Ministério do Equipamento Social (Ministry for Social Equipment)
Decree-Law no. 228/93, of June 22, established the system for approval, connection to basic telecommunications networks, marking, placing on the market and connection and use of telecommunications equipment, thus transposing Directive no. 91/263/CEE, of the European Council to Portuguese legislation.
This regulatory regime was based upon a terminal equipment approval system.
On the other hand, the regulatory regime for radiocommunications equipment, established by Decree-Law no. 147/87 of March 24, and Decree-Law no. 320/88 of September 14, is based upon the principle of homologation.
Technological evolution in the telecommunications sector caused by new technology, market developments and network legislation makes it necessary to reconsider the regulatory regime for telecommunications terminal equipment and radio equipment, in harmony with the development of Community legislation as defined by Directive no. 1999/5/CE of March 9, of the European Parliament and Council.
A regulatory regime aimed at the development of a single market for radio equipment and telecommunications terminal equipment should permit investment, manufacture and sales to take place at the pace of technology and market developments.
The new regulatory regime has broader scope than the previous one, and is based upon the liability of market players by making them responsible for guaranteeing compliance with applicable requirements and restrictions, through conformity assessment and marking procedures.
Establishing a clear distinction between placing equipment on the market and putting such equipment into service - and considering that radio equipment and telecommunications terminal equipment which conforms with the relevant essential requirements should be authorised to circulate freely - the new regime makes it possible to establish restrictions on putting radio equipment into service, in harmony with the recently published regime applicable to radiocommunications.
In this manner, the present diploma transposes the norms of Directive no. 1999/5/CE, of the European Parliament and Council, of March 9, on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity.
Under the terms established in paragraph a) of point 1 of article 198 of the Portuguese Constitution, the Government decrees the following:
The present diploma establishes the regulatory regime for free circulation, placing on the market, and putting into service in Portuguese territory of radio equipment and telecommunications terminal equipment as well as the regime of their conformity assessment and marking.
1 - The present diploma shall not apply to:
a) Apparatus exclusively used for activities associated to public security, defence, State security and State activities on enforcement of criminal law.
b) Apparatus listed in annex 1 to the present diploma, which forms an integral part thereof.
2 - Without prejudice to specific applicable legislation, the present diploma applies to:
a) Apparatus that falls under the terms of paragraph a) of article 3, which include, as an integral part or as an accessory, medical devices and active implantable medical devices within the meaning of Decree-Law no. 78/97, of April 7;
b) Apparatus that constitutes a component or a separate technical unit of a vehicle.
For the purposes of the present diploma, the following definitions shall apply:
a) 'apparatus' means any equipment that is either radio equipment or telecommunications terminal equipment or both;
b) 'telecommunications terminal equipment' means a product enabling communication or relevant component thereof which is intended to be connected directly or indirectly by any means whatsoever to interfaces of public telecommunications networks;
c) 'radio equipment' means a product, or relevant component thereof, capable of communication by means of the emission and/or reception of radio waves utilising the spectrum allocated to terrestrial/space radio communication;
d) 'radio waves' means electromagnetic waves of frequencies from 9 kHz to 3 000 GHz, propagated in space without artificial guide;
e) a network termination point - a physical connection point at which a user is provided with access to public telecommunications network;
f) 'interface' means a network termination point which is a physical connection point at which a user is provided with access to public telecommunications network, or an air interface specifying the radio path between radio equipment, in both cases with their respective technical specifications;
g) 'equipment class' means a class identifying particular types of apparatus which under the Directive are considered similar and those interfaces for which the apparatus is designed. Apparatus may belong to more than one equipment class;
h) 'technical construction file' means a file describing the apparatus and providing information and explanations as to how the applicable essential requirements have been met;
i) 'harmonised standard'; means a technical specification adopted by a recognised standards body under a mandate from the Commission in conformity with the applicable procedures, for the purpose of establishing a European requirement, compliance with which is not compulsory;
j) 'harmful interference' means interference which endangers the functioning of a radio navigation service or of other safety services or which otherwise seriously degrades, obstructs or repeatedly interrupts a radio communications service operating in accordance with the applicable legislation;
k) Notified body - a corporate body that is duly empowered under the terms of the present diploma, to pursue the acts of conformity assessment listed in annexes II to V, that form an integral part of the present diploma.
