Government Regulation No. 117 / 2016 Coll.
Government regulation on conformity assessment of products with regard to electromagnetic compatibility when making them available on the market
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Regulation
Effective from 20.04.2016
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117
GOVERNMENT REGULATION
of 30 March 2016
on the conformity assessment of products with regard to electromagnetic compatibility in their making available on the market
The Government mandates, pursuant to Sections 4 and 50 (5) of Act No. 90 / 2016 Coll., on the conformity assessment of specified products when making them available on the market ("the Act '):
Subject matter
(1) This Regulation implements the relevant European Union1 Regulation and regulates the technical requirements for products with regard to their electromagnetic compatibility which they must meet when placed on the market or put into service, the conditions and procedures for making them available on the market and the conformity assessment methods.
(2) This Regulation shall not apply to:
(a) radio and telecommunications terminal equipment covered by other legislation2);
(b) aeronautical equipment, provided that such equipment falls within the scope of the directly applicable European Union Regulation laying down common rules in the field of civil aviation (3) and is intended exclusively for airborne use, namely:
1. aircraft, except unmanned aircraft, and their engines, propellers, parts and non-installed equipment; and
2. unmanned aircraft, and their engines, propellers, parts and non-installed equipment, the design of which has been certified in accordance with the European Union provisions directly applicable to common rules in the field of civil aviation (3) and which are intended to be operated only on frequencies allocated under the Radio Regulations of the International Telecommunications Union for Protected Air Use;
(c) radio equipment used by radio amateurs within the meaning of the Radio Regulations adopted under the Constitution and Convention of the International Telecommunications Union4), unless the equipment is made available on the market; For the purposes of this Regulation, the following definitions apply:
(d) establishments having, by their very nature, such physical characteristics that:
1. are unable to cause or contribute to electromagnetic radiation exceeding a level enabling radio, telecommunications and other equipment to function in accordance with the intended use; and
2. operate without unacceptable deterioration in the presence of electromagnetic disturbances which are common in their operation in accordance with the intended use;
(e) tailored assessment kits for professionals intended exclusively for use in research and development facilities for such purposes.
Definition of terms
(1) For the purposes of this Regulation:
(a) apparatus or fixed installation,
(b) a finished apparatus or assembly of apparatus made available on the market as a separate functional unit intended for the end-user, which may be a source of electromagnetic interference or the operation of which may be affected by electromagnetic interference;
(c) by fixed installation, a set of several types of apparatus, and, where appropriate, devices which are assembled, installed and intended for permanent use at a pre-specified location;
(d) the electromagnetic compatibility of the equipment to operate satisfactorily in the electromagnetic environment without causing unacceptable electromagnetic interference of any other device in that environment;
(e) by electromagnetic interference, an electromagnetic phenomenon which may impair the functioning of the equipment; electromagnetic interference may be electromagnetic noise, unwanted signal or change in the environment itself,
(f) resistance to the capability of the equipment to function properly without deterioration of the quality of the function in the presence of electromagnetic interference;
(g) the purpose of ensuring the protection of human health, life or property;
(h) the electromagnetic environment of any electromagnetic phenomena observed at the site.
(2) The apparatus referred to in paragraph 1 (b) shall also:
(a) components or sub-assemblies intended for incorporation into the apparatus by the end-user which may be a source of electromagnetic interference or whose operation may be affected by electromagnetic interference;
(b) mobile installations defined as a set of instruments, or means, to move and operate at different locations.
Technical requirements
(1) Equipment must comply with the essential technical requirements set out in Annex 1 to this Regulation.
(2) Where the essential technical requirements laid down in Annex 1 to Regulation (EC) No 5 are applicable to installations, the essential requirements set out in Annex 1 to this Regulation shall not apply.
(3) Compliance with the essential technical requirements shall be demonstrated by conformity assessment.
Supply of equipment and putting into service
(1) Equipment may be made available on the market or put into service only if it is so carried out that, provided it is properly installed, maintained and used for the purposes for which it is intended, it complies with the requirements of this Regulation.
(2) Where an installation which meets the requirements referred to in paragraph 1 is subject to restrictions on putting into service or use under another legislation for the purpose of:
(a) overcoming an existing or anticipated problem of electromagnetic compatibility at a particular location; or
(b) the protection of public telecommunications networks or receivers and transmitters used for security purposes in well-defined situations in the spectrum;
the restriction must be notified without undue delay to the Technical Standardisation, Metrology and State Testing Office (hereinafter the Office), which shall inform the European Commission and the other Member States of the European Union thereof. This is without prejudice to procedures under other legislation6).
