ELECTROMAGNETIC COMPATIBILITY DIRECTIVE (2014/30/EU) AND RELEVANT TESTS
Purpose
ARTICLE 1 – (1) The purpose of this Regulation is to regulate the electromagnetic compatibility of equipment and to ensure the functioning of the market in a way that the equipment complies with an adequate level of electromagnetic compatibility.
Scope
ARTICLE 2 – (1) This Regulation covers the equipment defined in Article 5.
(2) This Regulation covers:
a) Equipment covered by the Radio and Telecommunications Terminal Equipment Regulation published in the Official Gazette No. 26472 dated 24/3/2007,
b) All tools, indicators, equipment, mechanisms, parts, apparatus, devices, or software used or intended to be used for operating or controlling an aircraft in flight, including aircraft, engine, propeller, and communication devices, as well as any equipment that is part of the body, engine, or propeller or used to maneuver the aircraft on the ground,
c) Radio equipment used by amateur radio operators, provided it is not placed on the market (All components to be attached by amateur radio operators, commercial equipment modified by amateur radio operators, and such modified equipment for use by amateurs are not considered as equipment placed on the market).
d) Equipment that does not have the ability to generate electromagnetic emissions exceeding the level necessary for the designed operation of the radio and telecommunications equipment and other equipment, or to contribute to such emissions,
e) Equipment that operates without unacceptable performance degradation due to electromagnetic interference resulting from normal usage,
f) Evaluation kits specifically produced for research and development purposes, intended solely for professionals and used in research and development facilities,
(3) In the event that the essential requirements for the equipment specified in paragraph 1 are more specifically regulated, partially or entirely, in another European Union legislation, this Regulation will not apply to these requirements or its application will be suspended as of the date the relevant legislation comes into effect.
Legal Basis
ARTICLE 3 – (1) This Regulation is prepared based on the Law No. 4703 on the Preparation and Implementation of Technical Legislation Related to Products, dated 29/6/2001.
Compliance with European Union Legislation
ARTICLE 4 – (1) This Regulation is prepared within the framework of compliance with European Union legislation, considering the European Parliament and Council Directive 2014/30/EU on Electromagnetic Compatibility, dated 26/2/2014.
Definitions
ARTICLE 5 – (1) The following terms used in this Regulation are defined as follows:
a) EU: European Union,
b) Accreditation: The official recognition by a national accreditation body that a conformity assessment body meets the requirements set out by the relevant national or international standards and additional requirements stipulated in applicable sector-specific regulations for performing a particular conformity assessment activity,
c) Immunity: The ability of the equipment to operate as designed without performance degradation when exposed to electromagnetic disturbance,
ç) Ministry: Ministry of Science, Industry, and Technology,
d) CE mark: A mark that indicates the product complies with all the relevant provisions of technical legislation regarding the affixing of the CE mark,
e) Device: Any apparatus or combination of apparatuses placed on the market ready for use, designed for a final user, and which may be affected by electromagnetic disturbance or may emit electromagnetic disturbance, including components or sub-components intended for use with the device, or movable installations and equipment intended to operate in certain locations,
f) Distributor: Any natural or legal person who places a device on the market, other than the manufacturer or importer,
g) Equipment: Any device or fixed installation,
ğ) Electromagnetic disturbance: Any electromagnetic noise, unwanted signal, or alteration in the propagation environment that may reduce the performance of the equipment,
h) Electromagnetic environment: All electromagnetic phenomena observable in a given location,
ı) Electromagnetic compatibility: The ability of equipment to function satisfactorily within its electromagnetic environment without causing electromagnetic disturbance to other equipment in the same environment,
i) Recall: Any measure to return a device already in the possession of the end user,
j) Safety purposes: Purposes aimed at ensuring the safety of persons and property,
k) Economic operator: Manufacturer, authorized representative, importer, and distributor,
l) Manufacturer: Any natural or legal person who manufactures or has designed or manufactured a device, and markets it under their name or trademark,
m) Importer: A natural or legal person established in Turkey who places a product on the domestic market imported from abroad,
n) Commission: European Commission,
o) Placing on the market: The act of making the device available on the market for distribution, consumption, or use, whether for a fee or free of charge,
ö) Withdrawal from the market: Any action taken to prevent a device from being placed on the market within the supply chain,
p) Placing on the domestic market: The first placing of a device on the domestic market,
r) Fixed installation: A combination of various types of devices intended to be permanently installed and used in a specific location, and other devices when applicable,
s) Technical specification: A document specifying the technical requirements that the equipment must meet,
ş) TÜRKAK: Turkish Accreditation Agency,
t) Conformity assessment body: A body performing conformity assessment activities, including calibration, testing, certification, and inspection,
u) Conformity assessment: The process of demonstrating whether the essential requirements of this Regulation have been met with regard to the device,
ü) Harmonized standard: A European standard accepted by the Commission upon request to implement harmonized European Union legislation,
v) Member state: A member state of the European Union,
y) Authorized representative: A natural or legal person established in Turkey who has been granted written authorization by the manufacturer to act on their behalf for specific tasks.
