Conformity Assessment - Radio Equipment (RED)

RADIO EQUIPMENT

Conformity Assessment under Government Regulation No. 426/2016 Coll.

Technical requirements for radio equipment are now covered by the new Act No. 90/2016 Coll. on conformity assessment. Radio equipment is therefore a specified product defined by Act No. 90/2016 Coll. and falls within the harmonized area.

Directive 2014/53/EU of the European Parliament and of the Council on the placing of radio equipment on the market repealed and replaced, as of June 13, 2016, Directive 1999/5/EC of the European Parliament and of the Council, which may be applied in parallel until June 13, 2017. This new directive has been implemented in the Czech Republic through the new Government Regulation No. 426/2016 Coll., which repealed and replaced Government Regulation No. 426/2000 Coll. on January 7, 2017. However, certain provisions of Directive 2014/53/EU of the European Parliament and of the Council have not yet been implemented in the new Government Regulation No. 426/2016 Coll., such as: the obligation for manufacturers, as of June 12, 2018, to register types of radio equipment in those categories characterized by a low level of compliance with essential requirements in a central system, and furthermore the obligation for manufacturers to provide certain parts of the technical documentation or the entire technical documentation upon registration. The European Commission (EC) will then assign a registration number to each registered type of radio equipment, which manufacturers must affix to the radio equipment placed on the market. The EC is expected to adopt a delegated act regarding the above provision before the end of 2018, and this act is expected to enter into force two months after the date of its notification. If the EP and the Council raise objections, the act will enter into force four months after the date of its notification.

TRANSITIONAL PERIOD
Radio equipment that complies with the requirements of Government Regulation No. 426/2000 Coll. prior to the effective date of Government Regulation No. 426/2016 Coll. (January 7, 2017), may continue to be placed on the market and put into service provided they were placed on the market before June 13, 2017.

SCOPE OF THE GOVERNMENT REGULATION
Radio equipment to which this Government Regulation No. 426/2016 Coll. does not apply is listed in Annex No. 1. Radio equipment is not subject to Government Regulation No. 118/2016 Coll., which concerns the conformity assessment of electrical equipment intended for use within certain voltage limits. However, the design of radio equipment must comply with the safety requirements for electrical equipment intended for use within certain voltage limits, but without applying a voltage limit, and the level of electromagnetic compatibility must fall within the scope of the requirements for products in terms of electromagnetic compatibility.

Government Regulation No. 426/2016 Coll. defines a class of radio equipment as a designation of a specific category of radio equipment considered to be similar, and the radio interfaces for which such radio equipment is intended. An interface is defined in Act No. 127/2005 Coll. on Electronic Communications as a radio interface for the transmission of radio waves between radio equipment. Government Regulation No. 426/2016 Coll. does not contain further definitions, as these are defined in Act No. 90/2016 Coll. on Conformity Assessment or in Act No. 127/2005 Coll. on Electronic Communications.

TECHNICAL DOCUMENTATION (TD)
(Section 15 of Government Regulation No. 426/2016 Coll.)
Technical documentation must be prepared prior to placing the radio equipment on the market. The TD must be continuously updated. The TD must contain at least the information specified in Annex No. 5 of Government Regulation No. 426/2016 Coll.:

• a general description of the radio equipment (including photographs or drawings; software or firmware version; user manual, safety information, and installation instructions),
• conceptual design and manufacturing drawings, diagrams of components, subassemblies, and circuits
• descriptions and explanations to aid in understanding the aforementioned drawings, diagrams, and the operation of the radio equipment,
• a list of the harmonized standards used, for which references have been published in the EU Official Journal,
• the parts of those harmonized standards that were applied
• a selected description of the solution for meeting the essential safety requirements set forth in Section 3 of Government Regulation No. 426/2016 Coll.
• other technical specifications, if harmonized standards were not used,
• a copy of the EU Declaration of Conformity,
• a copy of the EU type examination certificate with annexes issued by the relevant notified body, if Module B was used in the conformity assessment
• results of design calculations and testing
• test reports
• assurance that the radio equipment is designed for operation in at least one Member State without violating radio spectrum usage requirements (compliance with the requirement of Section 5(2) of Government Regulation No. 426/2016 Coll.)
• in the event of restrictions on its placing into service or other requirements for authorization of its use, the instructions for the radio equipment must contain information on the Member States or the geographical location where such restrictions or authorization requirements apply (compliance with Section 6(4) of Government Regulation No. 426/2016 Coll.)

TECHNICAL REQUIREMENTS
Detailed technical requirements that products must meet are set forth in Section 3 of Government Regulation No. 426/2016 Coll. The design of radio equipment must ensure:

• the protection of the health and safety of persons and domestic animals, and the protection of property to the extent of the essential requirements of safety principles for electrical equipment intended for use within certain voltage limits, but without applying a voltage limit,
• a level of electromagnetic compatibility within the scope of the requirements for products in terms of electromagnetic compatibility (pursuant to Government Regulation No. 117/2016 Coll.)
• the efficient use of the radio spectrum without harmful interference.

