Ministério da Economia (Ministry of Economy)
Decree-Law
(This is not an official translation of the law)
Decree-Law No. 325/2007, of 28 of September, as amended by Decree-Law No. 20/2009, of 19 January, sets out the rules, regarding electromagnetic compatibility, relating to the placing on the market and putting into service of equipment, including apparatus and fixed installations, transposing into the national legal order Directive 2004/108/EC http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:390:0024:0037:EN:PDF of the European Parliament and of the Council, of 15 December 2004, on the approximation of the laws of the Member States relating to electromagnetic compatibility of equipment and repealing Council Directive 89/336/EEC, of 3 May 1989
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&numdoc=389L0336&model=guichett&lg=en.
Directive 2014/30/EU http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0030 of the European Parliament and of the Council, of 26 February 2014, recasts and repeals Directive 2004/108/EC of the European Parliament and of the Council, of 15 December, introducing amendments in particular as regards obligations on economic operators required by the new European legal framework. This new framework arises from Regulation (EC) No. 765/2008
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008R0765 of the European Parliament and of the Council, of 9 July 2008, setting out the requirements for accreditation and market surveillance relating to the marketing of products, as well as from Decision No. 768/2008/EC
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008D0768 of the European Parliament and of the Council, of 9 July 2008, on a common framework for the marketing of products, which maintains the essential requirements with which equipment must comply, including apparatus and fixed installations.
This Decree-Law aims to transpose into the national legal order Directive 2014/30/EU of the European Parliament and of the Council, of 26 February 2014, and repeals Decree-Law No. 325/2007, of 28 of September.
This Decree-Law contains different and systematically separate provisions for apparatus and fixed installations, as the former may move freely within the European Union, whereas the latter are intended for permanent use at a predefined location, as assemblies of various types of apparatus and other devices, the composition and function of which correspond, in most cases, to the particular needs of their operators. This Decree-Law applies to all means of provision on the market, including online means.
The self-government bodies of the Autonomous Region of the Azores, Autoridade de Supervisão de Seguros e Fundos de Pensões (the Insurance and Pension Funds Supervisory Authority) and Associação Portuguesa de Seguradores (the Portuguese Association of Insurers) were heard.
The hearing of self-government bodies of the Autonomous Region of Madeira and of Conselho Nacional do Consumo (the National Consumer Council) was promoted.
Therefore,
Pursuant to paragraph 1 a) of article 198 of the Constitution, the Government hereby decrees as follows:
CHAPTER I
General provisions
Article 1
Subject-matter
This Decree-Law sets out the rules applicable to electromagnetic compatibility of equipment, transposing into the national legal order Directive 2014/30/EU of the European Parliament and of the Council, of 26 February 2014, on the harmonisation of the laws of the Member States relating to electromagnetic compatibility.
Article 2
Scope of application
1 - This Decree-Law shall apply to equipment as defined in the following article.
2 - This Decree-Law shall not apply to:
a) Equipment covered by Decree-Law No. 192/2000, of 18 August, which approved the regime of free movement, placing on the market, and putting into service in the national territory of radio equipment and telecommunications terminal equipment, as well as the regime of their conformity assessment and marking, transposing into the national legal order Directive 1999/5/EC http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31999L0005 of the European Parliament and of the Council, of 9 March 1999;
b) Aeronautical products, parts and appliances as referred to in Regulation (EC) No. 216/2008 http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008R0216 of the European Parliament and of the Council, of 20 February 2008, on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31991L0670, of 16 December 1991, Regulation (EC) No. 1592/2002
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&numdoc=302R1592&model=guichett&lg=en of the European Parliament and of the Council, of 25 October 2012, and Directive 2004/36/EC
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32004L0036 of the European Parliament and of the Council, of 21 April 2004;
c) Radio equipment used by radio amateurs within the meaning of the Radio Regulations adopted in the framework of the Constitution of the International Telecommunication Union and the Convention of the International Telecommunication Union, unless the equipment is made available on the market;
d) Equipment the inherent nature of the physical characteristics of which is such that:
i) It is incapable of generating or contributing to electromagnetic emissions which exceed a level allowing radio and telecommunication equipment, and other equipment, to operate as intended; and
ii) It operates without unacceptable degradation in the presence of the electromagnetic disturbance normally consequent upon its intended use;
e) Custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.
3 - For the purposes of point c) of the preceding paragraph, kits of components to be assembled by radio amateurs and equipment made available on the market and modified by and for the use of radio amateurs are not regarded as equipment made available on the market.
4 - Where, for the equipment referred to in paragraph 1, the essential requirements set out in annex I hereto, deemed to be an integral part hereof, are wholly or partly laid down more specifically by other European Union (EU) legislation, or corresponding national legislation emerging therefrom, this Decree-Law shall not apply to that equipment in respect of such requirements.
5 - This Decree-Law shall not affect the application of Union or national legislation regulating the safety of equipment.
Article 3
Definitions
For the purposes of this Decree-Law, the following definitions shall apply:
a) «Accreditation» means accreditation as defined in point 10 of Article 2 of Regulation (EC) No. 765/2008 of the European Parliament and of the Council, of 9 July 2008;
b) «Electromagnetic environment» means all electromagnetic phenomena observable in a given location;
c) «Apparatus» means any finished appliance or combination thereof made available on the market as a single functional unit, intended for the end-user and liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance;
d) «Conformity assessment» means the process demonstrating whether the essential requirements provided for in this Decree-Law relating to an apparatus have been fulfilled;
e) «Placing on the market» means the first making available of apparatus on the EU market;
f) «Electromagnetic compatibility» means the ability of equipment to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbances to other equipment in that environment;
g) «Making available on the market» means any supply of apparatus for distribution, consumption or use on the EU market in the course of a commercial activity, whether in return for payment or free of charge;
h) «Distributor» means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes apparatus available on the market;
i) «Equipment» means any apparatus or fixed installation;
j) «Technical specification» means a document that prescribes technical requirements to be fulfilled by the equipment;
k) «Manufacturer» means any natural or legal person who manufactures apparatus or has apparatus designed or manufactured, and markets that apparatus under his name or trade mark;
l) «Importer» means any natural or legal person established within the EU who places apparatus from a third country on the EU market;
m) «Immunity» means the ability of equipment to perform as intended without degradation in the presence of an electromagnetic disturbance;
n) «Fixed installation» means a particular combination of several types of apparatus and, where applicable, other devices, which are assembled, installed and intended to be used permanently at a predefined location;
o) «EU harmonisation legislation» means any EU legislation harmonising the conditions for the marketing of products;
p) «Authorised representative» means any natural or legal person established within the EU who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
q) «CE marking» means a marking by which the manufacturer indicates that the apparatus is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;
r) «Harmonised standard» means a harmonised standard as defined in point c) of paragraph 1 of article 2 of Regulation (EU) No. 1025/2012 http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32012R1025 of the European Parliament and of the Council, of 25 October 2012;
s) «Economic operators» means the manufacturer, the authorised representative, the importer and the distributor;
t) «Conformity assessment body» means a body that performs conformity assessment activities including calibration, testing, certification and inspection;
u) «National accreditation body» means a national accreditation body as defined in paragraph 11 of article 2 of Regulation (EC) No. 765/2008 of the European Parliament and of the Council, of 9 July 2008;
v) «Electromagnetic disturbance» means any electromagnetic phenomenon which may degrade the performance of equipment, such as an electromagnetic noise, an unwanted signal or a change in the propagation medium itself;
w) «Safety purposes» means the purposes of safeguarding human life or property;
x) «Recall» means any measure aimed at achieving the return of apparatus that has already been made available to the end-user;
y) «Withdrawal» means any measure aimed at preventing apparatus in the supply chain from being made available on the market;
2 - For the purposes of this Decree-Law, the following shall be considered as apparatus:
a) Components or sub-assemblies intended for incorporation into an apparatus by the end-user, which are liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance;
b) Mobile installations, defined as a combination of apparatus and, where applicable, other devices, intended to be moved and operated in a range of locations.
