Frequently Asked Questions - Testing
Warning: 22/1997 Coll., on technical requirements for products, in
as amended (hereinafter referred to as Act No. 22/1997 Coll.), is empowered to interpret it or to
individual government regulations issued to implement it, which would be binding on anyone.
Department of State Testing of the Office for Technical Standardization, Metrology and State Testing
(hereinafter referred to as "the Office") is responsible in particular for the provision of state testing within the scope of
22/1997 Coll., on technical requirements for products and on amendment and supplementation
90/2016 Coll., on conformity assessment
of specified products when they are made available on the market, as amended, and Act No.
206/2015 Coll., on pyrotechnic articles and their handling and on amendments to certain acts (Act
on pyrotechnics) and directly applicable EU legislation on the marketing of products.
Please note that it is not for the Authority to assess or decide whether particular products are
specified products within the meaning of Section 12 of Act No. 22/1997 Coll., on technical requirements for
products and amending and supplementing certain laws, as amended, and whether they fall within
the scope of the relevant government regulation or directly applicable EU regulation.
It is the responsibility of the manufacturer, importer or distributor, as the case may be, to decide which legislation
apply to the products of its interest. Nor is the Authority empowered to give an interpretation of the law or
to interpret the implementing regulations based on it. Thus, the answer to your question can also be considered
only as an expression of the opinion of the Office, which cannot be binding on anyone.
1. Who can I contact when placing products on the internal market?
2. What is the internal market?
3. When is the product placed on the market and when is it put into operation?
4. What are the obligations of economic operators when placing or supplying products on
the internal market?
5. What is the difference between authorization and accreditation in the sense of the Technical Requirements Act
on products?
6. How do I request an authorisation, notification or designation?
7. Does every product have to be CE marked? Where do I get the CE marking and who marks the product
Is he?
8. What is voluntary certification under the Technical Requirements Act?
on products?
(9) The specified products are specified in government regulations issued to implement this
law, with the CE marking applying only to those regulations which transpose directives
EC where this product marking applies.
10. What should I do if the product is not CE marked and the customer asks me to do so?
Can I label the product myself?
11. Do all products in the Czech Republic have to undergo testing procedures? What is a specified
product and how is its conformity assessment carried out? What products are specified
for conformity assessment when they are placed on the market?
12. What document must accompany the product if it is to be placed on the market or, if applicable, in
operation?
13. What is the difference between an authorised, notified and notified body?
14. Where can I get the text of the relevant regulations dealing with standardisation and
of the state testing department?
15. Who carries out the conformity assessment?
16. When the participation of an authorised (notified) person or notified body is necessary
of the subject in the conformity assessment process?
17. What is the procedure for the movement of products between Member States?
18. BREXIT-how to proceed when importing products into the UK?
19. How is the conformity assessment of products carried out?
20. How should I proceed when placing construction products on the market?
21. How should I proceed when placing machinery on the market?
22. How to assess the conformity of pressure equipment?
23. How to assess conformity for lifts?
24. How to assess conformity for products intended for use in potentially explosive atmospheres?
25. How to proceed when placing toys on the market?
26. What is the procedure for placing personal protective equipment (PPE) on the market?
27. How to proceed when placing electrical and electronic products on the market?
28. How to proceed with the marketing of medical devices and diagnostic medical devices
in vitro devices to the market?
29. Who should I contact with questions about medicines?
30. Who do I contact with questions about food?
31. Who should I contact with questions about cosmetics?
32. What is the procedure for placing non-specified products on the market?
1. Who can I contact when placing products on the internal market?
The Product Contact Point (ProCoP) offers free advice on the marketing of products
the EU internal market. In particular, it provides information on what technical requirements apply to a given product
Apply.
https://www.mpo.cz/cz/zahranicni-obchod/podnikani-v-EU/sluzby-pro-podnikatele-na-vnitrnimtrhu-eu/procop/default.htm
In the field of building products: https://eur-lex.europa.eu/legalcontent/CS/TXT/HTML/?uri=CELEX:52022XC0629(04)&from=EN
Furthermore, the Commission Communication - "Blue Guide" on the implementation of the EU product rules 2016
available here: https://eur-lex.europa.eu/legal-content/CS/TXT/?uri=CELEX:52016XC0726(02)
We recommend you to use the information from the publication "Placing products on the European internal market
Economic Area Procedures of economic operators Testing, inspection and
Certification Organisations of the Czech Republic - EU Member State (Version 2021)", which is available for download
on the page https://www.unmz.cz/statni-zkusebnictvi/program-rozvoje-zkusebnictvi/.
2. What is the internal market and the principle of mutual recognition?
The European Union's internal market is made up of the territory of all 27 EU Member States.
was and is to give rise to a space in which the so-called four fundamental freedoms apply, namely: free movement
goods, persons, services and capital.
Ensuring the free movement of goods is the cornerstone of a functioning EU internal market, and thus of the free movement of goods.
fair competition between market players. A number of products are at EU level
harmonised through specific sectoral regulations (machinery, such
equipment, toys, etc.). However, if products are not harmonised at European level, or only
In part, the free movement of goods is ensured through the principle of mutual recognition. According to
this principle, a Member State must authorise the placing on its market of a product if that product is
legally produced or traded in another Member State. Legally, this principle is anchored in
Regulation (EU) 2019/515 of the European Parliament and of the Council on mutual recognition of goods
lawfully placed on the market in another Member State and repealing Regulation
(EC) No 764/2008.
Member States recognise that even if products are manufactured in accordance with other regulations, standards
or procedures other than their own, these in principle guarantee a comparable level of safety and
they cannot deny them access to their market. In addition to EU Member States, the principle of reciprocity
recognition also applies to the Member States of the European Economic Area (i.e. in addition to the Member States of the
EU countries (Norway, Liechtenstein and Iceland) and Turkey, see more on: the principle of reciprocity
recognition in the internal market for goods and the procedure under Article 5 of the Regulation | MIT
3. When is the product placed on the market and when is it put into operation?
The definition of the terms "placing on the market" and "putting into service" is set out in Section 2
Act No. 22/1997 Coll., on technical requirements for products and on amendment and supplementation of certain
laws, as amended.
