Council Directive 96 /98/EC of 20 December, as amended by Commission Directive 98 /85/EC of 11 November, lays down common rules for the uniform application of existing international rules on the marine equipment intended to be shipped on ships, in order to comply with safety standards and safety certificates, in accordance with the testing standards developed by the international standards bodies and the International Maritime Organisation (IMO).

In this way, the application of the IMO rules for the approval of marine equipment is harmonised, through the use of uniform and mandatory criteria for international testing standards, in order to increase the safety at sea and prevent maritime pollution.

For this purpose, the marine equipment included in its scope is determined, whose presence on board is required by the international conventions, as well as the evaluation procedures of the aforementioned equipment for approval by the Member States and the requirements for the issue of the relevant safety certificates. The essential requirements to be met by the competent bodies for the assessment of conformity, as well as their arrangements for designation, are also regulated. Finally, it lays down the requirements, characteristics and conditions of the CE marking of these equipment.

On the other hand, Law 27/1992, of 24 November, of Ports of the State and of the Merchant Navy, establishes in its article 6 the consideration of Marina Mercante of the activities of management and control of the Spanish civil fleet, maritime safety, safety of navigation and human life at sea, technical and operational inspection of ships and the protection of the marine environment; and it recognises, in Article 74, between the objectives of the Merchant Marine policy in the framework of the powers assigned to the General Administration of the State in Article 149.1 of the Constitution, the protection of maritime safety of navigation and human life at sea, and protection of the marine environment. In addition, Article 86.5 of the aforementioned Law establishes the competence of the Ministry of Public Works for the ordination and execution of inspections and technical controls, of safety and of the prevention of pollution of Spanish vessels, and includes in the the scope of such management and inspection the approvals and approvals of the equipment and elements of the ship; finally, the specified article provides for the possibility that the effective implementation of the inspections and controls above to be carried out through collaborative entities in the terms that they regulate establish.

Consequently, it is necessary to adapt the Spanish legislation to that laid down in Directive 96 /98/EC, as amended by Directive 98 /85/EC, and to regulate the requirements to be met by marine equipment intended to be ships, as well as the placing on the market and putting into service of such equipment.

In its virtue, on the proposal of the Minister of Public Works, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting of May 14, 1999, DISCLAIMER:

CHAPTER I

General provisions

Article 1. Object.

This Royal Decree aims to increase safety at sea and to prevent maritime pollution through the uniform application, according to the criteria laid down in it, of the international instruments indicated in Article 2 to the marine equipment of Annex A to be taken on board vessels in which the Maritime Administration is competent, either directly or through collaborating entities, for the issue of safety certificates and to ensure the free movement of such equipment within the European Union.

Article 2. Definitions.

For the purposes of this Royal Decree:

a) Compliance assessment procedures:

the procedures laid down in Article 9 and in Annex B to this Royal Decree.

(b) Equipment: the devices specified in Annexes A. 1 and A. 2 which must be found on board a vessel to be used in accordance with international instruments or which may be voluntarily shipped for use, approved by the Administration in accordance with international instruments.

(c) Radio communications equipment: the equipment prescribed in Chapter IV of the SOLAS Convention (1974), in its version in force on 1 January 1999, and a two-way telephone number of metric waves for survival craft, prescribed by Regulation III/6.2.1 of that Convention.

d) International conventions:

1. The 1996 International Convention on Cargo Lines (LL66).

2. The Convention on International Rules for Preventing Collisions in the Sea of 1972 (COLRC/COLREG).

3. The International Convention for the Prevention of Pollution from Ships of 1973 (MARPOL).

4. The International Convention for the Safety of Human Life in the Sea of 1974 (SOLAS), together with the protocols and amendments to those conventions in force on 1 January 1999.

(e) International instruments: the international conventions and the resolutions and circulars of the International Maritime Organization (IMO) implementing them, as well as the relevant international standards for testing.

(f) Marking of conformity: the symbol referred to in Article 10, reproduced in Annex C.

g) Notified body: the body responsible for the conformity assessment, designated by the Directorate General of the Merchant Navy, under the provisions of Article 86.5 of the Law on Ports of the State and the Marina Mercante, and in accordance with the provisions of Article 8 of this Royal Decree.

(h) Contributing entity: private entities recognized and authorized by the General Directorate of the Merchant Navy to carry out inspections and controls on their behalf that they expressly enable them to do.

i) Embarking: installing or placing on board a ship.

(j) Safety certificates: certificates issued by or on behalf of the Administration in accordance with international conventions.

k) Buque: any vessel, platform or floating device, with or without displacement, suitable for navigation, subject to the relevant international conventions.

In any case, the vessels affected by the National Defense, those of the Spanish Navy and auxiliary vessels of the same and those who enjoy a special regime are excluded.

(l) Community vessel: any vessel in respect of which safety certificates are issued by Member States or on their behalf in accordance with international conventions. This definition does not include cases where the Administration of a Member State issues a certificate for a ship upon request from the Administration of a third country.

m) New vessel: any vessel whose keel has been placed or whose construction is at an equivalent stage on 17 February 1997 and subsequent dates.