Article 4
Making available on the market and/or putting into service
Equipment shall be made available on the market and/or put into service only where it complies with this Decree-Law, and shall be properly installed, maintained and used for its intended purpose.
Article 5
Free movement of equipment
1 - The making available on the market and/or the putting into service in the national territory of equipment which complies with this Decree-Law shall not be impeded for reasons relating to electromagnetic compatibility.
2 – Without prejudice to compliance with requirements provided for in this Decree-Law, equipment may be subject to the application of the following special measures concerning the respective putting into service or use:
a) Measures to overcome an existing or predicted electromagnetic compatibility problem at a specific site;
b) Measures taken for safety reasons to protect public telecommunications networks or receiving or transmitting stations when used for safety purposes in well-defined spectrum situations.
3 - Without prejudice to Directive 2015/1535 of the European Parliament and of the Council, of 9 September 2015, laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services, IAPMEI - Agência para a Competitividade e Inovação, I. P. (IAPMEI, I. P. – the Agency for Competitiveness and Innovation) shall notify the special measures referred to in the preceding paragraph to the European Commission and to other Member States.
4 - The display and/or demonstration at trade fairs, exhibitions or similar events of equipment not in conformity with this Decree-Law shall be permitted, provided that a visible sign clearly indicates that such equipment fails to comply with requirements established herein, and that it may not be made available on the market and/or put into service until it has been brought into conformity herewith.
5 – Without prejudice to the preceding paragraph, demonstration may only take place provided that adequate measures have been taken to avoid electromagnetic disturbances.
Article 6
Essential requirements
The equipment shall meet the essential requirements set out in annex I to this Decree-Law.
CHAPTER II
Obligations of economic operators
Article 7
Obligations of manufacturers
Manufacturers are required to:
a) Ensure that apparatus they place on the market have been designed and manufactured in accordance with the essential requirements set out in annex I hereto;
b) Draw up the technical documentation referred to in annex II or annex III hereto, deemed to be an integral part hereof;
c) Carry out the relevant conformity assessment procedure provided for in article 14, or to have it carried out;
d) Draw up an EU declaration of conformity and affix the CE marking where compliance of apparatus has been demonstrated by the procedure referred to in the preceding point;
e) Keep the technical documentation and the EU declaration of conformity for 10 years after the apparatus has been placed on the market;
f) Ensure that procedures are in place for series production to remain in conformity with this Decree-Law and to take into account changes in apparatus design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which conformity of apparatus is declared;
g) Ensure that apparatus which they have placed on the market bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the apparatus does not allow it, that the required information is provided on the packaging or in a document accompanying the apparatus;
h) Indicate on the apparatus their name, registered trade name or registered trade mark and a single postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the apparatus, in a language easily understood by end-users and the market surveillance authority;
i) Ensure that the apparatus is accompanied by instructions, information and labelling in Portuguese, written in a clear, understandable and intelligible way, as provided for in article 18;
j) Immediately take the corrective measures necessary to bring the apparatus into conformity, to withdraw it or recall it, if appropriate, where they consider or have reason to believe that an apparatus which they have placed on the market is not in conformity with this Decree-Law;
k) Immediately inform the market surveillance authorities of the Member States in which they made the apparatus available on the market where such apparatus presents a risk, giving relevant information, in particular, of the non-compliance and of any corrective measures taken;
l) Provide the market surveillance authority with all the information and documentation, in paper or preferably electronic form, necessary to demonstrate the conformity of the apparatus with this Decree-Law, in Portuguese or another language which can be easily understood by that authority, and further to a reasoned request therefrom;
m) Cooperate with the market surveillance authority, upon request, on any action taken to eliminate the risks posed by apparatus which they have placed on the market.
Article 8
Authorised representatives
1 - Manufacturers may, by a written mandate, appoint an authorised representative, who shall perform the tasks specified in the mandate.
2 - The obligations laid down in points a) and b) of the preceding article shall not be mandated.
3 – Without prejudice to other tasks that may be allowed to be performed, the mandate shall allow the authorised representative to:
a) Keep the EU declaration of conformity and the technical documentation at the disposal of the market surveillance authority for 10 years after the apparatus has been placed on the market;
b) Provide the market surveillance authority with all the information and documentation necessary to demonstrate the conformity of the apparatus, in Portuguese or another language which can be easily understood by that authority, and further to a reasoned request therefrom;
c) Cooperate with the market surveillance authority, at its request, on any action taken to eliminate the risks posed by the apparatus covered by the authorised representative’s mandate.
Article 9
Obligations of importers
1 - Importers shall only place on the market apparatus that are compliant with this Decree-Law.
