Decree-Law No. 57/2017, of 9 June



Planeamento e das Infraestruturas (Planning and Infrastructures)

Decree-Law


(This is not an official translation of the law)

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, transposed 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, on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity.

Directive 2014/53/EU http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.153.01.0062.01.ENG, of the European Parliament and of the Council of 16 April 2014, on the harmonisation of the laws of Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31999L0005, introduces significant amendments as regards obligations on economic operators that are involved in the radio equipment supply chain, required by the new European legal framework established by Regulation (EC) 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 by Decision 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.

As such, the new regulatory framework provides for the accountability of all economic operators that market radio equipment, in the different categories of manufacturer, authorised representative, importer and distributor, regardless of their place throughout the supply chain.

The penalty regime set out herein must also be highlighted, which this time was cast in general in the mould of the framework scheme of breaches within the communications sector, approved by Law No. 99/2009, of 4 September, as amended by Law No. 46/2011, of 24 June.

The self-government bodies of the Autonomous Regions were heard.

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 establishes a framework for the making available on the market, putting into service and use of radio equipment, transposing into the national legal order Directive 2014/53/EU http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.153.01.0062.01.ENG of the European Parliament and of the Council, of 16 April 2014, on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment.

Article 2
Scope of application

1 - This Decree-Law shall apply to radio equipment, except for:

a)  Equipment identified in annex I to this Decree-Law, deemed to be an integral part hereof;

b)  Equipment exclusively used for activities concerning public security, defence, State security, and the activities of the State in the area of criminal law.

2 - Radio equipment falling within the scope of this Decree-Law shall not be subject to Decree-Law No. 31/2017, of 22 March, except as set out in paragraph 1 a) of article 4 hereof.

Article 3
Definitions

For the purposes of this Decree-Law, the following definitions shall apply:

a) «Accreditation» means accreditation as defined in paragraph 10 of article 2 of Regulation (EC) 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;

b) «Conformity assessment» means the process demonstrating whether the essential requirements provided for in this Decree-Law relating to radio equipment have been fulfilled;

c) «Radio equipment class» means a class identifying particular categories of radio equipment which are considered similar, under this Decree-Law, and those radio interfaces for which the radio equipment is designed;

d) «Putting into service» means the first use of radio equipment in the European Union (EU) by its end-user;

e) «Placing on the market» means the first making available of radio equipment on the EU market;

f) «Making available on the market» means any supply of radio equipment 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;

g) «Distributor» means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes radio equipment available on the market;

h) «Radio equipment» means an electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radiodetermination, or an electrical or electronic product which must be completed with an accessory, such as antenna, so as to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radiodetermination;

i) «Technical specification» means a document that prescribes technical requirements to be fulfilled by radio equipment;

j) «Manufacturer» means any natural or legal person who manufactures radio equipment or has radio equipment designed or manufactured, and markets that equipment under his name or trade mark;

k) «Importer» means any natural or legal person established within the EU who places radio equipment from a third country on the EU market;

l) «Radio interface» means the technical specification of the use of radio spectrum;

m) «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 international and Community standards, as well as with Law No. 5/2004, of 10 February, as amended by Decree-Law No. 176/2007, of 8 May, by Law No. 35/2008, of 28 July, by Decree-Laws No. 123/2009, of 21 May, and 258/2009, of 25 September, by Laws No. 46/2011, of 24 June, and 15/2016, of 17 June;

n) «Union harmonisation legislation» means any EU legislation harmonising the conditions for the marketing of products;

o) «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;

p) «CE marking» means a marking by which the manufacturer indicates that the radio equipment is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;

q) «Harmonised standard» means harmonised standard as defined in paragraph 1 c) of article 2 of Regulation (EU) 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;

r) «Radio waves» means electromagnetic waves of frequencies lower than 3000 GHz, propagated in space without artificial guide;

s) «Economic operators» means the manufacturer, the authorised representative, the importer and the distributor;

t) «Conformity assessment body» means the body that performs conformity assessment activities;

u) «National accreditation body» means a national accreditation body as defined in paragraph 11 of article 2 of Regulation (EC) 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;

v) «Electromagnetic disturbance» means an electromagnetic phenomenon within the meaning of point v) of article 3 of Decree-Law No. 31/2017, of 22 March;

w) «Radio communication» means communication by means of radio waves;

x) «Radiodetermination» means the determination of the position, velocity and/or other characteristics of an object, or the obtaining of information relating to those parameters, by means of the propagation properties of radio waves;

y) «Recall» means any measure aimed at achieving the return of radio equipment that has already been made available to the end-user;

z) «Withdrawal» means any measure aimed at preventing radio equipment in the supply chain from being made available on the market.

Article 4
Essential requirements

1 - Radio equipment shall be constructed so as to ensure:

a)  The protection of health and safety of persons and of domestic animals and the protection of property, including the objectives with respect to safety requirements set out in Decree-Law No. 31/2017, of 22 March, except for provisions on the application of voltage limits;

b) An adequate level of electromagnetic compatibility as set out in Decree-Law No. 31/2017, of 22 March.

2 - Radio equipment shall be so constructed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference.

3 -  Radio equipment within certain categories or classes specified further to delegated acts of the European Commission shall be so constructed that it complies with the following essential requirements:

a) To interwork with accessories, in particular with common chargers;

b) To interwork via networks with other radio equipment;

c) To be able to be connected to interfaces of the appropriate type throughout the EU;

d) Not to harm the network or its functioning nor misuse network resources, thereby causing an unacceptable degradation of service;

e) To incorporate safeguards to ensure that the personal data and privacy of the user and of the subscriber are protected;

f)  To support certain features ensuring protection from fraud;

g) To support certain features ensuring access to emergency services;

h) To support certain features in order to facilitate its use by users with a disability;

i) To support certain features in order to ensure that software can only be loaded into the radio equipment where the compliance of the combination of the radio equipment and software has been demonstrated.

Article 5
Provision of information on the compliance of combinations of radio equipment and software

1 - The manufacturer of radio equipment and of software allowing radio equipment to be used as intended shall provide Autoridade Nacional de Comunicações (ANACOM) and the European Commission with information on the compliance of combinations of radio equipment, categories or classes specified further to a delegated act of the European Commission, and software with the essential requirements set out in the preceding article.

2 - Further to the adoption by the European Commission of implementing acts, operational rules shall be laid down for making the information on compliance available for the categories and classes specified by the delegated acts referred to in the preceding paragraph.

3 - Information referred to in the preceding paragraph shall result from a conformity assessment carried out in accordance with article 17, and shall be given in the form of an EU statement of compliance which includes the elements set out in annex VI to this Decree-Law, deemed to be an integral part hereof.

4 - Depending on the specific combinations of radio equipment and software, the information referred to in the preceding paragraph shall precisely identify the radio equipment and the software which have been assessed, and it shall be continuously updated.

Article 6
Registration of radio equipment types within some categories

1 - Prior to radio equipment being placed on the market, the manufacturer shall register, within a central system made available for the purpose by the European Commission, the radio equipment types within categories specified further to a delegated act of the European Commission that are affected by a low level of compliance with the essential requirements set out in article 4.

2 -  In the scope of the registration procedure, the manufacturer shall provide some, or where justified all, elements of the technical documentation listed in points a), d), e), f), g), h) and i) of annex V to this Decree-Law, deemed to be an integral part hereof, which shall include the elements specified further to a delegated act of the European Commission.

3 - The European Commission shall allocate to each registered radio equipment type a registration number, which the manufacturer shall affix on radio equipment placed on the market.

4 - Rules governing the registration and the affixing of the registration number on radio equipment, for the categories specified by the delegated acts provided for in paragraph 1, shall be set out by implementing acts of the European Commission.

Article 7
Making available on the market

Radio equipment shall be made available on the market only where it complies with this Decree-Law.

Article 8
Putting into service and use

1 - Radio equipment shall be put into service and used only where it complies with this Decree-Law when it is properly installed, maintained and used for its intended purpose.

2 - ANACOM shall be entitled to introduce additional requirements for the putting into service and/or use of radio equipment where the Authority intends:

a) To guarantee the effective and efficient use of the radio spectrum;

b) To avoid harmful interference and electromagnetic disturbances;

c) To safeguard public health.

Article 9
Notification of radio interface specifications and assignment of radio equipment classes

1 - ANACOM shall notify the radio interfaces which the Authority intends to regulate, except:

a) The radio interfaces which fully and without any deviation comply with the European Commission Decisions on the harmonised use of radio spectrum adopted pursuant to Decision 676/2002/EC http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2002:108:0001:0006:en:PDF of the European Parliament and of the Council, of 7 March 2002;

b)  The radio interfaces which, in accordance with implementing acts adopted by the European Commission on the equivalence of regulated radio interfaces, correspond to radio equipment which can be put into service and used without restrictions within the EU.

