Conformity assessment - electrical equipment for specific voltage limits

CONFORMITY ASSESSMENT - LVD (Low Voltage Equipment) as of April 20, 2016

Electrical equipment within certain voltage limits are specified products defined by Act No. 90/2016 Coll. on conformity assessment and fall within the harmonized scope. Directive No. 2014/35/EU entered into force on April 20, 2016, repealing Directive No. 2006/95/EC.

This new directive has been implemented in the Czech Republic through the new Government Regulation No. 118/2016 Coll., which repealed Government Regulation No. 17/2003 Coll. as of April 20, 2016; the latter had previously governed conformity assessment. Equipment meeting the requirements of Government Regulation No. 17/2003 Coll., which establishes technical requirements for low-voltage electrical equipment, may continue to be placed on the market provided it was placed on the market before April 20, 2016. Certificates issued by notified bodies pursuant to Government Regulation No. 17/2003 Coll. remain valid under this Regulation.

Government Regulation No.  118/2016 Coll. on the conformity assessment of electrical equipment intended for use within certain voltage limits when placed on the market applies only to electrical equipment intended for use within the range of rated voltages for alternating current from 50 to 1,000 V and for direct current from 75 to 1,500 V. In previous terminology, this equipment was referred to as “low-voltage electrical equipment.” Equipment and phenomena that do not fall within the scope of Government Regulation No.  118/2016 Coll. are listed in Annex 2 of this Regulation.

Electrical equipment may be placed on the market only if it meets the technical requirements set forth in Annex 1 to Government Regulation No.  118/2016 Coll. and if it has been manufactured in accordance with good engineering practice in terms of safety principles applicable in the European Communities. When properly installed, maintained, and used for the purpose for which it was manufactured, electrical equipment must not endanger the health and safety of persons, domestic animals, or property.

OBLIGATIONS OF ECONOMIC
OPERATORS A new provision regarding economic operators—manufacturers, authorized representatives, importers, and distributors—is included in Government Regulation No.  118/2016 Coll. contains a provision concerning economic operators—manufacturers, authorized representatives, importers, and distributors. In the interest of market surveillance, each economic operator must, upon request by market surveillance authorities, identify every economic operator who supplied them with the device and every economic operator to whom they supplied the device. Economic operators must provide this information for a period of ten years from the receipt or release of the device.

MANUFACTURERThe Conformity
Assessment Act No. 90/2016 Coll. requires the manufacturer to take steps on its own initiative to protect the market from products it has placed on the market and for which it subsequently discovers non-compliance. These steps are: bringing the product into compliance with the specified requirements or withdrawing the product from the market or circulation.

To protect consumer health and safety, the manufacturer is required to test samples of electrical equipment placed on the market and conduct investigations, as appropriate to the risks posed by such equipment, and, where applicable, maintain records of non-compliant products and product recalls, and inform the distributors to whom these products were supplied of these facts.

An importer or distributor is considered a manufacturer under Act No. 90/2016 Coll. and must fulfill the manufacturer’s obligations set forth in this Regulation if they place the device on the market under their own name or trademark, or if they modify a device that has already been placed on the market in a manner affecting compliance with this Regulation.

The manufacturer may appoint an authorized representative by written mandate. The authorized representative shall perform only the tasks specified by the manufacturer in the mandate. However, the manufacturer may not transfer its obligations regarding the design, manufacture of the product, and preparation of technical documentation to the authorized representative.

When placing instruments on the market, the manufacturer must ensure that the design and manufacture of the instruments comply with the essential technical requirements set forth in Annex 1 of Government Regulation No.  118/2016 Coll.

The manufacturer must prepare technical documentation in accordance with Annex No. 3 to Government Regulation No.  118/2016 Coll. The manufacturer of the devices carries out the relevant conformity assessment procedure in accordance with Government Regulation No.  118/2016 Coll. Upon demonstrating the device’s conformity through the conformity assessment procedure, the manufacturer shall draw up an EU Declaration of Conformity and affix the CE marking to the device. The manufacturer must retain the technical documentation and the EU Declaration of Conformity for a period of 10 years from the date the device is placed on the market.