SECOND CHAPTER
Essential Requirements, Placing on the Market and/or Putting into Service, Free Movement of Equipment
Essential Requirements
ARTICLE 6 – (1) The equipment must meet the essential requirements specified in Annex I.
Placing on the Market and/or Putting into Service
ARTICLE 7 – (1) The Ministry takes all necessary measures to ensure that the equipment is placed on the market and/or put into service only when it has been properly installed, maintained, used for its intended purpose, and complies with this Regulation.
Free Movement of Equipment
ARTICLE 8 – (1) The Ministry shall not prevent equipment that complies with this Regulation from being placed on the market and/or put into service for reasons related to electromagnetic compatibility.
(2) The requirements of this Regulation do not prevent the application of the following special measures related to the placing of equipment on the market or its use:
a) Measures to overcome existing or anticipated electromagnetic compatibility problems in a specific area.
b) Measures taken for security reasons to protect national communications networks or receiver and transmitter stations when used in well-defined spectrum situations for security purposes.
(3) These special measures shall be communicated to the Commission and EU member states through the Ministry via the Ministry of Economy, in accordance with the "Regulation on the Notification of Technical Legislation and Standards Between Turkey and the European Union" published in the Official Gazette No. 24715 on 3/4/2002.
(4) Provided that a clear indication is made that the equipment cannot be placed on the market or put into service until it complies with the conditions specified in this Regulation, the promotion and/or display of non-compliant equipment in trade fairs, exhibitions, or similar events is allowed. Promotion may only be conducted if appropriate measures are taken to prevent electromagnetic disturbance.
CHAPTER THREE
Obligations of Economic Operators
Obligations of Manufacturers
ARTICLE 9 – (1) Manufacturers shall ensure that the equipment is designed and manufactured in accordance with the essential requirements specified in Annex I when placing the equipment on the market.
(2) Manufacturers shall prepare the technical file referred to in Annex II or Annex III and apply or have applied the relevant conformity assessment procedure referred to in Article 16. In cases where the conformity assessment procedure demonstrates compliance with the safety requirements specified in Annex I, manufacturers shall draw up an EU Declaration of Conformity and affix the CE marking.
(3) Manufacturers shall keep the technical file and the EU Declaration of Conformity for 10 years from the date the equipment is placed on the market.
(4) Manufacturers shall ensure that the conformity of the equipment with this Regulation is maintained throughout its production. They shall follow any changes in the design of the equipment or its characteristics that are the basis for the conformity declaration, as well as changes in harmonized standards or other technical specifications, and take the necessary actions accordingly.
(5) Manufacturers shall ensure that, when a type, batch, or serial number, or any other means of identification is used to identify the equipment, this information is placed on the equipment. If the size or structure of the equipment does not allow this, the information must appear on the packaging or in a document accompanying the equipment.
(6) Manufacturers shall specify their names, registered trade names or trademarks, and the address where they can be contacted either on the equipment itself or, if this is not possible, on the packaging or in a document accompanying the equipment. Only one address for communication with the manufacturer shall be indicated. The contact details shall be provided in Turkish or in a language understood by the end users and accepted by the Ministry.
(7) Manufacturers shall ensure that instructions and safety information are provided in Turkish with the equipment. These instructions and safety information, as well as all labels, must be clear, understandable, and legible.
(8) If manufacturers are aware or should be aware that the equipment they have placed on the market does not comply with this Regulation, they must immediately take the necessary corrective actions to bring the equipment into conformity, withdraw it from the market, or, if necessary, recall it. In cases where the equipment poses a risk, manufacturers shall promptly and in detail inform the Ministry about all corrective actions taken due to non-compliance.
(9) Upon reasoned request, manufacturers shall provide the Ministry with all necessary information and documents proving the conformity of the equipment with this Regulation, either in printed or electronic form, in Turkish or in a language accepted by the Ministry. Manufacturers shall cooperate with the Ministry upon request to eliminate any risks associated with the equipment they have placed on the market.
CHAPTER THREE
Obligations of Economic Operators
Obligations of Manufacturers
ARTICLE 10 – (1) Manufacturers may appoint an authorized representative with a written authorization. The obligations set forth in the first paragraph of Article 9 and the obligation to prepare the technical file mentioned in the second paragraph of Article 9 are not among the powers of the authorized representative.
(2) The authorized representative shall perform the duties specified in the authorization document received from the manufacturer. The authorization document allows the authorized representative to at least do the following:
a) Keep the EU Declaration of Conformity and the technical file for 10 years from the date the device is placed on the market, for submission to the Ministry upon request.
b) Provide all information and documents required to demonstrate the equipment’s conformity to the Ministry upon reasoned request.
c) Cooperate with the Ministry upon request regarding any measures taken to eliminate any risks posed by the equipment, as mentioned in the authorization document of the authorized representative.
Obligations of Importers
ARTICLE 11 – (1) Importers shall place only devices that conform to this Regulation on the market.