General requirements for placing apparatus on the market, putting into service and connection
1 - The following essential requirements are applicable to all apparatus:
a) the protection of the health and safety of the user and any other person, including the objectives with respect to safety requirements contained in Decree-Law no. 117/88, of April 12, but with no voltage limit applying;
b) the protection requirements contained in Administrative Rule no. 767-A/93, of August 31, and other applicable legislation.
2 - Radio equipment shall be so constructed that it effectively uses the spectrum allocated to terrestrial/space radio communication and orbital resources so as to avoid harmful interference.
3 - Additional requirements may also apply to specific equipment classes or certain types of apparatus when a measure has been adopted by the European Commission determining that the apparatus shall be so constructed that:
a) it interworks via networks with other apparatus and that it can be connected to interfaces of the appropriate type throughout the European Union;
b) it does not harm the network or its functioning nor misuse network resources, thereby causing an unacceptable degradation of service;
c) it incorporates safeguards to ensure that the personal data and privacy of the user and of the subscriber are protected;
d) it supports certain functionalities ensuring avoidance of fraud;
e) it supports certain functionalities ensuring access to emergency services;
f) it supports certain functionalities in order to facilitate its use by users with a disability
4 - The Instituto das Comunicações de Portugal (ICP) is responsible for ensuring publication in the Diário da República of decisions by the European Commission which decide the applicability of the additional requirements specified in the previous point.
Trade Fairs and Exhibitions
1 - Apparatus that does not comply with the requirements of the present diploma may be displayed at trade fairs, exhibitions, and demonstrations.
2 - In the situation referred to in the previous point a notice must be prominently displayed indicating that the apparatus may not be sold or put into service until conformity has been guaranteed.
Purpose of apparatus
Apparatus must be installed, maintained and used in conformity with its intended purpose.
Placing on the market
Conditions for placing on the market
1 - No apparatus shall be placed on the market unless they comply with the applicable essential requirements of article 4, have been subject to a conformity assessment procedure and are duly marked, under the terms of the present diploma.
2 - In the situations referred to in article 4 (3), and in the event of apparatus that has already been placed on the market, the apparatus may be maintained in the market for the period indicated in the decision specified in article 4 (4).
Obligation to provide information
Manufacturers of apparatus or persons responsible for placing such apparatus on the market are obliged to:
a) Inform the user of the intended use of the apparatus;
b) Supply the user with a declaration of conformity to the essential requirements, together with the apparatus.
1 - For the purposes of the provisions of paragraph a) of article 8, the packaging and instructions for use of radio equipment should expressly:
a) contain an indication as to whether the radio equipment is intended to be used in Portuguese territory or a geographical area within Portuguese territory, identifying in the latter case the respective geographic areas;
b) alert the user, when appropriate, to any possible restrictions or requirements for authorisation of the use of such radio equipment;
2 - The terms of article 8 and point 1 of the present article should be complied with, without prejudice to the terms of article 27
3 - The placing on the market of radio equipment using frequency bands whose use is not harmonised throughout the community must be preceded by a notification to ICP.
4 - The obligation specified in the previous point falls upon the manufacturer, his legal representative or the importer of such equipment, in all cases established within the European Union.
5 - The notification specified in point 3 should be provided not less than four weeks before the date it is intended to place such radio equipment on the market and in particular must contain:
a) Information on its radio characteristics, in particular its frequency bands, channel spacing, type of modulation and RF power;
b) where appropriate the identification number of the notified body or bodies contacted for the purposes of the provisions specified in annexes IV and V;
6 - Without prejudice to the terms of the previous point, ICP is responsible for ensuring publication in the 3rd Series of the Diário da República, of the terms in which the notification should be made.
7 - ICP is responsible for evaluating the information supplied, and may at any time place conditions on the putting into service of radio equipment in the situations specified in article 12(1).
Telecommunications terminal equipment
For the purposes of the provisions of article 7(1), telecommunications terminal equipment must prominently display information that makes it possible to identify the public telecommunications network interfaces to which the equipment is intended to be connected.
Putting into service and right to connect
Putting into service
Apparatus shall be allowed to be put into service for its intended use provided that it complies with the suitable essential requirements specified in Article 4 and has been subject to a conformity assessment procedure, has the respective conformity declaration and is duly marked under the terms of the present diploma, without prejudice to the terms of article 12.