A product is placed on the market when it is first supplied in the course of a commercial activity. Supply means
the transfer or offer to transfer a product or the transfer of title to a product for the purpose of
distribution, use or consumption on the market of the European Union, unless a specific law provides otherwise. For
placed on the market shall also be deemed to include products manufactured or imported for operational purposes in the course of their own
the business of manufacturers or importers and products made available for re-use, if they are before
reuse, compliance with the legislation is assessed where this is provided for by government regulation.
Where necessary, the Government shall, by regulation, further define the concept of placing on the market for products to which
this Technical Regulation applies.
A product is put into service when it is first used by a user in the Member States of the European
union for the purpose for which it was made; where a government regulation so provides, the product shall be put into
operation at the time it is prepared or provided for such use. If the product is put
into operation in the workplace, the user is the employer.
For the purposes of Act No. 90/2016 Coll., on conformity assessment of specified products when they are supplied to
market, as amended, the placing on the market shall similarly mean the first supply of a product on
the European Union market.
Act No. 90/2016 Coll., on conformity assessment of specified products when they are supplied to the market, as amended by
does not provide for a uniform definition of "putting into service", however, in selected
cases, Part Two of this Act or government regulations by which the government
sets out the products to be assessed for conformity and the technical requirements that the products must meet
when placed on the market, put into service or used, including for personal use
the need of the manufacturer. These include recreational craft, pressure equipment, radio equipment or
meters or the directly applicable European regulation on gaseous fuel appliances.
4. What are the obligations of economic operators when marketing or supplying
products on the internal market?
The placing of products on the internal market is governed in particular by Act No. 102/2001 Coll., on general safety
22/1997 Coll., on technical requirements for products and Act No. 90/2016 Coll,
on the assessment of the conformity of specified products when made available on the market.
The basic rules can be found in the AAAO publication: placing products on the internal market
European Economic Area, Operator Procedures, version 2021.
News | IMPnet website (aaao.cz)
This document is intended primarily for manufacturers (located anywhere, incl. Czech Republic -
Czech Republic), placing products on the European Economic Area market. It is also intended for importers
products into the European Economic Area, their distributors and also their authorised
representatives of manufacturers established in countries of the European Economic Area, in particular
based in the Czech Republic.
5. What is the difference between authorization and accreditation in the sense of the Technical
product requirements?
The difference between accreditation and authorization results from Act No. 22/1997 Coll., on Technical Requirements
on products and amending and supplementing certain acts, as amended (hereinafter referred to as the "Act
č. 22/1997").
Authorisation is defined in Article 11(1) of Act No. 22/1997. "Authorisation" for the purposes of this Act means
means the authorisation of a legal person to carry out product conformity assessment activities including
the assessment of activities related to their production or, where appropriate, their re-use; and
defined in the technical regulations."
Authorisation for activities under this Act shall be granted within the defined scope by the Office for Technical
standardization, metrology and state testing. The list of authorised persons is available at
Pages: https://www.unmz.cz/statni-zkusebnictvi/autorizovane-osoby-oznamene-subjekty/seznam-ao-aos-uno/
Accreditation is defined in § 14, § 15, § 16 and § 17 of Act No. 22/1997. Accreditation is a certificate of
compliance with the requirements for carrying out the specific conformity assessment activity laid down in
harmonised standards or other documents applicable to the field of conformity assessment.
Accreditation is carried out by a legal person authorised by the Ministry of Industry and Trade
(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:
(https://www.cai.cz/wp-content/uploads/2019/07/Zakládací-listina-ČIA-12.-7.-2019.pdf)
A list of accredited bodies can be found at www.cai.cz
6. How do I request an authorisation, notification or designation?
The procedure for submitting an application for authorisation pursuant to Act No. 22/1997 or for notification pursuant to Act No.
90/2016, the Pyrotechnics Act or a notification or designation under the Railways Act is described
in Instruction 1: https://www.unmz.cz/statni-zkusebnictvi/pokyny-a-informace-odboru-statnihozkusebnictvi-unmz-a-dalsi-dokumenty-ke-stazeni/
7. What is the so-called voluntary certification carried out according to the Act on Technical
product requirements?
Act No. 22/1997 Coll., on technical requirements for products and on amendment and supplementation of certain
Laws, as amended, does not directly use the term "voluntary certification". For its
the provisions of Section 10 of this Act, which reads as follows:
"(1) Certification under this Act is an activity
1. a) by an authorised person carried out within the scope defined by the technical regulation, or
2. b) by an accredited person at the request of the manufacturer, importer or other person,
which certifies, by issuing a certificate, that the product or activities related to its manufacture,
or with its reuse, are in accordance with the technical requirements in the certificate
Said.
(2) Certificates issued by an authorised person shall be used for conformity assessment pursuant to Section 13(1),
certificates issued by an accredited body may be used in conformity assessment pursuant to § 13(1) only
in cases where the manufacturer, importer or other person is authorised to assess conformity."
Voluntary certification is therefore an activity carried out within the meaning of Article 10(1)(b) of Act No.
22/1997 Coll., while it should be specified that if it is not a procedure according to the said Act, then
voluntary certification can also be carried out by non-accredited bodies. Voluntary certification
are also carried out by accredited bodies that are part of authorised/notified persons
or notified bodies.
The scope of voluntary certification is basically governed by the requirements of the client and therefore the purpose for which
to which the certificate is to be applied.
8. Does every product have to be CE marked? Where do I get the CE marking and who does it
the product?
The CE marking may only be affixed to a product for which the affixing of this marking is specified
by law. In accordance with the Regulation (EC) of the European Parliament and of the Council
No 765/2008 of 9 July 2008 laying down requirements for accreditation and market surveillance
concerning the placing on the market of products and repealing Regulation (EEC) No 339/93, and in particular Art.
30, only the manufacturer or his authorised representative may affix the CE marking. This
The Regulation also sets out the requirements for the graphic design of the CE marking.
By affixing the CE marking or by having the CE marking affixed, the manufacturer declares that the product
conformity with all relevant requirements laid down in harmonisation legislation has been assessed
EU rules.
