Specified products
Manufacturers or importers may place a specified (designated) product on the market (or put it into service) only if it meets the technical requirements and its conformity has been assessed in accordance with the procedure established by the relevant implementing regulation (i.e., CE marking, Ccz marking, or Csk marking) and an EC Declaration of Conformity or another document specified in the regulation (e.g., a declaration of performance for construction products) must have been issued for it.
The specified products fall within the harmonized or non-harmonized area; for details, see Principles of Placing Products on the Market.
REGULATIONS, HARMONIZED AND SPECIFIED STANDARDS FOR SPECIFIED
PRODUCTS1. Harmonized area - sectors covered by Act No. 90/2016 Coll. (NLF) -
Low-voltage electrical equipment (NLF)
Personal protective equipment (NLF)
Recreational craft and personal watercraft (NLF)
Non-automatic weighing instruments (NLF)
Explosives for civil use when placed on the market (NLF)
Products in terms of their electromagnetic compatibility (NLF)
Equipment and protective systems intended for use in potentially explosive atmospheres (NLF)
In vitro diagnostic medical devices (NLF - effective from May 26, 2022)
Medical devices (NLF - effective from May 26, 2021)
2. Harmonized Area – Sectors Covered by Act No. 22/1997 Coll.
Aerosol dispensers
Exhaust emissions from spark-ignition engines of non-road mobile machinery
European rail system (high-speed and conventional)
Restriction of the use of certain hazardous substances in electrical and electronic equipment
Personal protective equipment (placed on the market before April 20, 2019)
Transportable pressure equipment
Gas-fired appliances (placed on the market before April 21, 2018)
marking Machinery
(as of January 20, 2027, machinery will fall under Act No. 90/2016 Coll. - see amendment by Act
No. 236/2024 Coll.)
Hot-water boilers burning liquid or gaseous fuels – efficiency (BED)
Medical devices – active implantable
Medical devices in vitro – diagnostic
3. Non-harmonized area – sectors covered by Act No. 22/1997 Coll.
Selected products for conformity assessment – specified by ČSN to Government Regulation No. 173/1997 Coll.
Interoperability of the European rail system
(Government Regulation No. 133/2005 Coll. (current version) repealed on February 1, 2022, by Act No. 426/2021 Coll.)