2 - When placing apparatus on the market, importers shall:
a) Ensure that the manufacturer has carried out the conformity assessment procedure referred to in article 14;
b) Ensure that the manufacturer has drawn up the technical documentation and has complied with the requirements set out in points g) and h) of article 7;
c) Ensure that the apparatus bears the CE marking and is accompanied by documents provided for herein;
d) Refrain from placing the apparatus on the market until it has been brought into conformity, where they consider or have reason to believe that the apparatus is not in conformity with the essential requirements set out in annex I hereto;
e) Immediately inform the manufacturer and the market surveillance authority where the apparatus presents a risk;
f) Indicate on the apparatus their name, registered trade name or registered trade mark and a single postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the apparatus, in a language easily understood by end-users and the market surveillance authority;
g) Ensure that the apparatus is accompanied by instructions and information referred to in article 18, in Portuguese and in a clear, understandable and intelligible way;
h) Ensure that, while an apparatus is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential requirements set out in annex I hereto;
i) Immediately take the corrective measures necessary to bring the apparatus into conformity, to withdraw it or recall it, if appropriate, where they consider or have reason to believe that an apparatus which they have placed on the market is not in conformity herewith;
j) Immediately inform the market surveillance authorities of the Member States in which they made the apparatus available on the market where such apparatus presents a risk, giving relevant information, in particular, of the non-compliance and of any corrective measures taken;
k) Keep the EU declaration of conformity for 10 years after the apparatus has been placed on the market, making it available to the market surveillance authority upon request;
l) Provide the market surveillance authority with all the information and documentation, in paper or preferably electronic form, necessary to demonstrate the conformity of the apparatus, in Portuguese or another language which can be easily understood by that authority, and further to a reasoned request therefrom;
m) Cooperate with the market surveillance authority, upon request, on any action taken to eliminate the risks posed by apparatus which they have placed on the market.
Article 10
Obligations of distributors
1 - When making apparatus available on the market, distributors shall comply with requirements set out in this Decree-Law.
2 - When placing apparatus on the market, distributors shall:
a) Ensure that the apparatus bears the CE marking;
b) Ensure that the apparatus is accompanied by documents provided for herein as well as by instructions and information referred to in article 18, in Portuguese and in a clear, understandable and intelligible way;
c) Ensure that the manufacturer and imported have complied with the requirements set out, respectively, in points g) and h) of article 7 and in point f) of paragraph 2 of the preceding article;
d) Refrain from placing the apparatus on the market until it has been brought into conformity, where they consider or have reason to believe that the apparatus is not in conformity with the essential requirements set out in annex I hereto;
e) Immediately inform the manufacturer or the importer and the market surveillance authority where the apparatus presents a risk;
f) Ensure that, while an apparatus is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential requirements set out in annex I hereto;
g) Take the corrective measures necessary to bring the apparatus into conformity, to withdraw it or recall it, if appropriate, where they consider or have reason to believe that an apparatus which they have made available on the market is not in conformity herewith;
h) Immediately inform the market surveillance authorities of the Member States in which they made the apparatus available on the market where such apparatus presents a risk, giving relevant information, in particular, of the non-compliance and of any corrective measures taken;
i) Provide the market surveillance authority with all the information and documentation, in paper or preferably electronic form, necessary to demonstrate the conformity of the apparatus, in Portuguese or another language which can be easily understood by that authority, and further to a reasoned request therefrom;
j) Cooperate with the market surveillance authority, upon request, on any action taken to eliminate the risks posed by apparatus which they have placed on the market.
Article 11
Application of obligations of manufacturers to importers and distributors
For the purpose of this Decree-Law, importers and distributors shall be subject to the obligations of the manufacturer under article 7, where they:
a) Place apparatus on the market under their name or trade mark; or
b) Modify apparatus already placed on the market in such a way that compliance with this Decree-Law may be affected.
Article 12
Identification of economic operators
1 – Upon request from the market surveillance authorities, economic operators shall identify who has supplied them with apparatus, and to whom they have supplied apparatus.
2 – The record of information referred to in the preceding paragraph shall be kept by the economic operator for 10 years after the date when:
a) It has been supplied with the apparatus;
b) It has supplied the apparatus.
CHAPTER III
Conformity of equipment
Article 13
Presumption of conformity of equipment
Equipment which is in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the EU, shall be presumed to be in conformity with the essential requirements set out in annex I hereto, covered by the referred standards or parts thereof.
Article 14
Conformity assessment procedures for apparatus
1 - Compliance of apparatus with the essential requirements set out in annex I hereto shall be demonstrated by means of either of the following conformity assessment procedures:
a) Internal production control set out in annex II hereto;
b) EU type examination that is followed by conformity to type based on internal production control set out in annex III hereto.
2 - The manufacturer may choose to restrict the application of the procedure referred to in point b) of the preceding paragraph to some aspects of the essential requirements, where the procedure referred to in point a) of the preceding paragraph is applied to the other aspects of the referred requirements.
Article 15
EU declaration of conformity
1 - The EU declaration of conformity shall state that the fulfilment of the essential requirements set out in annex I hereto has been demonstrated.
2 - The EU declaration of conformity shall:
a) Follow the model structure set out in annex IV, deemed to be an integral part hereof;
b) Contain the elements specified in the relevant modules set out in annexes II and III hereto;
c) Be in Portuguese and be continuously updated.
3 - Where apparatus is subject to more than one EU act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up, all acts concerned, including their publication references, being duly identified.
4 - By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the apparatus with the requirements laid down in this Decree-Law.
Article 16
General principles of the CE marking
The CE marking shall be subject to the general principles set out in article 30 of Regulation (EC) No. 765/2008 of the European Parliament and of the Council, of 9 July 2008.
Article 17
Rules and conditions for affixing the CE marking
1 - The CE marking shall be affixed visibly, legibly and indelibly to the apparatus or to its data plate, or where that is not possible or not warranted on account of the nature of the apparatus, it shall be affixed to the packaging and to the accompanying documents.
2 - The CE marking shall be affixed before the apparatus is placed on the market.
Article 18
Information concerning the use of apparatus
1 - Apparatus shall be accompanied by information on any specific precautions that must be taken when the apparatus is assembled, installed, maintained or used, in order to ensure that, when put into service, the apparatus is in conformity with the essential requirements set out in paragraph 1 of annex I hereto.
2 - Apparatus for which compliance with the essential requirements set out in paragraph 1 of annex I hereto is not ensured in residential areas shall be accompanied by a clear indication of such restriction of use, and also, where appropriate, on the packaging.
3 - The information required to enable apparatus to be used in accordance with the intended purpose of the apparatus shall be included in the instructions accompanying the apparatus.
Article 19
Fixed installations
1 - Apparatus which has been made available on the market and which may be incorporated into a fixed installation shall be subject to all relevant provisions for apparatus set out in this Decree-Law.
2 - Apparatus which is intended for incorporation into a fixed installation and is otherwise not made available on the market shall not be subject to the requirements set out in articles 6 to 12 and 14 to 18.
3 - Documentation accompanying apparatus referred to in the preceding paragraph shall identify the fixed installation and its electromagnetic compatibility characteristics, indicate the precautions to be taken for the incorporation of the apparatus into the fixed installation in order not to compromise the conformity of that installation, and also include the information referred to in points g) and h) of article 7 and in point f) of paragraph 2 of article 9.