1 - ICP may restrict the putting into service of radio equipment in order to:
a) Guarantee effective and appropriate use of the radio spectrum;
b) Guarantee avoidance of harmful interference;
c) Safeguard public health.
2 - ICP will ensure the publication of a notice in the 3rd series of the Diário da República, identifying the restrictions for putting into service under the terms of the previous point.
3 - The terms of the present diploma apply without prejudice to the applicability of radio legislation, in particular concerning the requirement for a network utilisation license and station license.
Telecommunications terminal equipment
Operators of public telecommunications networks shall not refuse to connect telecommunications terminal equipment to appropriate interfaces on technical grounds, where that equipment complies with the essential requirements specified in article 4
Exceptions to the obligation to connect
1 - ICP may authorise a public network operator to refuse connection, disconnect apparatus that has complied with the suitable essential requirements or withdraw it from service, when it considers that such apparatus:
a) causes serious damage to a network;
b) causes harmful interference;
c) harms the network or its functioning.
2 - Authorisation by ICP should be preceded by a duly reasoned request by the operator, accompanied by a set of general elements to be defined by ICP, including the following:
a) Proof of confirmation of the situations specified in the paragraphs of the previous point; b) b) Proof of the conformity assessment of the apparatus and its compliance with the essential requirements;
c) Reference to the harmonised standards or other standards which have been applied as well as others to be defined by ICP.
3 - ICP must decide within 20 days and may request clarifications and additional elements from the operator.
4 - ICP is responsible for informing the European Commission of decisions taken under the terms of the present article, and also proceed in conformity with the decisions issued under the terms of Directive no. 1999/5/CE.
1 - In duly proven emergency situations the operator may disconnect apparatus without prior authorisation from ICP, provided that both of the following conditions are complied with:
a) if the protection of the network requires the apparatus to be disconnected without delay;
b) if the user can be offered an alternative solution without any delay or cost
2 - In the case specified in the previous point, the operator must immediately inform ICP, presenting proof of the urgency of procedures, and verification of the conditions specified in point 1.
3 - ICP is responsible, after analysis of the documentation presented by the operator, to decide whether the operator should reconnect the apparatus, or maintain the decision to disconnect the apparatus, in this event informing the European Commission of the fact.
4 - ICP must proceed in conformity with decisions taken by the European Commission under the terms of Directive no. 1999/5/CE.
1 - Whenever ICP verifies that an apparatus does not comply with the requirements of the present diploma it may on duly reasoned grounds, decide that the apparatus should be withdrawn from the market or from service, prohibit its placing on the market or putting into service, or restrict its free circulation.
2 - ICP may prohibit or restrict the placing on the market or require the withdrawal from the market of radio equipment, whish has caused or which it reasonably considers will cause harmful interference with existing or planned services on nationally allocated frequency bands.
3 - In the event that ICP takes a decision in accordance with the provisions of the previous points, it shall immediately inform the European Commission of the said decisions, specifying the reasons for adopting them, in particular:
a) Incorrect application of the harmonised standards referred to in article 18 (1);
b) Shortcomings in the harmonised standards specified in article 18 (1);
c) Non-compliance with applicable essential requirements, specified in article 4, in the event that the apparatus does not meet the harmonised standards specified in article 18 (1);
d) The causes associated to harmful interference.
4 - ICP shall proceed in conformity with the decisions to be taken by the European Commission under the terms of Directive no. 1999/5/CE.
1 - One of the conformity assessment procedures identified in this chapter shall be used to demonstrate the compliance of the apparatus with all the relevant essential requirements specified in article 4.
2 - ICP shall ensure the publication of a notice in the 3rd series of the Diário da República, establishing the terms and elements that should be included in the declaration of conformity.
1 - Apparatus is presumed to conform with the applicable essential requirements if it meets the relevant harmonised standards or parts which cover these essential requirements, and whose reference numbers have been published in the Official Journal of the European Communities (OJEC).
2 - The presumption identified in the previous point does not preclude the need for conformity assessment with essential requirements, under the terms of the present diploma.
3 - ICP may decide on reasonable grounds that conformity with the harmonised standards does not guarantee compliance with the essential requirements specified in article 4. In this event, ICP should initiate the procedure specified in Directive no. 1999/5/CE, of March 9 of the European Parliament and Council.