(3) Equipment which does not comply with the requirements of this Regulation may be exhibited or shown at fairs, exhibitions and similar events, provided that it is evident from the visible indication that they may not be made available on the market or put into service until their conformity with the requirements of this Regulation has been ensured. Demonstration may take place provided that appropriate measures are taken to prevent electromagnetic interference.
Manufacturer
(1) The manufacturer shall, when placing the apparatus on the market, ensure that such apparatus is designed and manufactured in accordance with Section 3 (1), draw up the technical documentation referred to in Annex 2 or 3 to this Regulation and carry out or have carried out the relevant conformity assessment procedure referred to in Section 10.
(2) Where the conformity of the apparatus with the essential technical requirements has been demonstrated by the conformity assessment procedure, the EU manufacturer shall draw up a declaration of conformity and place the CE marking.
(3) The manufacturer shall keep the technical documentation and the EU declaration of conformity for a period of 10 years from the placing on the market of the apparatus.
(4) The manufacturer shall ensure that procedures are in place to ensure that serially manufactured products remain in conformity with the requirements laid down in this Regulation even where the design or parameters of the apparatus or the harmonised standards or other technical specifications on the basis of which the instrument is declared to conform are changed.
(5) The manufacturer shall ensure that the device which he has placed on the market has a type or series number or serial number or other element enabling it to be identified, or in cases where the size or nature of the apparatus does not allow the information required to be shown on the packaging or on the document accompanying the apparatus. They shall also ensure that the instructions and information referred to in § 13 (2) to (4) are attached to the apparatus in the Czech language. Such instructions, information and any markings shall be clear, understandable and easily understandable.
(6) The manufacturer shall indicate on the instrument or, if this is not possible, on the packaging or on the document accompanying the apparatus his name or business name or trade mark, as the case may be, and the address for service at which he may be contacted. The delivery address shall be the address of the place at which the manufacturer can actually be contacted. The contact details shall be given in a language easily understood by end-users and the supervisory authority.
Authorised representative
The authorised representative shall keep the EU declaration of conformity and the technical documentation at the disposal of the supervisory authority for 10 years after the instrument has been placed on the market.
Importer
(1) The importer shall, before placing the apparatus on the market, ensure that the manufacturer has carried out one of the conformity assessment procedures referred to in Section 10, has drawn up the technical documentation, has placed the CE marking on the apparatus, accompanied by the prescribed documents and has complied with the requirements laid down in Section 5 (5) and (6).
(2) The importer shall indicate on the apparatus or, if this is not possible, on the packaging or on the document accompanying the apparatus his name or business name or trade mark, as the case may be, and the address for service at which he can be contacted. The contact details shall be given in a language easily understood by the end-user and the supervisory authority.
(3) The importer shall ensure that the apparatus is accompanied by the instructions and information referred to in § 13 (2) to (4) in the Czech language.
(4) The importer shall, for a period of 10 years from the placing on the market of the apparatus, keep a copy of the EU declaration of conformity for market surveillance purposes and ensure that technical documentation can be submitted to the supervisory authorities upon request.
Distributor
Before making the apparatus available on the market, the distributor shall verify that the device bears the CE marking, that the required documents and instructions and the information referred to in § 13 (2) to (4) are accompanied by it in the Czech language and that the manufacturer and importer have complied with the relevant requirements set out in § 5 (5) and (6) and § 7 (2).
Time for identification of operator
The operator shall keep for a period of 10 years after the instrument has been placed on the market the data by which, at the request of the supervisory authority, the operator who supplied the apparatus to him or her may be identified.
Conformity assessment procedures
(1) Assessment of conformity with the essential requirements referred to in Article 3 (1) shall be carried out:
(a) internal production control (Module A) as set out in Annex 2 to this Regulation; or
(b) the EU type-examination (Module B), after which compliance with the type based on internal production control (Module C) set out in Annex 3 to this Regulation shall be carried out.
(2) A manufacturer may decide to apply the procedure referred to in paragraph 1 (b) only to certain aspects of essential requirements if the procedure referred to in paragraph 1 (a) applies to other aspects of essential requirements.
Presumption of conformity
Where the apparatus conforms to harmonised standards which concern the apparatus and to which references have been published in the Official Journal of the European Union or parts thereof, it shall be deemed to comply with the essential requirements set out in Annex 1 to this Regulation to which those standards or parts thereof apply.
EU declaration of conformity
(1) The EU declaration of conformity demonstrates compliance with the essential requirements set out in Annex 1 to this Regulation.
