{"id":1765,"date":"2020-02-18T15:31:41","date_gmt":"2020-02-18T14:31:41","guid":{"rendered":"https:\/\/unmz-wp.e-bs.cz\/?page_id=1765"},"modified":"2026-02-03T09:47:05","modified_gmt":"2026-02-03T08:47:05","slug":"frequently-asked-questions-experience","status":"publish","type":"page","link":"https:\/\/unmz.gov.cz\/en\/caste-dotazy\/casto-kladene-otazky-zkusebnictvi\/","title":{"rendered":"Frequently Asked Questions - Testing"},"content":{"rendered":"

Warning:<\/strong> 22\/1997 Coll., on technical requirements for products, in
\nas amended (hereinafter referred to as Act No. 22\/1997 Coll.), is empowered to interpret it or to
\nindividual government regulations issued to implement it, which would be binding on anyone.
\nDepartment of State Testing of the Office for Technical Standardization, Metrology and State Testing
\n(hereinafter referred to as \"the Office\") is responsible in particular for the provision of state testing within the scope of
\n22\/1997 Coll., on technical requirements for products and on amendment and supplementation
\n90\/2016 Coll., on conformity assessment
\nof specified products when they are made available on the market, as amended, and Act No.
\n206\/2015 Coll., on pyrotechnic articles and their handling and on amendments to certain acts (Act
\non pyrotechnics) and directly applicable EU legislation on the marketing of products.
\nPlease note that it is not for the Authority to assess or decide whether particular products are
\nspecified products within the meaning of Section 12 of Act No. 22\/1997 Coll., on technical requirements for
\nproducts and amending and supplementing certain laws, as amended, and whether they fall within
\nthe scope of the relevant government regulation or directly applicable EU regulation.
\nIt is the responsibility of the manufacturer, importer or distributor, as the case may be, to decide which legislation
\napply to the products of its interest. Nor is the Authority empowered to give an interpretation of the law or
\nto interpret the implementing regulations based on it. Thus, the answer to your question can also be considered
\nonly as an expression of the opinion of the Office, which cannot be binding on anyone.<\/p>\n

1. Who can I contact when placing products on the internal market?
\n2. What is the internal market?
\n3. When is the product placed on the market and when is it put into operation?
\n4. What are the obligations of economic operators when placing or supplying products on
\nthe internal market?
\n5. What is the difference between authorization and accreditation in the sense of the Technical Requirements Act
\non products?
\n6. How do I request an authorisation, notification or designation?
\n7. Does every product have to be CE marked? Where do I get the CE marking and who marks the product
\nIs he?
\n8. What is voluntary certification under the Technical Requirements Act?
\non products?
\n(9) The specified products are specified in government regulations issued to implement this
\nlaw, with the CE marking applying only to those regulations which transpose directives
\nEC where this product marking applies.
\n10. What should I do if the product is not CE marked and the customer asks me to do so?
\nCan I label the product myself?
\n11. Do all products in the Czech Republic have to undergo testing procedures? What is a specified
\nproduct and how is its conformity assessment carried out? What products are specified
\nfor conformity assessment when they are placed on the market?
\n12. What document must accompany the product if it is to be placed on the market or, if applicable, in
\noperation?
\n13. What is the difference between an authorised, notified and notified body?
\n14. Where can I get the text of the relevant regulations dealing with standardisation and
\nof the state testing department?
\n15. Who carries out the conformity assessment?
\n16. When the participation of an authorised (notified) person or notified body is necessary
\nof the subject in the conformity assessment process?
\n17. What is the procedure for the movement of products between Member States?
\n18. BREXIT-how to proceed when importing products into the UK?
\n19. How is the conformity assessment of products carried out?
\n20. How should I proceed when placing construction products on the market?
\n21. How should I proceed when placing machinery on the market?
\n22. How to assess the conformity of pressure equipment?
\n23. How to assess conformity for lifts?
\n24. How to assess conformity for products intended for use in potentially explosive atmospheres?
\n25. How to proceed when placing toys on the market?
\n26. What is the procedure for placing personal protective equipment (PPE) on the market?
\n27. How to proceed when placing electrical and electronic products on the market?
\n28. How to proceed with the marketing of medical devices and diagnostic medical devices
\nin vitro devices to the market?
\n29. Who should I contact with questions about medicines?
\n30. Who do I contact with questions about food?
\n31. Who should I contact with questions about cosmetics?
\n32. What is the procedure for placing non-specified products on the market?<\/p>\n

 <\/p>\n

1. Who can I contact when placing products on the internal market?<\/strong>
\nThe Product Contact Point (ProCoP) offers free advice on the marketing of products
\nthe EU internal market. In particular, it provides information on what technical requirements apply to a given product
\nApply.
\nhttps:\/\/www.mpo.gov.cz\/cz\/zahranicni-obchod\/podnikani-v-EU\/sluzby-pro-podnikatele-na-vnitrnim-trhu-eu\/procop\/default.htm<\/a><\/p>\n

Product Contact Point staff can be contacted at the following email address\u00a0procop@mpo.gov.cz<\/a>or by phone on +420 224 221 701.<\/p>\n

In the field of building products: https:\/\/www.mpo.gov.cz\/cz\/stavebnictvi-a-suroviny\/kontaktni-misto-pro-stavebni-vyrobky\/<\/a>
\nFurthermore, the Commission Communication - \u201eBlue Guide\u201c on the implementation of the EU product rules 2022
\navailable here: https:\/\/eur-lex.europa.eu\/legal-content\/CS\/TXT\/HTML\/?uri=CELEX:52022XC0629(04)&from=EN<\/a>
\nWe recommend you to use the information from the publication \"Placing products on the European internal market
\nEconomic Area Procedures of economic operators Testing, inspection and
\nCertification Organisations of the Czech Republic - EU Member State (Version 2021)\", which is available for download
\non the page\u00a0https:\/\/www.unmz.gov.cz\/statni-zkusebnictvi\/program-rozvoje-zkusebnictvi\/<\/a>.<\/p>\n

2. What is the internal market and the principle of mutual recognition?<\/strong>
\nThe European Union's internal market is made up of the territory of all 27 EU Member States.
\nwas and is to give rise to a space in which the so-called four fundamental freedoms apply, namely: free movement
\ngoods, persons, services and capital.
\nEnsuring the free movement of goods is the cornerstone of a functioning EU internal market, and thus of the free movement of goods.
\nfair competition between market players. A number of products are at EU level
\nharmonised through specific sectoral regulations (machinery, such
\nequipment, toys, etc.). However, if products are not harmonised at European level, or only
\nIn part, the free movement of goods is ensured through the principle of mutual recognition. According to
\nthis principle, a Member State must authorise the placing on its market of a product if that product is
\nlegally produced or traded in another Member State. Legally, this principle is anchored in
\nRegulation (EU) 2019\/515 of the European Parliament and of the Council on mutual recognition of goods
\nlawfully placed on the market in another Member State and repealing Regulation
\n(EC) No 764\/2008.
\nMember States recognise that even if products are manufactured in accordance with other regulations, standards
\nor procedures other than their own, these in principle guarantee a comparable level of safety and
\nthey cannot deny them access to their market. In addition to EU Member States, the principle of reciprocity
\nrecognition also applies to the Member States of the European Economic Area (i.e. in addition to the Member States of the
\nEU countries (Norway, Liechtenstein and Iceland) and Turkey, see more on: the principle of reciprocity
\nrecognition in the internal market for goods and the procedure under Article 5 of the Regulation | MIT<\/p>\n