1 - The manufacturer shall apply one of the conformity assessment procedures specified in the present diploma.
2 - The entire conformity assessment procedure must be conducted in Portuguese, but the notified body may waive this obligation, accepting another language.
Where the apparatus to be assessed for conformity with essential requirements falls within the scope of application of Decree-Law no. 117/88, of April 12 or Decree-Law no. 74/92, of April 29 its conformity may be demonstrated through one of the procedures specified in the respective diplomas or complementary legislation.
Terminal equipment that do not use the spectrum and radio receivers
Telecommunications terminal equipment that does not make use of the spectrum allocated to terrestrial/space radio communications and receiving parts of radio equipment shall be subject to one of the conformity assessment procedures laid down in Annexes II, IV or V.
Radio equipment with application of harmonised standards
Where the manufacturer has applied harmonised standards, the conformity assessment procedures of radio equipment that is not within the scope of the previous article, may be chosen from one of those laid down in Annexes III, IV or V.
Radio equipment without application of harmonised standards
Where the manufacturer has not applied harmonised standards, the conformity assessment procedures of radio equipment that is not within the scope of article 21, may be chosen from one of those laid down in Annexes IV or V.
Requirements of notified bodies
1 - The members of government responsible for the areas of communications and industry are responsible for designating the notified bodies.
2 - The quality standards and applicable assessment procedures for entities that seek to be designated as notified bodies are set by joint ministerial order of the members of government responsible for the areas of communications and industry.
3 - In order for an entity to be eligible to be designated as notified bodies it must be a corporate body with suitable skills, technical, economic and financial capacity and possess the staff and the means needed to carry out the acts relating to conformity assessment procedures.
4 In relation to conformity assessment procedures, referred to in the previous point, the staff responsible for inspections must have:
a) sound technical and professional training;
b) satisfactory knowledge of the requirements of the tests or inspections that are carried out and adequate experience of such tests or inspections;
c) the ability to draw up the certificates, records and reports required to authenticate the performance of the inspections.
5 - The notified body must take out liability insurance.
6 - The staff of the notified body must be:
a) Impartial. Their remuneration must not depend on the number of tests or inspections carried out nor on the results of such inspections;
b) Bound by professional secrecy with regard to all information gained in carrying out its tasks.
7 - The Instituto Português da Qualidade (IPQ) is responsible for notifying the European Commission of the designated notified bodies, and publish a notice in the 3rd series of Diário da República, with a reference of the list of notified bodies and surveillance authorities, which has been published by the European Commission.
1 - The notified body and its staff may not participate in entities that pursue or represent the activity of designers, manufacturers, suppliers or installers of radio equipment or telecommunications terminal equipment, or a network operator or a service provider.
2 - The notified body and its staff must be independent and not become directly involved in the design, construction, marketing or maintenance of radio equipment or telecommunications terminal equipment, nor represent the parties engaged in these activities.
3 - The terms of the previous points do not preclude the possibility of exchanges of technical information between the manufacturer and the notified body.
Responsibility for marking
The CE mark shall be affixed on the apparatus under the responsibility of the manufacturer, his legal representative within the European Union or the person responsible for placing the apparatus on the market.
Marking the apparatus
1 - Any apparatus complying with the applicable essential requirements shall bear the CE mark in conformity with Annex VI. The CE mark shall be:
a) Visible, legible and indelible;
b) Affixed to the product or in the respective characteristics plate, as well as the packaging where appropriate and the accompanying product documents.
2 - Where the conformity assessment procedure is carried out in accordance with Annexes III, IV or V, marking shall be accompanied by the identification number of all notified bodies used;
3 - In the case of radio equipment, the mark shall also:
a) Be accompanied by the equipment class identifier where one has been assigned, under the terms of a notice to be published by ICP in the Diário da República;
b) Include a user information item that the apparatus uses frequency bands whose use has not been harmonised throughout the European Union, under the terms of a notice to be published by ICP in the 3rd series of the Diário da República;
4 - The apparatus shall be identified by means of type, batch and serial number and also by the name of the manufacturer or the person responsible for placing the apparatus on the market.
