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Frequently asked questions (FAQ)

5. What are the procedures for assessing conformity?

Decree-Law no. 192/2000 of August 18 establishes four possible procedures for guaranteeing conformity with the essential requirements, depending on the category of apparatus that is intended to be placed in the market:

Type of apparatus

Conformity assessment procedures

Annex II

Annex III

Annex IV

Annex V

Telecommunications terminal equipment

X

-

X

X

Receiver elements of radio equipment

X

-

X

X

Radio equipment with application of harmonised standards

-

X

X

X

Radio equipment without or with only partial application of harmonised standards

-

-

X

X

The conformity assessment procedures are specified in the various annexes to Decree-Law no 192/2000 of 18 August (corresponding to the annexes to the R&TTE Directive):

  • Annex II - Internal Production Control;
  • Annex III - Internal production control plus specific apparatus tests;
  • Annex IV - technical construction file;
  • Annex V - Full quality assurance. 

The manufacturer, representative or entity responsible for placing the apparatus in the market should select one of the indicated procedures, applicable to the apparatus in question.

Annex II - Internal Production Control

This is the simplest procedure of the four. 

Scope of application: terminal equipment and receiver elements of radio apparatus:

It consists of:

  • preparation of technical documentation;
  • preparation of declaration of conformity;
  • placing of CE mark.

The technical documentation shall consist of a file which allows assessment of the conformity of the apparatus with the essential requirements, which file shall contain several items, including the following:

  • General description of the product;
  • Conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
  • Descriptions and explanations necessary for the understanding of said drawings and schemes  and the operation of the product;
  • List of the harmonised standards, applied in full or in part, and explanations of the solutions adopted to meet the applicable essential requirements where such standards have not been applied or do not exist;
  • Results of calculations made and of the examinations carried out;
  • Test reports. 

The manufacturer, the authorised representative thereof or the entity responsible for placing the equipment on the market (e.g. importer from a third country) shall maintain and make available the cited technical documentation for the purposes of inspection and enforcement for a period of 10 years following the manufacture date of the last unit of the product.

Annex III - Internal production control plus specific apparatus tests

Scope of application: radiocommunications apparatus subject to harmonised standards.

It consists of:

  • annex II;
  • radio tests.

In addition to the requirements contained in Annex II, this procedure requires radio tests to be carried out.

The manufacturer shall consult a notified authority, of its own choosing, which will determine the essential radio test suites to be carried out (unless the test suites are specified in the harmonised standards). 

The manufacturer shall:

  • Declare that these tests have been carried out;
  • Declare that the apparatus complies with the essential requirements;
  • Affix the notified body's identification number (see: declaration of conformity, marking of apparatus and indispensable information). 

The manufacturer, the authorised representative thereof or the entity responsible for placing the equipment on the market (e.g. importer from a third country) shall maintain and make available the cited technical documentation for the purposes of inspection and enforcement, for a period of 10 years following the manufacture date of the last unit of the product.

Annex IV - Technical construction file

Scope of application: Radiocommunications apparatus without or with only partial application of harmonised standards.

It consists of:

  • annex III;
  • preparation of technical file.

The technical file shall be prepared by the manufacturer, representative or entity responsible for placing the apparatus in the market and shall include:

  • the documentation listed in annex III;
  • the declaration of conformity to specific radio test suites described in Annex III. 

The technical file shall be submitted for the appraisal of various notified bodies, which, within a maximum of 4 weeks, shall give notice as to whether or not they consider the elements included in the file as constituting proof of the requirements specified in the legislation (see: declaration of conformity, marking of apparatus and indispensable information).

The manufacturer, the authorised representative thereof or the entity responsible for placing the equipment on the market (e.g. importer from a third country) shall maintain and make available the cited technical documentation for the purposes of inspectionhttps://www.anacom.pt/render.jsp?contentId=48777 and enforcement for a period of 10 years following the manufacture date of the last unit of the product.

Annex V - Full quality assurance

Scope of application: All radiocommunications and telecommunications equipment.

It consists of:

  • assessment of the full quality system;
  • declaration of conformity;
  • CE mark.

In this procedure, the manufacturer declares that its apparatus is in compliance with the essential requirements of Decree-Law no 192/2000 of 18 August, submitting its quality system to the assessment of a notified body.

The quality system shall cover the product design, manufacture, inspection and test stages. The notified body shall carry out audits at reasonable intervals, in order to certify the maintenance and application of the quality system.  This procedure may only be chosen if the entity to carry out the conformity assessment is the manufacturer.

The manufacturer shall maintain available, for the purposes of inspection during a period of at least 10 years after the manufacture of last apparatus:

  • documentation regarding the quality system;
  • documentation regarding alterations to, and updating of, the quality system;
  • decisions and assessment reports on the quality system by the notified bodies (see: declaration of conformity, marking of apparatus and indispensable information.

Indispensable information to be affixed to the apparatus

In accordance with Decree-Law no 192/2000 of 18 August, manufacturers, representatives or entities responsible for placing the apparatus on the market are obliged to supply consumers with detailed consumer information:

  • Instruction manuals in Portuguese;
  • User information on the purpose of the apparatus;
  • Indication as to whether the equipment is intended for use in the entire national territory or only a part thereof (indicating the respective geographic areas);
  • Warnings of possible restrictions or requirements to which use of the equipment in question may be subject. 

In addition to the above, the equipment must be identified with:

  • The type of apparatus, and batch and serial numbers;
  • Name of manufacturer or entity responsible for placing the apparatus in the market.

Marking of apparatus

  • CE marking - visible, legible and indelible, affixed to the product or on the respective characteristics plate, as well as the packaging and the documents accompanying the product (see annex VI of Decree-Law no 192/2000 of 18 August).
  • Identification of the notified bodieshttp://ec.europa.eu/enterprise/rtte/nb.htm contacted (usually a sequence of 4 digits), in the case of Annex III to V.
  • Identification of the equipment class, whenever one of these identifiers has been assigned.  Under the terms of the notice of the Ministry of Social Equipment, published in Diário da República, series III of 31 August 2000, there are two classes:

    - Class 1 - radio equipment which can be placed in the market and into service without restrictions (no identifier assigned).

    - Class 2 - radio equipment whose placing in the market is subject to restrictions (to this class the "warning sign" identifier is assigned and should be placed on the product's packaging). e.g. where use is made of frequency ranges which are not harmonized throughout the European Union. 

    R&TTE

Declaration of conformity

The declaration of conformity is issued by the manufacturer or by the entity responsible for assessing the conformity of the equipment; the declaration is a document in which the manufacturer declares that the apparatus complies with the terms of Directive 1999/5/EC (in addition to other applicable requisites), in particular the essential requirements.

The declaration of conformity must accompany the product, and be in Portuguese, carrying the date of its issue and the signature of the issuer:

"(name of manufacturer, representative or entity responsible for placing the apparatus in the market) declares that this apparatus complies with the terms of Directive 1999/5/EC of the European Parliament and Council of 9 March 1999, transposed into national legislation by Decree-Law no 192/2000 of 18 August."

In addition to this declaration of conformity, in the event that procedures III or IV are used, the manufacturer must issue a declaration, which should be included within the technical documentation, identifying which standards have been applied and which specific radio test suites have been determined by the notified body or bodies. 

This declaration shall be in accordance with the terms specified in EN 45 014.

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