(2) Importers shall ensure that the manufacturer has completed the necessary conformity assessment procedure specified in Article 16 before placing the equipment on the market. Importers must ensure that the manufacturer has prepared the technical file, the device carries the CE marking, the necessary documents are provided with the equipment, and that the manufacturer has met the requirements specified in the fifth and sixth paragraphs of Article 9. If the importer is aware or should be aware that the device does not comply with the essential requirements specified in Annex I, it shall not place the equipment on the market until it is brought into conformity. If the device poses a risk, the importer shall inform the manufacturer and the Ministry.
(3) Importers shall specify their names, registered trade names or trademarks, and the address at which they can be contacted on the device, or, if this is not possible, on the packaging or in a document accompanying the device. The contact information must be provided in Turkish or in a language easily understood by the end users and accepted by the Ministry.
(4) Importers shall ensure that the instructions and information mentioned in Article 20 are provided in Turkish with the device.
(5) Importers shall take all necessary precautions to ensure that the storage and transport conditions of the device do not endanger its conformity to the essential requirements specified in Annex I.
(6) If importers are aware or should be aware that the device they have placed on the market does not comply with this Regulation, they must immediately take corrective actions to bring the device into conformity, withdraw it from the market, or recall it. In cases where the device poses a risk, importers must inform the Ministry promptly and in detail about all corrective actions taken.
(7) Importers shall keep a copy of the EU Declaration of Conformity for 10 years from the date the equipment is placed on the market and make it available to the Ministry upon request. They must also ensure that the technical file is made available to the Ministry upon request.
(8) Upon reasoned request, importers shall provide the Ministry with all necessary information and documents proving the device’s conformity to this Regulation, either in printed or electronic form, in Turkish or in a language accepted by the Ministry. Importers shall cooperate with the Ministry upon request to eliminate any risks associated with the equipment they have placed on the market.
Obligations of Distributors
ARTICLE 12 – (1) Distributors shall act with due care regarding the requirements of this Regulation when placing the device on the market.
(2) Before placing a device on the market, distributors shall ensure that the device carries the CE marking, that the necessary documents and the instructions and other information referred to in Article 20 are provided in Turkish, and that the manufacturer and importer have complied with the obligations set forth in the fifth and sixth paragraphs of Article 9 and the third paragraph of Article 11. If the distributor knows or should know that the device does not comply with the essential requirements specified in Annex I, they shall not place the device on the market until it is brought into conformity. If the device poses a risk, the distributor shall inform the manufacturer, importer, and the Ministry.
(3) Distributors shall take precautions to ensure that the storage and transport conditions of the equipment do not endanger its conformity with the essential requirements specified in Annex I.
(4) If distributors know or should know that the devices they have placed on the market do not comply with the requirements of this Regulation, they shall ensure that corrective actions are taken to bring the device into conformity, withdraw it from the market, or recall it. If the device poses a risk, distributors shall inform the Ministry promptly and in detail about all corrective actions taken.
(5) Distributors shall provide the Ministry with all the necessary information and documents showing that the equipment conforms to this Regulation, either in printed or electronic form, upon reasoned request. Distributors shall cooperate with the Ministry upon request to eliminate any risks associated with the devices they have placed on the market.
When the Obligations of Manufacturers Apply to Importers and Distributors
ARTICLE 13 – (1) An importer or distributor who places a device on the market under their own name or brand or modifies an already marketed device in such a way that it affects its conformity with the requirements of this Regulation, shall be considered as a manufacturer for the purposes of this Regulation and shall be subject to the obligations of manufacturers set forth in Article 9.
Identification of Economic Operators
ARTICLE 14 – (1) Economic operators shall, upon request, provide the Ministry with information on the identity of:
a) All economic operators who supply them with equipment.
b) All economic operators to whom they supply equipment.
(2) Economic operators must be able to provide the information specified in the first paragraph for 10 years after receiving the equipment and 10 years after supplying the equipment.
CHAPTER FOUR
Conformity of the Equipment
Presumption of Conformity of the Equipment
ARTICLE 15 – (1) Products that conform to the harmonized standards published in the Official Journal of the European Union, or their corresponding Turkish Standards, or their relevant sections, are presumed to comply with the essential requirements specified in Annex I of this Regulation.
Conformity Assessment Procedures for Equipment
ARTICLE 16 – (1) The conformity of equipment with the essential requirements specified in Annex I is demonstrated through one of the following two conformity assessment procedures:
a) Internal control of production as regulated in Annex II.
b) AB type examination following an internal control of production-based conformity assessment as regulated in Annex III.
(2) The manufacturer may choose to apply the procedure mentioned in paragraph (b) of the first section of this article for specific aspects of the essential requirements, but for other aspects, the procedure in paragraph (a) of the first section must be applied.
EU Declaration of Conformity
ARTICLE 17 – (1) The EU Declaration of Conformity indicates that the essential requirements specified in Annex I have been met.
(2) The EU Declaration of Conformity is prepared in accordance with the provisions specified in Annex II and Annex III and is continuously updated, as outlined in Annex IV. If prepared in a language other than Turkish, the Turkish translation of the EU Declaration of Conformity is also included.