Other CE marks
1 - Where apparatus is subject to other legal provisions, which also require the affixing of the CE marking, the markings specified in annex VI shall indicate that the apparatus in question is also presumed to conform to those provisions.
2 - Should one or more of those provisions allow the manufacturer, during a transitional period, to choose which to apply, the CE marking shall only indicate conformity to the provisions applied by the manufacturer.
3 - The documentation, information and instructions manuals, which under the terms of the legal requirements mentioned in the previous point accompany the apparatus should include a version in the Portuguese language and contain express indication of those legal requirements with which the apparatus is in conformity.
1 - Any other marking may be affixed to apparatus provided that the visibility and legibility of the CE marking is not thereby reduced.
2 - The affixing of markings on apparatus that are likely to mislead third parties as to the meaning or form of the CE marking is prohibited.
1 - Operators of public telecommunications networks shall provide ICP with accurate and adequate technical specifications of all interfaces offered by them before the services provided through such interfaces are made publicly available.
2 - For the purposes of the previous point, the specifications should include:
a) sufficient details of technical interface specifications to permit the design of telecommunications terminal equipment capable of using all services provided through the corresponding interface;
b) all the information necessary to allow manufacturers to carry out relevant tests to check the essential requirements applicable to telecommunications terminal equipment;
3 - The information provided under the terms of the previous points shall be regularly updated.
4 - For the purposes of the previous points ICP is responsible for defining the information procedures to be observed by the operators and, in particular, set the deadline for updating such procedures.
5 - ICP is responsible for ensuring publication of the technical specifications of the interfaces referred to in point 1 in order to be easily accessible to interested parties. ICP should publish a notice in the 3rd series establishing the form and manner in which the said publication should be made.
6 - Without prejudice to the terms of the previous points, public telecommunications network operators are obliged to provide the information specified in points 1 and 2, whenever so requested by interested parties.
7 - ICP should inform the European Commission of the interfaces for which regulations have been approved, to the extent that such regulations have not already been notified under the terms relating to technical rules.
Surveillance and countermanding measures
1 - ICP is responsible for the compliance surveillance with the terms of the present diploma, without prejudice to the powers attributed to other entities, in particular to IPQ (Portuguese Quality Institute), Inspecção-Geral das Actividades Económicas (IGAE - General Inspectorate of Economic Activities) and the Direcção-Geral das Alfândegas (DGA - Customs Office).
2 - For the purposes of the previous point, ICP may request the collaboration of IGAE and DGA as part of its surveillance activities.
3 - Inspection by ICP is exercised through ICP staff that has been mandated for this purpose and other mandated agents that have been duly accredited by ICP's Board of Directors.
4 - In order to verify compliance with the regime established in the present diploma, ICP may undertake, at any time, suitable tests in order to check the conformity of apparatus with the respective conformity declaration.
5 - The costs resulting from carrying out tests of apparatus to be made under the terms of the previous point are to be borne by ICP, unless such apparatus is found to fail to conform with the respective declaration, in which case the costs will be borne by the manufacturer, his legal representative or the person responsible for placing the apparatus on the market.
6 - The inspected entities are obliged to supply ICP staff or agents mandated by ICP with verification of apparatus and network termination points, and supply the information required for checking and inspecting the obligations resulting from the present diploma, providing access to the respective premises and documentation.
1 - Countermanding proceedings will be conducted by the entity responsible for surveillance activities.
2 - In the case of countermanding proceedings that fall under the responsibility of ICP, the board of directors shall decide upon the initiation of such proceedings, which will then be co-ordinated by the respective services.
3 - Fines will be applied by:
a) The Comissão de Aplicação de Coimas em Matéria Económica (CACME - Commission for Application of Fines in Economic Affairs), in the case of proceedings undertaken by IGAE;
b) ICP's chairman in other cases.
4 - 60% of the amount of fines reverts to the State and the other 40% to the entities that apply the fine.