4 - The good engineering practices referred to in paragraph 2 of annex I hereto shall be documented and the documentation shall be held by the person or persons responsible at the disposal of the market surveillance authority for inspection for as long as the fixed installation is in operation.
5 - Where there are indications of non-compliance of the fixed installation, in particular, where there are complaints about disturbances being generated by the installation, the market surveillance authority may request evidence of compliance of the fixed installation, and, when appropriate, initiate an evaluation.
6 - Where non-compliance is established, the market surveillance authority shall impose appropriate measures to bring the fixed installation into compliance with the essential requirements set out in annex I hereto.
7 – The owner or holder of a fixed installation shall identify to the market surveillance authority the person or persons responsible for the establishment of compliance of a fixed installation with the relevant essential requirements.
CHAPTER IV
Notification of conformity assessment bodies
Article 20
Notifying authorities and notification
1 - For the purpose of this Decree-Law, Instituto Português da Qualidade, I. P. (IPQ, I. P. - the Portuguese Institute for Quality) shall be the notifying authority.
2 – It shall be incumbent on IPQ, I. P. to notify the European Commission of bodies in charge of performing the conformity assessment.
3 - IPQ, I. P. shall inform the European Commission of the respective procedures for the assessment and notification of conformity assessment bodies, as well as any change thereto.
4 – In order to notify the European Commission, IPQ, I. P. shall use the electronic notification tool developed and managed by the European Commission.
5 – Bodies shall only start operations for which an application for notification has been submitted to the European Commission where no objections are raised by the Commission or the other Member States within two weeks of a notification.
6 – Where IPQ, I. P. is informed by Instituto Português de Acreditação, I. P. (IPAC, I. P. – the Portuguese Accreditation Institute) that a notified body no longer meets the requirements laid down in article 22, or that it is failing to fulfil its obligations, it shall restrict, suspend or withdraw notification as appropriate, and immediately inform the European Commission and the other Member States accordingly.
7 - In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, IPQ, I. P. shall take appropriate steps to ensure that the files of that body are processed by another notified body.
8 – For the purpose of this Decree-Law, IPQ, I. P. shall be responsible for publishing references of harmonised standards, published in the Official Journal of the EU, applicable in the scope of Directive 2014/30/EU of the European Parliament and of the Council, of 26 February 2014.
Article 21
Accreditation of conformity assessment bodies
1 – The assessment and control of a conformity assessment body shall be incumbent on IPAC, I. P., as the national accreditation body, under paragraph 1 of article 2 of Decree-Law No. 23/2011, of 11 February, and paragraphs 1 and 2 of article 3 of Decree-Law No. 81/2012, of 27 March.
2 - For the purposes of notification, a conformity assessment body shall be previously accredited by IPAC, I. P., in the modalities corresponding to the intended conformity assessment activities.
3 – For the purpose of the preceding paragraph, an accredited conformity assessment body shall meet the requirements laid down in the following article.
Article 22
Requirements relating to notified bodies
1 - For the purposes of notification, conformity assessment bodies shall be legally constituted, have legal personality and be previously accredited by IPAC, I. P.
2 - Conformity assessment bodies shall take out liability insurance which shall cover all risks associated with their activity, the conditions and minimum capital of which shall be determined by administrative rule of the members of the Government in charge of the finance and economy fields.
3 - Conformity assessment bodies shall be third-party bodies independent of the organisation or the apparatus they assess.
4 – The requirement set out in the preceding paragraph shall be deemed to be met by any bodies belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of apparatus which they assess, on condition that their independence and the absence of any conflict of interest are demonstrated.
5 - Conformity assessment bodies shall also:
a) Ensure their own impartiality, as well as that of their top level management and of the personnel responsible for carrying out the conformity assessment tasks, refraining from performing consultancy services, or others, that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified;
b) Ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities;
c) Ensure that their personnel carry out the conformity assessment activities with professional integrity and technical competence, free from all pressures and inducements which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities;
d) Be capable of carrying out all the conformity assessment tasks assigned to them under annex III hereto, in relation to which they have been notified, whether those tasks are carried out by themselves, or on their behalf and under their responsibility;
e) Have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and have access to all necessary equipment or facilities;
f) Participate in the relevant standardisation activities and in the activities of the notified body coordination group established under the relevant EU harmonisation legislation, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of such activities, and apply as general guidance the administrative decisions and documents produced as a result of the work of that group.
6 - For each conformity assessment procedure and each kind of apparatus in relation to which they have been notified, conformity assessment bodies shall have at their disposal:
a) The necessary human resources with technical knowledge and appropriate experience to perform the conformity assessment tasks;
b) The descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures, as well as appropriate policies and procedures in place that distinguish between tasks they carry out as conformity assessment bodies and any other activity;
c) Procedures for the performance of activities which take due account of the size, sector and structure of an undertaking, the degree of complexity of the product technology in question and the mass or serial nature of the production process.
7 - The personnel responsible for carrying out conformity assessment tasks shall have:
a) Sound technical and vocational training covering all the conformity assessment activities in relation to which conformity assessment bodies have been notified;
b) Satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
c) Appropriate knowledge and understanding of the essential requirements set out in annex I hereto, of the applicable harmonised standards and of the relevant provisions of EU harmonisation legislation and of national legislation:
d) Ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
8 - The personnel of conformity assessment bodies shall also protect proprietary rights and observe professional secrecy with regard to all information obtained in carrying out their tasks under annex III hereto or any provision of national law giving effect to it, except in relation to IPQ, I. P., and IPAC, I. P.
9 - Conformity assessment bodies, their top level management and the personnel responsible for carrying out the conformity assessment tasks shall not:
a) Be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the apparatus which they assess, nor the representative of any of those parties; this shall not preclude the use of assessed apparatus that are necessary for the operations of the conformity assessment body or the use of such apparatus for personal purposes;
b) Be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those apparatus, or represent the parties engaged in those activities;
c) Make the remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of conformity assessment bodies dependent on the number of assessments carried out or on the results of those assessments.
Article 23
Presumption of conformity of notified bodies
Where conformity assessment bodies demonstrate their conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the EU, they shall be presumed to comply with the requirements set out in the preceding article in so far as the applicable harmonised standards cover such requirements.
Article 24
Subsidiaries of and subcontracting by notified bodies
1 - Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in article 22 and shall inform IPAC, I. P., and IPQ, I. P. accordingly.
2 - Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.
3 - Activities referred to in paragraph 1 shall be subcontracted or carried out by a subsidiary only with the agreement of the client.