3. When is the product placed on the market and when is it put into operation?<\/strong>
\nThe definition of the terms \"placing on the market\" and \"putting into service\" is set out in Section 2
\nAct No. 22\/1997 Coll., on technical requirements for products and on amendment and supplementation of certain
\nlaws, as amended.
\nA product is placed on the market when it is first supplied in the course of a commercial activity. Supply means
\nthe transfer or offer to transfer a product or the transfer of title to a product for the purpose of
\ndistribution, use or consumption on the market of the European Union, unless a specific law provides otherwise. For
\nplaced on the market shall also be deemed to include products manufactured or imported for operational purposes in the course of their own
\nthe business of manufacturers or importers and products made available for re-use, if they are before
\nreuse, compliance with the legislation is assessed where this is provided for by government regulation.
\nWhere necessary, the Government shall, by regulation, further define the concept of placing on the market for products to which
\nthis Technical Regulation applies.
\nA product is put into service when it is first used by a user in the Member States of the European
\nunion for the purpose for which it was made; where a government regulation so provides, the product shall be put into
\noperation at the time it is prepared or provided for such use. If the product is put
\ninto operation in the workplace, the user is the employer.
\nFor the purposes of Act No. 90\/2016 Coll., on conformity assessment of specified products when they are supplied to
\nmarket, as amended, the placing on the market shall similarly mean the first supply of a product on
\nthe European Union market.
\nAct No. 90\/2016 Coll., on conformity assessment of specified products when they are supplied to the market, as amended by
\ndoes not provide for a uniform definition of \"putting into service\", however, in selected
\ncases, Part Two of this Act or government regulations by which the government
\nsets out the products to be assessed for conformity and the technical requirements that the products must meet
\nwhen placed on the market, put into service or used, including for personal use
\nthe need of the manufacturer. These include recreational craft, pressure equipment, radio equipment or
\nmeters or the directly applicable European regulation on gaseous fuel appliances.<\/p>\n

4. What are the obligations of economic operators when marketing or supplying<\/strong>
\nproducts on the internal market?<\/strong>
\nThe placing of products on the internal market is governed in particular by Act No. 102\/2001 Coll., on general safety
\n22\/1997 Coll., on technical requirements for products and Act No. 90\/2016 Coll,
\non the assessment of the conformity of specified products when made available on the market.
\nThe basic rules can be found in the AAAO publication: placing products on the internal market of the European Economic Area. Procedures of economic operators and services of testing, inspection and certification organisations of the Czech Republic as an EU Member State, version 2025.
\nhttps:\/\/www.nlfnorm.cz\/informacni-portal\/1668\/publikace-aaao-uvadeni-vyrobku-na-trh<\/a>
\nThis document is intended primarily for manufacturers (located anywhere, incl. Czech Republic -
\nCzech Republic), placing products on the European Economic Area market. It is also intended for importers
\nproducts into the European Economic Area, their distributors and also their authorised
\nrepresentatives of manufacturers established in countries of the European Economic Area, in particular
\nbased in the Czech Republic.<\/p>\n

5. What is the difference between authorization and accreditation in the sense of the Technical<\/strong>
\nproduct requirements?<\/strong>
\nThe difference between accreditation and authorization results from Act No. 22\/1997 Coll., on Technical Requirements
\non products and amending and supplementing certain acts, as amended (hereinafter referred to as the \"Act
\n\u010d. 22\/1997\").
\nAuthorisation is defined in Article 11(1) of Act No. 22\/1997. \"Authorisation\" for the purposes of this Act means
\nmeans the authorisation of a legal person to carry out product conformity assessment activities including
\nthe assessment of activities related to their production or, where appropriate, their re-use; and
\ndefined in the technical regulations.\"
\nAuthorisation for activities under this Act shall be granted within the defined scope by the Office for Technical
\nstandardization, metrology and state testing. The list of authorised persons is available at
\nPages: List of AO and OS UNO - UNMZ<\/a>
\nAccreditation is defined in \u00a7 14, \u00a7 15, \u00a7 16 and \u00a7 17 of Act No. 22\/1997. Accreditation is a certificate of
\ncompliance with the requirements for carrying out the specific conformity assessment activity laid down in
\nharmonised standards or other documents applicable to the field of conformity assessment.
\nAccreditation is carried out by a legal person authorised by the Ministry of Industry and Trade
\n(the accreditation body), which is currently the Czech Institute for Accreditation, o.p.s. established by the Government of the Czech Republic through the Ministry of Industry and Trade in accordance with its charter:
\n(https:\/\/www.cai.cz<\/a>\/wp-content\/uploads\/2019\/07\/Zakl\u00e1dac\u00ed-listina-\u010cIA-12.-7.-2019.pdf)
\nA list of accredited bodies can be found at www.cai.cz<\/p>\n

6. How do I request an authorisation, notification or designation?<\/strong>
\nThe procedure for submitting an application for authorisation pursuant to Act No. 22\/1997 or for notification pursuant to Act No.
\n90\/2016, the Pyrotechnics Act or a notification or designation under the Railways Act is described
\nin Instruction 1: https:\/\/www.unmz.gov.cz\/statni-zkusebnictvi\/pokyny-a-informace-odboru-statnihozkusebnictvi-unmz-a-dalsi-dokumenty-ke-stazeni\/<\/a><\/p>\n

7. What is the so-called voluntary certification carried out according to the Act on Technical<\/strong>
\nproduct requirements?<\/strong>
\nAct No. 22\/1997 Coll., on technical requirements for products and on amendment and supplementation of certain
\nLaws, as amended, does not directly use the term \"voluntary certification\". For its
\nthe provisions of Section 10 of this Act, which reads as follows:
\n\"(1) Certification under this Act is an activity<\/em>
\n1. a) by an authorised person carried out within the scope defined by the technical regulation, or<\/em>
\n2. b) by an accredited person at the request of the manufacturer, importer or other person,<\/em>
\nwhich certifies, by issuing a certificate, that the product or activities related to its manufacture,<\/em>
\nor with its reuse, are in accordance with the technical requirements in the certificate<\/em>
\nSaid.<\/em>
\n(2) Certificates issued by an authorised person shall be used for conformity assessment pursuant to Section 13(1),<\/em>
\ncertificates issued by an accredited body may be used in conformity assessment pursuant to \u00a7 13(1) only<\/em>
\nin cases where the manufacturer, importer or other person is authorised to assess conformity.\"<\/em><\/p>\n

Voluntary certification is therefore an activity carried out within the meaning of Article 10(1)(b) of Act No.
\n22\/1997 Coll., while it should be specified that if it is not a procedure according to the said Act, then
\nvoluntary certification can also be carried out by non-accredited bodies. Voluntary certification
\nare also carried out by accredited bodies that are part of authorised\/notified persons
\nor notified bodies.
\nThe scope of voluntary certification is basically governed by the requirements of the client and therefore the purpose for which
\nto which the certificate is to be applied.<\/p>\n