The CE marking is the only marking certifying the conformity of a product with the relevant requirements
Community harmonisation legislation governing its siting. It is prohibited
place markings, signs or inscriptions on the product that could mislead a third party,
as to the meaning or shape of the CE marking. Any other marking may be affixed to the product
affixed provided that the visibility, legibility and meaning of the CE marking is not thereby reduced.
This is reflected in the legal system of the Czech Republic in particular in § 15 of Act No. 90/2016 Coll., on conformity assessment
90/2016), which provides that
the CE marking may only be affixed to a product for which the affixing of this marking is specified
by government decree. In addition, the marking must be visible, legible and indelible.
When assessing the conformity of a product according to a module involving the attachment of an identification number
of the notified body, shall be attached by the notified body that participated in the conformity assessment,
an identification number assigned to it by the European Commission. As instructed by the notified body
this number may be affixed to the CE marking by the manufacturer or his authorised representative. If he so determines
Government Regulation, they shall be added after the CE marking or, where appropriate, after the identification number of the notified body
specific markings on the subject or in another specified place. The markings may be accompanied by
pictograms or other signs indicating a particular risk or method of use. Manufacturer's definition and
of the authorised representative is contained in Sections 6 and 7 of Act No. 90/2016.
Pursuant to Article 4(b) of Act No. 90/2016, products intended for conformity assessment and technical requirements,
which products must comply with when they are placed on the market or put into service or use,
including use for the manufacturer's own use, shall be determined by the Government by regulations, which may furthermore
to specify the conditions and rules for drawing up the EU declaration of conformity and for placing
the CE marking or other marking; the government regulation shall also specify the form of the other marking and
method of placement.
By failing to comply with the relevant provisions concerning the affixing of the CE marking, natural and legal persons
persons are guilty of offences punishable by a fine pursuant to Sections 53 and 54 of Act No. 90/2016.
For the purposes of Act No. 22/1997 Coll., on Technical Requirements for Products (hereinafter referred to as "Act No.
22/1997"), Article 13(3) provides that the CE marking on a specified product shall indicate that
the product complies with the technical requirements set out in any government regulations that apply to it
and which provide for or permit such marking, and that the conformity assessment has complied with the prescribed
Procedure. The law further stipulates that if a product has been CE marked, it must not be simultaneously
marked with a Czech mark of conformity or a mark which, by its meaning or form, could
lead to confusion with the CE marking or other specified marking.
9. The specified products are specified in government regulations issued by
for the implementation of this Act, the CE marking being applied only to those
Regulations which transpose EC Directives in which this product marking
applied.
The relevant government regulation sets out which products are CE marked, under what conditions and how
in a way. It also specifies who affixes the CE marking to the product concerned. That person shall be
usually the manufacturer or his authorised representative (for definitions of these and other terms, see
in § 2 of Act No. 22/1997). Only those who are designated by the relevant government decree to measure the product
CE marking, may do so after the conformity assessment has been carried out. Otherwise, the person concerned shall
exposes the person to the risk of being prosecuted for an offence within the meaning of section 19 or 19a of this Act.
10.What should I do if the product is not CE marked and the customer asks for it?
requires me? Can I label the product myself?
If the product is not a specified product pursuant to Section 12(1)(a) of Act No. 22/1997 Coll., on
technical requirements for products and amending and supplementing certain acts, as amended
regulations, or under EU harmonisation regulations, nor is it covered by a government regulation, the product
with the designation CE does not provide.
If, after all, in this case the product had been CE-marked, the person who
he committed a violation of the law.
However, if it is a specified product that is to be covered by one (some) of the government regulations
or CE-marked in accordance with directly applicable EU legislation, then the conditions of this
labelling as specified in the relevant government regulations. These specify who and under what conditions
the product indicates. In the event that the CE marking is nevertheless carried out by someone else,
than what is specified in these Government Regulations, he would be in violation of the provisions of the Act.
This 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 a person who is not authorised to do soa.
A similar approach is applied in the case of Act No. 90/2016 Coll., on conformity assessment of specified
products and government regulations issued to implement it and EU harmonisation regulations (see detailed
information on question 4).
11.Do all products in the Czech Republic have to undergo testing procedures? What is it
a specified product and how is its conformity assessment carried out? What products
are provided for conformity assessment when they are placed on the market?
The Czech legal code does not define what a "trial procedure" is.
State testing is defined according to § 9 of Act No. 22/1997 Coll., on technical requirements for
products, as amended, as "the set of activities carried out by the Authority and persons
mandated under this Act, the purpose of which is to ensure that products specified under this
of the Act to assess their conformity with the technical requirements laid down by government regulations..."
Similarly, it is defined under Act No. 90/2016 Coll., on conformity assessment of specified products
in their supply to the market, as amended, as follows: "The State Testing Authority shall be responsible for
for the purposes of this Act means the activities by which the Authority carries out state administration in the field of assessment
conformity in the marketing of products under the common framework of the European Union... For the State Testing Service
activities carried out by the notified bodies in conformity assessment by the Authority shall also be considered." From these
definitions, it follows that state testing is a set of activities. Not all activities and procedures
conformity assessment is testing in the sense of testing or laboratory testing of specific
Products.
Only those products for which
this is provided for by law
Specified product according to § 12, paragraph 1, letter a) of Act No. 22/1997 Coll., on technical requirements
on products, as amended, such a product which presents an increased level of
threat to a legitimate interest and for which compliance must be assessed. It follows from the foregoing that no
all products in the Czech Republic must be subject to mandatory testing procedures, but only those
where the legislation so provides.
Pursuant to Section 4 of Act No. 90/2016 Coll., on conformity assessment of specified products when they are supplied to the
the market, the products to be assessed for conformity and the technical requirements that the products must meet when
the placing on the market, or putting into service or use, including use for its own
the needs of the manufacturer, the Government shall make regulations which may further specify (a) the methods of assessment
the conditions and rules for drawing up the EU declaration of conformity and for affixing the marking
CE or other marking; the government regulation shall also specify for other markings the form and manner of the marking
(c) procedures for the supply of products to the market, (d) details of the activities of the economic
bodies and notified bodies in conformity assessment.