The manufacturer must ensure that procedures are implemented for mass-produced products so that these products comply with Government Regulation No.  118/2016 Coll. The manufacturer must take into account any changes to the design or parameters of the device, as well as changes to the harmonized standards or other technical specifications on which conformity is declared.

The manufacturer must fulfill the obligations set forth in Government Regulation No.  118/2016 Coll. regarding the identification of the device, when providing their contact details on the packaging or in the document accompanying the device, and when preparing instructions, information, and labeling.

IMPORTER
The Conformity Assessment Act No. 90/2016 Coll. requires the importer to take steps on their own initiative to protect the market from products they have placed on the market and for which they subsequently discover non-conformity. These steps are: withdrawal of the product from the market or from circulation.

Government Regulation No.  118/2016 Coll. contains a provision regarding the obligations of importers of devices. The importer does not perform conformity assessment activities; their obligation is to ensure that these activities—the relevant conformity assessment procedures under Government Regulation No.  118/2016 Coll. To protect consumer health and safety, the importer is required to test samples of electrical equipment placed on the market and conduct investigations, as appropriate to the risks posed by such equipment; where necessary, the importer must maintain records of complaints, non-compliant electrical equipment, and recalls of electrical equipment from circulation, and must keep distributors informed of these activities on an ongoing basis.

The importer must also ensure that the manufacturer of the equipment prepares technical documentation, affixes the CE marking to the equipment, provides relevant product information, and includes the manufacturer’s identification on the packaging, in the documentation, or on the equipment in the Czech language. The importer must retain the technical documentation and a copy of the EU Declaration of Conformity for a period of ten years from the date the device is placed on the market.

In addition, the importer must provide their contact details in the Czech language on the device, on the packaging, or in the documentation. The importer must ensure that relevant information regarding the assembly, maintenance, installation, or use of the device, as well as any restrictions on the use of the device, is included in the instructions accompanying the device, which must be in the Czech language.

The importer bears full responsibility for the transport and storage of the device, ensuring that transport and storage conditions do not affect the device’s compliance with the essential requirements in Annex 1 of Government Regulation No. 118/2016 Coll.

The importer must cooperate with the supervisory authorities and provide them with the necessary information to demonstrate the device’s compliance with this regulation. The importer must not place on the market a device that does not comply with the essential requirements set forth in Annex 1 of Government Regulation
No.  118/2016 Coll. and must inform both the manufacturer and the market surveillance authorities if a risk is identified.

DISTRIBUTORThe Conformity
Assessment Act No. 90/2016 Coll. requires the distributor to take steps on their own initiative to protect the market from products they have placed on the market and for which they subsequently discover non-compliance. These steps are: withdrawal of the product from the market or from circulation.

Government Regulation No.   118/2016 Coll. contains a provision regarding the distributor’s obligations. Before placing the device on the market, the distributor verifies the CE marking on the device, the inclusion of all required documents, instructions, and information in the Czech language or in a language understandable to all consumers and end users in the EU Member State where the electrical equipment is to be placed on the market. Furthermore, the distributor shall verify compliance with the obligations of the manufacturer and importer (identification of the device, manufacturer, or importer, including the manufacturer’s or importer’s contact information). The distributor may place on the market only devices that comply with this Regulation; if non-compliance is detected, the distributor must not place the device on the market, and if a risk is identified, the distributor must inform the market surveillance authorities. In the event of product non-compliance, the distributor must take corrective measures, including, if necessary, withdrawing the product from the market or from circulation. The distributor must cooperate with the supervisory authorities and provide them with the necessary information to demonstrate the device’s compliance with this Regulation.