8. Does every product have to be CE marked? Where do I get the CE marking and who does it<\/strong>
\nthe product?<\/strong>
\nThe CE marking may only be affixed to a product for which the affixing of this marking is specified
\nby law. In accordance with the Regulation (EC) of the European Parliament and of the Council
\nNo 765\/2008 of 9 July 2008 laying down requirements for accreditation and market surveillance
\nconcerning the placing on the market of products and repealing Regulation (EEC) No 339\/93, and in particular Art.
\n30, only the manufacturer or his authorised representative may affix the CE marking. This
\nThe Regulation also sets out the requirements for the graphic design of the CE marking.
\nBy affixing the CE marking or by having the CE marking affixed, the manufacturer declares that the product
\nconformity with all relevant requirements laid down in harmonisation legislation has been assessed
\nEU rules.
\nThe CE marking is the only marking certifying the conformity of a product with the relevant requirements
\nCommunity harmonisation legislation governing its siting. It is prohibited
\nplace markings, signs or inscriptions on the product that could mislead a third party,
\nas to the meaning or shape of the CE marking. Any other marking may be affixed to the product
\naffixed provided that the visibility, legibility and meaning of the CE marking is not thereby reduced.
\nThis is reflected in the legal system of the Czech Republic in particular in \u00a7 15 of Act No. 90\/2016 Coll., on conformity assessment
\n90\/2016), which provides that
\nthe CE marking may only be affixed to a product for which the affixing of this marking is specified
\nby government decree. In addition, the marking must be visible, legible and indelible.
\nWhen assessing the conformity of a product according to a module involving the attachment of an identification number
\nof the notified body, shall be attached by the notified body that participated in the conformity assessment,
\nan identification number assigned to it by the European Commission. As instructed by the notified body
\nthis number may be affixed to the CE marking by the manufacturer or his authorised representative. If he so determines
\nGovernment Regulation, they shall be added after the CE marking or, where appropriate, after the identification number of the notified body
\nspecific markings on the subject or in another specified place. The markings may be accompanied by
\npictograms or other signs indicating a particular risk or method of use. Manufacturer's definition and
\nof the authorised representative is contained in Sections 6 and 7 of Act No. 90\/2016.
\nPursuant to Article 4(b) of Act No. 90\/2016, products intended for conformity assessment and technical requirements,
\nwhich products must comply with when they are placed on the market or put into service or use,
\nincluding use for the manufacturer's own use, shall be determined by the Government by regulations, which may furthermore
\nto specify the conditions and rules for drawing up the EU declaration of conformity and for placing
\nthe CE marking or other marking; the government regulation shall also specify the form of the other marking and
\nmethod of placement.
\nBy failing to comply with the relevant provisions concerning the affixing of the CE marking, natural and legal persons
\npersons are guilty of offences punishable by a fine pursuant to Sections 53 and 54 of Act No. 90\/2016.
\nFor the purposes of Act No. 22\/1997 Coll., on Technical Requirements for Products (hereinafter referred to as \"Act No.
\n22\/1997\"), Article 13(3) provides that the CE marking on a specified product shall indicate that
\nthe product complies with the technical requirements set out in any government regulations that apply to it
\nand which provide for or permit such marking, and that the conformity assessment has complied with the prescribed
\nProcedure. The law further stipulates that if a product has been CE marked, it must not be simultaneously
\nmarked with a Czech mark of conformity or a mark which, by its meaning or form, could
\nlead to confusion with the CE marking or other specified marking.<\/p>\n

9. The specified products are specified in government regulations issued by<\/strong>
\nfor the implementation of this Act, the CE marking being applied only to those<\/strong>
\nRegulations which transpose EC Directives in which this product marking<\/strong>
\napplied.<\/strong>
\nThe relevant government regulation sets out which products are CE marked, under what conditions and how
\nin a way. It also specifies who affixes the CE marking to the product concerned. That person shall be
\nusually the manufacturer or his authorised representative (for definitions of these and other terms, see
\nin \u00a7 2 of Act No. 22\/1997). Only those who are designated by the relevant government decree to measure the product
\nCE marking, may do so after the conformity assessment has been carried out. Otherwise, the person concerned shall
\nexposes the person to the risk of being prosecuted for an offence within the meaning of section 19 or 19a of this Act.<\/p>\n

10.What should I do if the product is not CE marked and the customer asks for it?<\/strong>
\nrequires me? Can I label the product myself?<\/strong>
\nIf the product is not a specified product pursuant to Section 12(1)(a) of Act No. 22\/1997 Coll., on
\ntechnical requirements for products and amending and supplementing certain acts, as amended
\nregulations, or under EU harmonisation regulations, nor is it covered by a government regulation, the product
\nwith the designation CE does not provide.<\/strong>
\nIf, after all, in this case the product had been CE-marked, the person who
\nhe committed a violation of the law.
\nHowever, if it is a specified product that is to be covered by one (some) of the government regulations
\nor CE-marked in accordance with directly applicable EU legislation, then the conditions of this
\nlabelling as specified in the relevant government regulations. These specify who and under what conditions
\nthe product indicates. In the event that the CE marking is nevertheless carried out by someone else,
\nthan what is specified in these Government Regulations, he would be in violation of the provisions of the Act.
\nThis implies, inter alia, that the customer has no right to require the product to bear the CE marking unless this marking is provided for by a government regulation or directly applicable EU regulation, or by <\/span>a person who is not authorised to do so<\/span>a.
\nA similar approach is applied in the case of Act No. 90\/2016 Coll., on conformity assessment of specified
\nproducts and government regulations issued to implement it and EU harmonisation regulations (see detailed
\ninformation on question 4).<\/p>\n

11.Do all products in the Czech Republic have to undergo testing procedures? What is it<\/strong>
\na specified product and how is its conformity assessment carried out? What products<\/strong>
\nare provided for conformity assessment when they are placed on the market?<\/strong>
\nThe Czech legal code does not define what a \"trial procedure\" is.
\nState testing is defined according to \u00a7 9 of Act No. 22\/1997 Coll., on technical requirements for
\nproducts, as amended, as \"the set of activities carried out by the Authority and persons
\nmandated under this Act, the purpose of which is to ensure that products specified under this
\nof the Act to assess their conformity with the technical requirements laid down by government regulations...\"
\nSimilarly, it is defined under Act No. 90\/2016 Coll., on conformity assessment of specified products
\nin their supply to the market, as amended, as follows: \"The State Testing Authority shall be responsible for
\nfor the purposes of this Act means the activities by which the Authority carries out state administration in the field of assessment
\nconformity in the marketing of products under the common framework of the European Union... For the State Testing Service
\nactivities carried out by the notified bodies in conformity assessment by the Authority shall also be considered.\" From these
\ndefinitions, it follows that state testing is a set of activities. Not all activities and procedures
\nconformity assessment is testing in the sense of testing or laboratory testing of specific
\nProducts.
\nOnly those products for which
\nthis is provided for by law
\nSpecified product<\/span> according to \u00a7 12, paragraph 1, letter a) of Act No. 22\/1997 Coll., on technical requirements
\non products, as amended, such a product which presents an increased level of
\nthreat to a legitimate interest and for which compliance must be assessed. It follows from the foregoing that no
\nall products in the Czech Republic must be subject to mandatory testing procedures, but only those
\nwhere the legislation so provides.
\nPursuant to Section 4 of Act No. 90\/2016 Coll., on conformity assessment of specified products when they are supplied to the
\nthe market, the products to be assessed for conformity and the technical requirements that the products must meet when
\nthe placing on the market, or putting into service or use, including use for its own
\nthe needs of the manufacturer, the Government shall make regulations which may further specify (a) the methods of assessment
\nthe conditions and rules for drawing up the EU declaration of conformity and for affixing the marking
\nCE or other marking; the government regulation shall also specify for other markings the form and manner of the marking
\n(c) procedures for the supply of products to the market, (d) details of the activities of the economic
\nbodies and notified bodies in conformity assessment.
\nFor ease of reference, a list of the specified products is provided on the following
\nUNMZ website: https:\/\/www.unmz.gov.cz\/statni-zkusebnictvi\/stanovene-vyrobky\/<\/a><\/p>\n