For ease of reference, a list of the specified products is provided on the following
UNMZ website: https://www.unmz.cz/statni-zkusebnictvi/stanovene-vyrobky/
12. What document must accompany the product if it is to be placed on the market,
or into service?
If the product is within the scope of Act No. 22/1997 Coll., on technical requirements for products and on
amendment and supplementation of certain laws, as amended, is to indicate the specified
products on the EU market requires the existence of an EC declaration of conformity in accordance with the government regulations that
were issued to implement the above-mentioned law and transpose the European harmonisation regulation,
or for the marketing of harmonised construction products, the existence of a declaration of performance
in accordance with directly applicable EU legislation, which is the European Regulation as of 1 July 2013
No 305/2011 of the Parliament and of the Council of 9 March 2011 laying down harmonised
conditions for the marketing of construction products and repealing Council Directive 89/106/EEC,
as corrected. Where a government regulation so provides, the manufacturer shall enclose an EC declaration of conformity
to the product. Government regulations of a purely national nature require the existence of declaration of conformitythat
shall, where the government regulation so provides, be attached to the product.
For products placed on the market within the scope of Act No. 90/2016 Coll., on conformity assessment of specified
products when they are made available on the market, as amended (hereinafter referred to as "Act No. 90/2016"),
the manufacturer must, where a government regulation so provides, draw up an EU declaration of conformity or other
a document confirming conformity and, where appropriate, attach it to the product. Other obligations of the manufacturer,
authorised representative, distributor and importer are set out in Act No. 90/2016.
Some government regulations require that other documents, such as the following, must also be attached to the product.
instructions for use.
13.What is the difference between an authorised, notified and notified person
subject?
The authorised body, the notified body and the notified body are legal persons established
under the Czech legal system, which have been authorised or authorised to perform
product conformity assessment activities in the field of state testing.
Authorised person is in accordance with § 11 paragraph 1 of Act No. 22/1997 Coll., on technical
requirements for products as amended (hereinafter referred to as Act No. 22/1997), the legal entity
the person in charge of the product conformity assessment activities including the assessment of activities
related to their manufacture or reuse, as the case may be, and as defined in
technical regulations.
Authorisation shall be granted within the defined scope by the Office by decision on the basis of an application if the applicant
meets the requirements laid down in the legislation. In accordance with Article 11(8) of Act No 22/1997
authorised persons become notified persons by notification pursuant to Article 7(7)(b)
Act No. 22/1997 or, in the cases provided for in the Government Decree, on expiry of a specified period from
notification, unless the European Commission or the other Member States of the European Union have objected within that period
object to the notification, and may exercise the activities of the notified person from the date of receipt of the notification
the Authority's notification that they have been notified.
In the framework of legislation falling under the so-called New Legislative Framework (NLF) and directly
applicable European regulations with entities on the basis of a request pursuant to Act No. 90/2016 Coll., on
assessing the conformity of specified products when they are placed on the market become notified bodies
(not authorised persons) pursuant to Sections 19 and 20 of the Act.
Note: Sometimes the term 'Notified Body' is used loosely.
in an unofficial sense, also for "Notified Bodies". In Czech
However, in legal terminology, the two terms (notified body and notified body) cannot be
arbitrarily confused, as they are enshrined differently in the legislation.
14. Where can I get the text of the relevant regulations dealing with the issue
standardization and state testing?
The texts of the relevant regulations are contained in the Collection of Laws of the Czech Republic, which is available on the website
Ministry of the Interior. EU rules are published in Official Journal of the EU.
An up-to-date overview of the regulations dealing with the issue of the ÚNMZ is also given in
at https://www.unmz.cz/statni-zkusebnictvi/informacni-portal-unmz/pravni-predpisy/
15. Who is responsible for carrying out the conformity assessment?
Conformity assessment is one of the conditions for placing specified products on the market. It is ensured by
the manufacturer or his authorised representative, or (if provided for by government regulation) the importer
or the distributor, in accordance with the conformity assessment procedure laid down for the product concerned in the relevant
government regulation or directly applicable EU law.
In doing so, it is always clearly established whether the assessment tasks can be carried out by the manufacturer
(importer) himself or whether he must request the performance of certain acts from an authorised (notified)
person or notified body.
16. When the participation of an authorised (notified) person or
notified body in the conformity assessment process?
Act No. 22/1997 Coll., on Technical Requirements, applies to manufacturers, importers and distributors in the Czech Republic.
No. 22/1997 as amended (hereinafter referred to as "Act No. 22/1997") and Act No. 90/2016 Coll., on
conformity assessment of specified products when they are made available on the market, as amended
(hereinafter referred to as "Act No 90/2016"). For products determined under these Acts, the relevant
Czech government regulations or directly applicable EU regulations. List of relevant government regulations
can also be found on the ÚNMZ website in the section dedicated to state testing.
A designated product is a product that poses a heightened level of threat to a legitimate interest
(see Section 12(1)(a) of Act No. 22/1997), and for which compliance must therefore be assessed (see Section 12
to § 13c of this Act), or falls within the scope of Act No. 90/2016.
Conformity assessment is one of the conditions for placing specified products on the market. Testing
only those products for which the legislation so provides (see above) shall be subject to mandatory procedures
mentioned). Conformity assessment shall be carried out by the manufacturer or his authorised representative, or by the importer
or the distributor, by the conformity assessment procedure laid down for the product concerned in the relevant Regulation
governments. In doing so, it is always clearly stated whether the assessment tasks can be carried out by the manufacturer
or his authorised representative, or the importer or distributor himself, or whether any of the following
the acts must be requested from an authorised (notified) person or notified body.
It follows, therefore, that not all specified products must be subjected to compulsory
test procedures involving an authorised (notified body) or notified body. It is
the relevant legislation(s) applicable to the product must always be followed. In view of
the fact that this question does not specify the product, our answer contains only generally applicable
statement.