For the purposes of this definition, the term "equivalent construction phase" means the one in which the identifiable construction begins as the own of a particular vessel or has begun, in respect of the vessel concerned, the construction, involving the use of not less than 50 tonnes of the total estimated structural material or 1 per 100 of that total, if this second value is lower.

n) Existing buque: any ship other than a new vessel.

n) Test standards: the standards set by some or some of the following bodies:

1. The International Maritime Organisation (IMO).

2. The International Organisation for Standardisation (ISO).

3. The International Electrotechnical Commission (CEI/IEC).

4. The European Committee for Standardisation (CEN).

5. The European Committee for Electronic Standardisation (CENELEC) and 6. o The European Telecommunications Standards Institute (ETSI).

in force on 1 January 1999 and established in accordance with the relevant international conventions and resolutions and IMO circulars for the definition of test methods and test results, exclusively in the form referred to in Annex A.

or) Approval: the conformity assessment procedures of the equipment produced, in accordance with the relevant test standards, and the issue of the relevant certificate.

Article 3. Scope of application.

This Royal Decree will apply to equipment intended for use on board:

(a) New vessels, located or not within the Spanish territory at the time of their construction.

(b) Existing vessels: that they shall not carry on board such equipment previously, or where the equipment to be carried on board is replaced, except where the international conventions permit otherwise, irrespective of whether the vessel is or is not located within the Spanish territory at the time the equipment is shipped.

Article 4. Security certificates.

1. For the issue or renewal of the safety certificates the Maritime Administration, or the collaborating entities, where appropriate, shall verify that the equipment on Spanish vessels for which it has issued safety certificates complies with the requirements of this Directive. the requirements of this Royal Decree.

2. Prior to the delivery of the safety certificate, a radio station operating licence shall be issued for radio communications equipment in accordance with the provisions of the International Regulations of Radio communications.

Article 5. Requirements.

1. The equipment specified in Annex A. 1, which is shipped on Spanish vessels as from 1 January 1999, shall comply with the requirements of that Annex.

2. Verification of compliance by marine equipment with the applicable requirements of international conventions and IMO resolutions and circulars shall be carried out in accordance with the relevant test rules and the procedures of the IMO. conformity assessment referred to in Annex A. 1. The approval of the devices in Annex 1.1. A. 1 including CEI/IEC and ETSI test standards shall be carried out in accordance with one of them, with the option of the builders or their authorised representatives established in the European Union.

Article 6. Marketing of marine equipment.

1. For placing on the market in Spain or on board a Spanish vessel, the equipment specified in Annex A. 1 shall bear the conformity marking or, where appropriate, comply with the provisions of this Royal Decree. The Maritime Administration shall issue or renew the certificates relating to that equipment.

2. Where it is established, by an inspection or other means, that the equipment subject to this Royal Decree and specified in Annex A. 1 with conformity marking is still correctly installed, maintained and used in accordance with its intended purpose, may endanger the safety and health of the crew, the passage or, where appropriate, other persons or affect the environment, the maritime administration shall take the precautionary measures necessary to ensure that such equipment is withdrawn from the market or prohibited or restricted to placing on the market or use on board a vessel for which it has issued security certificate. Such measures shall immediately inform the Commission and the other Member States, indicating whether the failure to comply with the Royal Decree is due to:

(a) Failure to comply with Article 5 (1) and (2).

(b) incorrect application of the test rules referred to in Article 5 (1) and (2).

c) Deficiencies in the test rules themselves.

3. Where it is established that a team falling within the scope of this Royal Decree bears the conformity marking without complying with the basic requirements of conformity, the Maritime Administration shall adopt the appropriate sanctioning resolution in accordance with the provisions of Title IV of Law 27/1992 of 24 November 1992, of Ports of the State and of the Merchant Marine, being informed by the Commission and the other Member States of the European Union.

Article 7. Control procedures.

1. New vessels, irrespective of their flag, which are not registered in an EU Member State and are to be registered in Spain, shall be subject to inspection by the Maritime Administration in order to verify that the They are effective as security certificates, comply with the provisions of this Royal Decree and bear the conformity marking or, in the judgment of that Administration, they are equivalent to the equipment approved under this Royal Decree. To this end, the shipowner must provide the administration with the list of marine equipment bearing the conformity marking, and those for which equivalence is requested.

2. If the equipment does not bear the conformity marking or the Administration considers that it is not equivalent, it will have to be replaced.

3. Where, in accordance with this Article, it is considered that a team is equivalent, the Administration shall issue a certificate, which shall always accompany the team and in which it shall contain the authorization for the equipment to be shipped, as well as any restriction or provision relating to the use of equipment.

4. In any event, the Administration shall require the radio communications equipment not to comply with the requirements of the radio spectrum.

5. The Maritime Administration may carry out analyses and examinations of samples of the equipment bearing the conformity marking, placed on the market in Spain, which have not yet been shipped, in order to verify their conformity with the provisions of this Royal Decree.

The costs of the analyses and examinations shall be borne by the Administration, where they are not provided for in the conformity assessment modules referred to in Annex B.

6. Similarly, where the international instruments defined in Article 2 require tests to be carried out on board the equipment complying with the provisions of this Royal Decree, for reasons of safety or pollution prevention, the Maritime administration may evaluate such equipment once installed on board, provided that this does not result in a duplication of the conformity assessment procedures already carried out. For such purposes, the Maritime Administration may require the manufacturer of the equipment, or its authorised representative in the EU or the person responsible for marketing, to submit the relevant inspection reports and tests.

CHAPTER II Compliance Assessment

Article 8. Bodies responsible for conformity assessment procedures.