2 - For the purpose of the assessment of the putting into service of radio equipment, economic operators shall consult the Frequency Information System (EFIS) set up by the European Radiocommunications Office, which specifies radio interfaces of the various Member States.

Article 10
Free movement of radio equipment

1 - The making available on the market in the national territory of radio equipment which complies with this Decree-Law shall not be impeded.

2 - The display at trade fairs, exhibitions, demonstrations or similar events of radio equipment not in conformity with this Decree-Law shall be permitted, provided that a visible sign clearly indicates that such equipment may not be made available on the market and/or put into service until it has been brought into conformity herewith.

3 - Without prejudice to the preceding paragraph, demonstrations shall only take place provided that adequate measures, defined by ANACOM, have been taken to avoid harmful interference, electromagnetic disturbances and risk to the health or safety of persons or of domestic animals or to property.

CHAPTER II
Obligations of economic operators

Article 11
Obligations of the manufacturer

1 - The manufacturer shall be required:

a) To ensure that radio equipment which he has placed on the market has been designed and manufactured in accordance with the essential requirements set out in article 4;

b) To ensure that radio equipment is so constructed that it can be operated in at least one Member State without infringing applicable requirements on the use of radio spectrum;

c) To draw up the technical documentation referred to in article 21;

d) To carry out the relevant conformity assessment procedure referred to in article 17 or to have it carried out;

e) To draw up an EU declaration of conformity and to affix the CE marking, in accordance with article 19 and paragraph 1 of article 20, where compliance of radio equipment has been demonstrated by the procedure referred to in the preceding point;

f) To keep the technical documentation and the EU declaration of conformity for 10 years after the radio equipment has been placed on the market;

g) To ensure that procedures are in place for series production of radio equipment to remain in conformity with essential requirements laid down in article 4;

h) To ensure that changes in the radio equipment design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which conformity of apparatus is declared are duly taken into account;

i) To carry out sample testing of radio equipment made available on the market, to investigate, and, if necessary, to keep a register of complaints, of non-conforming radio equipment and radio equipment recalls, keeping distributors informed of any such monitoring, when deemed appropriate with regard to the risks presented by radio equipment, and in order to protect the health and safety of end-users;

j) To ensure that radio equipment which he has placed on the market bears a type, batch or serial number or other element allowing its identification, or, where the size or nature of the radio equipment does not allow it, that the required information is provided on the packaging, or in a document accompanying the radio equipment;

k) To indicate on the radio equipment his name, registered trade name or registered trade mark and a postal address at which he can be contacted, indicating a single contact point, or, where the size or nature of radio equipment does not allow it, on its packaging or in a document accompanying the radio equipment, in a language easily understood by end-users and by the market surveillance authority;

l) To ensure that the radio equipment is accompanied by instructions and safety information, and written in Portuguese, in a clear, understandable and intelligible way;

m) To ensure that instructions include information required to use radio equipment in accordance with its intended use and, where applicable, a description of accessories and components, including software, which allow the radio equipment to operate as intended;

n) To ensure that radio equipment intentionally emitting radio waves includes information on the frequency bands and maximum radio-frequency power transmitted in the frequency band(s) in which the radio equipment operates;

o) To ensure that all items of radio equipment are accompanied by a copy of the EU declaration of conformity or by a simplified EU declaration of conformity, according to requirements provided for in paragraphs 3 and 4 of article 18;

p) To ensure that, in cases of restrictions on putting into service or of requirements for authorisation of use, instructions that accompany the radio equipment and the respective packaging provide information that allow the identification of the Member States or the geographical area within a Member State where such restrictions exist;

q) To immediately take the corrective measures necessary to bring the radio equipment into conformity, to withdraw it or recall it, if appropriate, where he considers or has reason to believe that the radio equipment is not in conformity with this Decree-Law;

r) To immediately inform the market surveillance authorities of the Member State in which he made the radio equipment available on the market where such radio equipment presents a risk, giving relevant information, in particular, of the non-compliance and of any corrective measures taken;

s) To provide market surveillance authorities, further to a reasoned request therefrom, with all the information and documentation in paper or, preferably, electronic form, necessary to demonstrate the conformity of the radio equipment with this Decree-Law, in a language which can be easily understood;

t) To cooperate with market surveillance authorities, upon request, on any action taken to eliminate the risks posed by radio equipment which he has placed on the market.

2 - For the purpose of this Decree-Law, importers or distributors shall be considered to be manufacturers, and shall be subject to the same duties, where they:

a) Place radio equipment on the market under their name or trade mark; or

b) Modify radio equipment already placed on the market in breach of the current legislation.

Article 12
Authorised representative

1 - The manufacturer 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) to e) 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 market surveillance authorities for 10 years after the radio equipment has been placed on the market;

b) Provide market surveillance authorities with all the information and documentation necessary to demonstrate the conformity of radio equipment, further to a reasoned request therefrom;

c) Cooperate with market surveillance authorities, at their request, on any action taken to eliminate the risks posed by radio equipment covered by the authorised representative’s mandate.

Article 13
Obligations of the importer

1 - The importer shall only place on the market radio equipment that is compliant with the essential requirements provided for in this Decree-Law.

2 - When placing radio equipment on the market, the importer shall:

a) Ensure that the appropriate conformity assessment procedure referred to in article 17 has been carried out by the manufacturer and that the radio equipment is so constructed that it can be operated in at least one Member State without infringing applicable requirements on the use of radio spectrum;

b) Ensure that the manufacturer has drawn up the technical documentation, that the radio equipment bears the CE marking and is accompanied by the information and documents referred to in article 11;

c) Ensure that the manufacturer has complied with the requirements set out in points j), k) and l) of paragraph 1 of article 11;

d) Refrain from placing the radio equipment on the market until it has been brought into conformity, where he considers or has reason to believe that the radio equipment is not in conformity with the essential requirements set out in article 4;

e) Inform the manufacturer and the market surveillance authorities where the radio equipment presents a risk;

f)  Indicate on the radio equipment his name, registered trade name or registered trade mark and the postal address at which he can be contacted or, where that is not possible, namely where the size of radio equipment does not allow it, or where the packaging must be opened for that purpose, in a document accompanying the radio equipment or on the packaging itself;

g) Ensure that contact details referred to in the preceding point are in a language easily understood by end-users and market surveillance authorities;

h) Ensure that the radio equipment is accompanied by instructions and safety information written in Portuguese and in clear language;

i)  Ensure that, while radio equipment is under his responsibility, its storage or transport conditions do not jeopardise its compliance with the essential requirements set out in article 4;

j) Carry out sample testing of radio equipment made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming radio equipment and radio equipment recalls, keeping distributors informed of any such monitoring, when deemed appropriate with regard to the risks presented by radio equipment, to protect the health and safety of end-users;

k) Immediately take the corrective measures necessary to bring radio equipment into conformity, to withdraw it or recall it, if appropriate, where he considers or has reason to believe that radio equipment which he has placed on the market is not in conformity with this Decree-Law;

l) Immediately inform the market surveillance authorities where radio equipment presents a risk, giving relevant information, in particular, of the non-compliance and of any corrective measures taken;

m) Keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities for 10 years after the radio equipment has been placed on the market and ensure that the technical documentation can be made available to those authorities, upon request;

n) Provide market surveillance authorities with all the information and documentation, in paper or preferably electronic form, necessary to demonstrate the conformity of the radio equipment, in a language which can be easily understood by those authorities, and further to a reasoned request therefrom;

o) Cooperate with market surveillance authorities, upon request, on any action taken to eliminate the risks posed by radio equipment which he has placed on the market.

3 - An importer shall be considered a manufacturer for the purposes of this Decree-Law and he shall be subject to obligations provided for in article 11, where:

a) He places radio equipment on the market under his name or trade mark; or

b) Modifies radio equipment already placed on the market in such a way that compliance with this Directive may be affected.

Article 14
Obligations of the distributor

1 - When making radio equipment available on the market, the distributor shall act with due care in relation to the requirements of this Decree-Law.

