What is Act No. 90 / 2016 Coll.?

Act No. 90 / 2016 Coll., on conformity assessment of specified products when making them available on the market — Law on conformity assessment of specified products when making them available on the market.

When it became Act No. 90 / 2016 Coll. effectiveness?

Act No. 90 / 2016 Coll. became effective 15.04.2016.

Is Act No. 90 / 2016 Coll. still valid?

Yes, Act No. 90 / 2016 Coll. is still valid and effective.

How many times was it Act No. 90 / 2016 Coll. amended?

Act No. 90 / 2016 Coll. has 13 time versions of the text.

Act No. 90 / 2016 Coll. - Law on conformity assessment of specifie...

90

THE LAW

of 3 March 2016

on conformity assessment of specified products when making them available on the market

Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

SUPPORT OF MARKET PRODUCTS

HLAVA I

GENERAL PROVISIONS

§ 1

Subject matter

(1) This law implements the relevant European Union provisions on a common framework for the marketing of products (1) and regulates the procedure of the State authorities in protecting the market against products which could endanger life, health, property or the environment or other public interest.

(2) This Act implements the provisions of the European Union relating to the supply of products on the market (2), following the European Union Regulation on a common framework for the marketing of products on the market (1) and the products which are laid down by the Government Regulations in accordance with those provisions,

(a) guidelines for making products available on the market and, where appropriate, putting products into service;

(b) the method for determining the conformity assessment products and the technical requirements to be met by the products;

(c) the rights and obligations of persons who place on the market or make available on the market and, where appropriate, put into service products for which compliance with the requirements laid down in the legislation is to be assessed before placing on the market;

(d) conformity assessment of products;

(e) performance of public administration in the field of state testing and market surveillance;

(f) the rights and obligations of persons authorised to carry out activities under this Act which are related to the state testing;

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

(3) This law further regulates market surveillance concerning the marketing and labelling of products following the directly applicable European Union Regulation in the field of accreditation and supervision.

(4) This law also provides for the exercise of public administration in the field of products to which the directly applicable European Union Regulation on the marketing of products relating to the common framework for the marketing of products is applicable and which are listed in Title I of Part Two or for which it is provided for in another law (4) concerning conformity assessment and the making available on the market.

§ 2

(1) The provisions of paragraphs 3 to 15 shall not apply to products covered by the relevant European Union Regulation. The provisions of Sections 17 to 26, Sections 50 and 51 shall apply to these products unless otherwise provided for in the relevant regulation of the European Union.

(2) For the products referred to in Part Two, Title II, Sections 3 to 15, Sections 17 to 26, Sections 50 and 51, unless otherwise provided for in Part Two, Title II.

§ 3

Terms

For the purposes of this Act:

(a) making available on the market the supply of a product for distribution, consumption or use on the European Union market in the course of a commercial activity, whether for consideration or free of charge;

(b) placing on the market the first supply of the product on the market of the European Union;

(c) the operator of the manufacturer, authorised representative, importer and distributor;

(d) by the manufacturer, the person who manufactures the product or has the product designed or manufactured and places it on the market under his name or trade mark or, if the Government's regulation so provides, uses it for his own use;

(e) by an authorised representative, 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 to the extent of his mandate;

(f) the importer of a person established in the European Union who places a product from a third country on the market of the European Union;

(g) by the distributor, the person, with the exception of the manufacturer or importer, who makes the product available on the market in the supply chain;

(h) a conformity assessment body, a person or an organisational component of a State that carries out conformity assessment activities, including calibration, testing, certification and inspection;

(i) conformity assessment procedure demonstrating that the essential technical requirements relating to the product, process, service, system or person laid down by the Government Regulation have been met;

(j) the CE marking indicating by the manufacturer that the product complies with the requirements laid down in the legislation governing its placement;

(k) technical requirements

1. the required product characteristics, which are in particular quality levels, characteristics, safety or dimensions, interoperability, health and environmental protection, including product requirements, as regards its trade name, nomenclature, symbols, testing and test methods, packaging, labelling and conformity assessment procedures, as well as production methods and processes affecting product characteristics; and

2. other requirements necessary for the protection of consumers or the environment after the placing on the market or putting into service, where appropriate, such as conditions of use, recycling, reuse or disposal of the product, provided that such conditions can significantly affect the composition or characteristics of the product or its placing on the market or putting it into service,

(l) by withdrawing from circulation a measure aimed at returning a product already delivered to the end user to the person who supplied the product to the end user;

(m) by withdrawing from the market a measure aimed at preventing the product in the supply chain from being made available on the market.

