred to in Section 9(2) before it is put into service.

(4) In the procedure referred to in the first sentence of Section 9(3), the distributor may not even put the meter into operation.

(5) In the procedure referred to in Section 9(4), the distributor's obligation shall also apply to meters which he has put into operation.

Section 8

Non-automatic weighing instruments

The Ministry shall establish by decree the zones of gravitational acceleration in the territory of the Czech Republic for the purpose of conformity assessment of scales with non-automatic operation.

Section 9

Equipment and protective systems intended for use in potentially explosive atmospheres

The Authority may, where it is in the interest of safety, authorise, on reasoned request, the placing on the market or putting into service without conformity assessment

(a) equipment or protective system intended for use in an explosive atmosphere; or
(b) safety, control and regulation equipment which is intended for use outside a potentially explosive atmosphere but is necessary for or contributes to the safe functioning of the products referred to in point (a).

PART THREE

MARKET SURVEILLANCE

Surveillance

(1) Supervision of whether products are supplied to the market, put into service or used by the manufacturer for his own use in accordance with the requirements laid down or with the requirements of the relevant European Union regulation, whether economic operators fulfil their obligations laid down by this Act and whether products are not unlawfully marked with the CE marking or other marking provided for under this Act or under the relevant European Union regulation shall be carried out by the supervisory authority, which is the Czech Trade Inspection Authority, or by another administrative authority if another law so provides.

(2) The supervisory authorities may

(a) carry out analyses or arrange for analyses to be carried out to verify whether products comply with the specified requirements or the requirements of the relevant European Union Regulation; such analyses shall be carried out by the competent authorities or persons; where the analysis has established that the product does not comply with the specified requirements or the requirements of the relevant European Union Regulation, the costs of carrying out the analysis shall be borne by the economic operator concerned,
(b) impose corrective measures on the economic operator to remedy the identified deficiencies, their causes and harmful consequences within a specified period of time or to take the necessary corrective measures to remedy them without undue delay,
(c) impose corrective measures on the economic operator to inform without delay persons who might be exposed to the risk arising from the product.

(3) Where the supervisory authority has reasonable doubt that a product does not comply with the requirements laid down or with the requirements of the relevant European Union Regulation, it may request from the notified body information and documents relating to the conformity assessment of that product, including certificates, technical documentation and test reports. In addition, the supervisory authority may initiate a review of the certificate by the notified body. Where the supervisory authority finds that the product does not comply with the requirements laid down or with the requirements of the relevant European Union Regulation, it shall inform the notified body which issued the certificate to that effect; it may also require the notified body to withdraw the certificate from the economic operator.

Protective measures

(1) Where the supervisory authority has reasonable grounds to suspect that a product does not comply with the specified requirements or the requirements of the relevant European Union Regulation, it shall prohibit the placing on the market, putting into service or use of the product by the manufacturer for its own use for the period necessary to make the necessary findings, if justified by the nature of the risk.

(2) The supervisory authority shall verbally notify the economic operator of the imposition of the measure referred to in paragraph (1) and shall make a written record thereof without undue delay. If the economic operator disagrees with the measure imposed, he may lodge objections to it, which shall be stated in the record, or he may lodge them in writing no later than 10 days from the date on which he was informed of the record. The supervisory authority shall decide on the objections lodged without delay. A written copy of the decision on the objections shall be delivered to the economic operator concerned. No appeal shall be admissible against the decision on objections.

(3) If the supervisory authority finds that the product presents a risk or that the identified deficiencies have not been corrected within the time limit referred to in Section 49(2)(b), it shall decide to prohibit the supply of the product on the market, the placing of the product into service or the use of the product by the manufacturer for his own use, or, where appropriate, to withdraw the product from the market or from circulation. If the grounds for imposing the prohibition no longer exist, the supervisory authority shall decide to amend or revoke it. An appeal against a decision under the first sentence shall not have suspensive effect.

(4) The supervisory authority shall also decide to prohibit the placing on the market, putting into service or use of the product by the manufacturer for his own use, or to withdraw the product from the market or from circulation, if the relevant economic operator fails to remedy deficiencies in response to a request from the supervisory authority under section 49(2)(b), consisting of

(a) the CE marking or other prescribed marking has been affixed in contravention of the provisions of this Act,
(b) the CE marking or other prescribed marking has not been affixed,
(c) the declaration of conformity has not been drawn up in accordance with a government regulation; or
(d) the technical documentation is not available or is incomplete.

(5) Formal deficiencies, the non-removal of which allows the supervisory authority to take a decision pursuant to paragraph 4, may be specified in more detail in a Government Decree. An appeal against a decision under paragraph 4 shall not have suspensive effect.