2 - When placing radio equipment on the market, the distributor shall:

a) Verify that the radio equipment bears the CE marking, according to requirements established in article 19 and paragraph 1 of article 20;

b) Verify that it is accompanied by the documents required by this Decree-Law and by the instructions and safety information, written in Portuguese and in clear language;

c) Verify that the manufacturer and the importer have complied with the requirements set out, respectively, in paragraph 1 b), j) and p) of article 11 and in paragraph 2 f) and g) of the preceding article;

d) Refrain from making radio equipment available until it has been brought into conformity, where he considers or has reason to believe that the radio equipment is not in conformity with the essential requirements set out in article 4;

e) Inform the manufacturer or the importer and the market surveillance authorities where radio equipment presents a risk;

f) Ensure that, while radio equipment is under his responsibility, its storage or transport conditions do not jeopardise its compliance with the essential requirements set out in article 4;

g) Take the corrective measures necessary to bring radio equipment into conformity, to withdraw it or recall it, if appropriate, where he considers or has reason to believe that radio equipment which he has made available on the market is not in conformity with this Decree-Law;

h) Inform the market surveillance authorities where radio equipment presents a risk, giving relevant information, in particular, of the non-compliance and of any corrective measures taken;

i) Provide market surveillance authorities with all the information and documentation, in paper or preferably electronic form, necessary to demonstrate the conformity of radio equipment, in a language which can be easily understood, and further to a reasoned request therefrom;

j) Cooperate with market surveillance authorities, upon request, on any action taken to eliminate the risks posed by radio equipment which he has placed on the market.

3 - The distributor shall be considered a manufacturer for the purposes of this Decree-Law and he shall be subject to obligations provided for in article 11, where he places radio equipment on the market under his name or trade mark or modifies radio equipment already placed on the market in such a way that compliance with this Decree-Law may be affected.

Article 15
Identification of economic operators

1 - Upon request from the market surveillance authorities, economic operators shall identify:

a) The economic operator who has supplied them with radio equipment;

b) The economic operator to whom they have supplied radio equipment.

2 - Economic operators shall be able to present the information referred to in the preceding paragraph for 10 years after they have been supplied with the radio equipment and for 10 years after they have supplied the radio equipment.

CHAPTER III
Conformity of radio equipment

Article 16
Presumption of conformity of radio equipment

Radio 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 article 4.

Article 17
Conformity assessment procedures

1 - It shall be incumbent on the manufacturer to perform a conformity assessment of the radio equipment with a view to meeting the essential requirements set out in article 4.

2 - The conformity assessment shall take into account all intended operating conditions and, for the essential requirement set out in paragraph 1 a) of article 4, the assessment shall also take into account the reasonably foreseeable conditions.

3 -  Where the radio equipment is capable of taking different configurations, the conformity assessment shall confirm whether the radio equipment meets the essential requirements set out in article 4 in all possible configurations.

4 - Compliance of radio equipment with the essential requirements set out in paragraph 1 of article 4 shall be demonstrated via any of the following conformity assessment procedures:

a) Internal production control, set out in annex II to this Decree-Law, deemed to be an integral part hereof;

b) EU-type examination that is followed by the conformity to type based on internal production control, set out in annex III to this Decree-Law, deemed to be an integral part hereof;

c) Conformity based on full quality assurance, set out in annex IV to this Decree-Law, deemed to be an integral part hereof.

5 - Where, in assessing the compliance of radio equipment with the essential requirements set out in paragraphs 2 and 3 of article 4, the manufacturer has applied harmonised standards the references of which have been published in the Official Journal of the EU, he shall use any of the following procedures:

a) Internal production control, set out in annex II to this Decree-Law;

b) EU-type examination that is followed by the conformity to type based on internal production control, set out in annex III to this Decree-Law;

c) Conformity based on full quality assurance, set out in annex IV to this Decree-Law.

6 - Where, in assessing the compliance of radio equipment with the essential requirements set out in paragraphs 2 and 3 of article 4, the manufacturer has not applied or has applied only in part harmonised standards the references of which have been published in the Official Journal of the EU, or where such harmonised standards do not exist, radio equipment shall be submitted with regard to those essential requirements to either of the following procedures:

a) EU-type examination that is followed by the conformity to type based on internal production control, set out in annex III to this Decree-Law;

b) Conformity based on full quality assurance, set out in annex IV to this Decree-Law.

Article 18
EU declaration of conformity

1 - The EU declaration of conformity shall be prepared by the manufacturer, who shall assume responsibility for the compliance of radio equipment with the essential requirements set out in article 4.

2 - The EU declaration of conformity shall:

a) Follow the model structure and elements set out in annex IV to this Decree-Law;

b) Be written in Portuguese and be continuously updated.

3 - Equipment may be accompanied by a simplified EU declaration of conformity, provided for in paragraph 1 o) of article 11, to replace the declaration of conformity referred to in the preceding paragraph.

4 - The simplified EU declaration of conformity referred to in the preceding paragraph shall be written in Portuguese, shall be continuously updated, and shall include:

a) The elements set out in annex VII to this Decree-Law, deemed to be an integral part hereof;

b) The internet address at which the full text of the EU declaration of conformity is available.

5 - Without prejudice to the preceding paragraph, the full text of the EU declaration of conformity to which the internet address referred therein refers shall be made available in a language easily understood by market surveillance authorities, the requirement for a Portuguese version of the text not being necessary.

6 - Where radio equipment is subject to more than one EU act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up, which shall contain the identification of the EU acts concerned and include their publication references.

Article 19
General principles of the CE marking

The CE marking shall be subject to the general principles set out in article 30 of Regulation (EC) 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, and shall meet requirements laid down in annex III to this Decree-Law.

Article 20
Rules and conditions for affixing the CE marking and the identification number of the notified body

1 -  The CE marking shall be affixed visibly, legibly and indelibly to the radio equipment or to its data plate, or, where that is not possible or not warranted on account of the nature of radio equipment, to the packaging and accompanying documents.

2 - The CE marking shall be affixed before the radio equipment is placed on the market.

3 - Where the conformity assessment procedure set out in annex IV to this Decree-Law is applied, the CE marking shall be followed by the identification number of the notified body.

4 - The identification number of the notified body referred to in the preceding paragraph shall be affixed by the notified body itself or, under its instructions, by the manufacturer or his authorised representative.

Article 21
Technical documentation

1 - The technical documentation shall contain all relevant data or details of the means used by the manufacturer to ensure that radio equipment complies with the essential requirements set out in article 4, including the elements set out in annex V to this Decree-Law.

2 - The technical documentation shall be drawn up before radio equipment is placed on the market and shall be continuously updated.

3 -  The technical documentation and correspondence relating to any EU-type examination procedure shall be drawn up in the official language of the Member State in which the notified body is established or in a language acceptable to that body.

4 - Where the technical documentation fails to comply with the preceding paragraphs, and to present relevant data or means used to ensure compliance of radio equipment with the essential requirements set out in article 4, the market surveillance authority may ask the manufacturer or the importer to have a test performed by a body acceptable to the market surveillance authority at the expense of the manufacturer or the importer within a specified period, in order to verify compliance.

CHAPTER IV
Notification of conformity assessment bodies

Article 22
Notifying authority 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 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 where no objections are raised by the Commission or the other Member States within two weeks of a notification.

Article 23
Accreditation of conformity assessment bodies

1 - The assessment and control of conformity assessment bodies shall be incumbent on Instituto Português de Acreditação, I. P. (IPAC, I. P. - the Portuguese Accreditation Institute), 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, conformity assessment bodies 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, accredited conformity assessment bodies shall meet the requirements laid down in the following article.

Article 24
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 planning and infrastructure and of finance fields.

3 - Conformity assessment bodies shall be third-party bodies independent of the organisation or the radio equipment 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 radio equipment 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, in particular of a financial nature, 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 in this Decree-Law, 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 radio equipment 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 conformity assessment procedures, ensuring the transparency and the ability of reproduction of those procedures, and appropriate policies and procedures to distinguish between tasks carried 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 undertakings, 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 article 4, 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 this Decree-Law 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 radio equipment which they assess, nor the representative of any of those parties; this shall not preclude the use of assessed equipment 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 that radio equipment, 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 25
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 reference numbers 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 26
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 24 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 annexes III and IV to this Decree-Law.

Article 27
Application for notification

1 - In order to carry out their 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 24;

b) The competence of the interested party for the performance of conformity assessment activities, of the conformity assessment module or modules and of the equipment or type(s) of equipment concerned.

Article 28
Operational obligations of notified bodies

Notified bodies shall:

a) Carry out conformity assessments in a proportionate manner, avoiding unnecessary burdens for economic operators, and according to conformity assessment procedures provided for in annexes III and IV to this Decree-Law;

b) Perform their activities taking due account of the size of undertakings, the sector in which they operate, their structure, the degree of complexity of the equipment technology in question and the mass or serial nature of the production process;

c) In the exercise of their functions, respect the degree of rigour and the level of protection required for the compliance of equipment with this Decree-Law;

d) Refrain from issuing the conformity assessment and require the manufacturer to take appropriate corrective measures, where they find that the essential requirements set out in article 4, the corresponding harmonised standards or other technical specifications have not been met;

e) Restrict, suspend or withdraw the certificate, where, in the course of the monitoring of conformity following the issue of a certificate, they find that equipment is no longer compliant and that the manufacturer has failed to take appropriate corrective measures.