1. In order to carry out the conformity assessment procedures referred to in Article 9, the General Directorate of the Merchant Navy, pursuant to the provisions of Article 86.5 of the Law on State Ports and the Merchant Navy, appoint the competent bodies for the assessment of conformity, and shall notify the European Commission of such bodies, specifying the tasks for which they have been appointed and the identification numbers which have previously been assigned to them. granted by the European Commission.

2. In order to be designated by the maritime authorities to carry out the procedures for assessing the conformity of a marine equipment, any body should respond to the criteria listed below. In the request of the maritime authorities that designation, the bodies should provide complete information and evidence to meet those criteria. The Maritime Administration may require the intervention of an impartial external body to assess any of these criteria:

(a) The notified bodies shall meet the requirements of the EN 45000 series.

(b) The notified body shall be independent and shall not be controlled by either manufacturers or suppliers.

(c) The notified body shall be established on the territory of the European Union.

(d) The notified body must have the qualifications, the technical experience and the staff, which allow it to issue approvals that comply with the provisions of this Royal Decree, as well as to ensure a high level of safety.

e) The notified body must be in a position to provide technical expertise in marine matters.

3. The notified body should maintain an exchange of information relationship with the maritime administration:

(a) The notified body shall submit to the Administration a procedure for the exchange of information.

(b) The notified body shall communicate to the maritime administration all information relevant to the certificates granted, refused or withdrawn.

(c) The Maritime Administration shall approve all equivalence, interpretation or permanent exemption from a provision of this Royal Decree before being considered by the notified body.

(d) The notified body shall inform the Administration of any change in its organisation which may influence the conditions of its designation.

4. The agency cited and its subsidiaries:

(a) The notified body may carry out conformity assessments for any economic operator established within or outside the European Union.

(b) A notified body may carry out assessments in any Member State or other non-European Union State, using the means at its disposal in its principal place of business or with the staff of its subsidiary abroad.

(c) Where the conformity assessment procedures are carried out by a subsidiary of the notified body, all the documentation relating to those procedures shall be issued by the notified body itself. name, and not on behalf of the subsidiary.

(d) The subsidiary of the notified body which is in another Member State may issue documents relating to conformity assessment procedures if notified by that State.

5. The General Directorate of the Merchant Navy shall carry out, at least every two years, either directly or through an impartial external body designated by it, inspections of the activities and operation of the notified bodies, in order to verify that they continue to comply with the requirements and conditions that were required for their recognition.

6. Failure by notified bodies to comply with any of the requirements and conditions shall result in the withdrawal of the authorization, immediately informing the European Commission and the other Member States of the authorization. resolution.

Article 9. Conformity assessment procedure.

1. The conformity assessment procedure set out in Annex B shall consist of:

A) Prior to their placing on the market, an EC type-examination (Module B), and the equipment subject to the option of the manufacturer or his authorised representative established in the Community, shall also be subject to his/her assessment according to any of the modules listed below, provided that they are referred to in the equipment in Annex A. 1.

(a) EC declaration of conformity with type (module C).

(b) EC declaration of conformity with type (production quality assurance) (module D).

c) EC declaration of conformity with type (product quality assurance) (module E).

(d) EC declaration of conformity with type (product verification) (module F).

B) Full CE Assurance of Total Quality (Module H).

2. Exceptionally, and in the case of equipment components manufactured individually or in small quantities and not in series or on a large scale, the conformity assessment procedure may be the EC verification per unit (module G).

3. In any event the declaration of conformity with the type shall be made in writing and shall contain the information specified in Annex B.

CHAPTER III

Conformity Marking

Article 10. Requirements, characteristics and conditions of the conformity marking.

1. The equipment referred to in Annex A. 1, which shall be in conformity with the relevant international instruments and manufactured in accordance with the conformity assessment procedures, shall bear the conformity marking laid down by the manufacturer or its authorised representative established in the European Union.

2. The conformity marking shall be followed by the identification number of the notified body which has carried out the conformity assessment procedure, if that body has participated in the production control phase, and the two the latest figures for the year in which the marking is placed. The identification number of the notified body shall be affixed, under its responsibility, by the body itself or by the manufacturer or his authorised representative established in the European Union.

3. The conformity marking model shall be the one reproduced in Annex C.

4. The conformity marking shall be affixed on the equipment or on its plate in such a way as to be visible, legible and indelible throughout the foreseeable lifetime of the equipment. However, where this is not possible or is not justified due to the nature of the equipment, it must be placed on its packaging, on a label or in a leaflet.

5. The affixing of markings or inscriptions which may mislead third parties in relation to the meaning or graphic design of the conformity marking shall be prohibited.

6. The conformity marking shall be affixed at the end of the production stage.

CHAPTER IV

Special Procedures

Article 11. Equipment which does not comply with conformity assessment procedures.

1. Without prejudice to Article 5, in exceptional circumstances of technical innovation, the Maritime Administration may allow equipment which does not comply with the conformity assessment procedures to be taken on board, if it is checks, by means of evidence or other means, to the satisfaction of the maritime administration, that the equipment concerned is at least as effective as the equipment which complies with the conformity assessment procedures.

In any case, the Administration will require that the radio communications equipment does not comply with the requirements of the radio spectrum.

Testing procedures will not introduce any discrimination between equipment manufactured in Spain and equipment manufactured in other Member States.

2. The Maritime Administration shall issue a certificate for the equipment to which this Article applies, a certificate which must always accompany the equipment and which shall include the authorization of the Spanish authorities to enable the equipment to be waterboarded, as well as any restrictions or provisions relating to its use.

