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Requirements for Safety Equipment of Ships, Procedure for Attestation of Conformity of Safety Equipment and for Affixing of Marks thereto, Form of Conformity Marks, Procedure for Testing of Safety Equipment and Installation of Equipment on Ships and Format of Equipment Certificate and Procedure for Issue thereof

Content

Requirements for Safety Equipment of Ships, Procedure for Attestation of Conformity of Safety Equipment and for Affixing of Marks thereto, Form of Conformity Marks, Procedure for Testing of Safety Equipment and Installation of Equipment on Ships and Format of Equipment Certificate and Procedure for Issue thereof - content
Issuer:Minister of Economic Affairs and Communications
Type:regulation
In force from:22.02.2019
In force until: In force
Translation published:16.06.2020

Requirements for Safety Equipment of Ships, Procedure for Attestation of Conformity of Safety Equipment and for Affixing of Marks thereto, Form of Conformity Marks, Procedure for Testing of Safety Equipment and Installation of Equipment on Ships and Format of Equipment Certificate and Procedure for Issue thereof1

Passed 28.09.2004 No. 183
RTL 2004, 130, 2017
Entry into force 08.10.2004

Amended by the following legal instruments (show)

PassedPublishedEntry into force
19.03.2009RTL 2009, 29, 37329.03.2009
02.07.2009RTL 2009, 56, 81816.07.2009
05.01.2012RT I, 11.01.2012, 114.01.2012
12.03.2013RT I, 15.03.2013, 930.11.2013
30.01.2014RT I, 04.02.2014, 307.02.2014
10.07.2014RT I, 16.07.2014, 104.12.2014
11.08.2015RT I, 12.08.2015, 1115.08.2015
15.03.2016RT I, 18.03.2016, 230.04.2016
14.09.2016RT I, 20.09.2016, 423.09.2016
05.02.2019RT I, 19.02.2019, 122.02.2019

The Regulation is established on the basis of subsection 191 (3) of the Maritime Safety Act.

Chapter 1 GENERAL PROVISIONS 

§ 1.  Objective

  The objective of this Regulation is to enhance safety at sea and prevent marine pollution through use of high-quality safety equipment (hereinafter equipment) on board ships in compliance with international conventions and legislation of the European Community (hereinafter Community) and Estonia.

§ 2.  Scope of regulation

 (1) This Regulation shall be applied to the equipment of ships entered or to be entered in the ship register of Estonia pursuant to the requirements of international conventions.
[RTL 2009, 29, 373 – entry into force 29.03.2009]

 (2) This regulation shall not be applied to the equipment placed on board ships in compliance with the requirements of international conventions before the entry into force of this Regulation.

 (3) If any other piece of legislation provides for requirements for the equipment within the scope of application of this Regulation, also the requirements provided for in such other piece of legislation shall be applied to such equipment.

 (4) The definitions used in the Product Conformity Act are used in this Regulation with specifications deriving from the Regulation.
[RT I, 04.02.2014, 3 – entry into force 07.02.2014]

 (5) Within the meaning of this Regulation:
 1) “conformity assessment procedures” mean the procedures specified in § 4 and Divisions 2–8 of Chapter 3 of this Regulation;
 2) “equipment” means the mandatory or non-mandatory equipment listed in Annex A to Council Directive 96/98/EC on marine equipment (OJ L 46, 17.2.1997, p. 25–56) and placed on board ships pursuant to international instruments and Estonian legislation which has been approved by the Maritime Administration or a recognised organisation;
[RTL 2009, 29, 373 – entry into force 29.03.2009]
 3) “radiocommunications equipment” means the equipment required by Chapter IV of the International Convention for the Safety of Life at Sea, 1974, together with its Protocols and amendments thereto in force (hereinafter SOLAS Convention), and two-way VHF radiotelephone apparatus as required by Regulation III/6.2.1 of the same Convention;
 4) “international conventions” mean:
– the 1996 International Convention on Load Lines;
– the 1972 Convention on the International Regulations for Preventing Collisions at Sea (hereinafter COLREG Convention);
– the 1973 International Convention for the Prevention of Pollution from Ships (hereinafter MARPOL Convention); and
– SOLAS Convention,
together with their Protocols and the amendments thereto in force;;
 5) “international instruments” mean the relevant international conventions, the relevant resolutions and circulars of the International Maritime Organization (IMO), and the relevant international testing standards;
 6) “conformity mark” means the symbol referred to in § 5 of this Regulation and corresponding to the form set out in Annex 3 to this Regulation;
 7) [repealed – RT I, 20.09.2016, 4 – entry into force 23.09.2016]
 8) “type approval” means the procedure for evaluating equipment produced in accordance with the appropriate testing standards and the issue of the appropriate certificate.