17. What is the procedure for the movement of products between Member States?
When moving goods in the course of business within the territory of EU Member States (or EEA countries)
it is the distribution of these goods (supplying them to the market) not their importation. It is an import if it is
a product from a non-EU country placed on the EU single market. Distributed products that are
22/1997 Coll., on technical requirements for products and on amendments to
and amendments to certain laws, as amended (hereinafter referred to as "Act No. 22/1997"), has
authorisation under the regulations to place on the market the manufacturer or his authorised representative in the EU; or
the importer or distributor. The obligations of the distributor arise, inter alia, from Article 13(9) of the Act
No 22/1997: "The distributor shall act to prevent the distribution of specified products which
manifestly do not meet the requirements of the law, in particular products not bearing the specified
marking." A distributor commits an offence by, inter alia, breaching any of the points listed
in Section 19a(3) or (5)(b) of Act No. 22/1997.
Where the manufacturer or his authorised representative has issued an EC declaration of conformity for a product and has provided
the product is CE marked, the distributor is not obliged to have this declaration available. But in view of
any problems with the distributed product in connection with market surveillance
we recommend that you obtain a declaration of conformity.
Similarly, the movement of goods in the course of trade within EU Member States
described in Act No. 90/2016 Coll., on conformity assessment of specified products when they are supplied to the
the market. The distributor's obligations under the Act are set out in Article 9 of the same Act.
In the case of specified products which do not fall within the European harmonised area, the
marketing in other EU Member States to take advantage of Regulation (EU)
2019/515 of 19 March 2019 on mutual recognition of goods listed in accordance with the legal
regulations 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).
18. BREXIT-how to proceed when importing products into the UK?
The United Kingdom of Great Britain and Northern Ireland has published information on imports of products into
UK market. More information can be found on this website:
Guidance on using the UKCA marking
Guidance on using the UKNI marking
Guidance on placing goods on the market in Great Britain
Guidance on placing goods on the market in Northern Ireland
A-Z of industry guidance to understand requirements for product types
UKMCAB database of UK conformity assessment bodies (approved bodies)
Guidance on placing construction products on the market in Great Britain
Guidance for regulating medical devices in the UK
Guidance on placing Civil Explosives on the market
Guidance on restrictions of Hazardous Substances in Electrical and Electronic Equipment (RoHS
and EEA) Regulations
Guidance for rail interoperability
Guidance for the manufacturing and marketing of fertilisers
Guidance for designated standards for cableway installations
19. How is the conformity assessment of products carried out?
Conformity assessment is mandatory only for those products for which the legislation so provides.
Procedures for conformity assessment of specified products are specified in government regulations
22/1997 Coll., on technical requirements for products and on amendments and
supplementing certain laws, as amended (hereinafter referred to as "Act 22/1997"), Act No.
90/2016 Coll., on conformity assessment of products when they are supplied to the market, as amended
("Act No 90/2016") or in a directly applicable EU regulation.
Conformity assessment of pyrotechnic products is regulated by Act No. 206/2015 Coll., on
pyrotechnic articles and their treatment and on amendments to certain acts (Act on
pyrotechnics), as amended, and Government Regulation No. 208/2015 Coll., on technical
requirements for pyrotechnic articles and their placing on the market. Information on the individual regulations
the government and the scope of activities of authorised persons (notified bodies) and notified bodies
are available on the ÚNMZ website www.unmz.cz in the state testing sector.
The MHRA does not decide whether a product is or is not a specified product, nor is it empowered to
on the interpretation of Act No. 22/1997, Act No. 90/2016, the Pyrotechnics Act and Government Regulations
issued for their implementation. The Authority is only giving its opinion on the issue in question.
20. How should I proceed when placing construction products on the market?
(1) Where a harmonised standard applies to a construction product, the following shall be followed
Regulation 305/2011 of the European Parliament and of the Council ("CPR"). The detailed procedure for
marketing of construction products with CE marking is described in the Information Portal at the link:
https://www.sgpstandard.cz/editor/unmz/?u=stav_vyr/1_29a_postup.htm
2) Where there is no harmonised standard for a construction product or where the product
deviates significantly from it, the manufacturer has a choice between two paths:
If a manufacturer would like to CE mark a product, he can apply withubject for technical
assessment (TAB) on the issue of eEuropean Technical Assessment (ETA) according to the European
Assessment Document (EAD). The list of mTABs is given here: EUROPA - European
Commission - Growth - Regulatory policy - NANDO
If it is not interested in CE marking, it shall place its product on the market in accordance with Government Regulation No. 163/2002
Coll., laying down technical requirements for selected construction products, as amended
163/2002 Coll.). The detailed procedure can be found here:
http://www.sgpstandard.cz/editor/unmz/?u=stav_vyr/1_29b_postup.htm
Current list of bodies authorised to act as independent third party assessors
conformity (i.e. either authorised persons according to NV No. 163/2002 Coll. or notified bodies according to
Regulation (CPR), can be found on the website of the Ministry of Health: https://www.unmz.cz/statni/zkusebnictvi/autorizovane-osoby-oznamene-subjekty/seznam-ao-os-a-uno/
Further information regarding the marketing of construction products is available at
the websites of the IOMH and the European Commission:
https://www.unmz.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/
https://ec.europa.eu/growth/sectors/construction/construction-products-regulation-cpr_en
Questions can be sent to the Contact Point for Construction Products at the MIT:
https://www.mpo.cz/cz/stavebnictvi-a-suroviny/kontaktni-misto-pro-stavebni-vyrobky/
21. How should I proceed when placing machinery on the market?
Act No. 22/1997 Coll. applies to manufacturers, importers and distributors of machinery in the Czech Republic,
on technical requirements for products and on amendment and supplementation of certain acts, as amended by
as amended (hereinafter referred to as "Act No. 22/1997").
The relevant Government Regulations of the Czech Republic shall apply to products specified under this Act. For machinery
Government Regulation No. 176/2008 Coll., on technical requirements for machinery, as amended by
No. 176/2008), which introduced into the Czech legal order
transposed Directive 2006/42/EC of the European Parliament and of the Council on machinery (hereinafter referred to as "the Directive
2006/42/EC").
All explanatory information related to the application of Directive 2006/42/EC can be found at
European Commission website http://ec.europa.eu/growth/sectors/mechanicalengineering/machinery/ and in particular in the revised Guide to the application of the Directive
2006/42/EC for machinery "Guide to application of Directive 2006/42/EC - Edition 2.1 -
July 2017", currently published in English only. The handbook is also used in
the application of Regulation No 176/2008.