(3) In cases where the device is subject to more than one piece of legislation requiring an EU Declaration of Conformity, a single EU Declaration of Conformity is prepared for all applicable legislation. The EU Declaration of Conformity contains a description of the relevant legislation, including the title, publication date, and publication references.
(4) It is assumed that the manufacturer assumes responsibility for ensuring the device’s conformity with the requirements of this Regulation upon preparing the EU Declaration of Conformity.
General Principles of the CE Marking
ARTICLE 18 – (1) The CE marking is subject to the principles specified in the "CE" Marking Regulation enacted by the Council of Ministers’ Decision No. 2011/2588, dated 16/12/2011.
Rules and Conditions for Affixing the CE Marking
ARTICLE 19 – (1) The CE marking is affixed to the device or its data plate in a visible, readable, and indelible manner. If this is not possible due to the device's design or cannot be guaranteed, the marking is placed on the product's packaging or accompanying documents.
(2) The CE marking is affixed before the device is placed on the market.
(3) The Ministry ensures that the process of affixing the CE marking is correctly implemented based on existing practices and intervenes if the marking is used improperly.
Information regarding the use of the device
Article 20 – (1) Information regarding all specific measures to be taken during the installation, setup, maintenance, or use of the device to ensure compliance with the essential requirements set out in Annex I is provided along with the device when it is put into service.
(2) A clear statement regarding such a usage restriction is included with the device where compliance with the essential requirements specified in Annex I cannot be ensured in residential areas. Additionally, if applicable, this statement is also included on the packaging.
(3) Information necessary to ensure the device is used for its intended purpose is included in the instructions provided with the device.
Fixed installations
ARTICLE 21 – (1) Devices that are placed on the market and can be incorporated into a fixed installation shall be subject to all the relevant provisions established in this Regulation. However, the requirements of Article 6, Articles 9 to 14, and Articles 16 to 20 shall not apply to devices designed solely to be incorporated into a fixed installation and not placed on the market in any other way. In such cases, the documents provided should indicate the fixed installation and its electromagnetic compatibility characteristics, and show the measures to be taken to ensure that the installation remains compliant when the device is incorporated into the fixed installation. The documents should also include the information specified in Article 9, paragraphs five and six, and Article 11, paragraph three. The good engineering practices specified in Annex I should be documented, and the relevant documents should be kept available for the Ministry as long as the fixed installation remains in operation by the responsible person(s).
(2) In the event of indications of non-compliance of the fixed installation, especially if there are complaints about disturbances caused by the installation, the Ministry may request evidence of the compliance of the fixed installation and, if necessary, initiate an assessment. If non-compliance is determined, the Ministry may require appropriate measures to be taken to bring the fixed installation into conformity with the essential requirements specified in Annex I.
(3) The Ministry shall establish the necessary provisions to determine the person or persons responsible for ensuring that the fixed installation complies with the relevant essential requirements.
FIFTH SECTION
Notified Bodies
Notification
ARTICLE 22 – (1) The Ministry shall notify the Commission and EU Member States through the Ministry of Economy about the bodies authorized to carry out third-party conformity assessment tasks under this Regulation.
ARTICLE 23 – (1) The Ministry is authorized to establish the procedures for the evaluation, designation, and monitoring of conformity assessment bodies, including compliance with Article 28.
ARTICLE 24 – (1) The procedures for the designation, evaluation, and monitoring of conformity assessment bodies shall be conducted:
a) In such a way as to avoid conflicts of interest with the conformity assessment bodies,
b) Within the framework of the principle of impartiality,
c) Ensuring that the personnel making decisions on the designation of conformity assessment bodies are separate from those evaluating these bodies,
ç) In a manner that conformity assessment bodies' activities or consulting services are not provided commercially or competitively,
d) Ensuring the confidentiality of the information obtained,
e) By employing a sufficient number of qualified personnel to ensure the proper and complete execution of the relevant tasks.
ARTICLE 25 – (1) The Ministry shall notify the Commission through the Ministry of Economy regarding the criteria for evaluating the qualifications of conformity assessment bodies, the procedures for their designation, the monitoring of the authorized bodies, and any changes to these matters.
ARTICLE 26 – (1) The conformity assessment body to be designated must meet the following qualifications:
(2) The conformity assessment body must be established in compliance with national legislation and have legal personality.
(3) The conformity assessment body must be an independent third party from the manufacturer or institution/business whose device it evaluates. A business association, trade union, or federation representing companies involved in the design, manufacturing, supply, installation, use, or maintenance of the evaluated devices can be accepted as a third-party body, provided that it proves its independence and has no conflict of interest.
(4) The highest-level managers of the conformity assessment body and the personnel responsible for conformity assessment tasks must not be involved in the design, manufacturing, supply, installation, usage, or maintenance of the devices they evaluate, nor can they represent any of these parties. This does not prevent the conformity assessment body from using the devices necessary for its activities or using them for personal purposes. A conformity assessment body, its top-level managers, and personnel responsible for conformity assessment tasks cannot directly participate in or represent parties involved in the design, manufacturing, marketing, installation, use, or maintenance of such devices. They must not engage in any activities that could negatively affect their independence in decision-making or prevent them from properly performing their duties. This also applies to consulting services. Conformity assessment bodies must ensure that the activities carried out by their branches, subsidiaries, or contractors do not compromise the confidentiality, objectivity, or impartiality of their conformity assessment activities.