3. Where the Maritime Administration authorises the embarkation on a Spanish vessel of equipment to which this Article applies, it shall immediately inform the Commission and the other Member States of the details of that authorisation, as well as of the reports. of all the relevant tests, assessments and conformity assessment procedures.

4. If a vessel with a fitted equipment, in another Member State under the conditions referred to in paragraph 1 of this Article, is registered in Spain, the Maritime Administration may take the necessary measures, which may include tests and Practices, to ensure that the team is at least as effective as another team that complies with the conformity assessment procedures.

Article 12. Temporary authorisations.

1. Without prejudice to Article 5, for reasons of testing or assessment of the equipment, the maritime administration may authorise the embarkation of equipment which does not comply with the conformity assessment procedures or which does not enter into the scope of Article 11, only if the following conditions are met:

(a) That the Administration issue a certificate which must always accompany the team and which includes the authorization of the Spanish Administration to be shipped, as well as any restriction or provision concerning its use.

b) That the authorization is limited to a short period of time.

c) That the equipment is not considered equivalent to a team that meets the requirements of this Royal Decree. It shall also not be used to replace it, which shall remain on board in a working condition and under conditions of immediate use.

2. In any event, the Administration shall require that the radio communication equipment does not comply with the requirements of the radio frequency spectrum.

Article 13. Derogation from compulsory approval.

1. In exceptional circumstances, duly justified to the Maritime Administration, where a vessel of the Spanish flag is to replace the equipment in a port outside the European Union where it is not possible for reasons of time, Time limits or costs for equipment submitted for Community type-approval, other equipment may be loaded in accordance with the following procedure:

(a) The equipment shall be accompanied by documents issued by a recognised body equivalent to a notified body if a mutual recognition agreement has been concluded between the Community and the relevant third country. bodies.

(b) Where it is impossible to comply with subparagraph (a), equipment possessing the documentation issued by a Member State of the IMO, which is a party to the relevant conventions certifying its conformity, may be taken on board. in accordance with the requirements of the IMO, provided that the following two paragraphs are complied with.

2. The nature and characteristics of such equipment shall be immediately reported to the Maritime Administration, which shall ensure as soon as possible that the equipment referred to in paragraph 1, as well as the relevant documentation relating to it, shall be notified. to the tests carried out, complies with the relevant requirements of the international instruments and this Royal Decree.

3. As regards the radio communications equipment, the General Administration of State shall require, in accordance with the rules in force, that such equipment does not comply with the requirements of the radio spectrum.

Additional disposition first. Regulatory implementation.

The equipment referred to in Article 3, for the purpose of guaranteeing its free movement, will be exclusively subject to the provisions of this Royal Decree.

Additional provision second. Derogations from the application of the Order of 10 June 1983.

They shall not apply to the equipment listed in Annex A. 1 to this Royal Decree, as well as to those other than those which are incorporated in that Annex, the rules for the approval of the various elements to be provided the national merchant vessels and vessels, as set out in Chapter I, General Provisions, Part A, Scope, Definitions, etc., Rule 2 of the Annex to the Order of 10 June 1983 on Additional Rules of Procedure application to the International Convention for the Safety of Life at Sea, 1974 and its Protocol of 1978, to national merchant vessels and vessels, with the exception of the convention's own rules.

Additional provision third. Appointment of representatives of the Spanish authorities.

By the Directorate General of the Merchant Navy, representatives of the Spanish administration should be appointed as part of the Committee referred to in Article 18 of Council Directive 96/98 EC.

Additional provision fourth. Transitional arrangements for the approval of equipment.

Equipment not included in Annex A. 1 (i.e. those listed in Annex A. 2, and those not included in those Annexes and requiring approval), as well as equipment on board ships not subject to international conventions They shall continue to be approved and approved in accordance with the rules in force. Notwithstanding the foregoing, such equipment shall be governed by the provisions of this Royal Decree at the time they are included in Annex A. 1 for ships subject to international conventions.

First transient disposition. Regulatory application exception.

This Royal Decree will not apply to the team already embarked on the date of its entry into force.

Second transient disposition. Regulation of certificates.

1. The certificates of approval and approval of the equipment listed in Annex A. 1, issued by the Maritime Administration, shall expire on 1 January 1999. Marine equipment manufactured from this last date must bear the corresponding conformity marking. However, marine equipment approved and approved before 1 January 1999 may be placed on the market and shipped on board vessels for a period of one year from that date.

2. The approval and approval certificates issued by the Maritime Administration, corresponding to the equipment listed in Annex A. 1 manufactured before 1 January 1999, shall permit the placing on the market and embarkation of such equipment. for a period of two years from 1 January 1999.

3. The approval and approval certificates issued by the Maritime Administration relating to the equipment listed in Annex A. 2 shall expire on the date specified therein and may be renewed in accordance with the rules applicable to them. applicable, except where they are moved to Annex A. 1, where the provisions of paragraphs 1 and 2 of this transitional provision apply in this case.

4. Radio communications equipment which does not have the CE mark, and which uses radio spectrum (by means of a hertian link or a network termination point), must be in possession of the certificate of acceptance governing the article 57 of the Law of 11/1998, of 24 April, General of Telecommunications, to be shipped and used on Spanish vessels. The certificate of acceptance shall be issued in accordance with the procedure laid down in Royal Decree 1787/1996 of 19 July 1996 by the General Secretariat of Communications of the Ministry of Public Works.