 (6) “Testing standards” mean the standards in force, established by:
 1) the International Maritime Organization (hereinafter IMO);
 2) the International Organization for Standardization;
 3) the International Electrotechnical Commission (hereinafter IEC);
 4) the European Committee for Standardization;
 5) the European Committee for Electrotechnical Standardization;
 6) International Telecommunication Union;
 7) the European Telecommunication Standards Institute (hereinafter ETSI);
 8) the European Commission;
 9) Estonian national standards body.
[RT I, 20.09.2016, 4 – entry into force 23.09.2016]

Chapter 2 REQUIREMENTS FOR EQUIPMENT OF SHIPS 

§ 3.  General requirements

 (1) The equipment listed in Annex A to Council Directive 96/98/EC which is placed on board ships after the entry into force of this Regulation shall conform to the requirements of the international instruments referred to in said Annex.
[RTL 2009, 29, 373 – entry into force 29.03.2009]

 (2) The conformity of equipment to the requirements of the relevant international conventions, and the relevant resolutions and circulars of the IMO which apply to the equipment shall be demonstrated solely in accordance with the relevant testing standards and the conformity assessment procedures referred to in Annex A to Council Directive 96/98/EC. For equipment listed in Annex A to Council Directive 96/98/EC, where both IEC and ETSI testing standards are given, those standards shall be alternatives and the manufacturer or the authorised representative of the manufacturer established within the Community may determine which of them is to be used.
[RTL 2009, 29, 373 – entry into force 29.03.2009]

§ 31.  Declaration of conformity

 (1) If equipment is placed on board ship, the manufacturer, the authorised representative of the manufacturer, the distributor or installer of the equipment shall provide the ship with a copy of the EU declaration of conformity covering such equipment, which shall be kept on board the ship until the equipment is removed from the ship.

 (2) A copy of the EU declaration of conformity shall be sent to a notified body.
[RT I, 20.09.2016, 4 – entry into force 23.09.2016]

Chapter 3 EVIDENCING CONFORMITY OF EQUIPMENT 

Division 1 General Provisions 

§ 4.  Conformity assessment procedures

 (1) The following conformity assessment procedures described in Divisions 2–8 of this Chapter shall be applied to marine equipment:
 1) type examination (module B) and, before equipment is placed on the market and according to the choice made by the manufacturer or the authorised representative of the manufacturer established within the Community from the possibilities indicated in Annex A to Council Directive 96/98/EC, the production quality assurance (module D), product quality assurance (module E), or product verification (module F);
[RT I, 20.09.2016, 4 – entry into force 23.09.2016]
 2) unit verification (module G) where sets of equipment are produced individually or in small quantities and not in series or in mass; or
 3) [repealed – RT I, 20.09.2016, 4 – entry into force 23.09.2016]

 (2) A declaration of conformity shall be prepared in writing and it shall include the information specified in Divisions 2–8 of this Chapter.

§ 5.  Affixing of marks to equipment

 (1) Equipment referred to in Annex A to Council Directive 96/98/EC which complies with the requirements of the relevant international instruments and is manufactured in accordance with the conformity assessment procedures specified in Divisions 2–8 of this Chapter shall have the conformity mark corresponding to the form set out in Annex 3 to this Regulation affixed to it by the manufacturer or the authorised representative of the manufacturer established within the Community.
[RTL 2009, 29, 373 – entry into force 29.03.2009]

 (2) The conformity mark shall be followed by the identification number of the notified body which has performed the conformity assessment procedure, if that body is involved in the production-control phase, and by the last two digits of the number of the year in which the conformity mark is affixed. The identification number of the notified body shall be affixed to the equipment either by the body itself or by the manufacturer or the authorised representative of the manufacturer established within the Community.