4 - Notified bodies shall keep at the disposal of IPAC, I. P., and IPQ, I. P. the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under annex III hereto.
Article 25
Application for notification
1 – In order to carry out its activity, conformity assessment bodies shall submit an application for notification using a standard computerised form available through the Entrepreneur’s Desk referred to in article 6 of Decree-Law No. 92/2010, of 26 July.
2 – Where electronic platforms are not available, and as such the preceding paragraph may not be met, applications concerned shall be submitted through any other means provided for in the law, namely using a computerised form available through the portal of IPQ, I. P.
3 - IPQ, I. P. shall request IPAC, I. P., within five days from the submission of the application referred to in paragraph 1, to provide access, consultation or copy of the accreditation certificate and respective technical annex, attesting:
a) That the interested party is compliant, fulfilling the requirements laid down in article 22;
b) Its competence for the performance of conformity assessment activities, of the conformity assessment module or modules and of the type(s) of apparatus concerned.
Article 26
Operational obligations of notified bodies
1 - Notified bodies shall carry out conformity assessments in accordance with the following requirements:
a) Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators, and according to conformity assessment procedures provided for in annex III hereto;
b) Take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the apparatus technology in question and the mass or serial nature of the production process;
c) Respect the degree of rigour and the level of protection required for the compliance of the apparatus with this Decree-Law;
d) Require the manufacturer to take appropriate corrective measures and not issue a certificate where it finds that the essential requirements set out in annex I hereto or corresponding harmonised standards or other technical specifications have not been met by the manufacturer;
e) Require the manufacturer to take appropriate corrective measures and suspend or withdraw the certificate, if necessary, where, in the course of the monitoring of conformity following the issue of a certificate, they find that an apparatus is no longer compliant;
f) Restrict, suspend or withdraw any certificates, as appropriate, where corrective measures are not taken or do not have the required effect.
Article 27
Appeal procedure
1 - An appeal procedure against decisions of the notified bodies shall be available.
2 – For the purpose of the preceding paragraph, notified bodies shall implement appeal procedures provided for in the technical accreditation standards they are required to meet, under applicable legislation on accreditation.
3 – The notified body shall publicly disclose the procedures referred to in the preceding paragraph.
4 – Without prejudice to paragraph 2, decisions of the notified bodies may be challenged in court, under the Code of Procedure of Administrative Courts, for decisions issued by private bodies acting under rules of administrative law.
Article 28
Information obligation of notified bodies
1 - Notified bodies shall inform IPQ, I. P. of the following:
a) Any refusal, restriction, suspension or withdrawal of a certificate;
b) Any circumstances affecting the scope of or conditions for notification;
c) Any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
d) Conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting, upon request.
2 - Notified bodies shall provide other notified bodies carrying out similar conformity assessment activities covering the same apparatus, including notified bodies from other Member States, with relevant information on issues relating to negative and, on request, positive conformity assessment results.
Article 29
Coordination of notified bodies
IPQ, I. P., shall ensure the participation of notified bodies, directly or by means of designated representatives, in the work of a sectoral group of notified bodies, established by the European Commission.
CHAPTER V
Surveillance, control of apparatus entering the market and European Union safeguard procedure
Article 30
Surveillance and control of apparatus entering the European Union market
Paragraph 3 of article 15 and articles 16 to 29 of Regulation (EC) No. 765/2008 of the European Parliament and of the Council, of 9 July 2008, shall apply to apparatus covered by this Decree-Law.
Article 31
Procedure for dealing with apparatus presenting a risk at national level
1 - The market surveillance authority shall carry out an evaluation in relation to the apparatus concerned covering all relevant requirements laid down in this Decree-Law, where it has sufficient reason to believe that the apparatus presents a risk to aspects of public interest protection.
2 - The relevant economic operators shall cooperate as necessary with the market surveillance authority in the evaluation of the apparatus.
3 - Where, in the course of the evaluation referred to in paragraph 1, the market surveillance authority finds that the apparatus does not comply with the requirements laid down in this Decree-Law, it shall without delay require the relevant economic operator to take all appropriate corrective actions to bring the apparatus into compliance with those requirements, to withdraw the apparatus from the market, or to recall it within a period as it may prescribe, commensurate with the nature of the risk.
4 - The market surveillance authority shall inform the relevant notified body of the results of the evaluation and of the actions which it has required the economic operator to take under the preceding paragraph.
5 – For the purpose of paragraph 3, article 21 of Regulation (EC) No. 765/2008 of the European Parliament and of the Council, of 9 July 2008, shall apply.
6 - Where the market surveillance authority considers that non-compliance is not restricted to the national territory, it shall inform the European Commission and the other Member States of the results of the evaluation, and of the actions which it has required the economic operator to take.
7 - The economic operator shall ensure that all appropriate corrective action is taken in respect of all the apparatus concerned that it has made available throughout the EU market.
8 - The market surveillance authority shall take all appropriate provisional measures to prohibit or restrict the apparatus’s being made available on the national market, to withdraw the apparatus from the market or to recall it, where the relevant economic operator does not take adequate corrective action within the period referred to in paragraph 3.
9 - The market surveillance authority shall inform the Commission and the other Member States, without delay, of measures taken under the preceding paragraph.
10 - The information referred to in the preceding paragraph shall include all available details, in particular:
a) The data necessary for the identification of the non-compliant apparatus and its origin;
b) The nature of the alleged non-compliance and the risk involved;
c) The nature and duration of measures taken;
d) The arguments put forward by the relevant economic operator.
11 - The market surveillance authority shall indicate whether the non-compliance is due to:
a) Failure of the apparatus to meet the requirements relating to aspects of public interest protection covered by this Decree-Law; or
b) Shortcomings in the harmonised standards referred to in article 13 conferring a presumption of conformity.
12 - Where, within three months of receipt of the information referred to in paragraph 9, no objection has been raised by either Member States or the European Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.
13 - Surveillance authorities shall ensure that appropriate restrictive measures are taken in respect of the apparatus concerned without delay, including its withdrawal from the market.
Article 32
European Union safeguard procedure
1 - Where, on completion of the procedure set out in paragraphs 7 to 9 of the preceding article, objections are raised against a measure that is taken, or where the European Commission considers a national measure to be contrary to EU legislation, the European Commission shall evaluate and determine whether the national measure is justified.
2 - Where the national measure is considered justified, the market surveillance authorities shall take the necessary measures to ensure that the non-compliant apparatus is withdrawn from their market, and shall inform the European Commission accordingly.
3 - Were the national measure is considered unjustified, the market surveillance authority shall withdraw that measure.