Products presenting a risk despite compliance with the requirements

(1) Where the supervisory authority, after carrying out the analyses referred to in section 49(2)(a) or after the investigations referred to in section 50(1), finds that a product which complies with the requirements laid down or with the requirements of the relevant European Union Regulation nevertheless presents a risk, it shall require the relevant economic operator to take all appropriate measures and to ensure, within a period of time proportionate to the nature of the risk, that the product concerned, if placed on the market, no longer presents that risk or to withdraw the product from the market or from circulation. An appeal against that decision shall not have suspensive effect.

(2) The economic operator shall ensure that all corrective measures are taken for all the products concerned which he has made available on the market in all Member States of the European Union.

(3) The economic operator shall inform the supervisory authority of the corrective measures without undue delay.

Notification obligation

(1) The supervisory authorities are obliged to notify the Ministry of Industry and Trade (hereinafter referred to as "the Ministry") of the adoption of measures concerning a product or a series of products in cases where the product presents a risk. This shall also apply in the case of a measure taken by the economic operator concerned on its own initiative and the supervisory authority receives information about this measure.

(2) The information provided to the Ministry shall include all available details, in particular the data necessary to identify the product, its origin, the supply chain, the risk posed by the product, the nature and duration of the measure taken by the supervisory authority and, where appropriate, information on voluntary action taken by the economic operator concerned.

(3) If the risk exceeds the territory of the Czech Republic, the Ministry shall immediately inform the European Commission and other Member States of the occurrence of such a product.

(4) If the Ministry receives information from the European Commission on the adoption of measures in relation to a product posing a risk, it shall forward this information without undue delay to the supervisory authorities for further action.

(5) In order to ensure the functioning of the information exchange system referred to in paragraphs 1 to 3, other legislation regulating the procedures, content and form of information on the occurrence of dangerous non-food products10) shall apply mutatis mutandis.

PART FOUR

SUBSCRIPTIONS

Offences by natural persons

(1) A natural person commits an offence by

(a) uses without authorisation the CE marking, any other marking provided for under implementing legislation issued to implement this Act or a marking under a relevant European Union regulation, or
(b) forges or alters a certificate or other document issued pursuant to an implementing regulation issued to implement this Act or a relevant regulation of the European Union,
(c) as a builder, breaches the obligations under section 30.

(2) A fine of up to CZK 20,000,000 may be imposed for an offence under subsection (1).

Offences by legal entities and natural persons engaged in business

(1) A legal or natural person commits an offence by

(a) uses unlawfully the CE marking, another prescribed marking pursuant to an implementing legal regulation issued for the implementation of this Act or a marking pursuant to a relevant regulation of the European Union,
(b) forges or alters a certificate or other document issued pursuant to an implementing regulation issued to implement this Act or a relevant regulation of the European Union,
(c) carries out a conformity assessment activity reserved for the purposes of this Act to a notified body without an authorisation under section 20(1),
(d) fails to comply with any of the protective measures issued under section 50(1), (3) or (4); or
(e) fails to comply with any of the measures imposed under Section 49(2)(b) or (c).

(2) A notified body commits an offence by

(a) carries out the activities of a notified body without the relevant authorisation in contravention of Section 20(1),
(b) fails to comply with any of the obligations under section 22(1) or (4), section 24, section 25(1), (3) or (4) or section 26; or
(c) fails to fulfil any of the obligations of a notified body under a directly applicable European Union regulation referred to in Articles 27 to 27d.

(3) A legal or natural person who is an economic operator, or a person who is a manufacturer, importer, authorised representative or distributor under the relevant European Union Regulation, commits an offence by placing on the market, putting into service or using for his own use a product in breach of his obligations

(a) without the CE marking or any other marking provided for in the implementing legislation issued to implement this Act or without the document provided for in a government regulation or a relevant regulation of the European Union, or
(b) with the CE marking or other marking prescribed under the implementing legislation issued to implement this Act or with a document which contravenes Section 14 or Section 15 or the relevant European Union Regulation.

(4) A legal person or a natural person engaged in business commits an offence by

(a) the economic operator fails to comply with any of the obligations under Sections 6 to 9 and 11 or any of the obligations under Sections 29, 30, 32, 34, 35, 37, 39, 40, 41, 44, 47, 47a and 48; or
(b) a person who, under the relevant European Union Regulation, is the manufacturer, authorised representative, importer or distributor fails to fulfil any of the obligations arising from the relevant European Union Regulation.

(5) The offence is punishable by a fine not exceeding

(a) CZK 50 000 000 if the offence is an offence under paragraph 3 or paragraph 1(d) or (e),
(b) CZK 20 000 000 if the offence is an offence under paragraph 1(a), (b) or (c) or paragraph 2(a),
(c) CZK 1 000 000 if the offence is an offence under paragraph 2(b) or (c),
(d) CZK 500 000 if the offence is an offence under paragraph 4.