§ 4

Products intended for conformity assessment and the technical requirements to be met by the products when placed on the market, where appropriate when placed on the market or when put into service or when used, including for their own use, shall be laid down by the Government by regulations in which it may further specify:

(a) the methods of conformity assessment;

(b) the conditions and rules for drawing up the EU declaration of conformity and for placing the CE marking or any other marking; a government regulation also sets out the form and manner of placement for other labelling,

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

(d) details of the activities of economic operators and notified bodies (Article 17) in conformity assessment.

§ 5

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

(3) Where a product complies with the requirements of European Union rules harmonising the conditions for the placing on the market of products (hereinafter referred to as the "European Union Harmonisation Regulation ') which apply to the product, public authorities shall not impede the making available on the market of the products in the Czech Republic from the aspects covered by those rules.

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

HLAVA II

ECONOMIC ENTITIES

§ 6

Manufacturer

(1) The manufacturer must ensure that the products are designed and manufactured in accordance with the requirements laid down. For mass-produced products, it shall ensure compliance with the requirements laid down throughout the production period, even if there are changes in the design or parameters of the product, or changes in the harmonised norem5) or changes in the document that prescribes the technical requirements to be met by the product, process or service for demonstration of conformity.

(2) The manufacturer shall draw up technical documentation and carry out or have carried out the conformity assessment procedure laid down by the Government Regulation. The scope and method of drawing up the technical documentation may be laid down by a government regulation. After demonstration of conformity, the manufacturer shall, in the cases provided for by the Government Regulation, draw up an EU declaration of conformity or another document attesting conformity (hereinafter referred to as "the declaration of conformity ') and place the CE marking or other designated marking. The technical documentation and the declaration of conformity shall be kept to the extent and for the period laid down by the Government Regulation.

(3) The manufacturer shall indicate on the product the information and identification data on the product and the identification and contact details relating to the product, as provided for by the Government Regulation. Where the size or nature of the product does not permit such information to be given on the product and unless otherwise provided for in the Government Regulation, it shall be required to indicate such information on the packaging of the product or on the document accompanying the product. The manufacturer must ensure that the product is accompanied by clear and comprehensible instructions and safety information in the Czech language. Where the Government Regulation so provides, the manufacturer shall attach to each product a copy of the declaration of conformity. The scope of the attached instructions and security information may be determined by the Government by a regulation.

(4) The manufacturer shall, in the cases and to the extent provided for by the Government Regulation, carry out tests on samples of the product and other necessary investigations concerning products placed on the market, keep records of complaints and non-compliant products and of the distributors to which he has supplied those products, in order to protect the health and safety of consumers.

(5) A manufacturer who considers or is required to have reason to believe that the product which he has placed on the market is not in conformity with the requirements laid down must take, without undue delay, the necessary and effective measures to bring the product into conformity with the requirements laid down, or to withdraw the product from the market or from circulation. Where a product poses a risk to life, health, property or the environment, or to other public interest (hereinafter referred to as "risk '), the manufacturer shall immediately inform the supervisory authority or the competent authorities of another Member State of the European Union in which it has made the product available on the market, as well as the measures taken or the withdrawal of the product from the market.

(6) The manufacturer shall provide the supervisory authority or the competent authority of the other Member State of the European Union in which the product has been made available on the market, at its reasoned request, with the information and supporting documents necessary to demonstrate the conformity of the product. Unless otherwise assessed, such information and supporting documents shall be provided in the official language of the Member State of the European Union concerned. The manufacturer shall provide those authorities with the synergies necessary to exercise their competence in order to eliminate the risks posed by the products placed on the market.

(7) The manufacturer is authorised to designate his authorised representative. The authorisation of an authorised representative shall not include the fulfilment of any of the obligations referred to in paragraph 1 or the obligation to draw up the required technical documentation, but shall allow it to keep a declaration of conformity and technical documentation and to provide cooperation to the supervisory authorities.