Machinery that complies with the subject matter and definitions of the above mentioned NV No. 176/2008 shall be
are generally covered by other government regulations, e.g. in the field of electromagnetic compatibility: the
117/2016 Coll., on the assessment of conformity of products with regard to electromagnetic compatibility
when making them available on the market, transposing the Directive of the European Parliament
and Council 2014/30/EU on the harmonisation of the laws of the Member States relating to
electromagnetic compatibility and which was issued to implement Act No. 90/2016 Coll,
on the assessment of conformity of specified products when made available on the market, as amended
(hereinafter referred to as "Act No. 90/2016"), electrical equipment intended for use within certain limits
118/2016 Coll., on conformity assessment of electrical equipment intended for
use within certain voltage limits when placed on the market, transposing the Directive
2014/35/EU of the European Parliament and of the Council, on the harmonisation of the laws of the Member States
relating to the supply of electrical equipment intended for use within certain voltage limits to
market and which was also issued to implement Act No. 90/2016.
In terms of other regulations, we recommend considering whether machinery is also covered by the Government Regulation
No. 116/2016 Coll. on conformity assessment of equipment and protective systems intended for use
in an explosive atmosphere or Government Regulation No. 481/2012 Coll., on restrictions on the use of
certain hazardous substances in electrical and electronic equipment.
Attention should be paid to Annex 4 to the National Instrument No. 176/2008 (Directive 2006/42/EC), which stipulates
the categories of machinery for which the conformity assessment procedure with the involvement of a third party must be applied
independent parties - Notified Persons. For other machinery falling within the scope of
No. 176/2008 (Directive 2006/42/EC), the conformity assessment is carried out by the manufacturer.
22. How to assess the conformity of pressure equipment?
Pressure equipment is assessed according to Government Regulation No. 219/2016 Coll., on conformity assessment of pressure equipment
equipment when making available on the market, transposing EU Directive 2014/68/EU
on the harmonisation of the laws of the Member States relating to the placing on the market of pressure equipment.
The conformity assessment of simple pressure vessels shall be carried out in accordance with the Government Regulation
119/2016 Coll., on conformity assessment of simple pressure vessels when they are supplied to the market,
whereby this Government Regulation transposes EU Directive 2014/29/EU on the harmonisation of legal
Member States' rules on the placing on the market of simple pressure vessels.
The conformity assessment of transportable pressure equipment shall be carried out in accordance with Government Regulation No.
208/2011 Coll., on technical requirements for transportable pressure equipment, which transposes
EU Directive 2010/35/EU on transportable pressure equipment and repealing Council Directives
76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC.
individual government regulations, the conformity assessment of products subject to the requirements of the above
the above-mentioned government regulations, the obligatory participation of the notified body or authorised/notified
persons, except where such mandatory participation in the conformity assessment of the product as required above
of these government regulations is not required and is solely the responsibility of the manufacturer to implement
conformity assessment of the product. With the mandatory participation of a notified body, resp.
authorised/certified persons (transportable pressure equipment) is then the output document
a certificate issued by the body or person providing information that the following are met
all relevant product requirements under some of the above government regulations.
Upon successful demonstration of conformity of the product, the manufacturer shall mark the product with the required conformity marking
(CE, π, Pi) and draw up a written EU declaration of conformity (or declaration of conformity). Proof of conformity
of the product with the requirements of the relevant government regulation, the manufacturer shall carry out the following on the basis of the use of
relevant harmonised standards to the given government regulation or directive - presumption of conformity.
Where non-harmonised standards are used, the manufacturer shall provide further evidence that the relevant
the requirements of the applicable government regulation.
The above mentioned government regulations / EU directives can be found on the ÚNMZ website, in the section State
Testing/specified products, under the name pressure equipment, simple pressure vessels,
transportable pressure equipment (https://www.unmz.cz/).
For pressure equipment (according to Government Regulation No. 219/2016 Coll.), the following are available on the ÚNMZ website
ÚNMZ/Proceedings current published Czech version of "Rules for the application of Directive 2014/68/EU
(PED) - Pressure Equipment", these rules are the working material for the application of the Directive
2014/68/EU, are developed in working groups of the European Commission and agreed
EU member states. Link to the English version published on the European Commission website:
"Guidelines - pressure equipment directive 2014/68/EU".
There is also a link to the public sector CIRCABC on the ÚNMZ website, where it is possible to
Find administrative decisions for transportable pressure equipment (Government Regulation No. 208/2011
Coll.): "TPED".
23.How to assess conformity for lifts?
The conformity assessment of new lifts is carried out in accordance with Government Regulation No. 122/2016 Coll., on
conformity assessment of lifts and their safety components (hereinafter referred to as "Government Regulation
No. 122/2016") issued to implement Act No. 90/2016 Coll., on conformity assessment of specified
products 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
on the ÚNMZ website www.unmz.cz in the section on state testing in the sector
specified products for lifts. The obligations of the supplier of lifts are set out in the Special
provisions for certain other products (TITLE II Section 1 § 28, § 29 and § 30) of Act No. 90/2016.
The Government Regulation incorporates Directive 2014/33/EU of the European Parliament and of the Council on the harmonisation of
Member States' legislation on lifts and safety components for lifts and
regulates the technical requirements for lifts and safety components for lifts, which must
comply with, when placed on the market or put into service, the conditions and procedures for the supply of safety
components for lifts on the market and methods of conformity assessment. Conformity assessment procedures for
safety components for lifts are specified in § 10 of Government Regulation No. 122/2016, assessment procedures
conformity for lifts is laid down in § 11 of the same government regulation.
Explanatory information can be found on the European Commission's website
http://ec.europa.eu/growth/sectors/mechanical-engineering/lifts_en, in particular in the Handbook
for the application of Directive 2014/33/EU lifts https://ec.europa.eu/docsroom/documents/29961
For lifts and safety components for lifts that meet the subject matter and definitions above
122/2016 are generally subject to other government regulations, e.g. in the field of
electromagnetic compatibility: government regulation no. 117/2016 Coll., on the assessment of conformity of products from
for electromagnetic compatibility when making available on the market, transposing the Directive
2014/30/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States
concerning electromagnetic compatibility and which was issued to implement Act No. 90/2016.