Article 29
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 Administrative Courts Proceedings Code, for decisions issued by private bodies acting under rules of administrative law.

Article 30
Notification procedure

1 - IPQ, I. P., shall notify only conformity assessment bodies which have satisfied the requirements laid down in article 24.

2 - IPQ, I. P., shall notify the European Commission and the other Member States using the electronic notification tool developed and managed by the European Commission.

3 - The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and the radio equipment concerned and the relevant attestation of competence.

4 - Conformity assessment bodies shall only perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification.

5 - IPQ, I. P., shall notify the Commission and the other Member States of any subsequent relevant changes to the notification.

Article 31
Changes to notifications

1 - Where IPQ, I. P. finds or is informed that a notified body no longer meets the requirements laid down in article 24, or that it fails to fulfil its obligations, it shall restrict, suspend or withdraw notification as appropriate, depending on the seriousness of the breach, and immediately inform the European Commission and the other Member States accordingly.

2 -  In the event of restriction, suspension or withdrawal of notification, or where the notified body, or recognized third 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.

Article 32
Information obligation on notified bodies

1 - Notified bodies shall inform IPQ, I. P. of the following:

a) Any refusal, restriction, suspension or withdrawal of an EU-type examination certificate or a quality system approval;

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) On request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.

2 -  Notified bodies shall provide the other notified bodies carrying out similar conformity assessment activities covering the same categories of radio equipment with relevant information on issues relating to negative and, on request, positive conformity assessment results.

3 -  Notified bodies shall fulfil information obligations under annexes III and IV to this Decree-Law.

Article 33
Coordination of notified bodies

IPQ, I. P., shall ensure the participation of bodies it notified, 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 radio equipment entering the market and European Union safeguard procedure

Article 34
European Union market surveillance and control of radio equipment entering the European Union market

Paragraph 3 of article 15 and articles 16 to 29 of Regulation (EC) 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, shall apply.

Article 35
Procedure for dealing with radio equipment presenting a risk at national level

1 - Where the market surveillance authorities believe that radio equipment presents a risk to the health or safety of persons or to other aspects of public interest protection covered by this Decree-Law, they shall carry out an evaluation in relation to the radio equipment concerned covering all relevant requirements laid down in this Decree-Law.

2 - The relevant economic operators shall cooperate as necessary with the market surveillance authorities.

3 - Where, in the course of the conformity evaluation referred to in paragraph 1, the market surveillance authorities find that the radio equipment does not comply with the requirements laid down in this Decree-Law, they shall without delay require the relevant economic operator to take all appropriate corrective actions to bring the radio equipment into compliance with those requirements, to withdraw the radio equipment from the market, or to recall it within a reasonable period, 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 the preceding paragraph, article 21 of Regulation (EC) 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, shall apply.

6 - Where market surveillance authorities consider that non-compliance is not restricted to the national territory, they shall inform the European Commission and the other Member States of the results of the evaluation, and of the actions the economic operator was required to take.

7 - The economic operator shall ensure that all appropriate corrective action is taken in respect of radio equipment concerned that it has made available in the market.

8 - Market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the radio equipment’s being made available on the market, to withdraw radio equipment 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 - Market surveillance authorities shall inform the European 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, in particular:

a) The data necessary for the identification of the non-compliant radio equipment and its origin;

b) The nature of the alleged non-compliance and the risk involved;

c) The nature and duration of national measures taken;

d) The arguments put forward by the relevant economic operator.

11 - Market surveillance authorities shall also indicate whether the non-compliance is due to:

a) Failure of the radio equipment to meet the relevant essential requirements set out in article 4, or

b) Shortcomings in the harmonised standards referred to in article 16 conferring a presumption of conformity.

12 - Market surveillance authorities other than those initiating the procedure under this article, shall without delay inform the European Commission and the other Member States:

a) Of any measures adopted;

b) Of any additional information at their disposal relating to the non-compliance of the radio equipment concerned; and

c) Of their objections, in the event of disagreement with the adopted national measure.

13 - Where, within three months of receipt of the information referred to in paragraph 7, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.

14 - Market surveillance authorities shall ensure that appropriate restrictive measures are taken in respect of radio equipment concerned without delay, including its withdrawal from the market.

Article 36
European Union safeguard procedure

1 - Where, on completion of the procedure set out in paragraphs 6 to 8 of the preceding article, objections are raised against a measure that is taken, or where the European Commission considers it 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, ANACOM shall take the necessary measures to ensure that the non-compliant radio equipment is withdrawn or recalled from the 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 37
Compliant radio equipment which presents a risk

1 - Where, having carried out an evaluation under paragraph 1 of article 40, market surveillance authorities find that, although radio equipment is in compliance with this Decree-Law, it presents a risk to the health or safety of persons, it shall require the relevant economic operator to take all appropriate corrective measures to ensure that the radio equipment concerned, when placed on the market, no longer presents that risk, to withdraw the radio equipment from the market or to recall it within a reasonable period, commensurate with the nature of the risk.

2 - The economic operator shall ensure that corrective action is taken in respect of all the radio equipment concerned that he has made available on the EU market.

3 - The market surveillance authority shall immediately inform the European Commission and the other Member States of measures taken under the preceding paragraph, including all available details, in particular:

a) The data necessary for the identification of the radio equipment concerned;

b) The origin and the supply chain of radio equipment;

c) The nature of the risk involved;

d) The nature and duration of the national measures taken.

Article 38
Formal non-compliance

1 - Without prejudice to article 35, market surveillance authorities shall require the economic operator to put an end to the non-compliance where they make one of the following findings:

a)  The CE marking has been affixed in violation of Article 30 of  Regulation (EC) 765/2008  , of the European Parliament and of the Council, of 9 July 2008, or of article 20;

b) The CE marking has not been affixed;

c) The identification number of the notified body has not been affixed or has not been duly affixed, where the conformity assessment procedure set out in annex IV to this Decree-Law is applied;

d) The EU declaration of conformity has not been drawn up;

e) The EU declaration of conformity has not been drawn up correctly;

f) Technical documentation is either not available or not complete;

g) The information referred to in paragraph 1 j) to l) of article 11 or in paragraph 2 f) to g) of article 13 is absent, false or incomplete;

h) The information on the intended use of radio equipment, the EU declaration of conformity or usage restrictions as set out in paragraph 1 l) to p) of article 11 do not accompany the radio equipment;

i) Requirements on identification of economic operators set out in article 15 are not fulfilled;

j) The registration obligation provided for in article 6 is not complied with.

2 - Where the non-compliance referred to in the preceding paragraph persists, market surveillance authorities shall take all appropriate measures to restrict or prohibit radio equipment being made available on the market or ensure that it is withdrawn or recalled from the market.

CHAPTER VI
Breach regime

Article 39
Market surveillance authorities

Without prejudice to powers conferred by law to other bodies, compliance with this Decree-Law shall be surveyed by ANACOM and by the Autoridade de Segurança Alimentar e Económica (ASAE – the Economic and Food Safety Authority).

Article 40
Surveillance by Autoridade Nacional de Comunicações

1 - For the purpose of the preceding article, ANACOM shall be assisted by police authorities, and shall be entitled also to request the collaboration of Autoridade Tributária e Aduaneira (AT - the Tax and Customs Authority) in the scope of surveillance activities.

2 - In order to verify compliance with the regime established this Decree-Law, ANACOM shall be entitled to carry out, at random intervals, appropriate tests to check compliance of radio equipment with the respective declaration of conformity and with essential requirements established in article 4.

3 - Where, as a result of tests referred to in the preceding paragraph, it is found that radio equipment is not in compliance with the respective declaration of conformity or with essential requirements provided for in this Decree-Law, charges incurred in carrying out such activities shall be borne by manufacturers, their representatives or importers.

4 - Charges referred to in the preceding paragraph shall be set in annex VIII to this Decree-Law, deemed to be an integral part hereof, on the basis of costs of tests incurred by ANACOM’s laboratories, and shall be settled by this Authority, in compliance with provisions of General Tax Law and the Code of Tax Procedure and Proceedings.

5 - Manufacturers, their representatives or importers shall also be liable for the reimbursement of charges that are indispensable to the referred tests and that are borne by ANACOM, namely charges with the transport and corresponding insurance of radio equipment.

6 - Economic operators shall provide all collaboration requested by ANACOM for the proper implementation of its surveillance functions, carried out under surveillance procedures provided for in articles 12 and 44 of ANACOM’s Statutes, approved by Law No. 39/2015, of 16 March, and shall:

a) Provide ANACOM’s officials or bodies mandated for this purpose with the necessary samples to verify compliance of radio equipment with essential requirements provided for in this Decree-Law and with the respective declarations of conformity;

b) Supply the necessary information to the monitoring and surveillance of obligations arising from this Decree-Law, allowing the access to the respective premises and documentation.