(5) Conformity assessment bodies and their personnel must carry out conformity assessment activities with the required high-level technical qualifications and professional competence and must act independently of any external pressure, inducement, or influence, especially when making decisions regarding financial matters.
(6) The conformity assessment body, whether it is carried out by the body itself or by others on its behalf and under its responsibility, must have the capacity to carry out all the conformity assessment tasks assigned to it under Annex III. The conformity assessment body must always meet the following mandatory requirements for each conformity assessment procedure and for each device category and type:
a) Personnel with sufficient technical knowledge and experience to carry out conformity assessment tasks.
b) Suitable procedures and policies that ensure the transparency or reproducibility of the conformity assessment process and the separation of the tasks performed by the conformity assessment body as a notified body from its other activities.
c) Methods that consider the size of the work, the sector, the organizational structure, the technological complexity of the product, and the volume or nature of the manufacturing process.
ç) Having the necessary tools and access to all required equipment or facilities to properly perform technical and administrative tasks related to conformity assessment.
(7) The personnel responsible for carrying out conformity assessment activities must meet the following requirements:
a) Sufficient technical and professional training covering all the conformity assessment activities assigned to the conformity assessment body as a notified body.
b) Sufficient knowledge of the requirements of the evaluations they perform and the necessary authority to carry out those evaluations.
c) Appropriate knowledge and understanding of the fundamental requirements set out in Annex I, applicable harmonized standards, and relevant provisions of EU legislation and national regulations.
d) The ability to prepare certificates, records, and reports that demonstrate the completion of the activities they carry out.
(8) Conformity assessment bodies responsible for carrying out conformity assessment activities, their top-level managers, and personnel ensure impartiality. The salaries of the top-level managers and personnel responsible for carrying out conformity assessment activities in a conformity assessment body cannot be dependent on the number of evaluations performed or the results of these evaluations.
(9) If responsibility is not assumed by the public under national legislation or if the Ministry is not directly responsible for conformity assessment, conformity assessment bodies shall take out professional liability insurance.
(10) The personnel of the conformity assessment bodies, except in cases related to the Ministry, shall maintain professional confidentiality regarding all information obtained during the performance of their duties under Annex-III or any provision referred to by national legislation. Intellectual property rights are protected.
(11) Conformity assessment bodies participate in relevant standardization activities and the work of groups formed by the EU under relevant technical regulations for the coordination of notified bodies, or ensure that personnel carrying out evaluation activities are informed about these activities. The decisions made and documents prepared as a result of the work of the group formed for the coordination of notified bodies are used as guidance documents.
The presumption of conformity of notified bodies.
Article 27 - (1) A conformity assessment body is presumed to conform to the requirements set out in Article 26, provided that it demonstrates compliance with the criteria specified in harmonized standards published in the Official Journal of the European Union or their relevant sections, and the applicable harmonized standards cover these requirements.
Approved bodies' branches, representations, and subcontractors.
ARTICLE 28 – (1) If an approved body assigns certain tasks related to conformity assessment to a subcontractor or uses a branch/representation for these activities, the body ensures that the subcontractor or branch/representation meets the requirements specified in Article 26 and informs the Ministry accordingly.
(2) In cases where these tasks are assigned, approved bodies assume full responsibility for the tasks carried out by the subcontractors or branches/representations.
(3) Activities to be carried out by approved bodies may only be given to a subcontractor or carried out by a branch/representation if the customer approves.
(4) Approved bodies keep records related to the evaluation of the subcontractor or branch/representation's qualifications and activities carried out under Annex III, and submit these records to the Ministry if necessary.
Notification application
ARTICLE 29 – (1) Those wishing to be designated as a notified body from conformity assessment bodies based in Turkey shall apply to the Ministry.
(2) Along with the application document, the necessary information regarding the conformity assessment activities they are qualified for, the conformity assessment module or modules, and the device, as well as, if applicable, an accreditation certificate proving that the conformity assessment body meets the requirements set out in Article 26, and an accreditation certificate issued in accordance with Article 7 of the Regulation on Conformity Assessment Bodies and Notified Bodies, enacted by the Council of Ministers Decision No. 2011/2621 of 16/12/2011, shall be submitted.
Notification Process
ARTICLE 30 – (1) The Ministry can assign only those conformity assessment bodies that meet the requirements specified in Article 26 as notified bodies.
(2) The Ministry shall notify the assigned bodies to the Commission and EU member states through the Ministry of Economy. The notification is made using the EU New Approach Notified Bodies Information System.
(3) The notification includes all details regarding the conformity assessment activities, the relevant conformity assessment modules, the device, and the organization’s competence.
(4) Within two weeks from the date of notification, the Commission or EU member states may request additional information or object to the notified body candidate's competence. After the assignment of an identification registration number by the Commission to the notified body, the Ministry assigns this body as a notified body.