For further information, we recommend e.g. the information service http://vytahy.tzb-info.czwho
includes information, interpretations and opinions on the application of legislation and technical standards to new
and elevators in operation. For information on technical standards, we recommend
the website of the Czech Agency for Standardization https://www.agentura-cas.cz/
24. How to assess the conformity of products intended for hazardous environments explosion?
If your company wants to manufacture and market a product intended for hazardous environments
116/2016 Coll., on the assessment of
conformity of equipment and protective systems intended for use in potentially explosive atmospheres in
their marketing. If your product falls into a category that requires an assessment
compliance with the participation of a notified body, then you can contact FTZÚ, s.p. - notified body in the Czech Republic
1026. Address, contacts and further information on the assessment of specific products can be found at
internet address: https://www.ftzu.cz/.
The text of the aforementioned government regulation or the relevant directive (2014/34/EU), the list of
harmonised standards etc. can be found on the website:
https://www.unmz.cz/urad/zarizeni-a-ochranne-systemy-urcene-pro-pouziti-v-prostredi-s -no-specific-explosion
Finally, we would like to remind you that, depending on the nature of the product, additional
regulations, e.g. government regulation no. 176/2008 Coll., on technical requirements for machinery, no.
117/2016 Coll., on conformity assessment of products in terms of electromagnetic compatibility in their
market supply, etc.
25. How to proceed when placing toys on the market?
For toys, the relevant requirements of Government Regulation No. 86/2011 must be met in order to place the product on the market
Coll., as amended (hereinafter referred to as "NV No. 86/2011").
In accordance with NV No. 86/2011 (or Directive 2009/48/EC of the European Parliament and of the Council), the manufacturer or its
before placing the toy on the market, the authorised representative shall confirm the conformity of the toy with the essential
the 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
draw up an EC declaration of conformity in accordance with Annex 3 of NV No 86/2011 (By drawing up this
the manufacturer's declaration confirms and accepts responsibility for the compliance of the toy with the essential requirements
No 86/2011), using the conformity assessment procedures according to Part Four of NV No 86/2011
including a safety assessment according to § 15 of NV No. 86/2011. The essential requirements of NV No 86/2011 are
are considered to be met in particular if they comply with harmonised standards.
It should be emphasised that only the manufacturer or his authorised representative may affix the CE marking to a toy.
representative, and likewise the declaration of conformity may only be drawn up by the manufacturer or his authorised representative
Deputy.
The importer's obligations relate in particular to verifying and ensuring that the manufacturer complies with the obligations before
placing the toy on the market, marking the toy with its identification data, keeping a copy of the EC
declaration of conformity and more. The distributor's obligations relate in particular to verifying that the toy is
delivered in accordance with the requirements of the relevant regulations, with all the relevant requirements.
In assessing whether the products in question are toys and for which age category they should be
intended, particular use can be made of the guidance on the interpretation of the Toy Safety Directive set out at
Page https://ec.europa.eu/growth/sectors/toys/safety/guidance_cs. Czech translations of some of the
These can be found here: https://www.unmz.cz/urad/preklady-pokynu-z-expertni-skupiny-pro-bezpecnost-hracek-ustavene-evropskou-komisi (please note that translations may not include
subsequent revisions made to the original document). In the guidelines you can find, among other things, instructions for
the assessment of so-called 'grey zone' products, i.e. those where there is doubt as to whether they belong to
the scope of the Directive.
Annex 1 to NV 86 sets out exemptions for products that are not considered toys.
Placing on the market is defined by Act No. 22/1997 Coll., as amended, in its Section 2(b).
However, the term 'placing on the market' refers to each individual product, not to the type of product, namely
whether it was produced as a single unit or as a series.
Government regulations and other information relating to toys are available on this website of the Ministry of Health:
https://www.unmz.cz/statni-zkusebnictvi/stanovene-vyrobky/ and on the European
Commission https://single-market-economy.ec.europa.eu/sectors/toys_en
26. How to proceed when placing personal protective equipment (PPE) on market?
The placing on the market of personal protective equipment shall be in accordance with directly applicable
Regulation (EU) No 2016/425 of the European Parliament and of the Council ("Regulation 2016/425") of
of 9 March 2016, on personal protective equipment (PPE) and repealing Directive
Council 89/686/EEC. The categories of PPE are now set according to the type of risk, no longer according to the type of
PPE. There have been some changes in the following categories.
The technical requirements for PPE, referred to as "Essential Requirements for the Protection of Health and
security" are set out in Annex II to Regulation (EU) 2016/425.
The Regulation also sets out, among other things, the product requirements and the details of the conformity assessment procedure. Provide
only the manufacturer or his authorised representative may CE mark the product, and the EU
the declaration of conformity, which shall accompany each item of PPE, may be drawn up only by the manufacturer or his
authorised representative. For more information on personal protective equipment, please visit:
https://www.unmz.cz/urad/osobni-ochranne-prostredky
Guidance on the use of PPE - Guide to the application of Regulation 2016/425 on personal data
protective equipment: https://ec.europa.eu/docsroom/documents/29201 . In Annex 20 of the Manual
to Regulation (EU) 2016/425 for guidance on categorising PPE.
Current list of harmonised standards for Regulation 2016/425 published in the Official Journal
The European Union is listed in this link: https://ec.europa.eu/docsroom/documents/46431. Here is
information should be sought as to whether a particular standard is harmonised, i.e. whether it provides a presumption
compliance.
27. How to proceed when placing electrical and electronic products on the market?
If the product falls under Government Regulation No. 118/2016 Coll., on conformity assessment of electrical
equipment intended for use within certain voltage limits when placed on the market (hereinafter referred to as 'NV
No. 118/2016") or Government Regulation No. 117/2016 Coll., on the assessment of conformity of products with regard to
electromagnetic compatibility in their placing on the market (hereinafter referred to as "NV No. 117/2016"), is according to
of these NVs shall be entitled to draw up an EC declaration of conformity and affix the CE marking to the product only
the manufacturer or its authorised representative established in the EU.