Article 33
Formal non-compliance
1 - Without prejudice to article 31, the market surveillance authority shall require the economic operator to put an end to the non-compliance where it finds that:
a) The CE marking has been affixed in violation of article 30 of Regulation (EC) No. 765/2008 of the European Parliament and of the Council, of 9 July 2008, or of article 17 of this Decree-Law;
b) The CE marking has not been affixed;
c) The EU declaration of conformity has not been drawn up;
d) The EU declaration of conformity has not been drawn up correctly;
e) Technical documentation is either not available or not complete;
f) The information referred to in points g) and h) of article 7 or in point f) of paragraph 2 of article 9 is absent, or it is false or incomplete;
g) Any other requirement provided for in articles 7 and 9 is not fulfilled.
2 - Where the non-compliance referred to in the preceding paragraph persists, the market surveillance authority shall take all appropriate measures to restrict or prohibit the apparatus being made available on the market or ensure that it is recalled or withdrawn from the market.
CHAPTER VI
Surveillance and breach regime
Article 34
Market surveillance authority
Without prejudice to the powers conferred by law to other bodies, compliance with this Decree-Law shall be monitored by Autoridade de Segurança Alimentar e Económica (ASAE – the Economic and Food Safety Authority) and, as regards electronic communications equipment, by Autoridade Nacional de Comunicações (ANACOM), as market surveillance authorities.
Article 35
External border control
It shall be incumbent on Autoridade Tributária e Aduaneira (the Tax and Customs Authority), under article 5 of Decree-Law No. 23/2011, to undertake the external border control of apparatus from third countries covered by this Decree-Law.
Article 36
Breaches and fines
1 – The infringement of article 16 shall be governed by article 6 of Decree-Law No. 23/2011, of 11 February.
2 - The violation of rules and conditions governing the affixing of the CE marking provided for in article 17 shall be deemed to be a breach liable to a fine from (Euro) 1000.00 to (Euro) 3740.00, where committed by a natural person, and from (Euro) 2500.00 to (Euro) 44,890.00, where committed by a legal person.
3 - The following infringements shall be deemed to be breaches liable to a fine from (Euro) 1000.00 to (Euro) 3740.00, where committed by natural persons, and from (Euro) 2500.00 to (Euro) 44,890.00, where committed by legal persons:
a) The making available on the market and/or putting into service, by any economic operator, of measuring devices that do not meet the essential requirements set out in annex I hereto, in violation of article 6;
b) Those committed by manufacturers, as follows:
a) Failure to comply with point a) of article 7;
b) Failure to draw up the technical documentation referred to in annex II or annex III hereto, under point b) of article 7;
c) Failure to carry out the relevant conformity assessment procedure, or to have it carried out, as provided for in point c) of article 7;
d) Failure to draw up an EU declaration of conformity or to affix the CE marking, as provided for in point d) of article 7;
e) Failure to keep the technical documentation and the EU declaration of conformity, as provided for in point e) of article 7;
f) Absence of procedures for series production to remain compliant, as provided for in point f) of article 7;
g) Absence of identification elements and of inscriptions in apparatus placed on the market, as provided for in point g) of article 7;
h) Failure to indicate their identification elements and respective contact details, as provided for in point h) of article 7;
i) Absence of instructions, information and labelling in apparatus placed on the market, as provided for in point i) of article 7;
j) Failure to take the necessary corrective measures, or to inform the market surveillance authorities of the Member States in which they made the apparatus available on the market, where such apparatus presents a risk, as provided for in points j) and k) of article 7;
k) Failure to comply with points l) and m) of article 7;
c) Those committed by authorised representatives, as follows:
i) Failure to keep the technical documentation and the EU declaration of conformity, as provided for in point a) of paragraph 3 of article 8;
ii) Failure to comply with point b) of paragraph 3 of article 8;
iii) Failure to cooperate with the market surveillance authority, as provided for in point c) of paragraph 3 of article 8;
d) Those committed by importers, as follows:
i) Failure to comply with paragraph 1 of article 9;
ii) Placing on the market apparatus intended to be used for the purposes referred to in paragraph 1 of article 2 and in paragraph 2 of article 3, without ensuring that the manufacturer has observed procedures and requirements provided for in points a) to c) of paragraph 2 of article 9;
iii) Not refraining from placing on the market apparatus not in conformity with the essential requirements set out in annex I hereto, as provided for in point d) of paragraph 2 of article 9;
iv) Failure to inform the manufacturer and the market surveillance authority where the apparatus presents a risk, as provided for in point e) of paragraph 2 of article 9;
v) Failure to indicate their identification elements and respective contact details, on the apparatus, on its packaging or in a document accompanying the apparatus, as provided for in point f) of paragraph 2 of article 9;
vi) Absence of safety instructions and information on the apparatus, as provided for in point g) of paragraph 2 of article 9;
vii) Failure to comply with point h) of paragraph 2 of article 9;
viii) Failure to take the necessary corrective measures, as provided for in point i) of paragraph 2 of article 9;
ix) Failure to inform the market surveillance authorities of the Member States in which they made the apparatus available on the market where such apparatus presents a risk, as provided for in point j) of paragraph 2 of article 9;
x) Failure to keep the EU declaration of conformity, as provided for in point k) of paragraph 2 of article 9;
xi) Failure to comply with point l) of paragraph 2 of article 9;
xii) Failure to cooperate with the market surveillance authority, as provided for in point m) of paragraph 2 of article 9;
e) Those committed by distributors, as follows:
i) Failure to comply with paragraph 1 of article 10;
ii) Placing on the market apparatus intended to be used for the purposes referred to in paragraph 1 of article 2 and in paragraph 2 of article 3, without ensuring that the manufacturer and the importer have observed procedures and requirements provided for in points a) and b) of paragraph 2 of article 10;
iii) Failure to ensure that the manufacturer has complied with requirements set out in points f), g) and h) of article 6, as provided for in paragraph 2 of article 10;
iv) Not refraining from placing on the market apparatus not in conformity with the essential requirements set out in annex I hereto, as provided for in point d) of paragraph 2 of article 10;
v) Placing on the market apparatus not in conformity with safety objectives, and where it presents a risk, failure to inform the manufacturer, the importer and the market surveillance authority, as provided for in point e) of paragraph 2 of article 10;
vi) Failure to ensure due storage or transport conditions, as provided for in point f) of paragraph 2 of article 10;
vii) Failure to take the necessary corrective measures, and to inform the market surveillance authorities of the Member States in which they made the apparatus available on the market where such apparatus presents a risk, as provided for points g and h) of paragraph 2 of article 10;
viii) Failure to comply with point i) of paragraph 2 of article 10;
ix) Failure to cooperate with the market surveillance authority, as provided for in point j) of paragraph 2 of article 10;
f) Those committed by any economic operators, as follows:
i) Failure to meet the request made by the market surveillance authority, as provided for in paragraph 1 of article 12;
ii) Failure by any economic operator to keep the record of information under the terms and within the deadlines provided for in paragraph 2 of article 12;
iii) Failure to comply with requirements on the EU declaration of conformity, as provided for in paragraph 2 of article 15;
4 - Breaches committed by negligence shall be punishable, minimum and maximum limits of fines being reduced by half.