Single repeal provision. Regulatory repeal.

As many provisions of equal or lower rank are repealed, they oppose the provisions of this Royal Decree.

Final disposition first. Regulatory enablement.

The Minister of Public Works is authorized to adapt the technical conditions of this Royal Decree when it results in the application of Community law rules and to dictate, in the field of their jurisdiction, the provisions necessary for the development and implementation of the said Royal Decree.

Final disposition second. Entry into force.

This Royal Decree will enter into force the day after its publication in the "Official State Gazette".

Given in Madrid on May 14, 1999.

JOHN CARLOS R.

The Minister of Development,

RAFAEL ARIAS-SALGADO MONTALVO

ANNEX A

(VIEW IMAGES PAGES 20402 TO 20419)

ANNEX B

Modules for compliance assessment

Type examination (module B)

1. A notified body must verify and certify that a representative of the production in question complies with the requirements of the international instruments applicable to it.

2. The manufacturer, or his authorised representative established in the EU, shall submit the application for the EC type-examination to the notified body of his choice.

The request will include:

The name and address of the manufacturer, and if the application is submitted by an authorized representative, also the name and address of the authorized representative.

A written declaration specifying that the same request has not been submitted simultaneously to any other notified body.

The technical documentation described in paragraph 3.

The applicant shall make available to the notified body a copy of the representative product of the production in question, hereinafter referred to as 'type' (a type may cover different variants of the product in question the differences between the variants do not affect the level of safety and the other requirements concerning the performance of the product. The notified body may request other copies if required by the test programme.

3. The technical documentation shall enable the conformity of the product to be assessed with the requirements of the relevant international instruments. To the extent necessary for this assessment, it shall include the design, standard structure, manufacture, installation and operation of the product in accordance with the description of the technical documentation set out in the Appendix to the Annex.

4. The notified body:

4.1 You will examine the technical documentation and verify that the type has been manufactured according to the technical documentation.

4.2 It shall carry out the appropriate checks and tests necessary to check whether the requirements of the applicable international instruments are in fact fulfilled.

4.3 It shall be agreed with the applicant on the place where the checks and tests shall be carried out.

5. If the type complies with the provisions of the relevant international instruments, the notified body shall issue the applicant with an EC-type examination certificate. The certificate shall include the name and address of the manufacturer, specifications on the equipment, the conclusions of the inspection, the conditions of validity of the certificate and the data necessary to identify the approved type.

A list of the relevant parts of the technical documentation shall be attached to the certificate and a copy shall be kept by the notified body.

If the notified body refuses to issue the EC type-examination certificate to the manufacturer, it shall give reasons for its decision in detail.

If the manufacturer reapplies for approval for a equipment which has been refused an EC type-examination certificate, his application to the notified body shall include all relevant documentation, including the reports original test, the precise reasons for the previous refusal, as well as specifications of the changes made to the equipment.

6. The applicant shall inform the notified body which has the technical documentation concerning the EC-type examination certificate of any modification of the approved product which is required to receive a new approval if such modifications are made. they are in conformity with the requirements or conditions laid down for the use of the product. This new approval shall be issued in the form of a supplement to the original EC type-examination certificate.

7. Each notified body shall, upon request, communicate to the Maritime Administration and to the other notified bodies the relevant information on the EC type-examination certificates and their supplements, issued or withdrawn.

8. The other notified bodies may receive copies of the EC type-examination certificates and/or their supplements. The annexes to the certificates shall be made available to the other notified bodies.

9. The manufacturer, or his authorised representative established in the EU, shall keep a copy of the EC type-examination certificates and their supplements together with the technical documentation for a period of at least 10 years from the date of the last date of manufacture of the product.

Compliance with type (module C)

1. The manufacturer, or his authorised representative established in the EU, shall ensure and declare that the products in question are in conformity with the type described in the EC type-examination certificate and comply with the requirements of the instruments (i) international agreements to apply them The manufacturer, or his authorised representative established in the EU, shall affix the conformity marking to each product and make a written declaration of conformity.

2. The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the conformity of the products manufactured with the type described in the EC type-examination certificate, as well as with the requirements of the instruments (i) international agreements to apply them

3. The manufacturer, or his authorised representative established in the EU, shall keep a copy of the declaration of conformity for a period of at least 10 years from the last date of manufacture of the product.

Assurance of production quality (module D)

1. The manufacturer who fulfils the obligations of paragraph 2 shall ensure and declare that the products concerned are in conformity with the type described in the EC type-examination certificate. The manufacturer or his authorised representative established in the EU shall affix the conformity marking to each product and make a written declaration of conformity. The marking shall be accompanied by the identification symbol of the notified body responsible for the surveillance referred to in paragraph 4.

2. The manufacturer shall apply an approved quality system for the production, inspection of finished products and tests as specified in paragraph 3 and shall be subject to the surveillance referred to in paragraph 4.

3. Quality system.

3.1 The manufacturer shall, for the products in question, submit an application for the assessment of his quality system to a notified body, which he shall choose.

The request will include:

All relevant information according to the category of products covered.

The documentation for the quality system.

The technical documentation of the approved type and a copy of the EC type examination certificate.

3.2 The quality system shall ensure the conformity of the products with the type described in the EC type-examination certificate.

All the elements, requirements and provisions adopted by the manufacturer must appear in a systematic and orderly documentation in the form of written measures, procedures and instructions. The documentation relating to the quality system shall allow for a uniform interpretation of the programmes, plans, manuals and quality records.