 (3) The conformity mark shall be affixed to the equipment or to its data plate so as to be visible, legible and indelible throughout the anticipated useful life of the equipment. If that is not possible or not warranted on account of the nature of the piece of equipment, it shall be affixed to the packaging of the product, to a label or to a leaflet. The conformity mark shall be affixed at the end of the production phase.

 (4) No marks or inscriptions which are likely to mislead with regard to the meaning or the graphics of the conformity mark shall be affixed to equipment.

 (5) If a conformity mark is reduced or enlarged, the proportions given in Annex 3 to this Regulation must be respected.

 (6) The various components of the conformity mark must have substantially the same vertical dimension, which may not be less than 5 mm. The height of different parts of the marks may be smaller for small devices.
[RTL 2009, 29, 373 – entry into force 29.03.2009]

§ 6.  Technical documentation

 (1) The technical documentation specified in Divisions 2–8 of this Chapter shall contain all relevant data and measures used by the manufacturer to ensure conformity of the equipment to the relevant requirements applicable thereto.

 (2) The technical documentation must make it possible to understand the design, manufacture and operation of the product, and must make it possible to assess compliance with the relevant requirements of this Regulation and of the applicable international instruments.

 (3) The technical documentation must, so far as they are relevant to assessment, include:
 1) a description of the type;
 2) conceptual-design, build standard and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc. of the product;
 3) descriptions and explanations necessary for understanding those drawings and schemes, including the operation of the product;
4 the results of design calculations made and impartial examinations carried out;
 5) impartial test reports;
 6) manuals for installation, use and maintenance;
 7) lists of requirements and testing standards applicable to the given equipment, including descriptions of the solutions made for compliance with the requirements.
[RT I, 20.09.2016, 4 – entry into force 23.09.2016]

 (4) Where appropriate, the technical documentation must contain the following:
 1) attestations relating to the equipment incorporated in the appliance;
 2) attestations and certificates relating to the methods of manufacture, inspection and monitoring of the appliance;
 3) any other document that makes it possible for the notified body to improve its assessment.

Division 2 Type examination (module B) 

§ 7.  Type examination (module B)

 (1) Type examination is a procedure whereby a notified body ascertains and attests that a specimen of the production complies with the provisions of this Regulation and the international instruments that apply to it.

 (2) The manufacturer or the authorised representative of the manufacturer established within the Community shall lodge an application for the type examination with only one notified body. Said application must include:
 1) the name and address of the manufacturer and, if the application is lodged by the authorised representative, their name and address as well;
 2) a written declaration that the same application has not been lodged simultaneously with any other notified body;
 3) the technical documentation specified in § 6 of this Regulation.

 (3) The applicant must place at the disposal of the notified body a specimen, representative of the production envisaged (hereinafter the “type”). The notified body may request further specimens if the testing requires more specimens.

 (4) A type may cover several versions of the product provided that the differences between the versions do not affect the level of safety or the other principles of performance of the product.

§ 8.  Obligations of notified body

 (1) A notified body is required to:
 1) examine the technical documentation and verify that the type has been manufactured in compliance therewith, also ascertain the components designed in accordance with the harmonised standards, and the components which have not been designed in adherence to harmonised standards;
 2) if no harmonised standards have been implemented, perform the appropriate examinations and tests or have them performed to check whether the measures taken ensure that the requirements of this Regulation and the applicable international instruments have actually been met;
 3) where harmonised standards have been implemented, perform the appropriate examinations and tests or have them performed to check whether the standards have been applied correctly;
 4) agree with the manufacturer the location where the examinations and necessary tests will be carried out;
 5) prepare an evaluation report which sets out the acts made pursuant to this section and the results thereof.
[RT I, 20.09.2016, 4 – entry into force 23.09.2016]

 (2) The notified body shall make the contents of the evaluation report specified in clause 5) of subsection (1) of this section fully or partially available to the public only with the permission of the manufacturer.
[RT I, 20.09.2016, 4 – entry into force 23.09.2016]

§ 9.  Type examination certificate

 (1) If the type meets the requirements of this Regulation and the applicable international instruments, the notified body shall issue a type examination certificate to the applicant.