12. What document must accompany the product if it is to be placed on the market,<\/strong>
\nor into service?<\/strong>
\nIf the product is within the scope of Act No. 22\/1997 Coll., on technical requirements for products and on
\namendment and supplementation of certain laws, as amended, is to indicate the specified
\nproducts on the EU market requires the existence of an EC declaration of conformity in accordance with the government regulations that
\nwere issued to implement the above-mentioned law and transpose the European harmonisation regulation,
\nor for the marketing of harmonised construction products, the existence of a declaration of performance
\nin accordance with directly applicable EU legislation, which is the European Regulation as of 1 July 2013
\nNo 305\/2011 of the Parliament and of the Council of 9 March 2011 laying down harmonised
\nconditions for the marketing of construction products and repealing Council Directive 89\/106\/EEC,
\nas corrected. Where a government regulation so provides, the manufacturer shall enclose an EC declaration of conformity
\nto the product. Government regulations of a purely national nature require the existence of declaration of conformity<\/span>that
\nshall, where the government regulation so provides, be attached to the product.
\nFor products placed on the market within the scope of Act No. 90\/2016 Coll., on conformity assessment of specified
\nproducts when they are made available on the market, as amended (hereinafter referred to as \"Act No. 90\/2016\"),
\nthe manufacturer must, where a government regulation so provides, draw up an EU declaration of conformity or other
\na document confirming conformity and, where appropriate, attach it to the product. Other obligations of the manufacturer,
\nauthorised representative, distributor and importer are set out in Act No. 90\/2016.
\nSome government regulations require that other documents, such as the following, must also be attached to the product.
\ninstructions for use.<\/p>\n

13.What is the difference between an authorised, notified and notified person<\/strong>
\nsubject?<\/strong>
\nThe authorised body, the notified body and the notified body are legal persons established
\nunder the Czech legal system, which have been authorised or authorised to perform
\nproduct conformity assessment activities in the field of state testing.
\nAuthorised person<\/span> is in accordance with \u00a7 11 paragraph 1 of Act No. 22\/1997 Coll., on technical
\nrequirements for products as amended (hereinafter referred to as Act No. 22\/1997), the legal entity
\nthe person in charge of the product conformity assessment activities including the assessment of activities
\nrelated to their manufacture or reuse, as the case may be, and as defined in
\ntechnical regulations.
\nAuthorisation shall be granted within the defined scope by the Office by decision on the basis of an application if the applicant
\nmeets the requirements laid down in the legislation. In accordance with Article 11(8) of Act No 22\/1997
\nauthorised persons become notified persons by notification pursuant to Article 7(7)(b)
\nAct No. 22\/1997 or, in the cases provided for in the Government Decree, on expiry of a specified period from
\nnotification, unless the European Commission or the other Member States of the European Union have objected within that period
\nobject to the notification, and may exercise the activities of the notified person from the date of receipt of the notification
\nthe Authority's notification that they have been notified.
\nIn the framework of legislation falling under the so-called New Legislative Framework (NLF) and directly
\napplicable European regulations with entities on the basis of a request pursuant to Act No. 90\/2016 Coll., on
\nassessing the conformity of specified products when they are placed on the market become notified bodies
\n(not authorised persons) pursuant to Sections 19 and 20 of the Act.
\nNote: Sometimes the term 'Notified Body' is used loosely.
\nin an unofficial sense, also for \"Notified Bodies\". In Czech
\nHowever, in legal terminology, the two terms (notified body and notified body) cannot be
\narbitrarily confused, as they are enshrined differently in the legislation.<\/p>\n

14. Where can I get the text of the relevant regulations dealing with the issue<\/strong>
\nstandardization and state testing?<\/strong>
\nThe texts of the relevant regulations are contained in the Collection of Laws of the Czech Republic, which is available on the website
\nMinistry of the Interior<\/a>. EU rules are published in Official Journal of the EU<\/a>.
\nAn up-to-date overview of the regulations dealing with the issue of the \u00daNMZ is also given in
\nat https:\/\/www.unmz.gov.cz\/statni-zkusebnictvi\/informacni-portal-unmz\/pravni-predpisy\/<\/a><\/p>\n

15. Who is responsible for carrying out the conformity assessment?<\/strong>
\nConformity assessment is one of the conditions for placing specified products on the market. It is ensured by
\nthe manufacturer or his authorised representative, or (if provided for by government regulation) the importer
\nor the distributor, in accordance with the conformity assessment procedure laid down for the product concerned in the relevant
\ngovernment regulation or directly applicable EU law.
\nIn doing so, it is always clearly established whether the assessment tasks can be carried out by the manufacturer
\n(importer) himself or whether he must request the performance of certain acts from an authorised (notified)
\nperson or notified body.<\/p>\n

16. When the participation of an authorised (notified) person or<\/strong>
\nnotified body in the conformity assessment process?<\/strong>
\nAct No. 22\/1997 Coll., on Technical Requirements, applies to manufacturers, importers and distributors in the Czech Republic.
\nNo. 22\/1997 as amended (hereinafter referred to as \"Act No. 22\/1997\") and Act No. 90\/2016 Coll., on
\nconformity assessment of specified products when they are made available on the market, as amended
\n(hereinafter referred to as \"Act No 90\/2016\"). For products determined under these Acts, the relevant
\nCzech government regulations or directly applicable EU regulations. List of relevant government regulations
\ncan also be found on the \u00daNMZ website in the section dedicated to state testing.
\nA designated product is a product that poses a heightened level of threat to a legitimate interest
\n(see Section 12(1)(a) of Act No. 22\/1997), and for which compliance must therefore be assessed (see Section 12
\nto \u00a7 13c of this Act), or falls within the scope of Act No. 90\/2016.
\nConformity assessment is one of the conditions for placing specified products on the market. Testing
\nonly those products for which the legislation so provides (see above) shall be subject to mandatory procedures
\nmentioned). Conformity assessment shall be carried out by the manufacturer or his authorised representative, or by the importer
\nor the distributor, by the conformity assessment procedure laid down for the product concerned in the relevant Regulation
\ngovernments. In doing so, it is always clearly stated whether the assessment tasks can be carried out by the manufacturer
\nor his authorised representative, or the importer or distributor himself, or whether any of the following
\nthe acts must be requested from an authorised (notified) person or notified body.
\nIt follows, therefore, that not all specified products must be subjected to compulsory
\ntest procedures involving an authorised (notified body) or notified body. It is
\nthe relevant legislation(s) applicable to the product must always be followed. In view of
\nthe fact that this question does not specify the product, our answer contains only generally applicable
\nstatement.<\/p>\n

17. What is the procedure for the movement of products between Member States?<\/strong>
\nWhen moving goods in the course of business within the territory of EU Member States (or EEA countries)
\nit is the distribution of these goods (supplying them to the market) not their importation. It is an import if it is
\na product from a non-EU country placed on the EU single market. Distributed products that are
\n22\/1997 Coll., on technical requirements for products and on amendments to
\nand amendments to certain laws, as amended (hereinafter referred to as \"Act No. 22\/1997\"), has
\nauthorisation under the regulations to place on the market the manufacturer or his authorised representative in the EU; or
\nthe importer or distributor. The obligations of the distributor arise, inter alia, from Article 13(9) of the Act
\nNo 22\/1997: \"The distributor shall act to prevent the distribution of specified products which
\nmanifestly do not meet the requirements of the law, in particular products not bearing the specified
\nmarking.\" A distributor commits an offence by, inter alia, breaching any of the points listed
\nin Section 19a(3) or (5)(b) of Act No. 22\/1997.
\nWhere the manufacturer or his authorised representative has issued an EC declaration of conformity for a product and has provided
\nthe product is CE marked, the distributor is not obliged to have this declaration available. But in view of
\nany problems with the distributed product in connection with market surveillance
\nwe recommend that you obtain a declaration of conformity.
\nSimilarly, the movement of goods in the course of trade within EU Member States
\ndescribed in Act No. 90\/2016 Coll., on conformity assessment of specified products when they are supplied to the
\nthe market. The distributor's obligations under the Act are set out in Article 9 of the same Act.
\nIn the case of specified products which do not fall within the European harmonised area, the
\nmarketing in other EU Member States to take advantage of Regulation (EU)
\n2019\/515 of 19 March 2019 on mutual recognition of goods listed in accordance with the legal
\nregulations to the market in another member state and repealing regulation (EC) No 764\/2008 (https:\/\/eurlex.europa.eu\/legal-content\/CS\/ALL\/?uri=CELEX:32019R0515<\/a>).<\/p>\n