In particular, such documentation will include an appropriate description of:

The quality objectives, the organization chart and the responsibilities and powers of the management staff in terms of the quality of the products.

The manufacturing processes, quality assurance and quality assurance techniques and the systematic activities to be carried out.

Tests and tests that are performed before, during, and after manufacturing, as well as how often they will be performed.

Quality dossiers, such as inspection reports and test and calibration data, reports on the qualification of the staff concerned, etc.

The means to monitor the achievement of the required quality of the products and the effective functioning of the quality system.

3.3 The notified body shall evaluate the quality system to determine whether it meets the requirements referred to in paragraph 3.2. It shall be presumed to comply with those requirements in the case of quality systems which develop the corresponding harmonised standards.

The team of auditors shall have at least one member who has experience in the assessment of the technology of the product concerned. The assessment procedure shall include an inspection visit to the manufacturer's premises.

You will then notify the manufacturer of your decision.

This notification shall include the findings of the control and the reasoned assessment decision.

3.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it in such a way as to continue to be appropriate and effective.

The manufacturer, or his authorised representative established in the EU, shall keep the notified body which has approved the quality system informed of any adaptation provided for in the EU.

The notified body shall assess the proposed amendments and decide whether the modified quality system still complies with the requirements set out in paragraph 3.2 or if a new assessment is required.

The notified body shall notify the manufacturer of its decisions. This notification shall include the conclusions of the control and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body.

4.1 The aim of monitoring is to ensure that the manufacturer duly fulfils the obligations imposed on him by the approved quality system.

4.2 The manufacturer shall allow the notified body to enter the manufacturing, inspection, testing and storage facilities so that it can carry out the necessary inspections and provide all the information required, in particular:

Quality system documentation; quality records, such as inspection reports and test and calibration data, reports on the qualification of the affected staff.

4.3 The notified body shall carry out regular audits to ensure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer.

4.4 In addition, the notified body may carry out unannounced inspection visits to the manufacturer. In the course of such visits, the notified body may carry out or carry out tests in order to verify, if deemed necessary, the proper functioning of the quality system. It shall submit to the manufacturer an inspection report and, if a test has been carried out, a test report.

5. For at least 10 years from the last date of manufacture of the product, the manufacturer shall have at the disposal of the Maritime Administration:

The documentation referred to in the second indent of paragraph 3.1.

The adaptations referred to in the second subparagraph of paragraph 3.4.

The decisions and reports of the notified body referred to in the last subparagraph of paragraph 3.4 and paragraphs 4.3 and 4.4.

6. Each notified body shall, upon request, communicate to the Maritime Administration and to the other notified bodies the relevant information concerning the approvals of quality systems issued and withdrawn.

Product Quality Assurance (Module E) 1. The manufacturer who fulfils the obligations of paragraph 2 ensures and declares that the products are in conformity with the type described in the EC type-examination certificate. The manufacturer or his authorised representative established in the EU shall affix the conformity marking to each product and make a written declaration of conformity. The marking shall be accompanied by the identification symbol of the notified body responsible for the surveillance referred to in paragraph 4.

2. The manufacturer shall use an approved quality system for final inspection and testing as specified in paragraph 3 and shall be subject to the surveillance referred to in paragraph 4.

3. Quality System:

3.1 The manufacturer shall, for the products in question, submit an application for the assessment of his quality system to a notified body, which he shall choose.

The request will include:

All relevant information according to the category of products covered.

The documentation for the quality system.

The technical documentation of the approved type and a copy of the EC type examination certificate.

3.2 According to the quality system, each product shall be examined and appropriate tests shall be carried out in order to ensure compliance with the requirements of the applicable international instruments. All the elements, requirements and provisions adopted by the manufacturer must appear in a systematic and orderly documentation in the form of written measures, procedures and instructions. The documentation of the quality system shall allow for a uniform interpretation of the programmes, plans, manuals and quality records.

In particular, it will include an appropriate description of:

The quality objectives, the organization chart and the responsibilities and powers of the management staff in terms of the quality of the products.

The controls and tests to be performed after manufacturing.

The means to verify the effective operation of the quality system.

Quality records, such as inspection reports and test data, calibration data, reports on the qualification of the affected staff.

3.3 The notified body shall evaluate the quality system to determine whether it meets the requirements referred to in paragraph 3.2. Where the latter complies with the relevant harmonised standard, it shall be presumed to conform to those requirements.

The team of auditors shall have at least one member who has experience in the assessment of the technology of the product concerned. The assessment procedure shall include an inspection visit to the manufacturer's premises.

You will then notify the manufacturer of your decision.

This notification shall include the findings of the control and the reasoned assessment decision.

3.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it in such a way as to continue to be appropriate and effective.

The manufacturer, or his authorised representative established in the EU, shall keep the notified body which has approved the quality system informed of any adaptation provided for in the EU.

The notified body shall assess the proposed amendments and decide whether the modified quality system still complies with the requirements set out in paragraph 3.2 or if a new assessment is required.

The notified body shall notify the manufacturer of its decisions. This notification shall include the conclusions of the control and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body.

4.1 The aim of monitoring is to ensure that the manufacturer duly fulfils the obligations imposed on him by the approved quality system.

4.2 The manufacturer shall allow the notified body's entry into the inspection, testing and storage facilities so that it can carry out the necessary inspections and provide all necessary information, in particular:

The documentation on the quality system.

The technical documentation.