§ 7

Authorised representative

The authorised representative shall carry out the tasks within the scope of his mandate and shall keep the certificates of conformity and the technical documentation for the period laid down in the Government Regulation. Upon request, it shall provide the supervisory authorities with the information and documentation necessary to demonstrate the conformity of the product and the synergies needed to exercise its competence in order to eliminate the risks posed by the products covered by its mandate.

§ 8

Importer

(1) The importer may only place on the market products which comply with the requirements laid down and must ensure that, for as long as they are placed on the market before they are placed on the market, this conformity is not jeopardised by storage and transport conditions.

(2) The importer must:

(a) before placing the product on the market, ensure that:

1. the manufacturer has carried out or had carried out an appropriate conformity assessment procedure for the imported product and has produced a technical dossier;

2. the product has been bearing the CE marking or other marking prescribed,

3. the product has been accompanied by a declaration of conformity, where provided for in the Government Regulation,

4. the product has been provided with clear and comprehensible instructions and safety information to the extent provided for by the Government Regulation; and

5. the manufacturer has complied with the requirements set out in Paragraph 6 (3); and

(b) keep a copy of the declaration of conformity for the period laid down in the Government Regulation and, at the reasoned request of the supervisory authority, ensure that the technical documentation is available.

(3) An importer who considers or has reason to believe that the product which he intends to place on the market does not comply with the requirements laid down may not place that product on the market until the product has been brought into conformity with the requirements laid down. Where a product presents a risk, the importer shall inform the manufacturer without delay, including information on the nature of the risk and its causes, as well as the measures taken by him or the withdrawal of the product from the market or recall, the supervisory authority.

(4) The importer shall indicate on the product the identification and contact details relating to his or her person established by the Government Regulation, or, if this is not possible or provided for by the Government Regulation, he / she shall indicate them on the packaging of the product or on the document accompanying the product. The importer must ensure that the product is accompanied by clear and comprehensible instructions and safety information in the Czech language.

(5) The importer shall, in the cases and to the extent laid down by the Government Regulation, carry out sample tests and other necessary investigations concerning products placed on the market, keep records of non-compliant products and recall products and inform the distributors to whom they have supplied those products.

(6) The importer shall provide the supervisory authority or the competent authority of another Member State of the European Union in which the product has been made available on the market, upon request, with the information and supporting documents necessary to demonstrate the conformity of the product. Unless otherwise assessed, such information and supporting documents shall be provided in the official language of the Member State of the European Union concerned. The importer shall, upon request, provide those authorities with the synergies necessary to exercise their competence in order to eliminate the risks posed by the products placed on the market.

(7) An importer who considers or has reason to believe that the product placed on the market does not comply with the requirements laid down shall immediately take the necessary measures to bring the product into conformity with those requirements or withdraw it from the market or recall it. Where a product presents a risk, it shall inform the manufacturer and the supervisory authority without delay, or the competent authority of the other Member State of the European Union in which it has made the product available, of the nature and causes thereof, as well as of the measures taken, or of the withdrawal or recall of the product from the market or of the product.

§ 9

Distributor

(1) The distributor shall act with due care to ensure that the products made available on the market by him comply with the requirements laid down and shall be obliged to ensure that, for as long as the products are placed on the market before they are placed on the market, the storage and transport conditions for compliance with the requirements laid down are not jeopardised.

(2) The distributor is required to verify, in the cases and to the extent specified by the Government Regulation prior to making the product available on the market, whether the product is bearing the CE marking or another designated mark, whether the product is accompanied by a declaration of conformity and clear and comprehensible instructions and safety information to the extent specified by the Government Regulation, whether the 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 Sections 6 (3) and 8 (4).

(3) A distributor which considers or has reason to believe that a product does not comply with the requirements laid down may not make that product available on the market until the product has been brought into conformity with those requirements. Where a product presents a risk, it shall inform the manufacturer or importer and the market surveillance authorities accordingly.

(4) The distributor is required to provide the supervisory authority or the competent authority of another Member State of the European Union in which the product has been made available on the market, upon request, with the information and supporting documents necessary to demonstrate the conformity of the product. The distributor shall, upon request, provide those authorities with the synergies needed to exercise their competence in order to eliminate the risks posed by the products it has made available on the market.