The distributor bears full responsibility for the transport and storage of the device, ensuring that transport and storage conditions do not affect the device’s compliance with the essential requirements in Annex 1.

PRESUMPTION OF CONFORMITY
The essential technical requirements are considered to be met if the electrical equipment complies with the safety requirements of harmonized Czech technical standards, or, where applicable, foreign technical standards that transpose a harmonized European standard in EU Member States. Where harmonized European technical standards do not exist, but the electrical equipment complies with standards incorporating the safety provisions of the International Electrotechnical Commission (IEC), provided that these safety provisions have been published by the Commission, or complies with the safety provisions of Czech technical standards in the absence of harmonized or IEC standards, then the conditions for placing the equipment on the market are also deemed to be met. Standards for safety provisions (IEC) and Czech standards for safety provisions for electrical equipment are published in the UNMZ Bulletin.

ESSENTIAL REQUIREMENTS
The essential requirements that products must meet (i.e., requirements for electrical equipment intended for use within certain voltage limits) are set forth in Annex No. 1 to Government Regulation No.  118/2016 Coll. and correspond to the essential safety requirements under the original Government Regulation No. 17/2003 Coll. If the equipment also falls under, for example, the Government Regulation laying down technical requirements for measuring instruments or the Government Regulation laying down technical requirements for medical devices, it must additionally meet the essential requirements of those regulations as well. Compliance with the essential requirements is demonstrated through conformity assessment.

CONFORMITY ASSESSMENT
When placing electrical devices on the market, the manufacturer must ensure that the design and manufacture of these devices comply with the essential technical requirements set forth in Annex 1 of Government Regulation No.  118/2016 Coll. The manufacturer shall prepare the required technical documentation specified in Annex No. 3 to Government Regulation No.  118/2016 Coll. and shall carry out or have carried out the conformity assessment procedure.

Internal production control (Module A) is the only conformity assessment procedure for electrical equipment pursuant to Annex 3 to Government Regulation No. 118/2016 Coll.

The importer does not perform conformity assessment activities, but is responsible for ensuring that these activities are carried out by the manufacturer.

The manufacturer must take the necessary measures in the manufacturing process to ensure that the electrical equipment manufactured complies with this technical documentation and with the other requirements of Government Regulation No. 118/2016 Coll.

EU DECLARATION OF
CONFORMITYIf the conformity of the electrical equipment with the essential technical requirements set out in Annex No. 1 to Government Regulation
No.  118/2016 Coll. has been demonstrated by this single conformity assessment procedure, the manufacturer shall draw up an EU Declaration of Conformity and affix the CE marking.

The manufacturer shall draw up the EU Declaration of Conformity in accordance with the model set out in detail in Annex 4 to Government Regulation No.  118/2016 Coll. The declaration of conformity may also be drawn up by an authorized representative on the manufacturer’s behalf and under the manufacturer’s responsibility, provided that the manufacturer has specified this activity in the mandate.

The manufacturer guarantees and declares, on its own responsibility, the conformity of the electrical equipment in question with the essential technical requirements set forth in Government Regulation No.  118/2016 Coll. If the electrical equipment is subject to multiple European Union harmonization regulations requiring the preparation of an EU Declaration of Conformity, a single EU Declaration of Conformity shall be prepared with references to all such regulations, including references to their publication. This single EU Declaration of Conformity may take the form of a dossier consisting of declarations of conformity issued for individual regulations. The EU Declaration of Conformity shall be translated into the language or languages required by the Member State of the European Union in which the electrical equipment is placed or supplied on the market. The manufacturer or its authorized representative must keep the EU Declaration of Conformity for a period of ten years from the date the electrical equipment is placed on the market for the purposes of the supervisory authority. A copy of the EU Declaration of Conformity shall be provided to the supervisory authority upon request.