Countermanding measures and fines
1 - Without prejudice to other applicable sanctions, the following constitute countermanding measures:
a) Non-compliance with the terms of point 2 of article 5;
b) Breach of the terms of point 1 of article 7;
c) Breach of the terms of paragraphs a) and b) of article 8;
d) Breach of the terms of point 2 of article 9;
e) Breach of the terms of point 3 of article 9;
f) Non-compliance with the terms of point 5 of article 9;
g) Breach of the terms of article 11;
h) Breach of the terms of article 13;
i) Breach of the terms of point 2 of article 15;
j) Breach of the terms of points 1 and 2 of article 27;
k) Breach of the terms of paragraphs a) and b) of point 3 of article 27;
l) Non-compliance with the terms of point 4 of article 27;
m) Breach of the terms of points 1 and 3 of article 28;
n) Breach of the terms of points 1 and 2 of article 29;
o) Breach of the terms of points 1 and 6 of article 30;
p) Non-compliance with the terms of article 38;
q) Breach of the terms of point 5 of annex II;
r) Breach of the terms of point 6 of annex II;
s) Breach of the terms of point 5 of annex III;
t) Breach of the terms of point 7 of annex IV;
u) Non-compliance with the terms of points 14, 15, 19 and 24 of annex V.
2 - The countermanding measures specified in the present diploma are to be punished with fines from 50 000$00 to 750 000$00 and from 1 000 000$00 to 9 000 000$00, according to whether they are practised by a single person or a corporate body.
3 - Intent and negligence are also liable to be punished.
In the case of the countermanding measures specified in paragraphs a), b), e), f), j), k), l), m) and n) of point 1 of article 33 the additional sanction may also be applied of confiscation of apparatus by the State, in the event that within 60 days after notification of the decision no request is made to return the sealed or disassembled apparatus.
Final and transitional provisions
Decisions of the European Commission
Within the scope of its attributions and competences, ICP is responsible for acting in conformity with the binding decisions made by the European Commission under the terms of Directive no. 1999/5/CE, publishing such decisions whenever considered necessary, depending on the entities for which the decision is intended.
Existing technical standards
1 - The technical standards adopted under the terms of Decree-Law no. 117/88, of April 12 and Decree-Law no. 74/92, of April 29 may be used for the presumption of conformity with the essential requirements contained in paragraphs a) and b) of point 1 of article 4.
2 - The common technical regulation adopted under the terms of Decree-Law no. 228/93, of June 22, and Decree-Law no. 119/96, of August 7, may be used for the presumption of conformity with the other applicable essential requirements referred to in article 4.
3 - For the purposes of the previous points, ICP will publish, via a notice in the 3rd series of the Diário da República, the references published in the OJEC concerning the standards and common technical regulation.
1 - Apparatus may be placed on the market and put into service if its placement on the market took place for the first time before the present diploma entered into force and up to April 7, 2001, and conforms with the terms of Decree-Law no. 228/93, of June 22, Decree-Law no. 119/96, of August 7, Decree-Law no. 147/87, of March 24, and Decree-Law no. 320/88, of September 14.
2 - ICP is responsible for deciding upon the obligations of telecommunications terminal equipment to comply with requirements that aim to impede serious deterioration in the fixed telephone service provided as part of the universal service.
3 - The obligation specified in the previous point may only be imposed until October 7, 2002.
4 - ICP is responsible for informing the European Commission of decisions taken under the terms of point 2, as well as for acting in conformity with the decisions taken by the Commission in this field, under the terms of Directive no. 1999/5/CE.
Communication of interfaces
1 - Public telecommunications network operators are responsible for communicating to ICP the technical specifications of existing interfaces under the terms of article 30, within 90 days after the present diploma enters into force.
2 - Cable distribution network operators authorised under the terms of Decree-Law no. 241/97, of September 18 are subject to articles 4 and 5 of Decree-Law no. 290-A/99, of July 30.
1 - Decree-Law no. 228/93, of June 22, and Decree-Law no. 119/96, of August 7 are revoked as well as the respective complementary legal dispositions.
2 -Paragraph d) of point 2 of article 16 of Decree-Law no. 241/97, of September 18 is revoked, as well as points 6 and 7 of Administrative Rule no. 791/98, of September 22, and the equipment and material to be used by cable distribution network operators in the respective networks and subject to the regulatory regime specified in the present diploma.
Equipment not covered by the scope of the present diploma
1 - Radio equipment used by radio amateurs within the meaning of paragraph c) of article 1 of Decree-Law no. 5/95, of January 17, unless such equipment is available commercially.
2 - Kits of components to be assembled by radio amateurs and commercial equipment modified by and for the use of radio amateurs are not regarded as commercially available equipment.