 (2) The type examination certificate shall include the name and address of the manufacturer, details of the equipment, the conclusions of the examinations and tests, the conditions of its validity and the necessary data for identification of the type.

 (3) A list of the relevant parts of the technical documentation must be annexed to the type examination certificate and a copy shall be preserved by the notified body.

 (4) If the notified body refuses to issue a type examination certification to the manufacturer, the notified body must give detailed reasons for the refusal. If the manufacturer reapplies for type approval for equipment for which a type examination certificate has been refused, their submission to the notified body must include, inter alia, the original test reports, the detailed reasons for the previous refusal and details of all modifications made to the equipment.

§ 10.  Amendment to type examination certificate

 (1) The person applying for type examination must inform the notified body that holds the technical documentation concerning the type examination certificate of all modifications to the approved type. If such modifications may affect compliance with the requirements of this Regulation or the prescribed conditions for use of the product, such modifications must receive prior approval. Such approval must be given in the form of an addition to the original type examination certificate.
[RT I, 20.09.2016, 4 – entry into force 23.09.2016]

 (2) If the notified body does not give an approval for the modifications, the notified body shall ascertain whether additional tests or a new conformity assessment procedure is needed.
[RT I, 20.09.2016, 4 – entry into force 23.09.2016]

§ 11.  Storage of documents and notification

 (1) Each notified body must, on request, notify the ship’s flag State administration and other notified bodies about the type examination certificates and additions issued and refused.
[RTL 2009, 29, 373 – entry into force 29.03.2009]

 (2) The other notified bodies have the right to receive copies of the type examination certificates and approvals of their additions. The annexes to the type examination certificates must be kept available to the other notified bodies.

 (3) The manufacturer or the authorised representative of the manufacturer established within the Community must store with the technical documentation copies of type examination certificates and their additions for at least 10 years after the last product has been manufactured.

Division 3 Conformity to Type (Module C) 
[Repealed - RT I, 20.09.2016, 4 - entry into force 23.09.2016]

§ 12.  Conformity to type (module C)

  [Repealed – RT I, 20.09.2016, 4 – entry into force 23.09.2016]

§ 13.  Duties of manufacturer

  [Repealed – RT I, 20.09.2016, 4 – entry into force 23.09.2016]

Division 4 Production Quality Assurance (Module D) 

§ 14.  Production quality assurance (module D)

 (1) Production quality assurance is a procedure in the course of which a manufacturer who satisfies the requirement specified in subsection (3) of this section shall assess and evidence that a product conforms to the type as described in the type examination certificate and the requirements of this Regulation and applicable international instruments.

 (2) The manufacturer or the authorised representative of the manufacturer established within the Community shall draw up a declaration of conformity and affix the conformity mark to each product. The conformity mark must be accompanied by the identification number of the notified body responsible for surveillance of the quality system as specified in § 18 of the Regulation.

 (3) The manufacturer shall operate in accordance with an approved quality system pursuant to § 15 of the Regulation in production, final product inspection and testing, and shall be subject to surveillance by the notified body as specified in § 18 of this Regulation.

§ 15.  Approval of quality system

 (1) The manufacturer shall lodge an application for approval of the quality system with a notified body.

 (2) The application must include:
 1) all relevant information for the product envisaged;
 2) the documentation concerning the quality system;
 3) the technical documentation of the approved type and a copy of the type examination certificate;
 4) name and address of the manufacturer, and, if the application is lodged by the authorised representative, their name and address as well;
[RT I, 20.09.2016, 4 – entry into force 23.09.2016]
 5) a written declaration of the applicant that the same application has not been lodged simultaneously with any other notified body.
[RT I, 20.09.2016, 4 – entry into force 23.09.2016]

 (3) The quality system must ensure that the product conforms to the type as described in the type examination certificate and the requirements of this Regulation and applicable international instruments.

