Conformity Assessment - Products from an EMC Perspective

Conformity Assessment – EMC (Electromagnetic Compatibility) as of April 20, 2016

Products, in terms of their electromagnetic compatibility, are specified products defined by Act No. 90/2016 Coll. on conformity assessment and fall within the harmonized area. On April 20, 2016, Directive 2014/30/EU entered into force, repealing Directive 2004/108/EC.

This new directive has been implemented in the Czech Republic through the new Government Regulation No. 117/2016 Coll., which repealed Government Regulation No. 616/2006 Coll. as of April 20, 2016; the latter had previously governed conformity assessment. Equipment meeting the requirements of Government Regulation No. 616/2006 Coll., on technical requirements for products regarding their electromagnetic compatibility, may continue to be supplied to the market and put into service provided it was placed on the market before April 20, 2016. Certificates issued by notified bodies pursuant to Government Regulation No. 616/2006 Coll. remain valid under this Regulation.

Act No. 90/2016 Coll. on conformity assessment was enacted in connection with the implementation of the New Legislative Framework (NLF) and new harmonization regulations.

Government Regulation No. 117/2016 Coll. specifically concerns: equipment (i.e., apparatus) or fixed installations.
Apparatus is a finished device or assembly of devices placed on the market as a single functional unit intended for the end user, which may be a source of electromagnetic interference or whose operation may be affected by electromagnetic interference. Components or subassemblies intended for incorporation into an apparatus by the end user are considered apparatus; mobile installations are sets of apparatus or equipment intended for movement and operation at various locations. A
fixed installation is a specific set of several types of apparatus or equipment that are assembled, installed, and intended for permanent use at a predetermined location.

Legal obligations regarding the placing of products on the market and putting into service
Equipment may be placed on the market or put into service only if it is properly installed, maintained, and used for the purposes for which it is intended, and if it complies with the requirements of this Regulation. An exception applies to equipment exhibited or demonstrated at trade fairs; however, such equipment must be clearly marked and may not be placed on the market or put into service until compliance with the requirements of this Regulation is ensured. Equipment exhibited or demonstrated shall not cause unacceptable electromagnetic interference with other equipment.

The essential requirements that products must meet (i.e., electromagnetic compatibility requirements) are listed in Annex No. 1 to Government Regulation No. 117/2016 Coll. and correspond to the technical requirements under the original Government Regulation No. 616/2006 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.

OBLIGATIONS OF ECONOMIC OPERATORSGovernment Regulation
No. 117/2016 Coll. now includes provisions 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 that supplied them with a device and every economic operator to whom they supplied a device. Economic operators must provide this information for a period of ten years from the receipt or release of the device.

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. 117/2016 Coll. The manufacturer must prepare technical documentation in accordance with Annex 2 or Annex 3 of Government Regulation No. 117/2016 Coll. The manufacturer of the devices shall carry out or have carried out the relevant conformity assessment procedure in accordance with Government Regulation No. 117/2016 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 established for mass-produced products so that these products comply with Government Regulation No. 117/2016 Coll. The manufacturer must take into account any changes to the design or parameters of the device, as well as changes to harmonized standards or other technical specifications on which conformity is declared.

The manufacturer must fulfill the obligations set forth in Government Regulation No. 117/2016 Coll. regarding the identification of the device, when providing contact information on the packaging or in the documentation 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. 117/2016 Coll. now includes 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. 117/2016 Coll.—are carried out by the manufacturer.
The importer must also ensure that the manufacturer of the devices prepares technical documentation, affixes the CE marking to the devices, provides the relevant product information, and includes the manufacturer’s identification on the packaging, in the documentation, or on the device 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 the provision of relevant information regarding the assembly, maintenance, installation, or use of the device, as well as restrictions on the use of the device, in the instructions accompanying the device, which must be in the Czech language.

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 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. 117/2016 Coll. The importer must not place on the market an instrument that does not comply with the essential requirements set forth in Annex 1 of Government Regulation No. 117/2016 Coll. and must inform both the manufacturer and the market surveillance authorities upon identifying a risk.

DISTRIBUTOR
The 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. 117/2016 Coll. now includes a provision regarding the distributor’s obligations. Before placing the device on the market, the distributor verifies the CE marking on the device and ensures that all required documents, instructions, and information in the Czech language are included. The importer verifies 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 supply the device to the market, and if a risk is identified, the distributor must inform the market surveillance authorities. 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. 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.

PRESUMPTION OF CONFORMITY WITH TECHNICAL REQUIREMENTS
Equipment that complies with harmonized standards or parts thereof, references to which have been published in the Official Journal of the European Union, is in conformity with the essential requirements set out in Annex I of Directive 2014/30/EU. This also applies when a Czech standard adopts an EN or when a foreign technical standard exists that adopts an EN. However, if the reference to a harmonized European standard has been withdrawn from the Official Journal of the EU, this presumption of conformity no longer applies. Annex I of Directive 2014/30/EU contains general requirements for equipment regarding electromagnetic interference and specific requirements for fixed installations.