18. BREXIT-how to proceed when importing products into the UK?<\/strong>
\nThe United Kingdom of Great Britain and Northern Ireland has published information on imports of products into
\nUK market. More information can be found on this website:
\nGuidance on using the UKCA marking<\/a>
\nGuidance on using the UKNI marking<\/a>
\nGuidance on placing goods on the market in Great Britain<\/a>
\nGuidance on placing goods on the market in Northern Ireland<\/a>
\nA-Z of industry guidance to understand requirements for product types<\/a>
\nUKMCAB database of UK conformity assessment bodies (approved bodies)<\/a>
\nGuidance on placing construction products on the market in Great Britain<\/a>
\nGuidance for regulating medical devices in the UK<\/a>
\nGuidance on placing Civil Explosives on the market<\/a>
\nGuidance on restrictions of Hazardous Substances in Electrical and Electronic Equipment (RoHS<\/a>
\nand EEA) Regulations
\nGuidance for rail interoperability<\/a>
\nGuidance for the manufacturing and marketing of fertilisers<\/a>
\nGuidance for designated standards for cableway installations<\/a><\/p>\n

19. How is the conformity assessment of products carried out?<\/strong>
\nConformity assessment is mandatory only for those products for which the legislation so provides.
\nProcedures for conformity assessment of specified products are specified in government regulations
\n22\/1997 Coll., on technical requirements for products and on amendments and
\nsupplementing certain laws, as amended (hereinafter referred to as \"Act 22\/1997\"), Act No.
\n90\/2016 Coll., on conformity assessment of products when they are supplied to the market, as amended
\n(\"Act No 90\/2016\") or in a directly applicable EU regulation.
\nConformity assessment of pyrotechnic products is regulated by Act No. 206\/2015 Coll., on
\npyrotechnic articles and their treatment and on amendments to certain acts (Act on
\npyrotechnics), as amended, and Government Regulation No. 208\/2015 Coll., on technical
\nrequirements for pyrotechnic articles and their placing on the market. Information on the individual regulations
\nthe government and the scope of activities of authorised persons (notified bodies) and notified bodies
\nare available on the \u00daNMZ website www.unmz.cz<\/a> in the state testing sector.
\nThe MHRA does not decide whether a product is or is not a specified product, nor is it empowered to
\non the interpretation of Act No. 22\/1997, Act No. 90\/2016, the Pyrotechnics Act and Government Regulations
\nissued for their implementation. The Authority is only giving its opinion on the issue in question.<\/p>\n

20. How should I proceed when placing construction products on the market?<\/strong>
\n(1) Where a harmonised standard applies to a construction product, the following shall be followed
\nRegulation 305\/2011 of the European Parliament and of the Council (\"CPR\"). The detailed procedure for
\nmarketing of construction products with CE marking is described in the Information Portal at the link:
\nhttps:\/\/www.sgpstandard.cz\/editor\/unmz\/?u=stav_vyr\/1_29a_postup.htm<\/a>
\n2) Where there is no harmonised standard for a construction product or where the product
\ndeviates significantly from it, the manufacturer has a choice between two paths:
\nIf a manufacturer would like to CE mark a product, he can apply withubject for technical<\/a>
\nassessment (TAB) on the issue of eEuropean Technical Assessment (ETA)<\/a> according to the European
\nAssessment Document (EAD). The list of mTABs is given here: EUROPA - European<\/a>
\nCommission - Growth - Regulatory policy - NANDO
\nIf it is not interested in CE marking, it shall place its product on the market in accordance with Government Regulation No. 163\/2002
\nColl., laying down technical requirements for selected construction products, as amended
\n163\/2002 Coll.). The detailed procedure can be found here:
\nhttp:\/\/www.sgpstandard.cz\/editor\/unmz\/?u=stav_vyr\/1_29b_postup.htm<\/a>
\nCurrent list of bodies authorised to act as independent third party assessors
\nconformity (i.e. either authorised persons according to NV No. 163\/2002 Coll. or notified bodies according to
\nRegulation (CPR), can be found on the website of the Ministry of Health: https:\/\/www.unmz.gov.cz\/statni\/zkusebnictvi\/autorizovane-osoby-oznamene-subjekty\/seznam-ao-os-a-uno\/<\/a>
\nFurther information regarding the marketing of construction products is available at
\nthe websites of the IOMH and the European Commission:
\nhttps:\/\/www.unmz.gov.cz\/statni-zkusebnictvi\/informacni-portal-unmz\/informacni-portal-unmz-specializovany-na-pravni-a-technicke-dokumenty-v-oblasti-uvadeni-stavebnich-vyrobku-na-jednotny-evropsky-trh-c233\/<\/a>
\nhttps:\/\/ec.europa.eu\/growth\/sectors\/construction\/construction-products-regulation-cpr_<\/a>en
\nQuestions can be sent to the Contact Point for Construction Products at the MIT:
\nhttps:\/\/www.mpo.cz\/cz\/stavebnictvi-a-suroviny\/kontaktni-misto-pro-stavebni-vyrobky\/<\/a><\/p>\n

21. How should I proceed when placing machinery on the market?<\/strong>
\nAct No. 22\/1997 Coll. applies to manufacturers, importers and distributors of machinery in the Czech Republic,
\non technical requirements for products and on amendment and supplementation of certain acts, as amended by
\nas amended (hereinafter referred to as \"Act No. 22\/1997\").
\nThe relevant Government Regulations of the Czech Republic shall apply to products specified under this Act. For machinery
\nGovernment Regulation No. 176\/2008 Coll., on technical requirements for machinery, as amended by
\nNo. 176\/2008), which introduced into the Czech legal order
\ntransposed Directive 2006\/42\/EC of the European Parliament and of the Council on machinery (hereinafter referred to as \"the Directive
\n2006\/42\/EC\").
\nAll explanatory information related to the application of Directive 2006\/42\/EC can be found at
\nEuropean Commission website http:\/\/ec.europa.eu\/growth\/sectors\/mechanicalengineering\/machinery\/<\/a> and in particular in the revised Guide to the application of the Directive
\n2006\/42\/EC for machinery \"Guide to application of Directive 2006\/42\/EC - Edition 2.1 -<\/a>
\nJuly 2017\", currently published in English only. The handbook is also used in
\nthe application of Regulation No 176\/2008.
\nMachinery that complies with the subject matter and definitions of the above mentioned NV No. 176\/2008 shall be
\nare generally covered by other government regulations, e.g. in the field of electromagnetic compatibility: the
\n117\/2016 Coll., on the assessment of conformity of products with regard to electromagnetic compatibility
\nwhen making them available on the market, transposing the Directive of the European Parliament
\nand Council 2014\/30\/EU on the harmonisation of the laws of the Member States relating to
\nelectromagnetic compatibility and which was issued to implement Act No. 90\/2016 Coll,
\non the assessment of conformity of specified products when made available on the market, as amended
\n(hereinafter referred to as \"Act No. 90\/2016\"), electrical equipment intended for use within certain limits
\n118\/2016 Coll., on conformity assessment of electrical equipment intended for
\nuse within certain voltage limits when placed on the market, transposing the Directive
\n2014\/35\/EU of the European Parliament and of the Council, on the harmonisation of the laws of the Member States
\nrelating to the supply of electrical equipment intended for use within certain voltage limits to
\nmarket and which was also issued to implement Act No. 90\/2016.
\nIn terms of other regulations, we recommend considering whether machinery is also covered by the Government Regulation
\nNo. 116\/2016 Coll. on conformity assessment of equipment and protective systems intended for use
\nin an explosive atmosphere or Government Regulation No. 481\/2012 Coll., on restrictions on the use of
\ncertain hazardous substances in electrical and electronic equipment.
\nAttention should be paid to Annex 4 to the National Instrument No. 176\/2008 (Directive 2006\/42\/EC), which stipulates
\nthe categories of machinery for which the conformity assessment procedure with the involvement of a third party must be applied
\nindependent parties - Notified Persons. For other machinery falling within the scope of
\nNo. 176\/2008 (Directive 2006\/42\/EC), the conformity assessment is carried out by the manufacturer.<\/p>\n