(5) A distributor who considers or is required to have reason to believe that the product which he has made available on the market does not comply with the requirements laid down must ensure that the necessary measures are taken to bring the product into conformity with those requirements, or withdraw it from the market or recall it. Where a product presents a risk, it shall inform the manufacturer or importer and the supervisory authority without delay, or the competent authority of the other Member State of the European Union in which it has made the product available, of the nature and causes thereof, as well as of the measures taken, or of the withdrawal or recall of the product from the market or of the product.

§ 10

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

§ 11

Economic operators shall identify all economic operators, at the request of the competent supervisory authorities, for the period laid down in the Government's regulation,

(a) which have supplied them with the product; or

(b) to which they have supplied the product.

HLAVA III

CONFORMITY ASSESSMENT

§ 12

Conformity assessment procedures

(1) Conformity assessment shall be carried out according to the conformity assessment modules and, where appropriate, their combinations, the use of which, or their combination for the relevant specified product, shall be laid down by the Government Regulation. The list of conformity assessment modules is set out in Annex 1 to this Act.

(2) Each module referred to in paragraph 1 shall include the procedures and actions provided for in conformity assessment by the manufacturer or, to the extent of its mandate, authorised representatives and conformity assessment bodies. Modules shall specify in particular the means of exchange of information between the manufacturer and the notified body and their scope, the scope of the product documentation, the production, or the quality system, the activity in assessing the suitability of the product design, the details of the product sampling, the scope and methods of testing of the product samples or their prototypes, the forms of conformity assessment conclusions, the differences in the assessment of the mass or unit production of the products and the procedures for quality system audits.

(3) In cases and to the extent provided for by a government regulation, the accredited in-house service of the manufacturer may participate in conformity assessment if it meets the following criteria:

(a) the inside body of the manufacturer is subject to accreditation granted in accordance with the European Union's directly applicable accreditation and supervision regulation (3);

(b) the inside body of the manufacturer shall form an organisational unit and its staff shall use such reporting methods between the manufacturer's organisational units which ensure their impartiality, as demonstrated by the accreditation body;

(c) the manufacturer's in-house service and its staff shall not participate in the design, manufacture, supply, installation, operation or maintenance of the products they assess and shall not participate in any activities likely to jeopardise their independent judgement or credibility in relation to the assessment activities;

(d) the inside body of the manufacturer shall provide services solely to the manufacturer of which it is part.

(4) The manufacturer of which the in-house unit is part or the accreditation body is required to provide, upon request by the Technical Standardisation, Metrology and State Testing Office (hereinafter referred to as "the Office"), information that the inside body of the manufacturer has been accredited, including the scope of that accreditation.

§ 13

Presumption of conformity

(1) Where the product conforms to harmonised standards (5) or parts thereof to which the references in the Official Journal of the European Union have been published, it shall be deemed to comply with the technical requirements set out in the Government Regulation concerning those standards or parts thereof.

(2) In the absence of harmonised standards and provided for by the Government Regulation, 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 which are deemed appropriate for correct conformity assessment.

§ 14

Declaration of conformity

(1) The manufacturer's declaration of conformity confirms that compliance with the essential technical requirements laid down in the Government Regulation has been demonstrated in conformity assessment.

(2) The declaration of conformity shall contain the information set out in Annex 2 to this Act, which is specified by the Government Regulation in relation to the product under consideration 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 marketed or made available on the market.

(3) Where a product is covered by several government regulations governing the drawing up of declarations of conformity and permitted by the Government, a single declaration of conformity shall be drawn up indicating the references to the European Union harmonisation provisions relating to the product concerned and, where appropriate, to the relevant regulations of the Government. This single declaration of conformity may, if permitted by the Government's regulation, take the form of a component consisting of the respective individual declarations of conformity.

§ 15

CE marking and other markings

(1) Only a product for which the location of that marking is laid down by a government regulation may be provided for by CE6.

(2) The CE marking shall be placed on the product before it is placed on the market; shall be positioned visibly, legibly and indelibly. The Government Regulation may provide for other means of placing the CE marking, in particular that the CE marking is to be placed on the product label or on its packaging or on documents accompanying the product.

(3) The CE marking when assessing conformity by module, including the connection of the notified body identification number, shall be accompanied by an identification number assigned to it by the European Commission. In accordance with the instructions of the notified body, this number may be attached to the CE marking by the manufacturer or his authorised representative.