Quality records, such as inspection reports and test and calibration data, reports on the qualification of the staff concerned, etc.

4.3 The notified body shall carry out regular audits to ensure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer.

4.4 In addition, the notified body may carry out unannounced inspection visits to the manufacturer. In the course of such visits, the notified body may carry out or carry out tests in order to verify, if deemed necessary, the proper functioning of the quality system; it shall submit to the manufacturer an inspection report and, if a test had been carried out, the report of the test.

5. For at least 10 years from the last date of manufacture of the product, the manufacturer shall have at the disposal of the national authorities:

The documentation referred to in the third indent of the second subparagraph of paragraph 3.1.

The adaptations referred to in the second subparagraph of paragraph 3.4.

The decisions and reports of the notified body referred to in the last subparagraph of paragraph 4.3 and 4.4.

6. Each notified body shall, upon request, communicate to the Maritime Administration and to the other notified bodies the relevant information concerning the approvals of quality systems issued and withdrawn.

Verification of products (module F) 1. The manufacturer, or his authorised representative established in the EU, shall ensure and declare that the products which have been subject to paragraph 3 are in conformity with the type described in the EC type-examination certificate.

2. The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the conformity of the products with the type described in the EC type-examination certificate. It shall affix the conformity marking to each product and draw up a declaration of conformity.

3. The notified body shall carry out appropriate examinations and tests in order to verify the conformity of the product with the requirements of the international instruments, either by monitoring and testing each product as specified in the paragraph 4, either by means of control and testing of the products on a statistical basis, as specified in paragraph 5, at the choice of the manufacturer.

3 bis. The manufacturer, or his authorised representative established in the EU, shall keep a copy of the declaration of conformity for at least 10 years from the last date of manufacture of the product.

4. Verification by control and test of each product.

4.1 All products shall be individually examined and appropriate tests shall be carried out to check their conformity with the type described in the EC type-examination certificate.

4.2 The notified body shall affix or send its identification symbol on the approved product and issue a certificate of conformity for the tests carried out.

4.3 The manufacturer, or his authorised representative established in the EU, must be in a position to present the notified body's certificates of conformity if required by the Maritime Administration.

5. Statistical verification.

5.1 The manufacturer shall present its products in the form of homogeneous lots and shall take all necessary measures to ensure the homogeneity of each batch produced.

5.2 All products will be available for verification in the form of homogeneous lots. A random sample shall be extracted from each batch, the products of which shall be individually examined, and appropriate tests shall be carried out for the purpose of verifying their conformity with the requirements of the international instruments are applicable and to determine the acceptance or rejection of the lot.

5.3 For accepted lots, the notified body shall affix or send its identification symbol on each product and shall issue in writing a certificate of conformity concerning the tests carried out. All products consisting of the lot may be placed on the market, except for those products which have been found to be non-compliant.

If a lot is rejected, the notified body or the competent authority shall take the necessary measures to prevent its placing on the market. In the case of frequent batch rejections, the notified body may suspend the statistical verification.

The manufacturer may, under the responsibility of the notified body, stamp the latter's identification symbol during the manufacturing process.

5.4 The manufacturer, or his authorised representative established in the Community, must be in a position to present the certificates of conformity of the notified body, if required by the Administration. maritime.

Verification Per Unit (Module G) 1. This module describes the procedure by which the manufacturer ensures and declares that the products concerned which have obtained the certificate referred to in paragraph 2 comply with the requirements of the international instruments which are applicable.

The manufacturer or his authorised representative established in the EU shall affix the conformity marking to each product and make a declaration of conformity.

2. The notified body shall examine the product and carry out appropriate tests to verify its conformity with the requirements of the international instruments applicable to them.

The notified body shall affix or send its identification number to the approved product and issue a certificate of conformity for the tests carried out.

3. The technical documentation shall aim to enable the conformity of the product to be assessed with the requirements of the international instruments and the understanding of its design, manufacture and operation.

Full Quality Assurance (Module H) 1. The manufacturer who fulfils the obligations laid down in paragraph 2 ensures and declares that the products concerned comply with the requirements of the international instruments applicable to them. The manufacturer or his authorised representative established in the EU shall affix the conformity marking to each product and make a written declaration of conformity.

The marking shall be accompanied by the identification symbol of the notified body responsible for the control referred to in paragraph 4.

2. The manufacturer shall apply an approved quality system for the design, manufacture and final inspection of the products and tests as specified in paragraph 3 and shall be subject to the control referred to in paragraph 4.

3. Quality system.

3.1 The manufacturer shall submit an application for the assessment of his quality system to a notified body. The request will include:

All relevant information according to the category of products covered.

The documentation for the quality system.

3.2 The quality system shall ensure the conformity of the products with the requirements of the applicable international instruments.

All the elements, requirements and provisions adopted by the manufacturer must appear in a systematic and orderly documentation in the form of written measures and procedures and instructions. The documentation of the quality system will allow for a uniform interpretation of quality measures and procedures, such as programmes, plans, manuals and quality dossiers.

In particular, it will include an appropriate description of:

The quality objectives, the organization chart and the responsibilities and powers of the management staff in terms of the quality of the products.

The technical specifications for design, including the standards to be applied and the assurance that the essential requirements of the international instruments applicable to the products will be met.

The techniques of control and verification of the design, processes and systematic activities that will be carried out at the time of the design of the products with regard to the category covered in products.

The corresponding techniques of manufacturing control, quality control and quality assurance, and the systematic activities that will be used.