22. How to assess the conformity of pressure equipment?<\/strong>
\nPressure equipment is assessed according to Government Regulation No. 219\/2016 Coll., on conformity assessment of pressure equipment
\nequipment when making available on the market, transposing EU Directive 2014\/68\/EU
\non the harmonisation of the laws of the Member States relating to the placing on the market of pressure equipment.
\nThe conformity assessment of simple pressure vessels shall be carried out in accordance with the Government Regulation
\n119\/2016 Coll., on conformity assessment of simple pressure vessels when they are supplied to the market,
\nwhereby this Government Regulation transposes EU Directive 2014\/29\/EU on the harmonisation of legal
\nMember States' rules on the placing on the market of simple pressure vessels.
\nThe conformity assessment of transportable pressure equipment shall be carried out in accordance with Government Regulation No.
\n208\/2011 Coll., on technical requirements for transportable pressure equipment, which transposes
\nEU Directive 2010\/35\/EU on transportable pressure equipment and repealing Council Directives
\n76\/767\/EEC, 84\/525\/EEC, 84\/526\/EEC, 84\/527\/EEC and 1999\/36\/EC.
\nindividual government regulations, the conformity assessment of products subject to the requirements of the above
\nthe above-mentioned government regulations, the obligatory participation of the notified body or authorised\/notified
\npersons, except where such mandatory participation in the conformity assessment of the product as required above
\nof these government regulations is not required and is solely the responsibility of the manufacturer to implement
\nconformity assessment of the product. With the mandatory participation of a notified body, resp.
\nauthorised\/certified persons (transportable pressure equipment) is then the output document
\na certificate issued by the body or person providing information that the following are met
\nall relevant product requirements under some of the above government regulations.
\nUpon successful demonstration of conformity of the product, the manufacturer shall mark the product with the required conformity marking
\n(CE, \u03c0, Pi) and draw up a written EU declaration of conformity (or declaration of conformity). Proof of conformity
\nof the product with the requirements of the relevant government regulation, the manufacturer shall carry out the following on the basis of the use of
\nrelevant harmonised standards to the given government regulation or directive - presumption of conformity.
\nWhere non-harmonised standards are used, the manufacturer shall provide further evidence that the relevant
\nthe requirements of the applicable government regulation.
\nThe above mentioned government regulations \/ EU directives can be found on the \u00daNMZ website, in the section State
\nTesting\/specified products, under the name pressure equipment, simple pressure vessels,
\ntransportable pressure equipment (https:\/\/www.unmz.gov.cz\/).
\nFor pressure equipment (according to Government Regulation No. 219\/2016 Coll.), the following are available on the \u00daNMZ website
\n\u00daNMZ\/Proceedings current published Czech version of \"Rules for the application of Directive 2014\/68\/EU
\n(PED) - Pressure Equipment\", these rules are the working material for the application of the Directive
\n2014\/68\/EU, are developed in working groups of the European Commission and agreed
\nEU member states. Link to the English version published on the European Commission website:
\n\"Guidelines - pressure equipment directive 2014\/68\/EU\".
\nThere is also a link to the public sector CIRCABC on the \u00daNMZ website, where it is possible to
\nFind administrative decisions for transportable pressure equipment (Government Regulation No. 208\/2011
\nColl.): \"TPED\".<\/p>\n

23.How to assess conformity for lifts?<\/strong>
\nThe conformity assessment of new lifts is carried out in accordance with Government Regulation No. 122\/2016 Coll., on
\nconformity assessment of lifts and their safety components (hereinafter referred to as \"Government Regulation
\nNo. 122\/2016\") issued to implement Act No. 90\/2016 Coll., on conformity assessment of specified
\nproducts when they are made available on the market (hereinafter referred to as \"Act No 90\/2016\"). The text of this Regulation can be found in
\non the \u00daNMZ website www.unmz.cz<\/a> in the section on state testing in the sector
\nspecified products for lifts. The obligations of the supplier of lifts are set out in the Special
\nprovisions for certain other products (TITLE II Section 1 \u00a7 28, \u00a7 29 and \u00a7 30) of Act No. 90\/2016.
\nThe Government Regulation incorporates Directive 2014\/33\/EU of the European Parliament and of the Council on the harmonisation of
\nMember States' legislation on lifts and safety components for lifts and
\nregulates the technical requirements for lifts and safety components for lifts, which must
\ncomply with, when placed on the market or put into service, the conditions and procedures for the supply of safety
\ncomponents for lifts on the market and methods of conformity assessment. Conformity assessment procedures for
\nsafety components for lifts are specified in \u00a7 10 of Government Regulation No. 122\/2016, assessment procedures
\nconformity for lifts is laid down in \u00a7 11 of the same government regulation.
\nExplanatory information can be found on the European Commission's website
\nhttp:\/\/ec.europa.eu\/growth\/sectors\/mechanical-engineering\/lifts_en<\/a>, in particular in the Handbook
\nfor the application of Directive 2014\/33\/EU lifts https:\/\/ec.europa.eu\/docsroom\/documents<\/a>\/29961
\nFor lifts and safety components for lifts that meet the subject matter and definitions above
\n122\/2016 are generally subject to other government regulations, e.g. in the field of
\nelectromagnetic compatibility: government regulation no. 117\/2016 Coll., on the assessment of conformity of products from
\nfor electromagnetic compatibility when making available on the market, transposing the Directive
\n2014\/30\/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States
\nconcerning electromagnetic compatibility and which was issued to implement Act No. 90\/2016.
\nFor further information, we recommend e.g. the information service http:\/\/vytahy.tzb-info.cz<\/a>who
\nincludes information, interpretations and opinions on the application of legislation and technical standards to new
\nand elevators in operation. For information on technical standards, we recommend
\nthe website of the Czech Agency for Standardization https:\/\/www.agenturacas.gov.cz<\/a>\/<\/p>\n

24. How to assess the conformity of products intended for hazardous environments <\/strong>explosion?<\/strong>
\nIf your company wants to manufacture and market a product intended for hazardous environments
\n116\/2016 Coll., on the assessment of
\nconformity of equipment and protective systems intended for use in potentially explosive atmospheres in
\ntheir marketing. If your product falls into a category that requires an assessment
\ncompliance with the participation of a notified body, then you can contact FTZ\u00da, s.p. - notified body in the Czech Republic
\n1026. Address, contacts and further information on the assessment of specific products can be found at
\ninternet address: https:\/\/www.ftzu.cz<\/a>\/.
\nThe text of the aforementioned government regulation or the relevant directive (2014\/34\/EU), the list of
\nharmonised standards etc. can be found on the website:
\nhttps:\/\/www.unmz.gov.cz\/urad\/zarizeni-a-ochranne-systemy-urcene-pro-pouziti-v-prostredi-s -no-specific-explosion<\/a>
\nFinally, we would like to remind you that, depending on the nature of the product, additional
\nregulations, e.g. government regulation no. 176\/2008 Coll., on technical requirements for machinery, no.
\n117\/2016 Coll., on conformity assessment of products in terms of electromagnetic compatibility in their
\nmarket supply, etc.<\/p>\n