 (4) All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions.

 (5) The quality-system documentation must permit common understanding of the quality programmes, plans, manuals and records.

 (6) The quality system documentation must include a detailed and adequate description of:
 1) the quality objectives and the organisational structure, responsibilities and management with regard to product quality;
 2) the manufacturing, quality-control and quality-assurance techniques, processes and systematic actions that will be used;
 3) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they shall be carried out;
 4) the quality records, such as inspection reports and test data, verification data, qualification reports of the personnel, etc.;
 5) the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

§ 16.  Obligations of notified body in assessment of quality system

 (1) The notified body shall assess the quality system to determine whether it satisfies the requirements laid down in § 15 of this Regulation. If relevant harmonised standards are implemented with the quality system, it shall be presumed to comply with the requirements laid down in § 15 of this Regulation.

 (2) The assessment team must have at least one member with experience in the product technology concerned and knowledge of the requirements of the relevant international instruments.
[RT I, 20.09.2016, 4 – entry into force 23.09.2016]

 (3) The assessment procedure must include a visit to the locations of manufacture.

 (4) The manufacturer shall be notified about the results of assessment. The notification must include the conclusions of the assessment and the reasoned assessment decision.

§ 17.  Adherence to and modification of quality system

 (1) The manufacturer shall perform the obligations arising out of the quality system as approved and uphold it so that it remains adequate and efficient.

 (2) The manufacturer or the authorised representative of the manufacturer established within the Community shall keep the notified body that has approved the quality system informed of any intended modifications of the quality system.

 (3) The notified body shall assess the modifications intended and decide whether the modified quality system will still satisfy the requirements laid down in § 15 of this Regulation or whether a reassessment is required. The notified body shall send a respective notice to the manufacturer, which shall include the conclusions of the assessment and the reasoned assessment decision.

§ 18.  Surveillance of quality system

 (1) The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

 (2) The manufacturer must allow the notified body access for surveillance purposes to the locations of manufacture, inspection, testing and storage. The manufacturer shall also provide the notified body with all necessary information, in particular:
 1) the quality system documentation;
 2) the quality records, such as inspection reports and test data, verification data and qualification reports of the personnel.

 (3) The notified body must periodically carry out inspections of the quality system to make sure that the manufacturer maintains and applies the quality system as approved. After the inspection the notified body shall provide the manufacturer with the respective report.

 (4) The notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out tests or cause tests to be carried out to check that the quality system is functioning correctly, if necessary. The notified body must provide the manufacturer with a report after an unannounced visit and, if a test has taken place, with a test report.

§ 19.  Storage of documents and notification

 (1) The manufacturer must, for at least 10 years after the last product has been manufactured, preserve the following documents:
 1) the documents concerning the quality system;
 2) the documents concerning modifications made in the quality system;
 3) the decisions, notices and reports from the notified body.

 (2) The notified body must, on request, provide the ship’s flag State administration and other notified bodies with the relevant information concerning the quality system approvals issued and withdrawn.
[RTL 2009, 29, 373 – entry into force 29.03.2009]

Division 5 Product Quality Assurance (Module E) 

§ 20.  Product quality assurance (module E)

 (1) Product quality assurance is a procedure in the course of which a manufacturer who satisfies the requirements specified in subsection (3) of this section shall assess and evidence that a product conforms to the type as described in the type examination certificate, and the requirements of this Regulation and of the applicable international instruments.

 (2) The manufacturer or the authorised representative of the manufacturer established within the Community shall draw up a declaration of conformity and affix the conformity mark to each product. The conformity mark must be accompanied by the identification number of the notified body responsible for surveillance of the quality system as specified in § 24 of this Regulation.

 (3) The manufacturer must operate in accordance with the quality system approved pursuant to § 21 of this Regulation in final inspection and testing, and shall be subject to surveillance by the notified body as specified in § 24 of this Regulation.

§ 21.  Approval of quality system

 (1) The manufacturer must lodge an application for approval of their quality system with a notified body.