(4) Where a government order so provides, specific indications shall be added after the CE marking or, where appropriate, after the identification number of the notified body or at another designated location. Pictograms or other marks indicating a specific risk or method of use may be attached to the labels.

HLAVA IV

STATE TEST

§ 16

(1) For the purposes of this Act, State testing means activities carried out by the Office in the field of conformity assessment in the field of marketing of products under the common framework of the European Union by:

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

(b) object to notifications made by other Member States of the European Union;

(c) decide on changes in their notification for notified bodies; and

(d) carry out checks on notified bodies.

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

Notification and control of notified bodies

§ 17

(1) The notified body may only be a legal entity with its registered office in the Czech Republic which meets the requirements set out in Section 23 and can be presumed to meet these requirements on a permanent basis and which offers guarantees of compliance with the obligations relating to the activities of notified bodies and the proper performance of that activity.

(2) Conformity assessment bodies shall notify the European Commission and the other Member States of the European Union of an Authority which is a notifying authority within the meaning of the European Union harmonisation rules and relevant European Union Regulations. The Authority also notifies the European Commission and the other Member States of the European Union of significant changes to 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 the monitoring of notified bodies and of changes to those procedures.

§ 18

(1) The procedure for notification shall be initiated following an application submitted to the Office by a conformity assessment body.

(2) The request for notification shall include, in addition to the general requirements laid down in the Administrative Rules, a description of the conformity assessment activities relating to the Government Regulations under this Act or to the relevant European Union Regulation, together with an indication of the conformity assessment procedures or modules and the products under consideration.

§ 19

(1) When assessing an application for the competence of a conformity assessment body for the purposes of notification, the Authority shall use an accreditation certificate issued by an accreditation body (7), if it is accompanied by an application. If the applicant does not submit an accreditation certificate or if the accreditation certificate does not document sufficient compliance with all the requirements under Section 23, the applicant shall provide the Office with all the required documents necessary for the assessment, recognition and periodic monitoring of compliance with those requirements.

(2) In the procedure for notification, the Office shall decide within 90 days of receipt of the request. Where the applicant demonstrates his or her competence in a manner other than by means of an accreditation certificate, that period shall be extended by 30 days.

(3) Where a conformity assessment body complies with the requirements and assumptions referred to in Article 17 (1), the Authority shall make the notification referred to in Article 17 (2), otherwise it shall reject the application.

(4) The notification shall include all details of the conformity assessment activities, the conformity assessment module and the product concerned and the information on the competence of the conformity assessment body in relation to the relevant European Union harmonisation Regulation or the relevant European Union Regulation applicable to the product concerned.

(5) The Office shall inform the applicant of the notification carried out by informing the applicant that the information on the date of the start of the authorisation to operate the notified body can be obtained from the European Commission information system on notified bodies and shall interrupt the procedure with a resolution marked on the file.

§ 20

(1) The authorisation to carry out the activities of a notified body shall be established by a conformity assessment body, unless neither the European Commission nor any of the Member States of the European Union objects to the notification within 2 weeks of the notification being made available, if the accreditation certificate has been used, or within 2 months of the notification being made available if the accreditation has not been applied.

(2) If neither the European Commission nor any of the Member States of the European Union objects to the notification referred to in paragraph 1, the Office shall state that fact on the file and inform the notified body accordingly. At the same time, without undue delay, it shall publish in the Office Bulletin a communication on the authorisation of 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 a certificate of origin or duration of the authorisation for conformity assessment activities agreed upon. Such confirmation may be requested in advance, together with the request for notification or during the procedure. The establishment of an authorisation shall make the notified body look as if its application has been granted.

(3) Where the European Commission or a Member State of the European Union objects to the notification referred to in paragraph 1, the Office shall invite the applicant to take action to remedy the deficiencies and shall give it a reasonable period of time. If the applicant removes the deficiencies within the specified period, he shall communicate this to the Office without undue delay. Where the Authority concludes that the applicant has remedied the deficiencies, it shall re-notify it in accordance with Article 17 (2). If the applicant does not remedy the deficiencies within the specified time limit, the Office shall reject the application.