(5) The Ministry informs the Commission and EU member states via the Ministry of Economy regarding any changes in the activities and characteristics of the notified body subject to notification.
The appointment of notified bodies
Article 31 – (1) After the European Commission assigns an identity registration number to the notified conformity assessment body, the Ministry designates this body as a notified body.
Changes in Appointments
ARTICLE 32 – (1) If the Ministry determines that the notified body no longer meets the requirements set out in Article 26 or fails to fulfill its obligations, or if it is informed of this situation, the Ministry will, depending on the seriousness of the non-compliance or failure to fulfill the obligations, restrict, suspend, or revoke the status of the notified body. The Ministry will immediately inform the Commission and EU member states about this matter through the Ministry of Economy.
(2) The Ministry will take appropriate measures to ensure that records and documents related to the conformity assessment procedures carried out by the notified body during its period of activity, which has been restricted, suspended, or revoked, or voluntarily ceased its activities, are processed by another notified body performing similar activities, or stored for submission to the Ministry upon request.
Objections to the Competence of Notified Bodies
ARTICLE 33 – (1) Upon request, the Ministry shall inform the Ministry of Economy to submit to the Commission all information regarding the appointment of the notified body or its continued compliance with the requirements.
(2) If the Commission or any EU member state requests an investigation into the technical competence and compliance with relevant legislation of a notified body appointed by the Ministry, the Ministry shall follow the procedure set out in Article 4 of Decision No. 1/2006 of the Turkey-EU Association Council.
Obligations of Notified Bodies Regarding Their Activities
Tabii, işte maddeyi birebir olarak İngilizceye çevirdim:
ARTICLE 34 – (1) The notified body shall carry out the conformity assessments in accordance with the conformity assessment procedure specified in Annex-III.
(2) Conformity assessments shall be carried out in such a way that they do not impose unnecessary burdens on economic operators. Conformity assessment bodies shall carry out their activities considering the size of the commitment, the sector in which they operate, the structure, the complexity level of the technology of the device in question, and the volume or qualification of the manufacturing process. In doing so, they shall also take into account the protection level and the degree of rigor required for ensuring the device’s compliance with this Regulation.
(3) If the notified body detects that a manufacturer has not met the basic requirements set out in Annex-I or the relevant harmonized standards or technical specifications, the notified body will request the manufacturer to take corrective actions and will not issue a conformity certificate.
(4) After a certificate is issued, if the notified body determines that the device is no longer compliant during the monitoring of conformity, it will request the manufacturer to take corrective actions and, if necessary, suspend or withdraw the certificate.
(5) If corrective actions are not taken or do not achieve the desired effect, the notified body shall restrict, suspend, or withdraw all related documents accordingly.
Appeals Against the Decisions of Notified Bodies
ARTICLE 35 – (1) The Ministry ensures that there is a mechanism for appealing the decisions of notified bodies.
Obligation of Notified Bodies to Provide Information
ARTICLE 36 – (1) Notified bodies shall inform the Ministry on the following matters:
a) The refusal, limitation, suspension, or withdrawal of a certificate.
b) Any situation affecting the scope and conditions of their notification.
c) Any information request received from the Ministry related to conformity assessment activities.
ç) Any cross-border activities and any other activities carried out in connection with their tasks, including subcontracting.
(2) Notified bodies shall also inform other notified bodies about non-compliant outcomes and, upon request, about compliant outcomes of conformity assessment activities they have performed for the same product.
Coordination of Notified Bodies
ARTICLE 37 – (1) Notified bodies participate in or ensure that the personnel performing evaluation activities are aware of the work carried out by the group established under the relevant technical regulation by the EU for the coordination of notified bodies. The decisions made and the documents prepared by the group for coordination of notified bodies are used as guidance documents.
SIXTH CHAPTER
Market Surveillance and Control, Device Control,
and Protection Measures Procedure
Market Surveillance and Control and Device Inspections
ARTICLE 38 – (1) In the market surveillance and control of devices, the provisions of the Regulation on Market Surveillance and Control of Products, published in the Official Gazette No. 2001/3529 dated 13/11/2001, shall apply.
Procedures to be followed for products posing a risk at the national level
ARTICLE 39 – (1) If the Ministry has a justification that a device within the scope of this Regulation poses a risk to the protection of public interest under this Regulation, the Ministry shall carry out an evaluation covering all the requirements set out in this Regulation for the relevant device. The relevant economic operators shall cooperate with the Ministry for this purpose. If the Ministry determines that the device does not comply with the requirements set out in this Regulation as a result of the evaluation, it will immediately request that the relevant economic operator take all appropriate corrective measures to bring the device into compliance with the relevant requirements, withdraw the device from the market, or recall it within a reasonable time proportional to the nature of the risk. The Ministry will inform the relevant notified body about this issue.
(2) The provisions of the Regulation on Market Surveillance and Control of Products and the Ministry of Science, Industry, and Technology Market Surveillance and Control Regulation, published in the Official Gazette No. 28429 dated 2/10/2012, are applicable for the measures mentioned in the first paragraph.