Article 41
External border control

It shall be incumbent on AT, under article 5 of Decree-Law No. 23/2011, of 11 February, to undertake the external border control of radio equipment from third countries covered by this Decree-Law.

Article 42
Examining breach proceedings

1 - Breach proceedings shall be examined by the body that carried out the surveillance activity, and shall be ensured by the respective services.

2 - For the purpose of the preceding paragraph, and according to the body that examined the file, it shall be incumbent on ANACOM’s Management Board and on ASAE’s General Inspector to determine the examination and closure of breach proceedings and the application of the corresponding penalties.

Article 43
Distribution of proceeds from fines

Proceeds from fines applied for violation of this Decree-Law shall revert at:

a) 60 % to the State;

b) 10 % to the body that draw up the file;

c) 20 % to the body that examined the file and applied the fine;

d) 10 % to IPQ, I. P.

Article 44
Breaches committed by manufacturers or their representatives and applicable penalties

1 - The following violations shall be deemed to be minor breaches:

a) Absence of the sign that indicates that the radio equipment displayed at a demonstration may not be made available on the market or put into service, in violation of paragraph 2 of article 10;

b) The drawing up of an EU declaration of conformity that fails to identify the publication references of legal acts of the EU, in violation of paragraph 6 of article 19.

2 - The following violations shall be deemed to be serious breaches:

a) The placing on the market of radio equipment without having been affixed the registration number allocated by the European Commission, in violation of paragraph 3 of article 6;

b) The placing on the market of radio equipment to which the CE marking has not been affixed, or where the affixed marking fails to comply with paragraph 1 e) of article 11;

c) Failure to inform distributors of monitoring activities carried out, in violation of paragraph 1 i) of article 11;

d) The placing on the market of radio equipment that fails to bears the type, batch or serial number, or of any other elements allowing the respective identification, in the media provided for in paragraph 1 j) of article 11;

e) The placing on the market of radio equipment that fails to indicate, on the radio equipment itself, on its packaging or in a document accompanying the radio equipment, his name, registered trade name or registered trade mark, and his contact postal address, with the indication of a single contact point, or where such data are not easily understood by end-users and by market surveillance authorities, under paragraph 1 k) of article 11;

f) The placing on the market of radio equipment that fails to be accompanied by instructions and safety information, written in Portuguese, in a clear, understandable and intelligible way for consumers and other end-users, in violation of paragraph 1 l) of article 11;

g) The placing on the market of radio equipment the instructions of which fail to include information required to use radio equipment in accordance with its intended use and, where applicable, a description of accessories and components, including software, which allow the radio equipment to operate as intended, in violation of paragraph 1 m) of article 11;

h) The placing on the market of radio equipment that intentionally emits radio waves and that fails to include information on the frequency bands and maximum radio-frequency power transmitted in the frequency band(s) in which the radio equipment operates, in violation of paragraph 1 n) of article 11;

i) The placing on the market of radio equipment without all items being accompanied by a copy of the EU declaration of conformity or by a simplified EU declaration of conformity, which must include the internet address at which the full text of the EU declaration of conformity is available, in violation of paragraph 1 o) of article 11;

j) The placing on the market of radio equipment subject to restrictions on putting into service or of requirements for authorisation of use, without the respective accompanying instructions and packaging providing information that allow the identification of the Member States or the geographical area within a Member State where such restrictions exist, in violation of paragraph 1 p) of article 11;

k) The appointment of an authorised representative for the performance of tasks provided for in paragraph 1a), c), d) and e) of article 11, in violation of paragraph 2 of article 11;

l) The issue of a mandate that fails to provide for obligations described in paragraph 3 a), b) and c) of article 12;

m) The preparation of the EU declaration of conformity that fails to comply with any of the requirements established in paragraph 3 and in paragraphs 4 to 6 of article 18, except for the identification of publication references of legal acts of the EU, in the case of this last paragraph;

n) The affixing in the radio equipment of any markings, signs and inscriptions liable to mislead third parties as to the meaning or the form of the CE marking, in violation of paragraph 1 of article 18 and of paragraph 5 of article 30 of Regulation (EC) 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.

3 - The following violations shall be deemed to be very serious breaches:

a) Failure to comply with the information obligation provided for in paragraph 1 of article 5;

b) Failure to register the type of radio equipment of categories affected by a low level of compliance with the essential requirements, as well as to provide the technical documentation required for that registration, in violation of paragraphs 1 and 2 of article 6;

c) The performance of radio equipment demonstrations without adequate measures defined by ANACOM being ensured, in violation of paragraph 3 of article 10;

d) The placing on the market of radio equipment that fails to meet essential requirements or that ensures the efficient use of radio spectrum, so as to avoid harmful interference, in violation of paragraph 1 a) of article 11;

e) The placing on the market of radio equipment that may not be operated in at least one Member State without infringing applicable requirements on the use of radio spectrum, in violation of paragraph 1 b) of article 11;

f) Failure to keep the full technical documentation, which must precisely identify the radio equipment and the software which have been assessed, and must be continuously updated, in violation of paragraph 1 f) of article 11, of paragraph 3 of article 5 and of article 21, or failure to provide such documentation to market surveillance authorities, as well as all other information and documentation necessary to demonstrate the conformity of the radio equipment with this Decree-Law, upon request, in paper or, preferably, electronic form, and in a language which can be easily understood by authorities, or the respective translation, as provided for in paragraph 1 s) of article 11 and paragraph 3 of article 5, in paragraph 4.2 of annex II, in paragraph 20 of Module B of annex III, in paragraph 6 of annex IV and in annex V;

g) Failure to carry out one of the relevant conformity assessment procedures, or to have it carried out, in violation of paragraph 1 d) of article 11, or do so without taking into account all intended operating conditions and also, where appropriate, the reasonably foreseeable conditions, in violation of paragraph 2 of article 17;

h) Failure to draw up an EU declaration of conformity, in violation of paragraph 1 e) of article 11;

i) Failure to keep the EU declaration of conformity for 10 years after the radio equipment has been placed on the market, in violation of paragraph 1 f) of article 11, and failure to provide a copy of that declaration to market surveillance authorities, upon request, in violation of paragraph 4.4 of annex II, paragraph 20 of Module B and paragraph 3.5 of Module C of annex III, as well as paragraph 5.4 of annex IV;

j) Failure to ensure that procedures are in place for series production of radio equipment to remain in conformity with essential requirements provided for in this Decree-Law, in violation of paragraph 1 g) of article 11;

k) Failure to ensure that changes in the radio equipment design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which conformity of apparatus is declared are duly taken into account, in violation of paragraph 1 h) of article 11;

l) Failure to carry out sample testing of radio equipment made available on the market, or to keep a register of complaints of non-conforming radio equipment and radio equipment recalls, in violation of paragraph 1 i) of article 11;

m) Failure to immediately take the corrective measures necessary to bring the radio equipment into conformity with this Decree-Law, to withdraw it or recall it, in violation of paragraph 1 q) of article 11, or paragraph 7 of article 35, or paragraph 2 of article 37;

n) Failure to immediately inform the market surveillance authorities of the Member States in which the radio equipment has been made available, where such radio equipment presents a risk, or to provide them with relevant information for that purpose, in violation of paragraph 1 r) of article 11;

o) Failure to cooperate with market surveillance authorities, in particular under articles 35 and 37, on any action taken to eliminate the risks posed by radio equipment he has placed on the market, in violation of paragraph 1 t) of article 11;

p) Non-fulfilment of the obligation provided for in paragraphs 1 and 2 of article 15;

q) Preparation of an EU declaration of conformity for equipment that fails to meet essential requirements, in violation of paragraph 1 of article 18;

r) Failure to have carried out a test of radio equipment performed by a body acceptable to the market surveillance authority, within the specified period and at his own expense, to ensure compliance of such equipment with the essential requirements, after being ordered to do so by the market surveillance authority, in violation of paragraph 4 of article 21.

4 - Minor breaches shall be are punishable by the following fines:

a) If committed by a natural person, a fine between (Euro) 200 and (Euro) 2 000;

b)  If committed by a micro enterprise, a fine between (Euro) 400 and (Euro) 4 000;

c) If committed by a small enterprise, a fine between (Euro) 1 000 and (Euro) 10 000;

d) If committed by a medium-sized enterprise, a fine between (Euro) 2 000 and (Euro) 20 000;

e) If committed by a large enterprise, a fine between (Euro) 5 000 and (Euro) 50 000.

5 - Serious breaches shall be are punishable by the following fines:

a) If committed by a natural person, a fine between (Euro) 750 and (Euro) 7 500;

b)  If committed by a micro enterprise, a fine between (Euro) 1 000 and (Euro) 10 000;

c) If committed by a small enterprise, a fine between (Euro) 2 500 and (Euro) 25 000;

d) If committed by a medium-sized enterprise, a fine between (Euro) 5 000 and (Euro) 50 000;

e) If committed by a large enterprise, a fine between (Euro) 12 500 and (Euro) 125 000.