§ 21

(1) The Office shall check that the bodies notified by it comply with the provisions of this law and comply with the regulations of the Government or of the relevant European Union Regulation. The notified body shall, upon request, demonstrate to the Authority the accuracy of its conclusions adopted in conformity assessment and, to that end, without undue delay, provide, in particular, the documentation on the basis of which those conclusions were adopted. In carrying out the inspection, the Authority shall also be empowered to identify facts relating to conformity assessment activities carried out by other bodies to which the notified body will assign specific conformity assessment tasks ("subcontractors').

(2) Where the Authority finds that a notified body no longer complies with the requirements laid down in Article 23, it shall decide, in view of the seriousness of the consequences of non-compliance with those requirements, to suspend, restrict or revoke the authorisation to carry out the activities of the notified body. The Authority shall inform the European Commission and the other Member States of the European Union without delay of such decisions.

(3) In the event of non-compliance pursuant to Article 23, where the Office considers that their non-compliance does not have a direct consequence of the proper performance of the activities of the notified body, the Authority shall decide to suspend the authorisation to carry out the activities of the notified body and shall set a time limit for rectification. Where the notified body informs the Authority of the remedy and finds the remedy sufficient, the decision to suspend the authorisation to carry out the activities of the notified body shall be revoked. If the notified body has not acted within the time limit set, the Authority shall decide to restrict or revoke the authorisation to carry out the activities of the notified body.

(4) Where the Office finds an infringement pursuant to paragraphs 24 to 26 which it considers to be less serious and does not indicate a non-compliance with the requirements set out in paragraph 23, it shall invite the notified body to take corrective action within the time limit set. If the Authority does not consider that such a procedure is sufficient, it shall, within the time limit laid down, impose a decision which is the first act in the suspension, restriction or revocation of the authorisation to carry out the activities of the notified body.

(5) The Office shall also decide on the suspension, restriction or revocation of the authorisation to carry out the activities of the notified body where the notified body so requests. In this case, compliance with the conditions laid down in Paragraph 22 (4) is a condition for the Authority's decision.

§ 22

(1) A legal person who, under the final decision of the Office, has been restricted or revoked by a valid authority to carry out the activities of a notified body shall:

(a) inform all economic operators concerned of this decision of the Office without undue delay;

(b) at the request of the economic operator concerned by the consequences of the change in the validity of the notification, transfer the rights and obligations relating to the assessment of conformity, including a subsequent verification of compliance with the conditions under which the certificate or other document certifying the facts established (hereinafter referred to as "the certificate") was issued, to the notified body with which that economic operator has concluded a contract pursuant to Article 24 (1), and inform the Office of the transfer of rights and obligations, including the transmission of the documentation,

(c) ensure that the relevant documentation concerning the activity of the notified body is made available to the Authority or the supervisory authority on request, for as long as the Authority has provided it with the decision to restrict or revoke the authorisation to carry out the activities of the notified body.

(2) Certificates and documents relating to conformity assessment, misissued by a notified body prior to the restriction or withdrawal of the authorisation to carry out the activities of the notified body, and not cancelled by it, are entitled to revoke the notified body which has taken over the rights and obligations referred to in paragraph 1 (b), or the supervisory authority, if they are found to have been misissued 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 supporting documents of the notifying notified body to complete the completed conformity assessment cases or to subsequently verify compliance with the conditions under which the certificate was issued.

(4) Where a notified body intends to terminate or restrict its activities without violating its obligations under the requirements of the provisions of Paragraph 23, it shall, before a decision by the Authority to restrict or revoke an authorisation to carry out the activities of a notified body, transfer the rights and obligations of another notified body; paragraph 1 (b) shall apply mutatis mutandis.

(5) In the event of the disappearance of a legal person who is a notified body, the latter shall, before the disappearance, transmit the relevant documentation relating to the activities of the notified body to the Office.

Notified bodies

§ 23

(1) The requirements for a notified body are:

(a) the conformity assessment body must be independent of and on the economic operator whose product it assesses; in so far as the Government's regulation does not preclude this, it may also be a conformity assessment body belonging to an economic association or professional association which brings together persons involved in the design, manufacture, supply, assembly, use or maintenance of the products assessed by the conformity assessment body, provided that it demonstrates its independence and absence of any conflict of interest;

(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, produce, supply, install, purchase, own, use or maintain the products they assess; they shall not be directly involved in the design, manufacture or construction, marketing, installation, use or maintenance of such products; they shall not represent or represent persons engaged in such activities. They shall not engage in any activity which may jeopardise their independent judgement and credibility in relation to the conformity assessment activities to which they are subject, including the provision of advisory services; This does not preclude the use of the products assessed, necessary for the operation of the conformity assessment body, or the use of such products for their own use,