Radio equipment in certain categories or classes must be published by the Czech Telecommunications Office in the Telecommunications Gazette in the form of a notice and must be designed to comply with the following essential requirements:

• interoperability with accessories, in particular with universal chargers
• operation in conjunction with other radio equipment via electronic communications networks
• the ability to connect to an appropriate type of interface throughout the Union as defined by Directive 2014/53/EU of the European Parliament and of the Council
• must not adversely affect the electronic communications network or its operation, must not misuse the resources of the electronic communications network, and must not cause unacceptable degradation of service
• must ensure the protection of personal data and the privacy of users and subscribers to electronic communications services
• must ensure protection against fraud
• must enable access to emergency calls
• must support functional characteristics to facilitate their use by users with disabilities
• must ensure the installation of software into radio equipment if the compliance of this combination of software and radio equipment with other legal regulations is demonstrated (e.g., Act No. 181/2014 Coll. on Cybersecurity)

CONFORMITY
ASSESSMENT1) The conformity assessment of radio equipment with technical requirements (Section 3 of Government Regulation No. 426/2016 Coll.) is performed by the manufacturer. When assessing conformity, the manufacturer shall take into account all intended conditions of use of the radio equipment. In the case of the technical requirement set forth in Section 3(1)(a) of Government Regulation No. 426/2016 Coll., the manufacturer shall also take into account reasonably foreseeable conditions of use. If the radio equipment can have different configurations, the conformity assessment must confirm that the radio equipment meets the technical requirements set forth in Section 3 of Government Regulation No. 426/2016 Coll. in all possible configurations.

2) Government Regulation No. 426/2016 Coll. establishes the following procedures with reference to the modules listed in Annexes 2 through 4:

Conformity assessment with the technical requirements under Section 3(1)(a) and (b) shall be carried out:

 3) If, when assessing the conformity of radio equipment with the technical requirements specified in Section 3(2) and (3) of Government Regulation No. 426/2016 Coll., the manufacturer applies harmonized standards for which references have been published in the Official Journal of the European Union, then the conformity assessment shall be carried out by:

 4)    If, when assessing the conformity of radio equipment with the technical requirements specified in Section 3(2) and (3) of Government Regulation No. 426/2016 Coll., the manufacturer partially applies harmonized standards for which references have been published in the Official Journal of the European Union, or does not apply harmonized standards at all, then the conformity assessment shall be carried out by:

PRESUMPTION OF
CONFORMITY Products that comply with harmonized standards are presumed to comply with the technical requirements set forth in Section 3 of Government Regulation No. 426/2016 Coll., to which these standards or parts thereof apply.

EU DECLARATION OF CONFORMITY
The templates for the EU Declaration of Conformity are set out in Annex No. 6 to Government Regulation No. 426/2016 Coll. The content of the simplified EU Declaration of Conformity is set out in Annex No. 7 to Government Regulation No. 426/2016 Coll. The full text of the EU Declaration of Conformity is available on the website whose address is specified in the simplified EU Declaration of Conformity in the language or languages required by the Member State in which the radio equipment is placed or supplied on the market. The EU Declaration of Conformity and the simplified EU Declaration of Conformity must be kept up to date. The EU Declaration of Conformity and the simplified EU Declaration of Conformity must be translated into the language or languages required by the Member State in which the radio equipment is placed or supplied on the market. If the radio equipment is subject to multiple EU harmonization regulations requiring the preparation of an EU Declaration of Conformity, a single EU Declaration of Conformity shall be drawn up with references to all such regulations. This single EU Declaration of Conformity may take the form of a dossier consisting of declarations of conformity issued for the individual regulations.

CE MARKING AND OTHER MARKINGS
The CE marking shall be affixed before the radio equipment is placed on the market. The CE marking shall be affixed visibly, legibly, and indelibly to the radio equipment or to its type plate, if the nature of the radio equipment does not allow it. The CE marking shall also be affixed visibly and legibly to the packaging, if the radio equipment is supplied in packaging. For reasons of visibility and legibility, the size of the CE marking shall not be less than 5 mm. In the conformity assessment procedure based on full quality assurance (Module H), the identification number of the notified body shall be affixed after the CE marking. The identification number of the notified body must be the same size as the CE marking and shall be affixed by the notified body or, under its instructions, by the manufacturer or its authorized representative.

PLACING RADIO EQUIPMENT ON THE MARKET AND PUTTING IT INTO
SERVICE Radio 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 the requirements of Government Regulation No. 426/2016 Coll. are met. Exceptions are trade fairs, exhibitions, and demonstration events, provided that the radio equipment is visibly marked as non-compliant with Government Regulation No. 426/2016 Coll.