5 – An attempted breach shall be punishable by the fine, especially softened, that applies to the completed breach.
Article 37
Additional penalties
Without prejudice to the civil and criminal liability incurred in, where justified by the seriousness of the breach and the fault of the actor, the competent authority, together with the fine, shall be entitled to apply the additional penalties provided for in the general regime of mere social breaches, set out in Decree-Law No. 433/82, of 27 October, as amended by Decree-Laws No. 356/89, of 17 October, 244/95, of 14 September, and 323/2001, of 17 December, as well as by Law No. 109/2001, of 24 December.
Article 38
Examining and deciding breach proceedings
1 - It shall be incumbent on ASAE to examine breach proceedings, except for those concerning electronic communications equipment, the examination of which shall be incumbent on ANACOM.
2 – Files drawn up by other bodies shall be submitted to ASAE, or in case electronic communications equipment is concerned, to ANACOM.
3 – The application of fines and of additional penalties shall be incumbent on ASAE’s Inspector General or to ANACOM’s Management Board, according to the body that examined the breach file.
Article 39
Distribution of proceeds from fines
Proceeds from fines applied by virtue of the violation to this Decree-Law shall revert to:
a) The State at 60%;
b) The body that draw up the file at 10%;
c) The body that examined and decided the breach proceedings at 20%;
d) IAPMEI, I. P. at 8%;
e) IPQ, I. P. at 2%.
Article 40
Subsidiary legislation
The general regime of mere social breaches, set out in Decree-Law No. 433/82, of 27 October, as amended by Decree-Laws No. 356/89, of 17 October, 244/95, of 14 September, and 323/2001, of 17 December, as well as by Law No. 109/2001, of 24 December, shall apply on a supplementary basis to breaches provided for in this Decree-Law.
CHAPTER VII
Additional, transitory and final provisions
Article 41
Autonomous Regions
1 – Without prejudice to powers conferred to ANACOM, actions and procedures required to implement this Decree-Law in the Autonomous Regions of Azores and Madeira shall be incumbent on bodies of the respective regional administrations to whom assignments and powers regarding the matters in question have been granted.
2 - Proceeds from fines applied in the Autonomous Regions shall constitute their own revenue.
Article 42
Monitoring of the implementation of the Decree-Law
1 – It shall be incumbent on IAPMEI, I. P. to monitor the application of this Decree-Law, of draft measures required to pursue its objectives and of measures intended to guarantee the liaison with the European Commission and with other Member States.
2 - It shall be incumbent on IAPMEI, I. P. to ensure national representation in the Committee provided for in article 41 of Directive 2014/30/EU of the European Parliament and of the Council, of 26 February 2014.
3 – For the purpose of the preceding paragraphs, IAPMEI, I. P. shall consult ANACOM, in particular as far as electronic communications equipment is concerned, and ASAE as regards other equipment.
Article 43
Transitory provision
Equipment placed on the market before 20 April 2016 that are in conformity with Decree-Law No. 325/2007, of 28 September, as amended by Decree-Law No. 20/2009, of 19 January, may be made available on the market or put into service.
Article 44
Repealing provision
Decree-Law No. 325/2007, of 28 September, as amended by Decree-Law No. 20/2009, of 19 January, is hereby repealed.
Article 45
Entry into force
This Decree-Law shall enter into force on the day following that of its publication.
Checked and approved in the Council of Ministers of 15 December 2016 - Augusto Ernesto Santos Silva - Augusto Ernesto Santos Silva - Mário José Gomes de Freitas Centeno - Pedro Manuel Dias de Jesus Marques - Manuel de Herédia Caldeira Cabral.
Promulgated on 23 February 2017.
Let it be published.
The President of the Republic, Marcelo Rebelo de Sousa.
Counter-signed on 15 March 2017.
The Prime Minister, António Luís Santos da Costa.
ANNEX I
[referred to in paragraph 4 of article 2, article 6, point a) of paragraph 7, points d) and h) of paragraph 2 of article 9, points d) and f) of paragraph 2 of article 10, article 13, paragraph 1 of article 14, paragraph 1 of article 15, paragraphs 1 and 2 of article 18, paragraphs 4 and 6 of article 19, point c) of paragraph 7 of article 22, point d) of article 26 and point a), sub-point iii) of point d) and sub-point iv) of point e) of paragraph 3 of article 36]
Essential requirements
1 - General requirements
Equipment shall be designed and manufactured, having regard to the state of the art, as to ensure that:
a) The electromagnetic disturbance generated does not exceed the level above which radio and telecommunications equipment or other equipment cannot operate as intended;
b) It has a level of immunity to the electromagnetic disturbance to be expected in its intended use, allowing it to operate without unacceptable degradation of its intended use.
2 - Specific requirements for fixed installations
Installation and intended use of components
A fixed installation shall be installed applying good engineering practices and respecting the information on the intended use of its components, with a view to meeting the essential requirements set out in the preceding paragraph.
ANNEX II
[referred to in point b) of article 7, point a) of paragraph 1 of article 14, point b) of paragraph 2 of article 15, and sup-point i) of point b) of paragraph 3 of article 36]
Module A: internal production control
1 - Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 to 5 of this annex, and ensures and declares on his sole responsibility that the apparatus concerned satisfy the requirements of this Decree-Law that apply to it.
2 - Electromagnetic compatibility assessment:
a) The manufacturer shall perform an electromagnetic compatibility assessment of the apparatus, on the basis of the relevant phenomena, with a view to meeting the essential requirements set out in paragraph 1 of annex I hereto;
b) The electromagnetic compatibility assessment shall take into account all normal intended operating conditions, and where the apparatus is capable of taking different configurations, the electromagnetic compatibility assessment shall confirm whether the apparatus meets the essential requirements set out in preceding paragraph 1 of annex I hereto in all the possible configurations identified by the manufacturer as representative of its intended use.