3 - Equipment falling within the scope of Decree-Law no. 167/99, of May 18, which establishes the norms to be applied to marine equipment to be manufactured or sold in Portuguese territory or to be installed in Portuguese shipping vessels.
4 - Cabling and wiring.
5 - Receive only radio equipment intended to be used only for the reception of sound and TV broadcasting services.
6 - Products, appliances and components within the meaning of Article 2 of Council Regulation (CEE) no. 3922/91, of December 16, on the harmonisation of technical requirements and administrative procedures in the field of civil aviation.
7 - Air-traffic management equipment and systems within the meaning of Decree-Law no. 242/95, of September 13, on the definition and use of compatible technical specifications for the procurement of air-traffic management equipment and systems.
Internal Production Control
1 - This Annex describes the procedure whereby the manufacturer or his authorised representative established within the Community, ensures and declares that the products concerned satisfy the applicable requirements.
2 - The manufacturer must establish the technical documentation, which must enable the conformity of the product with the essential requirements to be assessed, and must cover the design, manufacture and operation of the product.
3 - For the purposes of the previous point, the technical information should contain:
a) a general description of the product;
b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
c) descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product;
d) a list of the harmonised standards applied in full or in part, and descriptions and explanations of the solutions adopted to meet the applicable essential requirements where such standards have not been applied or do not exist;
e) results of design calculations made, examinations carried out, etc.;
f) test reports.
4 - The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured products with the technical documentation referred to in points 2 and 3 and with applicable requirements.
5 - The manufacturer, his authorised representative established within the Community or the entity responsible for placing the equipment on the market must keep the technical documentation for surveillance purposes for a period ending at least 10 years after the last product has been manufactured.
6 - The manufacturer or his authorised representative when established within the Community must affix the CE mark to each equipment and prepare a written declaration of conformity, keeping a copy of this declaration together with the technical documentation.
Internal production control plus specific apparatus tests
1 - This Annex consists of Annex II, plus the following supplementary requirements:
2 - For each type of apparatus, all essential radio test suites must be carried out by the manufacturer or on his behalf.
3 - The identification of the test suites that are considered to be essential is the responsibility of a notified body chosen by the manufacturer except where the test suites are defined in the harmonised standards.
4 - In the determination of the test suites to be carried out, the notified body must take due account of previous decisions made by notified bodies acting together.
5 - The manufacturer, his authorised representative or importer, in any case established within the Community must:
a) declare that these tests have been carried out;
b) declare that the apparatus complies with the essential requirements;
c) affix the notified body's identification number during the manufacturing process.
Technical construction file
1 - This Annex consists of Annex III plus the following supplementary requirements:
2 - The manufacturer must establish a technical construction file composed of the following elements, where applicable:
a) The technical documentation described in point 3 of Annex II;
b) Declaration of conformity to specific radio test suites described in point 3 of Annex III.
3 - The manufacturer, his authorised representative established within the Community or the person responsible for placing the apparatus on the market, must present the file to one or more notified bodies.
4 - Whenever the technical construction file is presented to more than one notified body, the entities identified in point 3 must inform each of the notified bodies of others who have received the file.
5 - The notified body must review the technical construction file and within a maximum of four weeks of receipt of the file may either:
a) Issue an opinion to the manufacturer, his representative established within the Community or the person responsible for placing the apparatus on the market that it has not been properly demonstrated that the requirements of the present diploma have been met, and must inform the other notified bodies who have received the file accordingly; or,
b) Issue an opinion to the entities identified in the previous point that the file proves compliance with the requirements established by the present diploma.
6 - After confirmation of either of the previous two possibilities, the apparatus may be placed on the market, without prejudice to Articles 9(3) and 15.
7 - The manufacturer or his authorised representative established within the Community or the person responsible for placing the apparatus on the market must keep the file for a period ending at least 10 years after the last apparatus has been manufactured at the disposal of the relevant national authorities for inspection.
Full quality assurance
1 - Full quality assurance is the procedure whereby it is ensured and declared that the products concerned satisfy the requirements of the present diploma that apply to them.
2 - The manufacturer must affix the marks referred to in Article 27 of the present diploma to each product and draw up a written declaration of conformity.