If the product falls under Government Regulation No. 426/2016 Coll., on conformity assessment of radio equipment
when placing them on the market (hereinafter referred to as "NV No 426/2016"), it is not necessary to declare compliance with the basic
118/2016 or 117/216, as the basic requirements according to NV no.
426/2016 include both electrical safety and electromagnetic compatibility requirements. U
for the specified products covered by NV No 426/2016, only the EU Declaration of Conformity can be issued
to NV No. 426/2016.
Further requirements relating to the placing on the market of electrical and electronic products are set out in
in the government regulations referred to in this point.
28. How to proceed with the marketing of medical devices and diagnostic
in vitro medical devices on the market?
The manufacturer is obliged to determine whether its product falls under the EP and Council Regulation (EU) 2017/745 on
medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation
(EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC ('MDR'); or
Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (hereinafter referred to as the IVDR). If the product
it is a medical device as defined in Article 2 of the MDR or IVDR or it is
covered by Article 1(2) of the MDR, then the manufacturer, importer, distributor or authorised representative
follow Articles 10, 11, 13 and 14 of the MDR and IVDR and other relevant articles of the MDR and IVDR.
in case of ambiguity as to whether a product falls under MDR or IVDR it is possible to request a legally binding
an opinion from the competent authority of the Member State. In the Czech Republic, this competent authority is
authority, the State Institute for Drug Control (hereinafter referred to as SÚKL), which issues the relevant opinion for
fee.
In the case of placing medical devices on the Czech market, it is also necessary to comply with Act 89/2021
378/2007 Coll., on pharmaceuticals and on amendments to Act No.
of certain related laws (the Medicines Act), as amended, which is the MDR
adapted to the Czech legal system.
The European Commission issues a number of clarification documents on the individual MDR requirements and
IVDR and it is highly recommended to follow these documents. All documents are published on
European Commission website in English and some of them are also available in Czech
on the SÚKL website.
https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorseddocuments-and-other-guidance_en#sec3
https://www.niszp.cz/cs/doporucujici-pokyny-ek-cz
29. Who should I contact with questions about medicines?
Medicinal product means a medicinal product falling within the definition set out in Article 2 of Act No 378/2007
Coll., on Medicinal Products and on Amendments to Certain Related Acts (hereinafter referred to as the "Medicinal Products Act"). Most
tasks in the field of pharmaceuticals are ensured by the State Institute for Drug Control (hereinafter referred to as "SÚKL") and the Ministry of
Health (hereinafter referred to as "MZ").
Questions about medicines can be directed to one of the following public institutions. Other bodies that
are involved in the provision of medicines are listed in Title 2 of the Medicines Act including their
The Authority is not involved in any of the tasks relating to the field of pharmaceuticals except for marketing
medical devices with the drug.
30. Who do I contact with questions about food?
Food is regulated by Act No. 110/1997 Coll., on Food and Tobacco
products and amending and supplementing certain related laws. State supervision over compliance with
the obligations laid down in this Act shall be carried out pursuant to Section 14 of the Foodstuffs Act by (a) the authorities
public health protection, namely the regional sanitary stations, the Ministry of Defence and the Ministry of
the State Veterinary Administration, b) the State Agricultural and Food Inspection Authority.
Questions about food can be addressed to one of the following public institutions. The Authority is not involved
on any of the food-related tasks.
31. Who should I contact with questions about cosmetics?
An overview of the legislation regulating the import of cosmetic products as well as a link to
The National Reference Centre for Cosmetics, which also performs reference tests on cosmetic
products can be found on the website of the National Institute of Health under the following links.
http://www.szu.cz/tema/bezpecnost-potravin/pozadavky-pro-uvadeni-do-obehu
http://www.szu.cz/narodni-referencni-centrum-pro-kosmetiku?highlightWords=kosmetika
The manual of the Ministry of Health on imports from third countries can be used, which summarizes the
important requirements for their marking:
https://www.mzcr.cz/pozadavky-na-uvedeni-kosmetickych-pripravku-ze-zemi-mimo-evropskou-unii-na-trh-eu-dovoz/and a manual for distributors (the product has already been accepted in the EU by another Member State)
https://www.mzcr.cz/pozadavky-na-distribuci-kosmetickych-pripravku-na-uzemi-evropske-unie/.
Further questions regarding cosmetics can be addressed to the State Institute of Health. The Authority is not involved
on any of the cosmetics assignments.
32. What is the procedure for placing non-specified products on the market?
If the product is not specified by any of the government regulations issued to implement Law no.
22/1997 Coll., on technical requirements for products, as amended, nor to implement
Act No. 90/2016 Coll., on conformity assessment of specified products when they are placed on the market in
as amended, or Act No. 206/2015 Coll,
on pyrotechnic articles and their treatment and on amendments to certain acts (Act on
pyrotechnics), as amended, laying down technical requirements for so-called specified
products, i.e. products which present a higher degree of threat to a legitimate interest and for which
therefore, compliance with the requirements of these regulations must be assessed, the assessment procedures are not applicable
compliance under this legislation.
However, all products placed on the market must, inter alia, comply with the requirements of Law No. 102/2001
Coll., on general product safety and on amendments to certain acts (Act on general product safety
634/1992 Coll., on Consumer Protection, as amended
as amended. These laws do not fall within the competence of the ÚNMZ, but within the competence of the
Ministry of Industry and Trade of the Czech Republic, where you can get more information about them.
The manufacturer must also identify other legislation that applies to his product and follow
in accordance with them. All national legislation can be found in the Collection of Laws. European
the regulations are available in the Official Journal of the European Union
For your information, we also present the possibility of voluntary certification, whereby at the request of the manufacturer, importer
or other persons, accredited persons may certify by issuing a certificate that the product complies with
with the technical requirements specified in the certificate (see Section 10(1)(b) of Act No. 22/1997 Coll.).
The scope of the voluntary certification shall in principle be governed by the requirements of the client and the purpose for which it is to
the certificate can be used.
The list of accredited entities including the subject of accreditation is available on the website
Czech Institute for Accreditation http://www.cia.cz/
There is much to explore
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