3 - Technical documentation:
a) The manufacturer shall establish the technical documentation, which shall make it possible to assess the apparatus conformity to the relevant requirements, and include an adequate analysis and assessment of the risk(s);
b) The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the apparatus, containing, wherever applicable, at least the following elements:
i) A general description of the apparatus;
ii) Conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
iii) Descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the apparatus;
iv) A list of the harmonised standards applied in full or in part, the references of which have been published in the Official Journal of the EU;
v) Descriptions of the solutions adopted to meet the essential requirements of this Decree-Law, including a list of other relevant technical specifications applied, where those harmonised standards have not been applied;
vi) The technical documentation shall specify the parts of harmonised standards that have been partly applied;
vii) Results of design calculations made, examinations carried out, etc.;
viii) Test reports.
4 – Manufacturing.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured apparatus with the technical documentation referred to in the preceding paragraph and with the essential requirements set out in paragraph 1 of annex I.
5 - CE marking and EU declaration of conformity:
a) The manufacturer shall affix the CE marking to each individual apparatus that satisfies the applicable requirements of this Decree-Law;
b) The manufacturer shall draw up a written EU declaration of conformity for each apparatus model, which shall specify the apparatus for which it was drawn up, and keep it together with the technical documentation at the disposal of the market surveillance authorities for 10 years after the apparatus has been placed on the market;
c) A copy of the EU declaration of conformity shall be made available to the market surveillance authorities upon request.
6 - Authorised representative.
The manufacturer’s obligations set out in the preceding paragraph may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
ANNEX III
[referred to in point b) of article 7, point b) of paragraph 1 of article 14, point b) of paragraph 2 of article 15, point d) of paragraph 5 and paragraph 8 of article 22, paragraph 4 of article 24, point a) of article 26, and sub-point i) of point b) of paragraph 3 of article 36]
PART A
Module B: EU-type examination
1 - EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of an apparatus and verifies and attests that the technical design of the apparatus meets the essential requirements set out in paragraph 1 of annex I hereto.
2 - EU-type examination shall be carried out by assessment of the adequacy of the technical design of the apparatus through examination of the technical documentation referred to in paragraph 4 of this annex, without examination of a specimen (design type), and may be restricted to some aspects of the essential requirements as specified by the manufacturer or his authorised representative.
3 - The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice.
4 - The application shall specify the aspects of the essential requirements for which examination is requested and shall include:
a) The name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
b) A written declaration that the same application has not been lodged with any other notified body;
c) The technical documentation, which shall make it possible to assess the apparatus conformity with the applicable requirements of this Decree-Law and shall include an adequate analysis and assessment of the risk(s);
d) The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the apparatus;
e) The technical documentation shall contain, wherever applicable, at least the following elements:
i) A general description of the apparatus;
ii) The conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
iii) Descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the apparatus;
iv) A list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the EU, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Decree-Law, including a list of other relevant technical specifications applied;
v) The technical documentation shall specify the parts of harmonised standards that have been partly applied;
vi) Results of design calculations made, examinations carried out, etc.;
vii) Test reports.
5 - The notified body shall examine the technical documentation to assess the adequacy of the technical design of the apparatus in relation to the aspects of the essential requirements for which examination is requested.
6 - The notified body shall draw up an evaluation report that records the activities undertaken in accordance with the preceding paragraph and their outcomes, and shall release the content of that report, in full or in part, only with the agreement of the manufacturer, without prejudice to its obligations vis-à-vis Instituto Português da Qualidade, I. P. (IPQ, I. P. - the Portuguese Institute for Quality).
7 - Where the type meets the requirements of this Decree-Law that apply to the apparatus concerned, the notified body shall issue an EU-type examination certificate to the manufacturer.
8 - The certificate referred to in the preceding paragraph shall contain the name and address of the manufacturer, the conclusions of the examination, the aspects of the essential requirements covered by the examination, the conditions, if any, for its validity and the necessary data for identification of the approved type, the attachment of one or more annexes to the EU-type examination certificate being allowed.
9 - The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured apparatus with the examined type to be evaluated and to allow for in-service control.
10 - Where the type does not satisfy the applicable requirements of this Decree-Law, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
11 - The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Decree-Law, determining whether such changes require further investigation, and if so, the notified body shall inform the manufacturer accordingly.
12 - The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the apparatus with the essential requirements of this Decree-Law or the conditions for validity of that certificate.
13 - Modifications referred to in the preceding paragraph shall require additional approval in the form of an addition to the original EU-type examination certificate.
14 - Each notified body shall inform IPQ, I. P., concerning the EU-type examination certificates and/or any additions made thereto, issued or withdrawn, and shall, periodically or upon request, make available to IPQ, I. P., the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.
15 - Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning certificates issued and/or additions introduced thereto.
16 - The European Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto.
17 - On request, the European Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body.
18 - The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate.
19 - The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the market surveillance authorities for 10 years after the apparatus has been placed on the market.
20 - The manufacturer’s authorised representative may lodge the application referred to in paragraph 3 and fulfil all obligations set out in paragraphs 11 to 13 and 19, provided that they are specified in the mandate.
PART B
Module C: conformity to type based on internal production control
1 - Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 3, and ensures and declares that the apparatus concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Decree-Law that apply to them.
2. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured apparatus with the approved type described in the EU-type examination certificate and with the requirements of this Decree-Law that apply to them.
3 - CE marking and EU declaration of conformity
a) The manufacturer shall affix the CE marking to each individual apparatus that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Decree-Law;
b) The manufacturer shall draw up a written EU declaration of conformity for each apparatus model and keep it at the disposal of the national authorities for 10 years after the apparatus has been placed on the market, the identification of the apparatus model for which the EU declaration of conformity has been drawn up being specified therein;
c) A copy of the EU declaration of conformity shall be made available to the market surveillance authority upon request.
4 - Authorised representative
The manufacturer’s obligations, set out in the preceding paragraph, may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
ANNEX IV
[referred to in point a) of paragraph 2 of article 15]
EU declaration of conformity (No. XXXX) (1)
1 - Apparatus model/product (product, type, batch or serial number).
2 - Name and address of the manufacturer or his authorised representative.
3 - This declaration of conformity is issued under the sole responsibility of the manufacturer.
4 - Object of the declaration (identification of apparatus allowing traceability, which may include a colour image of sufficient clarity where necessary for the identification of the apparatus).
5 - The object of the declaration described above is in conformity with the relevant EU harmonisation legislation.
6 - References to the relevant harmonised standards used, including the date of the standard, or references to the other technical specifications, including the date of the specification, in relation to which conformity is declared.
7 - Where applicable, the notified body: … (name, number) performed … (description of intervention) and issued the certificate.
8 - Additional information:
Signed for and on behalf of:
(place and date of issue):
(name, function) (signature):
(1) It is optional for the manufacturer to assign a number to the declaration of conformity.