CEMARKING
The CEmarking is affixed before the electrical equipment is placed on the market. If it is not possible to affix the CE marking directly to the electrical equipment, the CE marking must be affixed to the packaging in which the device is supplied and to the accompanying documents (instructions for use or warranty certificate). The CE marking declares to customers and users that the product complies with the technical requirements of all applicable legal regulations that the manufacturer has applied. The general principles of the CE marking are set forth in Regulation (EC) No. 765/2008 of the European Parliament and of the Council.

CONFORMITY ASSESSMENT - LVD (Low-Voltage Electrical Equipment) until April 19, 2016

Low-voltage electrical equipment is a specified product defined by Act No. 22/1997 Coll. and falls within the harmonized scope.

When properly installed, maintained, and used for the purpose for which it was manufactured, electrical equipment must not endanger the safety of persons, domestic and farm animals, or property. For the purposes of this regulation, low-voltage electrical equipment is considered to be any equipment intended for use within the range of rated voltages from 50 V to 1000 V for alternating current and rated voltages from 75 V to 1500 V for direct current. Annex No. 1 to Government Regulation No. 17/2003 Coll. contains a list of equipment that does not fall under Government Regulation No. 17/2003 Coll.

Presumption of
Conformity: Technical requirements are considered met if the electrical equipment complies with the safety requirements of harmonized Czech technical standards or, where applicable, foreign technical standards that transpose a harmonized European standard in EU Member States. Where no harmonized European technical standards exist, but the electrical equipment complies with specified standards incorporating the safety provisions of the International Electrotechnical Commission (IEC) or the International Commission for Electrotechnical Approvals (CEE), and provided that these safety provisions have been published by the Commission, the conditions for placing the product on the market are deemed to be met. Where there are no harmonized European technical standards or published IEC or CEE safety provisions, the electrical equipment must comply with the safety requirements of Czech technical standards.

Essential
RequirementsElectrical equipment may be placed on the market only if it meets the technical requirements set forth in Annex No. 2 to Government Regulation No. 17/2003 Coll., which establishes technical requirements for low-voltage electrical equipment (Directive 2006/95/EC of the European Parliament and of the Council), and if it has been manufactured in accordance with good engineering practice in terms of safety principles applicable in the European Communities. Assessment of conformity with the requirements set forth in Government Regulation No. 17/2003 Coll. is carried out through an internal production control procedure in accordance with Annex No. 3 to Government Regulation No. 17/2003 Coll. The manufacturer or its authorized representative, who complies with the provisions of Government Regulation No. 17/2003 Coll., ensures and declares that the electrical equipment meets all relevant requirements of Government Regulation No. 17/2003 Coll. The manufacturer or its authorized representative must prepare technical documentation in accordance with Government Regulation No. 17/2003 Coll., and must keep it within the territory of the European Community so that it is available to the supervisory authority for a period of at least 10 years after the end of production of the electrical equipment. If the manufacturer of the electrical equipment is not established in any of the EU Member States, nor is its authorized representative, this obligation to prepare and keep the technical documentation is fulfilled by the person placing the electrical equipment on the market. The technical documentation must enable the assessment of the conformity of the electrical equipment with the requirements of Government Regulation No. 17/2003 Coll. and must contain all the elements specified in Government Regulation No. 17/2003 Coll.

Declaration of ConformityThe
manufacturer of the electrical equipment or its authorized representative may issue a declaration of conformity if the conformity of the electrical equipment has been assessed in accordance with Annex No. 3 to Government Regulation No. 17/2003 Coll.

CE
MarkingThe CEmarking on electrical equipment indicates to customers and users that it complies with the technical requirements of all applicable legal regulations that the manufacturer has applied. If the electrical equipment meets the requirements of Government Regulation No. 17/2003 Coll., the manufacturer or authorized representative shall affix the CE marking to it. If it is not possible to affix the CE marking directly to the electrical equipment, the CE marking must be affixed to the packaging in which the device is supplied and to the accompanying documents (user manual or warranty certificate).