During demonstrations, measures must be taken (e.g., pursuant to Section 19b, § 25, and § 100 of Act No. 127/2005 Coll.) to prevent harmful interference, electromagnetic interference (pursuant to Government Regulation No. 117/2016 Coll.), and threats to the health and safety of persons or domestic animals or to property. 

MANUFACTURER’S
OBLIGATIONS The manufacturer must:

• ensure that the radio equipment is designed and manufactured in accordance with the requirements of § 3 of Government Regulation No. 426/2016 Coll.
• prepare technical documentation in accordance with Annex No. 5 of Government Regulation No. 426/2016 Coll.
• carry out or have carried out the relevant conformity assessment procedure set out in Section 11 of Government Regulation No. 426/2016 Coll.
• ensure that the radio equipment is designed so that it can be operated in at least one Member State of the European Union without violating the requirements for the use of the radio spectrum
• after demonstrating the conformity of the radio equipment through the conformity assessment procedure, draw up an EU declaration of conformity and affix the CE marking in accordance with Section 14 of Government Regulation No. 426/2016 Coll.
• retain the technical documentation and the EU Declaration of Conformity for a period of 10 years from the date the radio equipment is placed on the market
• ensure that identification data and information about the radio equipment (type number, series, serial number, or other identifying feature) are provided; if the nature or size of the radio equipment does not allow for this information to be displayed on the product, the required information must be provided on the packaging or in a document accompanying the radio equipment
• indicate on the radio equipment, in a language understandable to end users and the supervisory authority, the manufacturer’s name, trade name, or trademark and a contact address (a single point of contact for the manufacturer); if the nature or size of the product does not allow for the inclusion of this information, the required information must be provided on the packaging or in a document accompanying the radio equipment
• ensure that the radio equipment is accompanied by clear, comprehensible, and easily understandable instructions and safety information for consumers and other end users; the instructions must also include a description of the accessories or components, including software, that enable the radio equipment to be used for its intended purpose; in the case of radio equipment that intentionally emits radio waves, the instructions and safety information must include information on:

          a) all frequency bands in which the radio equipment operates, and
b) the maximum radio frequency power transmitted in the frequency band in which the radio equipment is operated.

• ensure that a copy of the EU Declaration of Conformity or the simplified EU Declaration of Conformity is included with each piece of radio equipment
• in the case of a simplified EU declaration of conformity, ensure that the contents of the simplified EU declaration of conformity include the website address where the full text of the EU declaration of conformity can be obtained
• in the event of restrictions on the putting into service of the radio equipment or the existence of additional requirements for authorizing its use, indicate this information on the packaging so that the Member States or geographical area of a Member State where such restrictions on putting into service or such requirements for authorizing use are in force can be identified; the manufacturer must include this information in the instructions for the radio equipment
• conduct tests on samples of radio equipment placed on the market and other investigations to protect the health and safety of end users in light of the risks posed by the radio equipment; these tests must be conducted to the extent necessary to confirm or refute the risk posed by the radio equipment and in light of the intended use specified by the manufacturer
• maintain a register of complaints regarding non-compliant radio equipment and records of radio equipment recalls, and keep distributors informed of these activities on an ongoing basis
• ensure, in the case of series production, compliance with the specified requirements throughout the entire production process, even in the event of changes to the design or parameters of the radio equipment, or changes to the harmonized standards or technical specifications according to which the radio equipment’s conformity is declared

OBLIGATIONS OF THE AUTHORIZED REPRESENTATIVE
The authorized representative must:

• keep the technical documentation and the EU Declaration of Conformity for a period of 10 years from the date the radio equipment is placed on the market

OBLIGATIONS OF THE IMPORTER
The importer must:

• ensure, prior to placing the radio equipment on the market, that the manufacturer has carried out the relevant conformity assessment procedure in accordance with Section 11 of Government Regulation No. 426/2016 Coll.
• ensure that the design of the radio equipment allows for operation in at least one Member State without violating the requirements for the use of the radio spectrum
• ensure that the manufacturer has prepared the technical documentation
• ensure that the manufacturer affixes the CE marking to the radio equipment
• ensure that the manufacturer provides identification details and information about the radio equipment (type number, series, serial number); if the nature or size of the radio equipment does not allow this, the manufacturer must provide the required information on the packaging or in a document accompanying the radio equipment
• ensure that the manufacturer indicates on the radio equipment their name, trade name, or trademark and a contact address (a single point of contact for the manufacturer); if the nature or size of the radio equipment does not allow for this information to be provided, the required information must be provided on the packaging or in a document accompanying the radio equipment
• ensure that the radio equipment is accompanied by clear, comprehensible, and easily understandable instructions and safety information for consumers and end-users; the instructions must also include a description of the accessories or components, including software, that enable the radio equipment to be used for its intended purpose; in the case of radio equipment that intentionally emits radio waves, the instructions and safety information must include information on:

        a) all frequency bands in which the radio equipment operates, and
b) the maximum radio frequency power transmitted in the frequency band in which the radio equipment is
operated