25. How to proceed when placing toys on the market?<\/strong>
\nFor toys, the relevant requirements of Government Regulation No. 86\/2011 must be met in order to place the product on the market
\nColl., as amended (hereinafter referred to as \"NV No. 86\/2011\").
\nIn accordance with NV No. 86\/2011 (or Directive 2009\/48\/EC of the European Parliament and of the Council), the manufacturer or its
\nbefore placing the toy on the market, the authorised representative shall confirm the conformity of the toy with the essential
\nthe requirements of Regulation (EC) No 86\/2011 by affixing the CE marking to the toy in accordance with Article 13 of Regulation (EC) No 86\/2011 and
\ndraw up an EC declaration of conformity in accordance with Annex 3 of NV No 86\/2011 (By drawing up this
\nthe manufacturer's declaration confirms and accepts responsibility for the compliance of the toy with the essential requirements
\nNo 86\/2011), using the conformity assessment procedures according to Part Four of NV No 86\/2011
\nincluding a safety assessment according to \u00a7 15 of NV No. 86\/2011. The essential requirements of NV No 86\/2011 are
\nare considered to be met in particular if they comply with harmonised standards.
\nIt should be emphasised that only the manufacturer or his authorised representative may affix the CE marking to a toy.
\nrepresentative, and likewise the declaration of conformity may only be drawn up by the manufacturer or his authorised representative
\nDeputy.
\nThe importer's obligations relate in particular to verifying and ensuring that the manufacturer complies with the obligations before
\nplacing the toy on the market, marking the toy with its identification data, keeping a copy of the EC
\ndeclaration of conformity and more. The distributor's obligations relate in particular to verifying that the toy is
\ndelivered in accordance with the requirements of the relevant regulations, with all the relevant requirements.
\nIn assessing whether the products in question are toys and for which age category they should be
\nintended, particular use can be made of the guidance on the interpretation of the Toy Safety Directive set out at
\nPage https:\/\/ec.europa.eu\/growth\/sectors\/toys\/safety\/guidance_cs. Czech translations of some of the
\nThese can be found here: https:\/\/www.unmz.gov.cz\/urad\/preklady-pokynu-z-expertni-skupiny-pro-bezpecnost-hracek-ustavene-evropskou-komisi (please note that translations may not include
\nsubsequent revisions made to the original document). In the guidelines you can find, among other things, instructions for
\nthe assessment of so-called 'grey zone' products, i.e. those where there is doubt as to whether they belong to
\nthe scope of the Directive.
\nAnnex 1 to NV 86 sets out exemptions for products that are not considered toys.
\nPlacing on the market is defined by Act No. 22\/1997 Coll., as amended, in its Section 2(b).
\nHowever, the term 'placing on the market' refers to each individual product, not to the type of product, namely
\nwhether it was produced as a single unit or as a series.
\nGovernment regulations and other information relating to toys are available on this website of the Ministry of Health:
\nhttps:\/\/www.unmz.gov.cz\/statni-zkusebnictvi\/stanovene-vyrobky<\/a>\/ and on the European
\nCommission https:\/\/single-market-economy.ec.europa.eu\/sectors\/toys_en<\/a><\/p>\n

26. How to proceed when placing personal protective equipment (PPE) on <\/strong>market?<\/strong>
\nThe placing on the market of personal protective equipment shall be in accordance with directly applicable
\nRegulation (EU) No 2016\/425 of the European Parliament and of the Council (\"Regulation 2016\/425\") of
\nof 9 March 2016, on personal protective equipment (PPE) and repealing Directive
\nCouncil 89\/686\/EEC. The categories of PPE are now set according to the type of risk, no longer according to the type of
\nPPE. There have been some changes in the following categories.
\nThe technical requirements for PPE, referred to as \"Essential Requirements for the Protection of Health and
\nsecurity\" are set out in Annex II to Regulation (EU) 2016\/425.
\nThe Regulation also sets out, among other things, the product requirements and the details of the conformity assessment procedure. Provide
\nonly the manufacturer or his authorised representative may CE mark the product, and the EU
\nthe declaration of conformity, which shall accompany each item of PPE, may be drawn up only by the manufacturer or his
\nauthorised representative. For more information on personal protective equipment, please visit:
\nhttps:\/\/www.unmz.gov.cz\/urad\/osobni-ochranne-prostredky<\/a>
\nGuidance on the use of PPE - Guide to the application of Regulation 2016\/425 on personal data
\nprotective equipment: https:\/\/ec.europa.eu\/docsroom\/documents\/29201<\/a> . In Annex 20 of the Manual
\nto Regulation (EU) 2016\/425 for guidance on categorising PPE.
\nCurrent list of harmonised standards for Regulation 2016\/425 published in the Official Journal
\nThe European Union is listed in this link: https:\/\/ec.europa.eu\/docsroom\/documents\/46431<\/a>. Here is
\ninformation should be sought as to whether a particular standard is harmonised, i.e. whether it provides a presumption
\ncompliance.<\/p>\n

27. How to proceed when placing electrical and electronic products on the market?<\/strong>
\nIf the product falls under Government Regulation No. 118\/2016 Coll., on conformity assessment of electrical
\nequipment intended for use within certain voltage limits when placed on the market (hereinafter referred to as 'NV
\nNo. 118\/2016\") or Government Regulation No. 117\/2016 Coll., on the assessment of conformity of products with regard to
\nelectromagnetic compatibility in their placing on the market (hereinafter referred to as \"NV No. 117\/2016\"), is according to
\nof these NVs shall be entitled to draw up an EC declaration of conformity and affix the CE marking to the product only
\nthe manufacturer or its authorised representative established in the EU.
\nIf the product falls under Government Regulation No. 426\/2016 Coll., on conformity assessment of radio equipment
\nwhen placing them on the market (hereinafter referred to as \"NV No 426\/2016\"), it is not necessary to declare compliance with the basic
\n118\/2016 or 117\/216, as the basic requirements according to NV no.
\n426\/2016 include both electrical safety and electromagnetic compatibility requirements. U
\nfor the specified products covered by NV No 426\/2016, only the EU Declaration of Conformity can be issued
\nto NV No. 426\/2016.
\nFurther requirements relating to the placing on the market of electrical and electronic products are set out in
\nin the government regulations referred to in this point.<\/p>\n

28. How to proceed with the marketing of medical devices and diagnostic<\/strong>
\nin vitro medical devices on the market?<\/strong>
\nThe manufacturer is obliged to determine whether its product falls under the EP and Council Regulation (EU) 2017\/745 on
\nmedical devices, amending Directive 2001\/83\/EC, Regulation (EC) No 178\/2002 and Regulation
\n(EC) No 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC ('MDR'); or
\nRegulation (EU) 2017\/746 of the European Parliament and of the Council on in vitro diagnostic medical devices and
\nrepealing Directive 98\/79\/EC and Commission Decision 2010\/227\/EU (hereinafter referred to as the IVDR). If the product
\nit is a medical device as defined in Article 2 of the MDR or IVDR or it is
\ncovered by Article 1(2) of the MDR, then the manufacturer, importer, distributor or authorised representative
\nfollow Articles 10, 11, 13 and 14 of the MDR and IVDR and other relevant articles of the MDR and IVDR.
\nin case of ambiguity as to whether a product falls under MDR or IVDR it is possible to request a legally binding
\nan opinion from the competent authority of the Member State. In the Czech Republic, this competent authority is
\nauthority, the State Institute for Drug Control (hereinafter referred to as S\u00daKL), which issues the relevant opinion for
\nfee.
\nIn the case of placing medical devices on the Czech market, it is also necessary to comply with Act No. 375\/2022 Coll., on medical devices and in vitro diagnostic medical devices, as amended, which adapts MDR and IVDR to the Czech legal system.<\/p>\n