 (2) The application must include:
 1) all relevant information for the product envisaged;
 2) documentation concerning the quality system;
 3) the technical documentation of the approved type and a copy of the type examination certificate;
 4) the name and address of the manufacturer and, if the application is lodged by the authorised representative, their name and address as well;
[RT I, 20.09.2016, 4 – entry into force 23.09.2016]
 5) a written declaration of the applicant that the same application has not been lodged simultaneously with any other notified body.
[RT I, 20.09.2016, 4 – entry into force 23.09.2016]

 (3) Under the quality system, each product must be examined and tested in order to ensure its compliance with the requirements of this Regulation and of the applicable international instruments.

 (4) All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions.

 (5) The quality system documentation must ensure common understanding of the quality programmes, plans, manuals and records.

 (6) The quality system documentation must, in particular, include a detailed and adequate description of:
 1) the quality objectives and the organisational structure, responsibilities and management with regard to product quality;
 2) the examinations and tests that will be carried out after manufacture;
 3) the means of monitoring the effective operation of the quality system;
 4) the quality records, such as inspection reports and test data, verification data, qualification reports of the personnel, etc.

§ 22.  Obligations of notified body in assessment of quality system

 (1) The notified body shall assess the quality system to determine whether it satisfies the requirements laid down in § 21 of this Regulation. If relevant harmonised standards are implemented with the quality system, it shall be presumed to comply with the requirements laid down in § 21 of this Regulation.

 (2) The assessment team must have at least one member with experience in the product technology concerned and knowledge of the requirements of the relevant international instruments.
[RT I, 20.09.2016, 4 – entry into force. 23.09.2016]

 (3) The assessment procedure must include a visit to the locations of manufacture.

 (4) The manufacturer shall be notified about the results of assessment. The notification must include the conclusions of the assessment and the reasoned assessment decision.

§ 23.  Adherence to and modification of quality system

 (1) The manufacturer shall perform the obligations arising out of the quality system as approved and uphold it so that it remains adequate and efficient.

 (2) The manufacturer or the authorised representative of the manufacturer established within the Community shall keep the notified body that has approved the quality system informed of any intended modifications of the quality system.

 (3) The notified body shall assess the modifications intended and decide whether the modified quality system will still satisfy the requirements laid down in § 21 of this Regulation or whether a reassessment is required. The notified body shall send a respective notice to the manufacturer, which shall include the conclusions of the assessment and the reasoned assessment decision.

§ 24.  Surveillance of quality system

 (1) The purpose of surveillance of the quality system is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

 (2) The manufacturer must allow the notified body access for surveillance purposes to the locations of inspection, testing and storage. The manufacturer shall also provide the notified body with all necessary information, in particular:
 1) the quality system documentation;
 2) the technical documentation;
 3) the quality records, such as inspection reports and test data, verification data and qualification reports of the personnel.

 (3) The notified body must periodically carry out inspections of the quality system to make sure that the manufacturer maintains and applies the quality system as approved. After the inspection the notified body shall provide the manufacturer with the respective report.

 (4) The notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out tests or cause tests to be carried out to check that the quality system is functioning correctly, if necessary. The notified body must provide the manufacturer with a report after an unannounced visit and, if a test has taken place, with a test report.

§ 25.  Storage of documents and notification

 (1) The manufacturer must, for at least 10 years after the last product has been manufactured, preserve the following documents:
 1) the documents concerning the quality system;
 2) the documents concerning modifications made in the quality system;
 3) the decisions, notices and reports from the notified body.

 (2) The notified body must, on request, provide the ship’s flag State administration and other notified bodies with the relevant information concerning the quality system approvals issued and withdrawn.
[RTL 2009, 29, 373 – entry into force 29.03.2009]

Division 6 Product Verification (Module F) 

§ 26.  Product verification (module F)

 (1) Product verification is a procedure in the course of which a manufacturer or the authorised representative of the manufacturer established within the Community evaluates and evidences that the products subject to the provisions of subsection (4) of this section conform to the type as described in the type examination certificate and the relevant requirements of this Regulation and of the applicable international instruments.