• ensure that a copy of the EU Declaration of Conformity or the simplified EU Declaration of Conformity is included with each radio device
• in the case of a simplified EU Declaration of Conformity, ensure that the contents of the simplified EU Declaration of Conformity include the website address where the full text of the EU Declaration of Conformity can be obtained
• in the event of restrictions on the putting into service of the radio equipment or the existence of additional requirements for authorization of its use, must include this information on the packaging so that the Member States or geographical area of a Member State where such restrictions on putting into service or such requirements for authorization of use are in force can be identified; must ensure that the manufacturer includes this information in the instructions for the radio equipment
• indicate on the radio equipment, in a language understandable to end users and the supervisory authority, their name, trade name, or trademark and a contact address where they can be reached; if the nature or size of the radio equipment does not allow for the inclusion of this information, the required information must be provided on the packaging or in a document accompanying the product
• ensure that the radio equipment is accompanied by comprehensible instructions and safety information for consumers and end users in the Czech language
• retain a copy of the EU Declaration of Conformity for 10 years from the date the radio equipment is placed on the market for the purposes of the supervisory authorities
• submit technical documentation upon request by the competent supervisory authority
• conduct tests on samples of radio equipment placed on the market and other investigations to protect the health and safety of end users in light of the risks posed by the radio equipment; these tests must be conducted to the extent necessary to confirm or refute the risk posed by the radio equipment and in light of the intended use specified by the manufacturer
• maintain a register of complaints regarding non-compliant radio equipment and records of radio equipment withdrawn from circulation, and keep distributors informed of these activities on an ongoing basis
• bear full responsibility for the transport and storage of radio equipment so that the conditions of transport and storage do not affect the radio equipment’s compliance with the requirements set forth in Government Regulation No. 426/2016 Coll.

DISTRIBUTOR’S OBLIGATIONS
The distributor must:

• verify, prior to placing the radio equipment on the market, that the radio equipment bears the CE conformity marking
• verify, prior to placing the radio equipment on the market, that the required documentation, instructions, and safety information in the Czech language are included with the radio equipment
• verify that the manufacturer has designed the radio equipment to allow operation in at least one Member State without violating radio spectrum usage requirements
• verify whether the manufacturer has provided identification details and information about the radio equipment (type number, series, serial number); if the nature or size of the radio equipment does not permit this, the manufacturer must provide the required information on the packaging or in a document accompanying the radio equipment
• verify whether the manufacturer has indicated on the radio equipment its name, trade name, or trademark and a contact address (a single point of contact for the manufacturer); if the nature or size of the radio equipment does not allow for the indication of this information, the required information must be provided on the packaging or in a document accompanying the radio equipment
• verify that the manufacturer has provided clear, comprehensible, and easily understandable instructions and safety information for consumers and other end users with the radio equipment; the instructions must also include a description of the accessories or components, including software, that enable the radio equipment to be used for its intended purpose; in the case of radio equipment that intentionally emits radio waves, the instructions and safety information must include information on:

         a) all frequency bands in which the radio equipment operates, and
b) the maximum radio frequency power transmitted in the frequency band in which the radio equipment is
operated.

• verify that the manufacturer has included a copy of the EU Declaration of Conformity or the simplified EU Declaration of Conformity with each piece of radio equipment
• in the case of a simplified EU declaration of conformity, verify that the content of the simplified EU declaration of conformity includes the website address where the full text of the EU declaration of conformity can be obtained
• verify, in the event of restrictions on the putting into service of the radio equipment or the existence of additional requirements for authorization of its use, whether the manufacturer has included this information on the packaging so that the Member States or geographical area of a Member State where these restrictions on putting into service or these requirements for authorization of use are in force can be identified; must verify whether the manufacturer has included this information in the instructions for the radio equipment
• verify whether the importer has indicated on the radio equipment, in a language understandable to end-users and the supervisory authority, their name, trade name, or trademark and a contact address where they can be reached; if the nature or size of the radio equipment does not allow for the inclusion of this information, the required information must be provided on the packaging or in a document accompanying the product

SUPERVISORY AUTHORITIES

• The Czech Trade Inspection Authority inspects radio equipment on the market.
• The Czech Telecommunications Office inspects radio equipment in operation.

Note regarding errors in Government Regulation No. 426/2016 Coll.:

• In Section 5(1), the reference to Section 10 is incorrect—the correct reference should be to Section 11
• In Section 9(c), the reference to Section 7(2) is incorrect—it should correctly refer to Section 8(2)