The European Commission issues a number of clarification documents on the individual MDR requirements and
\nIVDR and it is highly recommended to follow these documents. All documents are published on
\nEuropean Commission website in English and some of them are also available in Czech
\non the S\u00daKL website.
\nhttps:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en#sec3<\/a>
\nhttps:\/\/www.niszp.cz\/cs\/doporucujici-pokyny-ek-cz<\/a><\/p>\n

29. Who should I contact with questions about medicines?<\/strong>
\nMedicinal product means a medicinal product falling within the definition set out in Article 2 of Act No 378\/2007
\nColl., on Medicinal Products and on Amendments to Certain Related Acts (hereinafter referred to as the \"Medicinal Products Act\"). Most
\ntasks in the field of pharmaceuticals are ensured by the State Institute for Drug Control (hereinafter referred to as \"S\u00daKL\") and the Ministry of
\nHealth (hereinafter referred to as \"MZ\").
\nQuestions about medicines can be directed to one of the following public institutions. Other bodies that
\nare involved in the provision of medicines are listed in Title 2 of the Medicines Act including their
\nThe Authority is not involved in any of the tasks relating to the field of pharmaceuticals except for marketing
\nmedical devices with the drug.<\/p>\n

30. Who do I contact with questions about food?<\/strong>
\nFood is regulated by Act No. 110\/1997 Coll., on Food and Tobacco
\nproducts and amending and supplementing certain related laws. State supervision over compliance with
\nthe obligations laid down in this Act shall be carried out pursuant to Section 14 of the Foodstuffs Act by (a) the authorities
\npublic health protection, namely the regional sanitary stations, the Ministry of Defence and the Ministry of
\nthe State Veterinary Administration, b) the State Agricultural and Food Inspection Authority.
\nQuestions about food can be addressed to one of the following public institutions. The Authority is not involved
\non any of the food-related tasks.<\/p>\n

31. Who should I contact with questions about cosmetics?<\/strong>
\nAn overview of the legislation regulating the import of cosmetic products as well as a link to
\nThe National Reference Centre for Cosmetics, which also performs reference tests on cosmetic
\nproducts can be found on the website of the National Institute of Health under the following links.
\nhttps:\/\/szu.cz\/temata-zdravi-a-bezpecnosti\/kosmeticke-pripravky\/<\/a>
\nThe manual of the Ministry of Health on imports from third countries can be used, which summarizes the
\nimportant requirements for their marking:
\nhttps:\/\/www.mzcr.cz\/pozadavky-na-uvedeni-kosmetickych-pripravku-ze-zemi-mimo-evropskou-unii-na-trh-eu-dovoz<\/a>\/<\/p>\n

Manual for distributors (the product has already been accepted in the EU by another Member State)
\nhttps:\/\/www.mzcr.cz\/pozadavky-na-distribuci-kosmetickych-pripravku-na-uzemi-evropske-unie\/<\/a>.
\nFurther questions regarding cosmetics can be addressed to the State Institute of Health. The Authority is not involved
\non any of the cosmetics assignments.<\/p>\n

32. What is the procedure for placing non-specified products on the market?<\/strong>
\nIf the product is not specified by any of the government regulations issued to implement Law no.
\n22\/1997 Coll., on technical requirements for products, as amended, nor to implement
\nAct No. 90\/2016 Coll., on conformity assessment of specified products when they are placed on the market in
\nas amended, or Act No. 206\/2015 Coll,
\non pyrotechnic articles and their treatment and on amendments to certain acts (Act on
\npyrotechnics), as amended, laying down technical requirements for so-called specified
\nproducts, i.e. products which present a higher degree of threat to a legitimate interest and for which
\ntherefore, compliance with the requirements of these regulations must be assessed, the assessment procedures are not applicable
\ncompliance under this legislation.
\nHowever, all products placed on the market must comply with, among other things: regulation (EU) of the European Parliament and of the Council 2023\/988<\/a> of 10 May 2023 on general product safety, amending Regulation (EU) No. 1025\/2012<\/a> and Directive (EU) of the European Parliament and of the Council 2020\/1828<\/a> and repealing the Directive of the European Parliament and of the Council 2001\/95\/EC<\/a> and Council Directive 87\/357\/EEC<\/p>\n

and Act No. 634\/1992 Coll., on Consumer Protection, as amended by
\nas amended. These laws do not fall within the competence of the \u00daNMZ, but within the competence of the
\nMinistry of Industry and Trade of the Czech Republic, where you can get more information about them.
\nThe manufacturer must also identify other legislation that applies to his product and follow
\nin accordance with them. All national legislation can be found in the Collection of Laws. European
\nthe regulations are available in the Official Journal of the European Union
\nFor your information, we also present the possibility of voluntary certification, whereby at the request of the manufacturer, importer
\nor other persons, accredited persons may certify by issuing a certificate that the product complies with
\nwith the technical requirements specified in the certificate (see Section 10(1)(b) of Act No. 22\/1997 Coll.).
\nThe scope of the voluntary certification shall in principle be governed by the requirements of the client and the purpose for which it is to
\nthe certificate can be used.
\nThe list of accredited entities including the subject of accreditation is available on the website
\nCzech Institute for Accreditation http:\/\/www.cia.cz\/<\/a><\/p>\n

There is much to explore<\/strong><\/p>\n

Visit other parts of our website to find out more.<\/strong><\/p>","protected":false},"excerpt":{"rendered":"

Upozorn\u011bn\u00ed: \u00daNMZ nen\u00ed z\u00e1konem \u010d. 22\/1997 Sb., o technick\u00fdch po\u017eadavc\u00edch na v\u00fdrobky, ve zn\u011bn\u00ed pozd\u011bj\u0161\u00edch p\u0159edpis\u016f (d\u00e1le jen z\u00e1kon 22\/1997 Sb.), zmocn\u011bn k jeho v\u00fdkladu a ani k v\u00fdkladu jednotliv\u00fdch na\u0159\u00edzen\u00ed vl\u00e1dy vydan\u00fdch k jeho proveden\u00ed, kter\u00fd by byl pro kohokoliv z\u00e1vazn\u00fd. Odbor st\u00e1tn\u00edho zku\u0161ebnictv\u00ed \u00da\u0159adu pro technickou normalizaci, metrologii a st\u00e1tn\u00ed zku\u0161ebnictv\u00ed (d\u00e1le jen […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":1763,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_seopress_robots_primary_cat":"","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","_lmt_disableupdate":"no","_lmt_disable":"","footnotes":""},"class_list":["post-1765","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/pages\/1765","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/comments?post=1765"}],"version-history":[{"count":2,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/pages\/1765\/revisions"}],"predecessor-version":[{"id":12200,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/pages\/1765\/revisions\/12200"}],"up":[{"embeddable":true,"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/pages\/1763"}],"wp:attachment":[{"href":"https:\/\/unmz.gov.cz\/en\/wp-json\/wp\/v2\/media?parent=1765"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}