6 - Very serious breaches shall be are punishable by the following fines:

a) If committed by a natural person, a fine between (Euro) 1 500 and (Euro) 15 000;

b)  If committed by a micro enterprise, a fine between (Euro) 2 000 and (Euro) 20 000;

c) If committed by a small enterprise, a fine between (Euro) 5 000 and (Euro) 50 000;

d) If committed by a medium-sized enterprise, a fine between (Euro) 10 000 and (Euro) 100 000;

e) If committed by a large enterprise, a fine between (Euro) 25 000 and (Euro) 250 000.

7 - Where breaches provided for in paragraph 2 a), b), d), e), f), g), h), i), j), n) and o) and in paragraph 3 c), d), e), j), k), m) and o) are committed, the additional penalty of confiscation of equipment may be applied.

Article 45
Breaches committed by importers

1 - The following violations shall be deemed to be minor breaches:

a) Absence of the sign that indicates that the radio equipment displayed at a demonstration may not be made available on the market or put into service, in violation of paragraph 2 of article 10.

2 - The following violations shall be deemed to be serious breaches:

a) The violation of any of the obligations established in paragraph 2 b) of article 13, except for those referred in point c) of the following paragraph;

b) The placing on the market of radio equipment that fails to indicate, on the radio equipment itself, on its packaging or in a document accompanying the radio equipment, his name, registered trade name or registered trade mark, and his contact postal address, in violation of paragraph 2 f) of article 13;

c) The placing on the market of radio equipment where contact data indicated are not easily understood by end-users or by market surveillance authorities, in violation of paragraph 2 g) of article 13;

d) The placing on the market of radio equipment that fails to be accompanied by instructions and safety information, written in Portuguese, in a clear, understandable and intelligible way for consumers and other end-users, in violation of paragraph 2 h) of article 13.

3 - The following violations shall be deemed to be very serious breaches:

a) The performance of radio equipment demonstrations without adequate measures defined by ANACOM being ensured, in violation of paragraph 3 of article 10;

b) The placing on the market of radio equipment without any of the obligations provided for in paragraph 2 a) of article 13 being fulfilled;

c) The placing on the market of radio equipment without ensuring that the manufacturer has drawn up the technical documentation, in violation of paragraph 2 b) of article 13;

d) The placing on the market of radio equipment that is not in conformity with the essential requirements, as provided for in paragraph 2 d) of article 13;

e) Failure to inform the manufacturer and the market surveillance authorities where the radio equipment presents a risk, in violation of paragraph 2 e) of article 13;

f) Failure to meet the obligation to ensure that, while radio equipment is under his responsibility, storage or transport conditions do not jeopardise its compliance with the essential requirements, in violation of paragraph 2 i) of article 13;

g) Non-compliance with any of the obligations established in paragraph 2 j) of article 13;

h) Failure to immediately take the corrective measures necessary to bring the radio equipment into conformity with this Decree-Law, to withdraw it or recall it, in violation of paragraph 2 k) of article 13 and paragraph 7 of article 35;

i) Failure to immediately inform the market surveillance authorities where such radio equipment presents a risk, or to provide them with relevant information for that purpose, in violation of paragraph 2 l) of article 13;

j) Failure to keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities for 10 years after the radio equipment has been placed on the market and to ensure that the technical documentation can be made available to those authorities, in violation of paragraph 2 m) of article 13;

k) Failure to provide market surveillance authorities with all the information and documentation, including all elements and conditions required by article 4, necessary to demonstrate the conformity of the radio equipment with this Decree-Law, in a language which can be easily understood by those authorities, in violation of paragraph 2 n) of article 13 and paragraph 3 of article 5;

l) Failure to cooperate with market surveillance authorities, in particular under articles 35 and 37, on any action taken to eliminate the risks posed by radio equipment he has placed on the market, in violation of paragraph 2 o) of article 13;

m) Non-fulfilment of information obligations provided for in article 15;

n) Failure to have carried out a test of radio equipment performed by a body acceptable to the market surveillance authority, within the specified period and at his own expense, to ensure compliance of such equipment with the essential requirements, after being ordered to do so by the market surveillance authority, in violation of paragraph 4 of article 21.

4 - Minor breaches shall be are punishable by the following fines:

a) If committed by a natural person, a fine between (Euro) 200 and (Euro) 2 000;

b) If committed by a micro enterprise, a fine between (Euro) 400 and (Euro) 4 000;

c) If committed by a small enterprise, a fine between (Euro) 1 000 and (Euro) 10 000;

d) If committed by a medium-sized enterprise, a fine between (Euro) 2 000 and (Euro) 20 000;

e) If committed by a large enterprise, a fine between (Euro) 5 000 and (Euro) 50 000.

5 - Serious breaches shall be are punishable by the following fines:

a) If committed by a natural person, a fine between (Euro) 750 and (Euro) 7 500;

b) If committed by a micro enterprise, a fine between (Euro) 1 000 and (Euro) 10 000;

c) If committed by a small enterprise, a fine between (Euro) 2 500 and (Euro) 25 000;

d) If committed by a medium-sized enterprise, a fine between (Euro) 5 000 and (Euro) 50 000;

e) If committed by a large enterprise, a fine between (Euro) 12 500 and (Euro) 125 000.

6 - Very serious breaches shall be are punishable by the following fines:

a) If committed by a natural person, a fine between (Euro) 1 500 and (Euro) 15 000;

b)  If committed by a micro enterprise, a fine between (Euro) 2 000 and (Euro) 20 000;

c) If committed by a small enterprise, a fine between (Euro) 5 000 and (Euro) 50 000;

d) If committed by a medium-sized enterprise, a fine between (Euro) 10 000 and (Euro) 100 000;

e) If committed by a large enterprise, a fine between (Euro) 25 000 and (Euro) 250 000.

7 - Where breaches provided for in paragraph 2 a), b), c) and d) and in paragraph 3 a), b), c), d), f) and h) are committed, the additional penalty of confiscation of equipment may be applied.

Article 46
Breaches committed by distributors

1 - The following violations shall be deemed to be minor breaches:

a) Absence of the sign that indicates that the radio equipment displayed at a demonstration may not be made available on the market or put into service, in violation of paragraph 2 of article 10.

2 - The following violations shall be deemed to be serious breaches:

a) The placing of radio equipment on the market without the CE marking being affixed to the radio equipment itself, to its data plate or to the packaging, or where the CE markings are not visibly, legibly and indelibly affixed, in violation of paragraph 2 a) of article 14;

b) The placing on the market of radio equipment that fails to be accompanied by instructions and safety information, written in Portuguese, in a clear, understandable and intelligible way for consumers and other end-users, in violation of paragraph 2 b) of article 14;

c) Non-compliance with any of the obligations established in paragraph 2 c) of article 14, except for the obligation provided for in point b) of the following paragraph.

3 - The following violations shall be deemed to be very serious breaches:

a) The performance of radio equipment demonstrations without adequate measures defined by ANACOM being ensured, in violation of paragraph 3 of article 10;

b) The placing on the market of radio equipment without ensuring that it was manufactured so that it may be used in at least one of the Member States of the EU without infringing the conditions for use of radio spectrum in force, in violation of paragraph 2 c) of article 14;

c) The placing on the market of radio equipment that fails to meet essential requirements, as provided for in paragraph 2 d) of article 14;

d) Failure to inform the manufacturer, the importer or the market surveillance authorities where radio equipment presents a risk, in violation of paragraph 2 e) of article 14;

e) Failure to meet the obligation to ensure that, while radio equipment is under his responsibility, storage or transport conditions do not jeopardise its compliance with the essential requirements, in violation of paragraph 2 f) of article 14;

f) Failure to immediately take the corrective measures necessary to bring the radio equipment into conformity with this Decree-Law, to withdraw it or recall it, in violation of paragraph 2 g) of article 14 and paragraph 7 of article 35;

g) Failure to inform the market surveillance authorities where such radio equipment presents a risk, or to provide them with relevant information for that purpose, in violation of paragraph 2 h) of article 14;

h) Failure to provide market surveillance authorities with all the information and documentation necessary to demonstrate the conformity of the radio equipment with this Decree-Law, in paper or, preferably, electronic form, in a language which can be easily understood by those authorities, in violation of paragraph 2 i) of article 14;

i) Failure to cooperate with market surveillance authorities on any action taken to eliminate the risks posed by radio equipment he has placed on the market, in violation of paragraph 2 j) of article 14, paragraph 7 of article 35 and paragraph 2 of article 37.

j) Non-fulfilment of information obligations provided for in article 15.