(2) The EU declaration of conformity shall be drawn up in accordance with the model set out in Annex 4 to this Regulation. The declaration shall contain the information set out in the relevant modules listed in Annexes 2 and 3 to this Regulation and shall be kept up to date. The EU declaration of conformity shall also be translated into the language (s) required by the Member State of the European Union in which the apparatus is placed in service or made available on the market.
(3) Where the apparatus is covered by several European Union harmonisation provisions providing for the drawing up of an EU declaration of conformity, a single EU declaration of conformity shall be drawn up with references to all those provisions under which conformity has been assessed, including references to their publication. This single EU declaration of conformity may take the form of a component consisting of declarations of conformity issued for each Regulation.
CE marking and other marking and information
(1) The CE marking shall be placed visibly, legibly and indelibly on the instrument or the data label. Where this is not possible or cannot be done with regard to the nature of the apparatus, the label shall be placed on the packaging if the apparatus is supplied in it and on the accompanying documents.
(2) The apparatus shall be accompanied by a warning of the special measures to be taken when the apparatus is installed, installed, maintained or used to ensure that, when put into service, the apparatus complies with the essential requirements set out in point 1 of Annex 1 to this Regulation.
(3) In the case of apparatus for which the essential requirements laid down in point 1 of Annex 1 to this Regulation are not guaranteed when it is used in residential areas, such a restriction on use must be clearly indicated on the apparatus and, where appropriate, on its packaging.
(4) The information necessary for the use of the apparatus in accordance with the purpose to which it is intended must be provided in the instructions accompanying the apparatus.
Fixed installations
(1) An apparatus which is intended solely for incorporation into a fixed installation and is otherwise not separately made available on the market may not comply with the essential requirements laid down in § 3 (1), with the requirements of § 6 to 12 and § 14 and 15 of the Act, including those laid down in § 5 to 13, provided that the accompanying documentation indicates:
(a) data identifying the fixed installation for which the apparatus is intended, the characteristics of its electromagnetic compatibility and the measures to be taken with regard to the installation of the apparatus in the fixed installation so as not to jeopardise the conformity of the installation; and
(b) the data referred to in § 5 (5) first sentence, § 5 (6) and § 7 (2).
(2) The conformity assessment of a fixed installation shall be carried out by the installation operator or by the authorised person where:
(a) the fixed installation shows signs of non-conformity, in particular when referring to interference; and
(b) The Czech Telecommunications Authority shall not, in the course of a procedure under another legislative provision (7), find that the documents submitted by the installation operator or by a person authorised by him, in particular accompanying documentation, the documentation provided for in point 2 of Annex 1 to this Regulation, or other documents, adequately demonstrate compliance with the requirements laid down.
Formal deficiencies
A formal deficiency shall be considered to be:
(a) the CE marking has been placed in breach of Article 30 of Regulation (EC) No 765 / 2008 of the European Parliament and of the Council of 9 July 2008 laying down requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339 / 93 or Article 13 (1);
(b) the CE marking has not been affixed;
(c) the EU declaration of conformity has not been drawn up;
(d) the EU declaration of conformity has not been drawn up in accordance with this Regulation;
(e) the technical documentation is missing or incomplete;
(f) the information provided for in Article 5 (6) or Article 7 (2) is missing or incorrect or incomplete; or
(g) another administrative requirement referred to in § 6 (5) and (6) or § 8 (3), (6) and (7) of the Act and § 5 or § 7 has not been met.
Transitional provisions
(1) Equipment complying with the requirements laid down in Decree-Law No 616 / 2006 Coll. may continue to be made available on the market and put into service if it was placed on the market before 20 April 2016.
(2) Valid certificates and other documents certifying the facts established issued by the notified persons under Government Regulation 616 / 2006 Coll. remain in force and are considered to be certificates and other documents certifying the facts established under this Regulation.
Repeal
Government Decree No. 616 / 2006 Coll., on technical requirements for products in terms of their electromagnetic compatibility, is repealed.
Efficacy
This Regulation shall enter into force on 20 April 2016.
Prime Minister:
Sobotka v. r.
Minister for Industry and Trade:
Ing. Mládek, CSc., v. r.
Příloha č. 1
Annex No 1 to Government Regulation No 117 / 2016 Coll.
BASIC TECHNICAL REQUIREMENTS
1. General requirements
The equipment shall be so designed and constructed as to ensure that, taking into account the state of the technique achieved, that:
(a) the electromagnetic interference they cause does not exceed the level at which radio and telecommunications equipment or other equipment are unable to function in accordance with the intended use; and
(b) achieve the level of resistance to electromagnetic interference expected during their operation in accordance with the intended use, which allows them to operate without unacceptable deterioration of operation in accordance with the intended use.