(c) the conformity assessment body and personnel must carry out conformity assessments at the highest level of professional credibility and the required technical competence in a specific field and must not be subjected to any pressures and incentives, in particular financial ones, which may affect their judgement or the results of their conformity assessment activities;

(d) the conformity assessment body must be able to carry out all the conformity assessment activities imposed on the notified body by the relevant government regulations under this law or by the relevant European Union Regulation, whether carried out by the notified body itself or carried out on its behalf and under its responsibility;

(e) the conformity assessment body shall always be provided with the necessary:

1. personnel with the expertise and experience necessary to carry out conformity assessment tasks;

2. a description of the procedures under which conformity assessment is carried out and which ensure the transparency of those procedures and the possibility of reopening them; apply appropriate rules and procedures to distinguish between tasks performed by a notified body and other activities;

3. procedures for carrying out activities which take due account of the size, sector, structure of undertakings, the degree of complexity of the technology of the product in question and the mass or serial form of its production;

(f) the conformity assessment body must have the means necessary to carry out the technical and administrative tasks related to conformity assessment and have access to all necessary equipment or equipment;

(g) personnel involved in conformity assessment shall:

1. have technical and professional training relating to all conformity assessment activities to which the notification relates;

2. have knowledge of the assessment requirements they carry out and the appropriate authorisation to carry out such assessment;

3. 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,

4. be able to draw up certificates, protocols and reports demonstrating that assessments have been carried out;

(h) the conformity assessment body must ensure that the activities of its subcontractors do not jeopardise the confidentiality, objectivity and impartiality of its conformity assessment activities;

(i) the conformity assessment body must ensure the remuneration of management members and staff in such a way that the remuneration does not depend on the number of assessments made or the results thereof;

(j) the conformity assessment body must have an insurance of liability for damage caused by the activities of the notified body, with an insurance performance limit of an appropriate scale for such activities;

(k) the conformity assessment body must ensure that workers are required to maintain confidentiality in respect of any information they obtain in the performance of their duties under this law or under the relevant European Union Regulation.

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

(3) The requirements for notified bodies referred to in paragraphs 1 and 2 with regard to technical means and staffing may be specified in government regulations.

§ 24

(1) Notified bodies shall carry out conformity assessment activities in accordance with the conformity assessment procedures laid down in the Government Regulations or in the relevant European Union Regulations. In doing so, they shall act on their behalf and on their responsibility under the Treaties (8), the purpose of which is to carry out conformity assessment activities or to check compliance with the conditions under which the certificate was issued. The essential elements of the contract 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 disproportionate burdens on economic operators. The notified bodies shall 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 in question and the mass or serial nature of the production process. Such bodies shall respect the degree of rigour and the level of protection that the product complies with the requirements laid down or the requirements of the relevant European Union Regulation.

(3) Where the notified body finds that the manufacturer does not comply with the essential technical requirements laid down in the Government Regulation, the relevant European Union Regulation, the relevant harmonised standards or the document prescribing the technical requirements to be met by the product, procedure or service to demonstrate compliance with the product, it shall invite the manufacturer to take corrective action and shall not issue a certificate.

(4) If, during the verification of compliance with the conditions under which the certificate was issued, the notified body finds that the product no longer meets the requirements applicable to the issue of the certificate, it shall invite the manufacturer to take corrective action and may, depending on the nature and gravity of the non-compliance, restrict or suspend the certificates in question or withdraw them.

(5) If the manufacturer does not take corrective measures or if those measures do not have the desired effect, the notified body shall restrict or suspend the validity of the certificates concerned or withdraw the certificate.

(6) At the request of the manufacturer, the notified body shall communicate the level of the limit of the insurance performance agreed under the injury liability insurance caused by the activity of the notified body.

Citation	Act No. 90 / 2016 Coll., on conformity assessment of specified products when making them available on the market
Regulation Type	Law
Author	-
Collection	Code of Laws

Date of Promulgation	31.03.2016
Effective from	15.04.2016
Effective until	-
Status	Valid

Act No. 90 / 2016 Coll.

Law on conformity assessment of specified products when making them available on the market

Contents