The controls and tests to be carried out before, during and after manufacture and their frequency.

Quality records, such as inspection reports and test data, calibration data, reports on the qualification of the affected staff, etc.

The means to verify the achievement of the desired quality in design and product, and the effective functioning of the quality system.

3.3 The notified body shall evaluate the quality system to determine whether it meets the requirements referred to in paragraph 3.2. It will of course comply with these requirements in the case of quality systems which develop the corresponding harmonised standards.

The team of auditors shall have at least one member who has experience in the assessment of the technology of the product concerned. The assessment procedure shall include a visit to the manufacturer's premises.

You will then notify the manufacturer of your decision.

This notification shall include the findings of the control and the reasoned assessment decision.

3.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it in such a way as to continue to be appropriate and effective.

The manufacturer, or his authorised representative established in the EU, shall keep the notified body which has approved the quality system informed of any adaptation provided for in the EU.

The notified body shall assess the proposed amendments and decide whether the modified quality system still complies with the requirements set out in paragraph 3.2 or if a new assessment is required.

The notified body shall notify the manufacturer of its decisions. This notification shall include the conclusions of the control and the reasoned assessment decision.

4. EC surveillance under the responsibility of the notified body.

4.1 The aim of monitoring is to ensure that the manufacturer duly fulfils the obligations imposed on him by the approved quality system.

4.2 The manufacturer shall authorise the notified body to have access, for inspection purposes, to its design, manufacturing, inspection, testing and storage facilities and shall provide it with all the necessary information, in particular:

The documentation on the quality system.

The quality records foreseen by the design phase of the quality system, such as the results of the analyses, calculations, tests, etc.

Quality records dedicated to manufacturing such as inspection reports and test data, calibration data, reports on the qualification of the affected staff, etc.

4.3 The notified body shall carry out regular audits to ensure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer.

4.4 In addition, the notified body may carry out unannounced inspection visits to the manufacturer. In the course of such visits, the notified body may carry out or carry out tests in order to verify, if deemed necessary, the proper functioning of the quality system; it shall submit to the manufacturer an inspection report and, if a test had been carried out, the report of the test.

5. For at least 10 years from the last date of manufacture of the product, the manufacturer shall have at the disposal of the national authorities:

The documentation referred to in the second indent of the second subparagraph of paragraph 3.1.

The adaptations referred to in the second subparagraph of paragraph 3.4.

The decisions and reports of the notified body referred to in the last subparagraph of paragraph 3.4 and in paragraphs 4.3 and 4.4.

6. Each notified body shall, upon request, communicate to the Maritime Administration and to the other notified bodies the relevant information concerning the approvals of the quality systems issued or withdrawn.

7. Design control.

7.1 The manufacturer shall submit a design control application to a single notified body.

7.2 The application shall allow for the understanding of the design, manufacture and operation of the product and the assessment of its conformity with the requirements of the international instruments.

The request will include:

The technical specifications of the design, including the rules that have been applied.

The necessary demonstrative evidence of their suitability, in particular where the standards referred to in Article 5 have not been fully applied.

These demonstrative tests shall include the results of the tests performed in an appropriate laboratory of the manufacturer or on behalf of the manufacturer.

7.3 The notified body shall examine the application and, where the design meets the requirements of the international instruments applicable to it, issue an EC design examination certificate to the applicant.

The certificate shall include the conclusions of the examination, its conditions of validity, the data necessary for the identification of the approved design and, where appropriate, a description of the operation of the product.

7.4 The applicant shall keep the notified body that has issued the EC design examination certificate informed of any modifications to the approved design. The notified body shall sanction the approval of the proposed amendments in those cases where the changes may affect conformity with the essential requirements of the international instruments, or with the conditions laid down. of the use of the product. This supplementary approval shall be made in the form of a supplement to the EC design examination certificate.

7.5 The notified bodies shall, upon request, communicate to the Maritime Administration and to the other notified bodies the relevant information on:

EC design examination certificates and add-ons issued.

Approvals and the EC complementary design approvals withdrawn.

APPENDIX TO ANNEX B

Technical documentation provided by the manufacturer to the notified body

The provisions set out in this Appendix shall apply to all modules in Annex B.

The technical documentation referred to in Annex B shall comprise all relevant data or means used by the manufacturer to ensure that the equipment complies with the relevant essential requirements.

The technical documentation shall make it possible to understand the design, manufacture and operation of the product and make it possible to assess conformity with the requirements of the applicable international instruments.

To the extent that it is relevant to the assessment, the documentation will comprise:

A general description of the type.

Drawings and schemes of conceptual design, standard structure and manufacturing of components, subcomponents, circuits, etc.

The descriptions and explanations necessary for the understanding of such drawings and schemes, including the operation of the product.

The results of the design calculations performed, the unbiased examinations carried out, etc.

The reports of the unbiased trials.

Installation, utilization, and maintenance manuals.

The design documentation will contain the following items, as appropriate:

Certificates relative to the equipment built into the device.

Certificates relating to methods of manufacture or inspection or surveillance of the device.

Any other document that allows the notified body to improve its assessment.

ANNEX C

Conformity Marking

The compliance markup will have the following layout:

LOGO

(VIEW PAGE 20425 IMAGE)

If the size of the marking is reduced or increased, the proportions of this logo must be preserved.

The various components of the conformity marking shall be approximately the same height, which shall not be less than 5mm.

This minimum dimension can be exempted for small devices.