2. Special requirements for fixed installation
Installation and use of components
The fixed installation shall be installed using good practice rules and taking into account data on the intended use of components in order to meet the essential requirements set out in point 1. The rules of good practice shall be documented and the documentation shall be kept by the installation operator or the authorised person for the duration of the installation at the disposal of the supervisory authorities.
Příloha č. 2
Annex No 2 to Government Regulation No 117 / 2016 Coll.
INTERNAL PRODUCTION MANAGEMENT (MODULE A)
1. Internal production control
Internal production control is a conformity assessment procedure whereby the manufacturer carries out the activities set out in points 2, 3, 4 and 5 of this Annex and guarantees and declares, under its responsibility, that the instruments concerned comply with the requirements of this Regulation which apply to them.
2. Assessment of electromagnetic compatibility
The manufacturer shall carry out an assessment of the electromagnetic compatibility of the apparatus on the basis of the relevant phenomena in order to meet the essential requirements set out in point 1 of Annex 1 to this Regulation.
All normal operating conditions shall be taken into account when assessing electromagnetic compatibility. If the apparatus can have different configurations, the electromagnetic compatibility assessment shall confirm that the apparatus complies with the essential requirements of point 1 of Annex 1 in all possible configurations which the manufacturer shall designate as representative for the intended use of the apparatus.
3. Technical documentation
The manufacturer shall draw up the technical documentation. The documentation shall allow the instrument's conformity assessment to be carried out with the relevant requirements and shall include an appropriate analysis and risk assessment.
The technical documentation shall specify the relevant requirements and, to the extent necessary for the assessment, shall relate to the design, manufacture and operation of the apparatus. The technical documentation shall include, where relevant, at least the following elements:
(a) the overall description of the apparatus;
(b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits and, where appropriate, other design documentation;
(c) the descriptions and explanations needed to understand these drawings, diagrams and the functioning of the apparatus;
(d) a list of harmonised standards to which the references in the Official Journal of the European Union have been published and which have been applied in full or in part, and a description of the solutions chosen to meet the essential requirements of this Regulation, where such harmonised standards have not been applied, including a list of other relevant technical specifications which have been applied. In the case of partly applied harmonised standards, the technical documentation shall include those parts which have been used;
(e) the results of the design calculations, the examinations carried out and, where appropriate, other results of the calculations and checks;
(f) test reports.
4. Production
The manufacturer shall take all necessary measures to ensure that the production process and its control ensure compliance of the manufactured apparatus with the technical documentation set out in point 3 and with the essential requirements set out in point 1 of Annex 1 to this Regulation.
5. CE marking and EU declaration of conformity
5.1. The manufacturer shall place the CE marking on each individual apparatus meeting the relevant requirements of this Regulation.
5.2. The manufacturer shall draw up a written EU declaration of conformity for the instrument model and shall keep it at the disposal of the supervisory authority for 10 years after the instrument has been placed on the market together with the technical documentation. The EU declaration of conformity shall indicate the instrument for which it has been drawn up.
A copy of the EU declaration of conformity shall be provided to the supervisory authority upon request.
6. Compulsory representative
The manufacturer's activities set out in point 5 may be carried out by his authorised representative on his behalf and under his responsibility, provided that the manufacturer has so specified in the authorised representative's mandate.
Příloha č. 3
Annex No 3 to Government Regulation No 117 / 2016 Coll.
EU type-examination (Module B)
1. The EU type-examination shall be part of a conformity assessment procedure in which the notified body shall examine the technical design of the apparatus and verify and confirm that the technical design of the apparatus meets the essential requirements set out in point 1 of Annex 1 to this Regulation.
2. The EU type-examination shall be carried out by assessing the suitability of the technical design of the apparatus by reviewing the technical documentation referred to in point 3 without checking the sample (design type). It may be limited to certain aspects of the essential requirements as specified by the manufacturer or his authorised representative.
