Conformity Assessment of Machinery

Machinery is a specific type of product defined by Act No. 22/1997 Coll., which falls within the harmonized scope. Under Act No. 22/1997 Coll., a manufacturer or importer of machinery is required to place only safe products on the market. Directive 2006/42/EC on machinery and amending Directive 95/16/EC (as amended) (amendments: No. 2009/127/EC, No. 596/2009/EC amending 2006/42/EC, No. 167/2013, No. 2014/33/EU, amending, (EU)2024/2749) is implemented in Czech legislation as Government Regulation No. 176/2008 Coll. on technical requirements for machinery (as amended) by Government Regulation No. 170/2011 Coll., Government Regulation No. 229/2012 Coll., Government Regulation No. 176/2008 Coll. will be repealed effective January 20, 2027, pursuant to Act No. 236/2024 Coll.

Government Regulation No. 176/2008 Coll. (as amended) applies to the following products:

machinery,
interchangeable equipment,
safety components,
lifting accessories,
chains, ropes, and straps,
removable mechanical transmission devices,
incomplete machinery.

The definition of machinery is set forth in Section 2 of Government Regulation No. 176/2008 Coll. (as amended).

Before placing machinery on the market or putting it into service, the manufacturer or its authorized representative must ensure:

compliance with the relevant safety and health requirements;
conformity assessment in accordance with the procedures set forth in Section 5 of Government Regulation No. 176/2008 Coll. (as amended);
technical documentation in accordance with Annex No. 7 to Government Regulation No. 176/2008 Coll. (as amended), which demonstrates compliance with the requirements of Government Regulation No. 176/2008 Coll. (as amended);
issuance of an EC Declaration of Conformity in accordance with Annex No. 2 to Government Regulation No. 176/2008 Coll. (as amended) and its attachment to the machinery;
affixing the CE marking to the machinery.

Before placing incomplete machinery on the market, the manufacturer or its authorized representative must ensure:

the preparation of the relevant technical documentation in accordance with Part B of Annex No. 7 to Government Regulation No. 176/2008 Coll. (as amended);
preparation of assembly instructions in accordance with Annex 6 to Government Regulation No. 176/2008 Coll. (as amended);
the preparation of a declaration of incorporation in accordance with Part 1, Section B of Annex No. 2 to Government Regulation No. 176/2008 Coll. (as amended).

Presumption of Conformity

For machinery manufactured in accordance with a harmonized European standard published in the Official Journal of the European Union, a harmonized Czech standard, or a foreign technical standard transposing a harmonized European standard, there is a presumption of conformity with the essential health and safety requirements set forth in these harmonized standards. However, if the reference to the harmonized European standard has been withdrawn from the Official Journal of the EU, this presumption of conformity no longer applies.

Essential Requirements

The essential health and safety requirements regarding the design and construction of machinery are set forth in Annex No. 1 to Government Regulation No. 176/2008 Coll. (as amended) and are binding. These essential requirements include, for example: safety principles, materials and products, lighting, the design of machinery in terms of handling, ergonomics, the operator’s station, the seat, control systems, the safety and reliability of control systems, control devices, starting and stopping, selection of control or operating modes, power failure, protection against mechanical hazards, characteristics of guards and protective devices, risks associated with other hazards, maintenance, and information. The manufacturer or its authorized representative must ensure a risk assessment (risk analysis) for the specific machinery and determine the health and safety requirements. This involves applying practical experience, knowledge of technical standard requirements, information about the machinery, and the manufacturer’s technical capabilities, etc.; therefore, it is advisable to conduct a high-quality risk assessment in collaboration with a notified body.

The conformity assessment of machinery listed in Annex 4 of Government Regulation No. 176/2008 Coll. (as amended), which was manufactured in accordance with a harmonized European standard, is carried out by the manufacturer or its authorized representative:

either through internal production control of the machinery in accordance with Annex No. 8 to Government Regulation No. 176/2008 Coll. (as amended), or
by a notified body, which ascertains and verifies through EC type examination in accordance with Annex 9 of Government Regulation No. 176/2008 Coll. (as amended) whether the machinery model specified in Annex 4 of Government Regulation No. 176/2008 Coll. (as amended) meets the requirements of the said regulation, or
by a notified body that assesses and approves a comprehensive quality assurance system and subsequently applies it in accordance with Annex No. 10 to Government Regulation No. 176/2008 Coll. (as amended).

Conformity assessment of machinery listed in Annex No. 4 to Government Regulation No. 176/2008 Coll. (as amended) and which has not been manufactured in accordance with a harmonized European standard is carried out by the manufacturer or its authorized representative:

by a notified body, which determines and verifies, through EC type examination in accordance with Annex 9 of Government Regulation No. 176/2008 Coll. (as amended), whether the model of machinery listed in Annex 4 of Government Regulation No. 176/2008 Coll. (as amended) meets the requirements of the said regulation, and by assessing conformity through internal production control of the machinery in accordance with Annex No. 8 to Government Regulation No. 176/2008 Coll. (as amended), or
by a notified body that assesses and approves a comprehensive quality assurance system and subsequently applies it in accordance with Annex No. 10 to Government Regulation No. 176/2008 Coll. (as amended).

Conformity assessment of machinery not listed in Annex 4 of Government Regulation No. 176/2008 Coll. (as amended) is performed by the manufacturer or its authorized representative:

through internal production control of the machinery in accordance with Annex No. 8 of Government Regulation No. 176/2008 Coll. (as amended). When preparing the risk analysis and conformity assessment, it is advantageous to collaborate with a notified body and have the product certified as a basis for the manufacturer’s own conformity assessment

EC Declaration of Conformity

The EC Declaration of Conformity applies exclusively to machinery in the condition in which it was placed on the market and does not apply to components subsequently added by the end user or subsequent modifications made by the end user. Annex No. 2 to Government Regulation No. 176/2008 Coll. (as amended) contains the information that must be included in the EC Declaration of Conformity; among other things, it specifies detailed information on the applicable legal regulations or their provisions that the manufacturer or its authorized representative has applied. The original EC Declaration of Conformity must be retained by the manufacturer of the machinery/partly completed machinery or their authorized representative for a period of at least ten years from the last day of manufacture of the machinery/partly completed machinery.

CE Marking

The manufacturer of the machinery or their authorized representative is required to affix the CE marking. The CE marking on the product indicates to customers and users that it complies only with the legal regulations applied by the manufacturer or their authorized representative. If a comprehensive quality assurance procedure is used in the conformity assessment, the identification number of the notified body must be added. Additional requirements for affixing the CE marking are set forth in Annex No. 3 to Government Regulation No. 176/2008 Coll. (as amended). Machinery bearing the CE marking and accompanied by an EC Declaration of Conformity in accordance with Annex No. 2 to Government Regulation No. 176/2008 Coll. (as amended) is considered to comply with the requirements of this Regulation.

Additional information:

Guide to the Application of the Machinery Directive 2006/42/EC (2nd edition – June 2010) (English version Edition 2.2 – October 2019)

Harmonized standards for Directive 2006/42/EC

Notified Bodies in the EU

Overview of bodies authorized to perform conformity assessment activities for machinery and other useful links