4 - Minor breaches shall be are punishable by the following fines:

a) If committed by a natural person, a fine between (Euro) 100 and (Euro) 1 000;

b) If committed by a micro enterprise, a fine between (Euro) 200 and (Euro) 2 000;

c) If committed by a small enterprise, a fine between (Euro) 500 and (Euro) 5 000;

d) If committed by a medium-sized enterprise, a fine between (Euro) 1 000 and (Euro) 10 000;

e) If committed by a large enterprise, a fine between (Euro) 2 500 and (Euro)) 25 000.

5 - Serious breaches shall be are punishable by the following fines:

a) If committed by a natural person, a fine between (Euro) 375 and (Euro) 3 750;

b) If committed by a micro enterprise, a fine between (Euro) 500 and (Euro) 5 000;

c) If committed by a small enterprise, a fine between (Euro) 1 250 and (Euro) 12 500;

d) If committed by a medium-sized enterprise, a fine between (Euro) 2 500 and (Euro) 25 000;

e) If committed by a large enterprise, a fine between (Euro) 6 500 and (Euro) 65 000.

6 - Very serious breaches shall be are punishable by the following fines:

a) If committed by a natural person, a fine between (Euro) 750 and (Euro) 7 500;

b) If committed by a micro enterprise, a fine between (Euro)1 000 and (Euro) 10 000;

c) If committed by a small enterprise, a fine between (Euro) 2 500 and (Euro) 25 000;

d) If committed by a medium-sized enterprise, a fine between (Euro) 5 000 and (Euro) 50 000;

e) If committed by a large enterprise, a fine between (Euro) 12 500 and (Euro) 125 000.

7 - Where breaches provided for in paragraph 2 a), b) and c) and in paragraph 3 a), b), c), d), e), h) and j) are committed, the additional penalty of confiscation of equipment may be applied.

Article 47
Violation of article 20

1 - Violation of principles provided for in article 20 shall be governed by article 6 of Decree-Law No. 23/2011, of 11 February, which implements on the national legal order Regulation (EC) 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.

2 - The violation of rules and conditions for affixing the CE marking, established in article 19 of this Decree-Law, shall be deemed to be a breach, punishable by a fine between (Euro) 1 000 and (Euro) 3 740, in the case of natural persons, and between (Euro) 2 500 and (Euro) 44 890, in the case of legal persons.

Article 48
General breach provisions

1 - The application of penalties shall not exempt the offender from fulfilling the duty or the order, if still possible.

2 - Breaches provided for in this statutory instrument, committed in their attempted or negligent form, shall be punishable, under article 4 of Law No. 99/2009, of 4 September, as amended by Law No. 46/2011, of 24 June, which approves the framework scheme of breaches within the communications sector.

CHAPTER VII
Additional, transitory and final provisions

Article 49
Publication

ANACOM shall publish in its website the references of delegated acts and implementing acts adopted by the European Commission under Directive 2014/53/EU http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.153.01.0062.01.ENG, of the European Parliament and of the Council, of 16 April 2014.

Article 50
Autonomous Regions

1 - Without prejudice to powers conferred to ANACOM, actions and procedures required to implement this Decree-Law in the Autonomous Regions of the 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 51
Transitory provision

1 - Paragraph 1 of article 6 shall apply as from 12 June 2018.

2 - Radio equipment placed on the market before 13 June 2017 that are in conformity with Decree-Law No. 192/2000, of 18 August, may be made available on the market or put into service.

Article 52
Repealing provision

Decree-Law No. 192/2000, of 18 August, is hereby repealed.

Article 53
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 27 April 2017. - António Luís Santos da Costa - Augusto Ernesto Santos Silva - Mário José Gomes de Freitas Centeno - Pedro Manuel Dias de Jesus Marques - Manuel de Herédia Caldeira Cabral.

Promulgated on 8 June 2017.

Let it be published.

The President of the Republic, Marcelo Rebelo de Sousa.

Counter-signed on 8 June 2017.

The Prime Minister, António Luís Santos da Costa.


ANNEX I

[referred to in paragraph 1a) of article 2]

Equipment not covered by this Decree-Law

1 - Radio equipment used by radio amateurs within the meaning of article 1, definition 56, of the International Telecommunications Union (ITU) Radio Regulations, unless the equipment is made available on the market.

The following shall be regarded as not being made available on the market:

a) Radio kits for assembly and use by radio amateurs;

b) Radio equipment modified by and for the use of radio amateurs;

c) Equipment constructed by individual radio amateurs for experimental and scientific purposes related to amateur radio.

2 - Marine equipment falling within the scope of Decree-Law No. 167/99, of 18 May, and subsequent amendments, which lays down the rules that govern marine equipment to be manufactured or marketed on national territory or to be installed on national vessels subject to security-clearance, by virtue of applicable international conventions;

3 - Airborne products, parts and appliances falling within the scope of Article 3 of Regulation (EC) 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.

4 - Custom-built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.


ANNEX II

[referred to in paragraph 4 a) and 5 a) of article 17 and in paragraph 3 f) and i) of article 44]

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, 3 and 4 of this annex, and ensures and declares on his sole responsibility that the radio equipment concerned satisfies the essential requirements set out in article 4.

2 - Technical documentation

The manufacturer shall establish the technical documentation in accordance with article 20.

3 - Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured radio equipment with the technical documentation referred to in paragraph 2 of this annex and with the relevant essential requirements set out in article 4.

4 - CE marking and EU declaration of conformity

4.1 - The manufacturer shall affix the CE marking in accordance with articles 19 and 20 to each item of radio equipment that satisfies the applicable requirements of this Decree-Law.

4.2 - The manufacturer shall draw up a written EU declaration of conformity for each radio equipment type and keep it for 10 years after the radio equipment has been placed on the market, together with the technical documentation.

4.3 - The EU declaration of conformity shall identify the radio equipment for which it has been drawn up.

4.4 - The manufacturer shall make available a copy of the EU declaration of conformity, drawn up under annex VI to this Decree-Law, to market surveillance authorities, upon request.

5 - 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 paragraphs 4 b), 5 b) and 6 a) of article 17, article 19, paragraph 4 of article 26, point a) of article 28, paragraph 3 of article 32, and paragraph 3 f) and i) of article 44]

Modules B and C

EU-type examination and conformity to type based on internal production control

When reference is made to this annex, the conformity assessment procedure shall follow modules B (EU-type examination) and C (conformity to type based on internal production control) of this annex.

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 the radio equipment and verifies and attests that the technical design of the radio equipment meets the essential requirements set out in article 4.

2 - EU-type examination shall be carried out by assessment of the adequacy of the technical design of the radio equipment through examination of the technical documentation and supporting evidence referred to in paragraph 3 of this annex, without examination of a specimen (design type).

3 - The manufacturer shall lodge an application for EU-type examination with a single notified body.

4 - The application for EU-type examination shall include:

a) The name and address of the manufacturer and of the authorised representative, if the application is lodged by the latter;

b) A written declaration that the same application has not been lodged with any other notified body;

c) The technical documentation, which shall:

i) Make it possible to assess the radio equipment’s conformity with the applicable requirements of this Decree-Law and include an adequate analysis and assessment of the risks;

ii) Specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the radio equipment;

iii) Contain, wherever applicable, the elements set out in annex V to this Decree-Law;

d)  The supporting evidence for the adequacy of the technical design solution, which shall:

i)  Mention any documents that have been used, in particular where the relevant harmonised standards have not been applied or have not been fully applied;

ii) Include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

5 - The notified body shall examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the radio equipment.

6 -  The notified body shall draw up an evaluation report that records the activities undertaken in accordance with the preceding paragraph and their outcomes, which shall only be disclosed, in full or in part, with the agreement of the manufacturer, without prejudice to its obligations as provided in paragraphs 13, 14, 15 and 18.

7 - The notified body shall issue an EU-type examination certificate to the manufacturer only where the type meets the requirements that apply to the radio equipment concerned, under this Decree-Law.

8 - The certificate referred to in the preceding paragraph shall contain:

a) The name and address of the manufacturer;

b) The conclusions of the examination;

c)  The aspects of the essential requirements covered by the examination;

d) The conditions, if any, for its validity; and

e)  The necessary data for identification of the assessed type.

9 - The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured radio equipment 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, and shall determine whether such changes require further investigation, informing 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 radio equipment with the essential requirements of this Decree-Law or the conditions for validity of that certificate.

13 - Modifications referred to in the final part of 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 its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto which it has refused, suspended or otherwise restricted.

15 - Each notified body shall also 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 such certificates and/or additions thereto which it has issued.

16 - Each notified body shall inform the Member States of EU-type examination certificates it has issued and/or additions thereto in those cases where harmonised standards the references of which have been published in the Official Journal of the European Union have not been applied or not been fully applied.