3. The manufacturer shall submit an application for EU type-examination to the single notified body which he has chosen.
The application shall specify the aspects of the essential requirements to be reviewed. The application shall also include:
(a) the name and address of the manufacturer and, where the application is made by an authorised representative, his name and address;
(b) a written declaration that the same application has not been lodged with another notified body;
(c) technical documentation. The technical documentation shall allow the conformity of the apparatus to be assessed with the relevant requirements of this Regulation and shall include an appropriate analysis and risk assessment. The technical documentation shall specify the relevant requirements and, to the extent necessary for the assessment, shall relate to the design, manufacture and operation of the apparatus. The technical documentation shall include, where relevant, at least the following:
(i) the overall description of the apparatus,
(ii) conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
(iii) descriptions and explanations necessary for understanding these drawings, diagrams and the functioning of the apparatus;
(iv) a list of harmonised standards to which the references in the Official Journal of the European Union have been published and which have been applied in full or in part, and a description of the solutions chosen to meet the essential requirements laid down in this Regulation, where those harmonised standards have not been applied, including a list of other relevant technical specifications which have been applied. In the case of partly applied harmonised standards, the technical documentation shall indicate only those parts which have been used,
(v) the results of the design calculations, the examinations carried out and, where appropriate, the other results of the calculations or checks; and
(vi) test reports.
4. The notified body shall review the technical documentation in order to assess the adequacy of the technical design of the apparatus in relation to the aspects of the essential requirements which are required to be reviewed.
5. The notified body shall draw up an evaluation report recording the activities carried out under point 4 and their results. Without prejudice to the obligations of the notified body towards the Authority, the notified body shall publish the content of the report, in full or in part, only with the agreement of the manufacturer.
6. Where the type meets the requirements of this Regulation which apply to the apparatus, the notified body shall issue the manufacturer with an EU-type examination certificate. This certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the information on the aspects of the essential requirements to which it was subject, the conditions of validity of the certificate and the data necessary to identify the approved type. The EU type-examination certificate may be accompanied by 1 or more annexes.
The EU-type examination certificate and its annexes shall contain all information to enable the assessment of whether the manufactured instruments are in conformity with the type under examination and to carry out in-service checks.
Where the type does not comply with the requirements laid down in this Regulation, the notified body shall refuse to issue an EU-type examination certificate and inform the applicant thereof, stating in detail the reasons for the refusal.
7. The notified body shall ensure that it is informed of any changes to the generally accepted state of the art which would indicate that the approved type may no longer comply with the requirements laid down in this Regulation; where such a situation occurs, it shall decide whether such changes require additional investigations and inform the manufacturer accordingly.
The manufacturer shall inform the notified body which keeps the technical documentation concerning the EU-type examination certificate of any modifications to the approved type which may affect the conformity of the apparatus with the essential requirements of this Regulation or the conditions of validity of the certificate. Such modifications shall be approved by the notified body in the form of an addendum to the original EU-type examination certificate.
8. Each notified body shall inform the Authority of the EU type-examination certificates or additions thereto it has issued or withdrawn and shall make available to the Authority, on a regular or on request, a list of such certificates or additions which it has rejected, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies of the EU type-examination certificates or additions thereto which it has rejected, withdrawn, suspended or otherwise restricted, and, at the request of the other notified bodies, of the certificates or additions it has issued.
The European Commission, the Member States of the European Union and other notified bodies may request a copy of the EU-type examination certificates or additions thereto from the notified body. The European Commission and the Member States of the European Union may request a copy of the technical documentation and the results of the examination carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as a file of the technical file, including the documentation submitted by the manufacturer, until the expiry of the period of validity of the EU-type examination certificate.
9. For a period of 10 years from the placing on the market of the apparatus, the manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions, together with the technical documentation, for the purposes of the supervision authority.
10. The manufacturer's authorised representative may submit the application referred to in point 3 and carry out the activities set out in points 7 and 9, if the manufacturer has so specified by the authorised representative.
Conformity to type based on internal production control (Module C)
1. Conformity to type based on internal production control is part of the conformity assessment procedure carried out by the manufacturer for the activities set out in points 2 and 3 and guarantees and declares that the instruments concerned are in conformity with the type described in the EU-type examination certificate and comply with the requirements laid down in this Regulation which apply to them.
2. Production
The manufacturer shall take all necessary measures to ensure that the production process and its control ensure compliance of the manufactured apparatus with the approved type described in the EU-type examination certificate and with the requirements of this Regulation applicable to them.
3. CE marking and EU declaration of conformity
3.1. The manufacturer shall place the CE marking on each individual apparatus which conforms to the type described in the EU-type examination certificate and meets the relevant requirements laid down in this Regulation.
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Regulation Information
| Citation | Government Regulation No. 117 / 2016 Coll., on the Assessment of Conformity of Products in view of electromagnetic compatibility when making them available on the market |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 18.04.2016 |
|---|---|
| Effective from | 20.04.2016 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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