3 - The manufacturer must operate an approved quality system for design, manufacture and final product inspection and testing as specified in points 4 to 17 and must be subject to surveillance as specified in points 18 to 23 of the present annex.
4 - For the purposes of the terms of the previous point, the manufacturer must lodge an application for assessment of his quality system with a notified body.
5 - The application must include:
a) all relevant information for the products envisaged;
b) the quality system's documentation.
6 - The quality system must ensure compliance of the products that are submitted to it with the essential requirements that apply to them.
7 - 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.
8 - The quality system documentation referred to in the previous point must ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records, and must contain in particular an adequate description of:
a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality;
b) the technical specifications, including the harmonised standards and technical regulations as well as relevant test specifications that will be applied and, where the standards referred to in Article 18(1) will not be applied in full, the means that will be used to ensure that the essential requirements of the present diploma that apply to the products will be met;
c) the design control and design verification techniques, processes and systematic actions that will be used when designing the products pertaining to the product category covered;
d) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
e) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out, as well as the results of the tests carried out before manufacture where appropriate;
f) the means by which it is ensured that the test and examination facilities respect the appropriate requirements for the performance of the necessary test;
g) the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.;
h) the means to monitor the achievement of the required design and product quality and the effective operation of the quality system.
9 - The notified body must assess the quality system to determine whether it satisfies the requirements referred to in the previous point.
10 - The notified body must presume compliance with the requirements specified in point 8 in respect of quality systems that implement the relevant harmonised standard.
11 - The notified body must assess in particular whether the quality control system ensures conformity of the products with the requirements of the present diploma in the light of the relevant documentation supplied in respect of points 5 and 8 of the present annex, including, where relevant, test results supplied by the manufacturer.
12 - For the purposes of the previous point, the auditing team must include an assessment visit to the manufacturer's premises, and must have at least one member experienced as an assessor in the product technology concerned.
13 - The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.
14 - The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and efficient.
15 - The manufacturer or his authorised representative must keep the notified body that has approved the quality system informed of any intended updating of the quality system.
16 - The notified body must evaluate the modifications proposed under the terms of the previous point and decide whether the amended quality system will still satisfy the requirements referred to in point 8 of the present annex or whether a reassessment is required.
17 - The decision by the notified body, under the terms of the previous point, including the conclusions of the examination and the reasoned assessment decision, must be notified to the manufacturer.
18 - The purpose of surveillance to be carried out by notified bodies is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
19 - The manufacturer must allow the notified body access for inspection purposes to the locations of design, manufacture, inspection and testing, and storage and must provide it with all necessary information, in particular:
a) the quality system documentation;
b) the quality records as foreseen by the design part of the quality system, such as results of analyses, calculations, tests, etc.;
c) the quality records as foreseen by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
d) the manufacturer must permit visits to be made by the notified body to its premises without prior notice;
20 - The notified body must carry out audits at reasonable intervals to make sure that the manufacturer maintains and applies the quality system.
21 - For the purposes of the terms of the previous point, the notified body must provide an audit report to the manufacturer.
22 - Additionally, the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may carry out tests or have them carried out in order to check the proper functioning of the quality system where necessary;
23 - The notified body must provide the manufacturer with a report of the visit made under the terms of the previous point and, if a test has been carried out, with a test report.
24 - The manufacturer must, for a period ending at least 10 years after the last product has been manufactured, keep at the disposal of the national authorities:
a) the documentation referred to in paragraph b) of point 5;
b) the updating referred to in point 15 of the present annex;
c) the decisions and reports from the notified body which are referred to in points 17, 22 and 24.
25 - Each notified body must make available to the other notified bodies the relevant information concerning quality system approvals including reference to the product(s) concerned, issued and withdrawn.
The CE mark
The CE conformity marking must consist of the initials 'CE' taking the following form:
1 - If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.
2 - The CE marking must have a height of at least 5 mm except where this is not possible on account of the nature of the apparatus.
Checked and approved in Council of Ministers on July 7, 2000. - António Manuel de Oliveira Guterres - Jorge Paulo Sacadura Almeida Coelho - Joaquim Augusto Nunes Pina Moura - António Luís Santos Costa.
Proclaimed on July 27, 2000.
Let this be published.
President of the Republic, JORGE SAMPAIO.
Counter signed on August 1, 2000.
Acting Prime Minister, Jaime José Matos da Gama.