(3) If the Ministry considers that the non-compliance is not limited to the country, it informs the Commission and EU Member States through the Ministry of Economy regarding the results of the evaluation and the measures to be taken by the economic operators.
(4) The economic operator shall ensure that appropriate corrective actions are taken for all devices placed on the market.
(5) If the relevant economic operator fails to take sufficient corrective actions within the period specified in the first paragraph, the Ministry shall take all appropriate temporary measures to prohibit or restrict the device’s presence on the market, withdraw the device from the market, or recall it. The Ministry will promptly inform the Commission and the EU Member States about these measures through the Ministry of Economy.
(6) The information referred to in the fifth paragraph of this article shall include all available details, particularly the data required to identify non-compliant devices, the origin of the devices, the nature of the alleged non-compliance and the associated risk, the nature and duration of the measures taken, and the arguments put forward by the relevant economic operator. The Ministry shall indicate whether the non-compliance is due to any of the following reasons:
a) The device does not meet the requirements regarding the protection of public interest covered by this Regulation.
b) Deficiencies in the harmonized standards in which the conformity presumption mentioned in Article 15 is accepted.
(7) The Ministry, based on the information transmitted by the Commission regarding a procedure initiated in the EU market, shall notify the Commission and the EU Member States through the Ministry of Economy of any measure it accepts to be implemented regarding the non-compliance of the relevant device and any additional information it possesses; furthermore, if it objects to the notified measure, it shall notify its objections to the Commission and EU Member States through the Ministry of Economy.
(8) If no objection is raised by an EU Member State or the Commission against the temporary measure taken by the Ministry within three months after the information provision process specified in the fifth paragraph of this article, the measure shall be considered justified.
(9) The Ministry ensures that appropriate restrictive measures, such as the withdrawal of the device from the market, are taken without delay regarding the relevant device.
Protection Measures Procedure
ARTICLE 40 – (1) If objections are made by EU Member States and the Commission against the measure specified in the fourth and fifth paragraphs of Article 39 and if the Commission concludes after an examination that the measure is not based on valid grounds, the measure shall be repealed.
Formal Non-compliance
ARTICLE 41 – (1) Without prejudice to Article 39, in case any of the following findings occur, the Ministry shall ask the relevant economic operator to eliminate the non-compliance:
a) The CE mark being affixed in a manner that contradicts the general principles specified in the “CE Marking Regulation”.
b) The CE mark not being affixed.
c) The absence of an EU declaration of conformity.
ç) The EU declaration of conformity not being properly issued.
d) The absence or incompleteness of the technical file.
e) The absence, incorrectness, or incompleteness of the information specified in the sixth paragraph of Article 9 and the third paragraph of Article 11.
f) Any non-compliance with the requirements specified in Article 9 or Article 11, other than those stated in (e).
(2) If the non-compliance specified in the first paragraph of this article persists, the Ministry shall take all appropriate measures to restrict or prevent the presence of the device in the market and shall ensure the device is withdrawn or recalled from the market.
SEVENTH CHAPTER
Miscellaneous and Final Provisions
Committee Proceedings
ARTICLE 42 – (1) The Ministry participates in the activities of the Electromagnetic Compatibility Committee established by the Commission.
Administrative Sanctions
ARTICLE 43 – (1) Those who act contrary to the provisions of this Regulation are subject to the provisions of the Law on the Preparation and Implementation of Technical Legislation on Products No. 4703.
Regulatory Authority
ARTICLE 44 – (1) The Ministry is authorized to make regulations related to the implementation of this Regulation.
Repealed Regulation
ARTICLE 45 – (1) The Electromagnetic Compatibility Regulation (2004/108/EC) published in the Official Gazette No. 26680 on 24/10/2007 has been repealed. References made to the repealed regulation in other regulations are considered to have been made to this Regulation.
Transitional Provision
TRANSITIONAL ARTICLE 1 – (1) The Ministry shall not prevent the placing on the market or putting into service of equipment that complies with the Electromagnetic Compatibility Regulation (2004/108/EC) published in the Official Gazette No. 26680 on 24/10/2007 and which was placed on the market before the entry into force of this Regulation.
Enforcement
ARTICLE 46 – (1) This Regulation shall enter into force on the date of its publication.
Execution
ARTICLE 47 – (1) The Minister of Science, Industry, and Technology shall execute the provisions of this Regulation.
There are two main principles in Electromagnetic Compatibility:
A - Electromagnetic Emission
B - Immunity to Electromagnetic Interference
A series of standards specifically examine both of these phenomena for a product or a group of products.
In many cases, both phenomena are addressed and examined in the same standard.
Standards are grouped as follows:
1 - Basic Standards
2 - Generic Standards
3 - Product Family Standards
4 - Product Standards
Basic Standards: These standards generally include the individual definition for each Disturbing Wave event, the explanation of the phenomenon, detailed test methods, description and explanation of the test setup, and the measurement devices used.
The purpose of basic standards is to be referenced in the Generic, Product Family, and Product standards.