Conformity assessment with the essential requirements is carried out:
a) through internal production control in accordance with Annex 2 of Government Regulation No. 117/2016 Coll., orb)
through EU type examination, followed by conformity to type based on internal production control in accordance with Annex 3 of Government Regulation No. 117/2016 Coll. For certain aspects of the essential requirements, the manufacturer may combine these conformity assessment procedures.

EU DECLARATION OF CONFORMITY
After demonstrating conformity, the manufacturer or its authorized representative (if the manufacturer has specified this obligation in its authorization) is required, pursuant to Government Regulation No. 117/2016 Coll., to draw up an EU declaration of conformity or another document confirming conformity. A template for the EU Declaration of Conformity is provided in Annex No. 4 to Government Regulation No. 117/2016 Coll. The manufacturer must retain the EU Declaration of Conformity for a period of ten years from the date the device was placed on the market, together with the technical documentation, for the use of national authorities. The EU Declaration of Conformity must specify the device for which it was drawn up. A copy of the EU Declaration of Conformity shall be provided to the supervisory authority upon request. Due to the specific characteristics of fixed installations, the EU Declaration of Conformity may not apply to fixed installations.

CE
MARKING The manufacturer shall affix the CE marking to each individual device that conforms to the type described in the EU type examination certificate and meets the relevant requirements of Government Regulation No. 117/2016 Coll. The general principles of CE marking are set forth in Regulation (EC) No. 765/2008 of the European Parliament and of the Council.
The CE marking shall be affixed before the device is placed on the market. The CE marking on the product indicates to customers and users that it complies only with the legal regulations applied by the manufacturer or its authorized representative. The CE marking shall be affixed visibly, legibly, and indelibly to the device or its nameplate. If this is not possible or the nature of the device does not allow for the affixing of the CE marking, the CE marking must be affixed to the packaging in which the device is supplied and to the accompanying documents. Due to the specific characteristics of fixed installations, the affixing of the CE marking may not apply to fixed installations.

Conformity Assessment - EMC (Electromagnetic Compatibility) until April 19, 2016

Products, in terms of their electromagnetic compatibility, are specified products defined by Act No. 22/1997 Coll. and fall within the harmonized scope.

Electromagnetic compatibility is the ability of equipment to function satisfactorily in an electromagnetic environment without causing unacceptable electromagnetic interference to other equipment in that environment. Equipment, devices, fixed installations, and assemblies of equipment or devices must be assessed prior to their placing on the market in accordance with Government Regulation No. 616/2006 Coll., on technical requirements for products in terms of their electromagnetic compatibility.

Presumption of Conformity
: The essential requirement for a specified product that complies with the provisions of the harmonized European standard (HEN) for that product is deemed to be met. This also applies when a Czech standard adopts an EN or when a foreign technical standard exists that adopts an EN. 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 requirements that specified products must meet are listed in Annex 1 to Government Regulation
No. 616/2006 Coll. This means that the safety requirements and specific requirements for fixed installations and the use of components for the intended purpose must be met. At the same time, however, a device that also falls under, for example, Government Regulation No. 464/2005 Coll., which establishes technical requirements for measuring instruments, or under Government Regulation No. 54/2015 Coll., which establishes technical requirements for medical devices, must also meet the essential requirements of these regulations.

The manufacturer of the device or its authorized representative may also perform the conformity assessment with the essential requirements using the procedure set forth in Annex No. 3 to Government Regulation No. 616/2006 Coll. This conformity assessment procedure is consistent with the internal production control procedure set forth in Annex 2; however, the manufacturer of the device or its authorized representative must supplement it with a request for assessment of the technical documentation by a notified body. The manufacturer of the device or its authorized representative must inform the notified body of which aspects of the essential requirements are to be assessed. During the assessment, the notified body reviews the technical documentation and evaluates whether the product adequately demonstrates compliance with the requirements of Government Regulation No. 616/2006 Coll. If the product meets the requirements, the notified body issues a statement confirming this compliance, and the manufacturer or authorized representative then attaches the notified body’s statement to the documentation. The statement from the notified body to the product’s purchaser demonstrates that the product has been assessed by an independent and officially recognized authority. The manufacturer may use the statement from the notified body as the basis for issuing an EC Declaration of Conformity.

EC Declaration of Conformity
: Product conformity is certified by issuing an EC Declaration of Conformity and affixing the CE marking to the product. After fulfilling all relevant essential requirements for the device, the manufacturer or its authorized representative may issue an EC Declaration
of Conformity in accordance with Government Regulation No. 616/2006 Coll. The EC Declaration of Conformity must also be retained for a period of 10 years following the cessation of production of the relevant device. If neither the manufacturer nor the authorized representative is established in the EU, then for the purposes of the relevant supervisory authorities, the person placing the device on the EU market is responsible for retaining the technical documentation and the EC Declaration of Conformity.

The
CEmarking on a product indicates to customers and users that it complies only with the legal regulations applied by the manufacturer or its authorized representative. If this is not possible or the nature of the device does not allow for the placement of the CE marking, the CE marking must be placed on the packaging in which the device is supplied and on the accompanying documents.