Common provisions on offences

(1) Offences under sections 53 and 54 shall be dealt with by the supervisory authority, except for offences under sections 54(1)(c) and 54(2), which shall be dealt with by the Office.

(2) Fines shall be collected by the authority which imposed them.

(3) The imposition of an administrative penalty may not be waived for offences under section 54(1)(d) and (e) and section 54(3).

PART FIVE

COMMON, TRANSITIONAL AND ENABLING PROVISIONS

Common provisions

The provisions of the Act that relate to relations with the Member States of the European Union also apply to relations with the States that make up the European Economic Area and the Swiss Confederation.

With the exception of Part One of Title IV, Parts Three and Four, notified entities are also those entities that have been notified to the European Commission and the Member States of the European Union by other Member States of the European Union, or entities that are considered as such on the basis of international agreements to which the Czech Republic is bound.

Enabling provisions

The Ministry shall issue a decree implementing § 48b.

Transitional provisions

Entities that have been notified to the European Commission and other Member States of the European Union pursuant to Section 11b of Act No. 22/1997 Coll., as in force before the date of entry into force of this Act, and are authorised to carry out the relevant activities pursuant to 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, shall be deemed to have been notified pursuant to this Act.

Notification proceedings commenced pursuant to Section 11b of Act No. 22/1997 Coll., as in force before the date of entry into force of this Act, and not completed by the date of entry into force of this Act, shall be completed pursuant to Act No. 22/1997 Coll., as in force before the date of entry into force of this Act.

PART SIX

EFFECTIVENESS

This Act shall enter into force on the fifteenth day after the date of its promulgation, except for the provisions of Section 47(2) which shall enter into force on 12 June 2018.

Hamáček v. r.

Zeman v. r.

Sobotka v. r.

Annex 1

Conformity assessment modules

Conformity assessment uses the following modules:

a) Module A: Internal production control,
(b) Module A1: Internal production control with supervised product testing,
(c) Module A2: Internal production control together with supervised product checks at random intervals,
(d) Module B: EU type-examination,
(e) Module C: Conformity to type based on internal production control,
(f) Module C1: Conformity to type based on internal production control together with supervised product testing,
(g) Module C2: Conformity to type based on internal production control together with supervised product checks at random intervals,
(h) Module D: Conformity to type based on quality assurance of the manufacturing process,
i) Module D1: Quality assurance of the production process,
(j) Module E: Conformity to type based on product quality assurance,
k) Module E1: Quality assurance of output inspection and product 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 product-by-product verification,
(o) Module H: Compliance based on full quality assurance,
(p) Module H1: Conformity based on full quality assurance together with design review.

Annex 2

The declaration of conformity shall contain the following information:

EU DECLARATION OF CONFORMITY

No. xxxxxx (unique product identification):

Name and address of the manufacturer or authorised representative:

This Declaration of Conformity is issued under the sole responsibility of the manufacturer

(or the person responsible for the installation):

Subject of the declaration (identification of the product to enable it to be traced back;

may possibly contain a photograph):

The subject matter of the declaration described above complies with the harmonisation legislation

European Union regulations: xxxxxxxx

References to the relevant harmonised standards used or specifications,

on the basis of which compliance is declared:

Alternatively: the notified body ... (name, number) ... carried out ... (description of the intervention) ...

and issued a certificate: ....

Further information:

Signed for, and on behalf of: ...................

(place and date of issue)

(name, position), (signature)

Note:

The information given here may be made more specific depending on the product under consideration

by government decree

Footnotes:

1) Decision No 768/2008/EC of the European Parliament and of the Council 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 placing 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 placing on the market of electrical equipment intended 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 Amendments and Additions to Certain Acts, as amended.

5) Article 2(1)(c) 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 to 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) § 2652 et seq. of Act No. 89/2012 Coll., the Civil Code.

9) Section 2(2)(c) of Act No. 183/2006 Coll., on spatial planning and building regulations (Building Act).

10) Government Regulation No. 396/2004 Coll., on the procedures, content and form of information on 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 Council Directive 89/686/EEC.

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

13) Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableways and repealing Directive 2000/9/EC.

14) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

15) Article 39 of Regulation (EU) 2017/745 of the European Parliament and of the Council.

16) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.

17) Article 35 of Regulation (EU) 2017/746 of the European Parliament and of the Council.

18) Regulation (EU) 2019/1009 of the European Parliament and of the Council laying down rules for the placing on the market of EU fertiliser products, amending Regulations (EC) No 1069/2009 and 1107/2009 and repealing Regulation (EC) No 2003/2003.