The use of these basic standards does not grant the right to affix the CE mark.
Therefore, basic standards are not published as "Harmonized Standards" in the Official Journal of the European Union.
Examples:
- IEC 61000-4 Series: Measurement techniques for immunity to electromagnetic interference
- ENV 50140: "Immunity to Electromagnetic Interference" tests against radio-frequency electromagnetic fields
Generic Standards: These standards are generally applicable to all products used in the same environment. The standards contain the limit values that should be used for EMC phenomena that may be decisive for products. Reference to basic standards is made for testing methods. "Generic Standards" are considered for harmonization and therefore published in the Official Journal of the European Union. The use of these standards can give the right to affix the CE mark. However, this requires that there is no "Product Family or Product Standard" for the relevant product. This is because such standards take precedence over "Generic Standards". General "Generic Standards" are grouped into four standards covering all environmental conditions and the most important EMC phenomena related to "Emission" and "Immunity".
Electromagnetic Emission:
EN 50081-1: Electromagnetic Compatibility (EMC) Generic Standard "Emission" (Part 1: Devices in residential areas, workplaces, restaurants, hotels, as well as small businesses) (Generic Emission Standard)
EN 50081-2: Electromagnetic Compatibility (EMC) Generic Standard "Emission" (Part 2: Devices in industrial areas) (Generic Emission Standard)
Immunity to Interference:
EN 50082-1: EMC; Generic Standard "Immunity to Interference" (Part 1: Devices in residences, workplaces, restaurants, hotels, small businesses) (Generic Immunity Standard)
EN 50082-2: EMC; Generic Standard "Immunity to Interference" (Part 2: Devices in industrial areas) (Generic Immunity Standard)
Product Family Standards: "Product family standards" are defined for related product groups. Test levels and limit values are required. These standards are considered for harmonization and therefore published in the Official Journal of the European Union. They can be used for certification under the CE Marking. If a product family standard exists, only this standard is used.
Example: EN 55015; Limit values and measurement methods for electromagnetic disturbances from fluorescent lamps (Emission)
Product Standards: These standards are similar to "Product Family Standards," but unlike product family standards, they are defined for a specific type of product. "Product Standards" always take precedence over "Generic Standards."
Example: EN 50061: Safety conditions for implantable pacemakers, EN 50091-2: Uninterruptible power supply systems (UPS) (Part 2: EMC Requirements)
Tests:
In the tests conducted, standards are based on the product's standard description. During this process, the device is treated as a "Black Box."
External Box
Various tests are performed on the following:
- Direct Current (DC) and Alternating Current (AC) power supply input and output
- Signal, Data, Measurement, and Control input and output
- Functional Grounding connection.
Measurement of Emission: Generally, the following measurements are involved:
• Measurement of electromagnetic wave radiation (Radiated magnetic field emission)
• Measurement of conducted emission (on device connection conductors)
• Measurement of power disturbance (Power Disturbance)
• Measurement of steady-state intermittent fragile disturbance waves
• Low-frequency network disturbance waves
• Measurement of electromagnetic wave radiation (Radiated magnetic field emission):
Open Area Test Site (OATS):
This refers to the measurement of direct electromagnetic wave emission from a device. The field strength is measured with a measurement antenna at a specific distance. These measurements cannot be made in a laboratory. In particular, the "Emission" requirements in EN 55022 and EN 55011 should be examined at an "Open Area Test Site" (OATS).
Alternatively, an "Anechoic Chamber" can be used. This is a reflection-free zone made of absorbent material on the walls and ceiling (and sometimes the floor). In this case, the conditions of an "Open Area Test Site" can be simulated.
Frequency Range: Electromagnetic wave emission measurement is typically performed in the frequency range of 30 MHz to 1 GHz at the "Open Area Test Site". However, in many cases, lower and higher frequencies also apply. Electrical field strengths are measured above 30 MHz, while magnetic field strengths are measured below 30 MHz.
• Measurement of Conducted Emission (Conducted Emission):
This involves tests on conductors, where high-frequency voltage is measured (usually in the electrical network; connection conductors, but communication or load output conductors may also be involved). This method is typically performed in the frequency range of 9 kHz to 30 MHz.
Measurement of Power Disturbance (Power Disturbance): In some standards, for "measuring disturbing wave power", a "Coupling Ring" is used for measurements above 30 MHz instead of an "Open Area Test Site". A "Coupling Ring" is a combination of a current clamp and an absorption filter. It is moved along the "network connection cable" to determine the maximum value of the "disturbing wave power". A measurement that should be conducted with the help of a "Coupling Ring" from 30 MHz to 300 MHz (sometimes up to 1000 MHz) is included in EN55014.
Measurement of Steady-State Intermittent Fragile Disturbance Waves: The measurement arrangements for continuous disturbance waves are insufficient for measuring impulsive disturbance waves. Additionally, the length of the pulse should be determined using an oscilloscope or a special pulse "analyzer". These types of disturbance waves are primarily created by switching components such as thermostats.
• Low-Frequency Network Disturbance Waves:
a- Network Harmonic Distortion (Harmonic Distortion):