 (2) The manufacturer must take all measures necessary to ensure that the manufacturing process ensures that the products conform to the type as described in the type examination certificate and the relevant requirements of this Regulation and of the applicable international instruments.

 (3) [Repealed – RT I, 20.09.2016, 4 – entry into force 23.09.2016]

 (4) The notified body must carry out the appropriate examinations and tests in order to check that the product complies with the requirements of the international instruments either by examination and testing of every product as specified in § 27 of this Regulation, or by examination and testing of products on a statistical basis, as specified in § 28 of this Regulation, at the choice of the manufacturer.

 (5) The manufacturer or his authorised representative established within the Community shall keep a copy of the declaration of conformity for at least 10 years after the last product has been manufactured.

§ 27.  Verification by testing of every product

 (1) All products must be individually examined and appropriate tests shall be carried out in order to verify their conformity to the type as described in the type examination certificate and the requirements of this Regulation and of the applicable international instruments.

 (2) The notified body must affix its identification number or cause it to be affixed to each approved product and draw up a written certificate of conformity relating to the tests carried out.

 (3) The manufacturer or the authorised representative of the manufacturer established within the Community shall submit the notified body’s certificate of conformity on request to the ship’s flag State administration.
[RTL 2009, 29, 373 – entry into force 29.03.2009]

§ 28.  Statistical method

 (1) The manufacturer must present his products in the form of homogeneous lots and must take all measures necessary to ensure that the manufacturing process ensures the homogeneity of each product.

 (2) All products must be available for verification in the form of homogeneous lots. A random sample must be drawn from each lot. Products in a sample must be individually examined and appropriate tests shall be carried out. On the basis of the results of examination and testing it shall be ascertained that the product lot complies with the requirements of this Regulation and of the international instruments which apply to them.

 (3) In the case of accepted lots, the notified body shall affix its identification number or cause it to be affixed to each product, and shall draw up a written certificate of conformity relating to the tests carried out. All products in the lot may be put on the market except those products from the sample which are found not to comply.

 (4) If a lot is rejected, the notified body or the market supervisory authority shall take appropriate measures to prevent that the lot will be put on the market. In the event of frequent rejection of lots the notified body may suspend statistical verification.

 (5) The manufacturer may, with the consent of the notified body, affix the latter’s identification number to a product during the manufacturing process.

 (6) The manufacturer or the authorised representative of the manufacturer established within the Community shall submit the notified body’s certificates of conformity on request to the ship’s flag State administration.
[RTL 2009, 29, 373 – entry into force 29.03.2009]

§ 281.  Storage of certificate of conformity

  The manufacturer shall preserve the certificate of conformity for at least 10 years after the last product has been manufactured, but not for a shorter period of time than throughout the anticipated useful life of the equipment concerned.
[RT I, 20.09.2016, 4 – entry into force 23.09.2016]

Division 7 Unit Verification (Module G) 

§ 29.  Unit verification (module G)

 (1) Unit verification is a procedure in the course of which a manufacturer shall ensure and declare that a product for which a certificate of conformity has been issued conforms to the requirements of this Regulation and the applicable international instruments.

 (2) The manufacturer or the authorised representative of the manufacturer established within the Community shall affix the conformity mark to the product and draw up a declaration of conformity.

 (3) The notified body shall examine the individual product and carry out appropriate tests to ensure that it conforms to the requirements.

 (4) The notified body shall affix its identification number or cause it to be affixed to the approved product and shall draw up a certificate of conformity concerning the tests carried out.

 (5) The aim of the technical documentation is to enable conformity to the requirements of this Regulation and of the applicable international instruments to be assessed and the design, manufacture and operation of the product to be understood.