17 - Member States, the European Commission and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto.

18 - On request, the Member States and the European Commission may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body.

19 - 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 for 10 years after the radio equipment has been assessed or until the expiry of the validity of that certificate.

20 - 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 national authorities for 10 years after the radio equipment has been placed on the market.

21 - The manufacturer’s authorised representative may lodge the application referred to in paragraph 3 and fulfil the obligations set out in paragraphs 10, 11 and 19, provided that they are specified in the mandate.

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 radio equipment concerned is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Decree-Law that apply to it.

2 - Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured radio equipment with the approved type described in the EU-type examination certificate and with the requirements of this Decree-Law that apply to it.

3 - CE marking and EU declaration of conformity

3.1 - The manufacturer shall affix the CE marking in accordance with articles 19 and 20 to radio equipment that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Decree-Law.

3.2 - On account of the nature of radio equipment, the height of the «CE» marking affixed to radio equipment may be lower than 5 mm, provided that it remains visible and legible.

3.3 - The manufacturer shall draw up a written EU declaration of conformity for each radio equipment type and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the radio equipment has been placed on the market.

3.4 - The EU declaration of conformity shall identify the radio equipment for which it has been drawn up.

3.5 -  A copy of the EU declaration of conformity, issued under annex VI to this Decree-Law, shall be made available to the relevant authorities upon request.

4 - Authorised representative

The manufacturer’s obligations set out in paragraph 3 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 paragraphs 4 c), 5 c) and 6 b) of article 17, paragraph 3 of article 20, paragraph 4 of article 26, point a) of article 28, paragraph 3 of article 32, paragraph 1 c) of article 38, paragraph 3 f) and i) of article 44]

Module H

Conformity Based on Full Quality Assurance

1 - Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5, and ensures and declares on his sole responsibility that the radio equipment concerned satisfies the requirements of this Decree-Law that apply to it.

2 - Manufacturing

The manufacturer shall operate an approved quality system for design, manufacture, final radio equipment inspection and testing of the radio equipment concerned as specified in paragraph 3 and shall be subject to surveillance as specified in paragraph 4, both of this annex.

3 - Quality system

3.1 - The manufacturer shall lodge an application for assessment of his quality system with a notified body, for the radio equipment concerned.

3.2 - The application shall include:

a) The name and address of the manufacturer and of the authorised representative, if the application is lodged by the latter;

b)  The technical documentation for each radio equipment type intended to be manufactured, which shall contain, wherever applicable, the elements set out in annex V to this Decree-Law;

c) The documentation concerning the quality system; and

d) A written declaration that the same application has not been lodged with any other notified body.

3.3 - The quality system shall ensure compliance of the radio equipment with the requirements of this Decree-Law that apply to it.

3.4 - All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions.

3.5 - The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records, and 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 design specifications, including standards, that will be applied and, where the relevant harmonised standards will not be applied in full, the means that will be used to ensure that the essential requirements of this Decree-Law that apply to the radio equipment will be met;

c) The design control and design verification techniques, processes and systematic actions that will be used when designing radio equipment pertaining to the radio equipment type 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;

f) The quality records, such as inspection reports and test data, calibration data and reports concerning the qualifications of the personnel;

g) The means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.

3.6 - The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraphs 3.3. to 3.5.

3.7 - The notified body shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.

3.8 -  In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant radio equipment field and radio equipment technology concerned, and knowledge of the applicable requirements of this Decree-Law.

3.9 - The audit shall include an assessment visit to the manufacturer’s premises.

3.10 - The auditing team shall review the technical documentation referred to in paragraph 3.1 b) of this annex to verify the manufacturer’s ability to identify the applicable requirements of this Decree-Law and to carry out the necessary examinations with a view to ensuring compliance of the radio equipment with those requirements.

3.11 - The decision shall be notified to the manufacturer or his authorised representative, and shall contain the conclusions of the audit and the reasoned assessment decision.

3.12 - The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

3.13 - The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

3.14 -  The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraphs 3.3 to 3.5 or whether a reassessment is necessary.

3.15 The decision of the notified body, which shall contain the conclusions of the examination and the reasoned assessment decision, shall be notified to the manufacturer.

4 - Surveillance under the responsibility of the notified body

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

4.2 - The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:

a) The quality system documentation;

b) The quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests;

c) The quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data and reports concerning the qualifications of the personnel.

4.3 - The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

4.4 - The notified body may carry out surveys without prior notice to the manufacturer.

4.5 - During such surveys, the notified body may, if necessary, carry out radio equipment tests, or have them carried out, in order to check the proper functioning of the quality system.

4.6 -  The notified body shall provide the manufacturer with a survey report and, if tests have been carried out, with a test report.

5 - CE marking and EU declaration of conformity

5.1 - The manufacturer shall affix the CE marking in accordance with articles 19 and 20 and, under the responsibility of the notified body referred to in paragraph 3.1 hereto, the latter’s identification number to each item of radio equipment that satisfies the applicable requirements set out in article 3.

5.2 - The manufacturer shall draw up a written EU declaration of conformity for each radio equipment type and keep it at the disposal of the national authorities for 10 years after the radio equipment has been placed on the market.

5.3 -  The EU declaration of conformity shall identify the radio equipment type for which it has been drawn up.

5.4 - A copy of the EU declaration of conformity, issued under annex VI to this Decree-Law, shall be made available to market surveillance authorities upon request.

6 - The manufacturer shall, for a period ending 10 years after the radio equipment has been placed on the market, keep at the disposal of the market surveillance authorities:

a) The technical documentation referred to in paragraph 3.1 hereto;

b) The documentation concerning the quality system referred to in paragraph 3.1;

c) The change referred to in paragraphs 3.13 and 3.14, as approved;

d) The decisions and reports of the notified body referred to in paragraphs 3.13, 3.14 and 4.3 to 4.6.

7 - Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.

8 - Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.

9 - Authorised representative

The manufacturer’s obligations set out in paragraphs 3.1, 3.13, 3.14, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.


ANNEX V

[referred to in paragraph 2 of article 6, paragraph 1 of article 21, and paragraph 3 f) of article 44]

Contents of Technical Documentation

The technical documentation shall contain, wherever applicable, at least the following elements:

a) A general description of the radio equipment including:

i) Photographs or illustrations showing external features, marking and internal layout;

ii) Versions of software or firmware affecting compliance with essential requirements;

iii) User information and installation instructions.

b) Conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits and other relevant similar elements;

c) Descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the radio equipment;

d) 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 European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements set out in article 4, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;

e) Copy of the EU declaration of conformity;

f) Where the conformity assessment module in annex III has been applied, copy of the EU-type examination certificate and its annexes as delivered by the notified body involved;

g) Results of design calculations made, examinations carried out, and other relevant similar elements;

h) Test reports;

i) An explanation of the compliance with the requirement of paragraph 1 b) of article 11 and of the inclusion or not of information on the packaging in accordance with paragraph 1 p) of article 11.


ANNEX VI

[referred to in paragraph 2 a) of article 18]

EU Declaration of Conformity (No XXX)

(the issue of a number to the declaration is optional)

1 - Radio equipment (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 the radio equipment allowing traceability; it may include a colour image of sufficient clarity where necessary for the identification of the radio equipment): ...

5 - The object of the declaration described above is in conformity with national legislation and the relevant Union harmonisation legislation: Directive 2014/53/EU http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.153.01.0062.01.ENG, of the European Parliament and of the Council of 16 April 2014; other Union harmonisation legislation, where applicable: …

6 - References to the relevant harmonised standards used or to other technical specifications in relation to which conformity is declared, including the respective identification numbers, version and, where applicable, date of issue: …

7 - Where applicable, the notified body … (name, number) … performed … (description of intervention) … and issued the EU-type examination certificate: …

8 - Where applicable, description of accessories and components, including software, which allow the radio equipment to operate as intended and covered by the EU declaration of conformity: …

9 - Additional information: Signed for and on behalf of: … (place and date of issue) (name, function) (signature)


ANNEX VII

[referred to in paragraph 4 a) of article 18]

Simplified EU Declaration of Conformity

The simplified EU declaration of conformity referred to in paragraphs 3 and 4 of article 18 shall be provided as follows:

Hereby, [name of manufacturer] declares that the radio equipment type [designation of type of radio equipment] is in compliance with Directive 2014/53/EU http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.153.01.0062.01.ENG, of the European Parliament and of the Council of 16 April 2014.

The full text of the EU declaration of conformity is available at the following internet address: …


ANEXO VIII

(referred to in paragraph 4 of article 40)

Charges with tests intended to check conformity of radio equipment
No. of Tests Amount
1 600.00 €
2 1000.00 €
3 1400.00 €
4 1800.00 €
5 or more 2200.00 €