 (6) The manufacturer shall preserve the certificate of conformity for at least 10 years after the last product covered by the given certificate of conformity has been manufactured, but not for a shorter period of time than throughout the anticipated useful life of the equipment concerned.
[RT I, 20.09.2016, 4 – entry into force 23.09.2016]

Division 8 Full Quality Assurance (Module H) 
[Repealed - RT I, 20.09.2016, 4 - entry into force 23.09.2016]

§ 30.  Full quality assurance (module H)

  [Repealed – RT I, 20.09.2016, 4 – entry into force 23.09.2016]

§ 31.  Approval of quality system

  [Repealed – RT I, 20.09.2016, 4 – entry into force 23.09.2016]

§ 32.  Obligations of notified body in assessment of quality system

  [Repealed – RT I, 20.09.2016, 4 – entry into force 23.09.2016]

§ 33.  Adherence to and modification of quality system

  [Repealed – RT I, 20.09.2016, 4 – entry into force 23.09.2016]

§ 34.  Surveillance of quality system

  [Repealed – RT I, 20.09.2016, 4 – entry into force 23.09.2016]

§ 35.  Storage of documents and notification

  [Repealed – RT I, 20.09.2016, 4 – entry into force 23.09.2016]

§ 36.  Design examination

  [Repealed – RT I, 20.09.2016, 4 – entry into force 23.09.2016]

Chapter 4 ISSUE OF CERTIFICATES 

§ 37.  Maritime safety certificates and ship radio licence

 (1) Upon issue of maritime safety certificates, the Maritime Administration shall verify that the equipment on board ships complies with the requirements of this Regulation.

 (2) Radiocommunications equipment shall not unduly affect the requirements of the radio-frequency spectrum.

 (3) The Consumer Protection and Technical Regulatory Authority shall issue a ship radio licence specified in subsection 11 (6) of the Electronic Communications Act before the issue of maritime safety certificates.
[RT I, 19.02.2019, 1 – entry into force 22.02.2019]

§ 38.  Equipment certificate

 (1) The Maritime Administration or a recognised organisation shall issue an equipment certificate in accordance with the form set out in Annex 4 to this Regulation, which shall include the permit to place the equipment on board the ship and establish the specific requirements related to the use of the equipment, if any, regarding the following equipment:
 1) equipment carried on a ship to be entered in the ship register of Estonia, which is considered equivalent to equipment having type approval or bearing conformity mark in compliance with the requirements of this Regulation;
 2) equipment with specific technical innovations specified in subsection 191 (5) of the Maritime Safety Act;
 3) equipment to be tested or assessed as specified in subsection 191 (6) of the Maritime Safety Act, whereas the certificate pertaining to the equipment to be tested or assessed shall be issued for as short period of time as possible.

 (2) The Maritime Administration shall inform the European Commission and the Member States of the Community about any equipment with specific technical innovations which is permitted to be placed on board a ship, and shall send them the test reports and results of conformity assessment.

 (3) The Maritime Administration may require that the manufacturer of equipment, the authorised representative of the manufacturer established within the Community or the person responsible for placing the equipment on the market submit the test reports.


1Council Directive 96/98/EC on marine equipment (OJ L 046, 17.02.1997, p. 25–56), amended by Directives 98/85/EC (OJ L 315, 25.11.1998, p. 14–34), 2001/53/EC (OJ L 204, 28.07.2001, p. 1–28), 2002/75/EC (OJ L 254, 23.09.2002, p. 1–46), 2002/84/EC (OJ L 324, 29.11.2002, p. 53–58), 2008/67/EC (OJ L 171, 1.7.2008, p. 16–62), 2009/26/EC (OJ L 113, 5.05.2009, p. 1–52), 2010/68/EU (OJ L 305, 20.11.2010, p. 1–54), 2011/75/EU (OJ L 239, 15.09.2011, p. 1–51), 2012/32/EU (OJ L 312, 10.11.2012, p. 1–61), 2013/52/EU (OJ L 304, 14.11.2013, p. 1–60), 2014/93/EU (OJ L 220, 25.7.2014, p. 1–78) and 2015/559/EU (OJ L 95, 10.4.2015, p. 1–66). Directive 2014/90/EU of the European Parliament and of the Council on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.08.2014, p. 146–185). [RT I, 20.09.2016, 4 – entry into force 23.09.2016]

Annex 1
[Repealed - RTL 2009, 29, 373 - entry into force 29.03.2009]

Annex 2
[Repealed - RTL 2009, 29, 373 - entry into force 29.03.2009]

Annex 3 Form of conformity mark

Annex 4 Form of equipment certificate

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