Annexes to COM(1997)257 - Connected telecommunications equipment and the mutual recognition of the conformity of equipment - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(1997)257 - Connected telecommunications equipment and the mutual recognition of the conformity of equipment. |
|---|---|
| document | COM(1997)257  |
| date | March 9, 1999 |
EQUIPMENT NOT COVERED BY THIS DIRECTIVE AS REFERRED TO IN ARTICLE 1(4)
1. Radio equipment used by radio amateurs within Article 1, definition 53, of the International Telecommunications Union (ITU) radio regulations unless the equipment is available commercially.
Kits of components to be assembled by radio amateurs and commercial equipment modified by and for the use of radio amateurs are not regarded as commercially available equipment.
2. Equipment falling within the scope of Council Directive 96/98/EC of 20 December 1996 on marine equipment(1).
3. Cabling and wiring.
4. Receive only radio equipment intended to be used solely for the reception of sound and TV broadcasting services.
5. Products, appliances and components within the meaning of Article 2 of Council Regulation (EEC) No 3922/91 of 16 December 1991 on the harmonisation of technical requirements and administrative procedures in the field of civil aviation(2).
6. Air-traffic-management equipment and systems within the meaning of Article 1 of Council Directive 93/65/EEC of 19 July 1993 on the definition and use of compatible technical specifications for the procurement of air-traffic-management equipment and systems(3).
(1) OJ L 46, 17.2.1997, p. 25.
(2) OJ L 373, 31.12.1991, p. 4. Regulation as amended by Commission Regulation (EC) No 2176/96 (OJ L 291, 14.11.1996, p. 15).
(3) OJ L 187, 29.7.1993, p. 52. Directive as last amended by Commission Directive 97/15/EC (OJ L 95, 10.4.1997, p. 16).
ANNEX II
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 10(3)
Module A (internal production control)
1. This module describes the procedure whereby the manufacturer or his authorised representative established within the Community, who carries out the obligations laid down in point 2, ensures and declares that the products concerned satisfy the requirements of this Directive that apply to them. The manufacturer or his authorised representative established within the Community must affix the CE marking to each product and draw up a written declaration of conformity.
2. The manufacturer must establish the technical documentation described in point 4 and he or his authorised representative established within the Community must keep it for a period ending at least 10 years after the last product has been manufactured at the disposal of the relevant national authorities of any Member State for inspection purposes.
3. Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the Community market.
4. The technical documentation must enable the conformity of the product with the essential requirements to be assessed. It must cover the design, manufacture and operation of the product, in particular:
- a 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,
- a list of the standards referred to in Article 5, applied in full or in part, and descriptions and explanations of the solutions adopted to meet the essential requirements of the Directive where such standards referred to in Article 5 have not been applied or do not exist,
- results of design calculations made, examinations carried out, etc.,
- test reports.
5. The manufacturer or his authorised representative must keep a copy of the declaration of conformity with the technical documentation.
6. The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured products with the technical documentation referred to in point 2 and with the requirements of this Directive that apply to them.
ANNEX III
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 10(4)
(Internal production control plus specific apparatus tests)(1)
This Annex consists of Annex II, plus the following supplementary requirements:
For each type of apparatus, all essential radio test suites must be carried out by the manufacturer or on his behalf. The identification of the test suites that are considered to be essential is the responsibility of a notified body chosen by the manufacturer except where the test suites are defined in the harmonised standards. The notified body must take due account of previous decisions made by notified bodies acting together.
The manufacturer or his authorised representative established within the Community or the person responsible for placing the apparatus on the market must declare that these tests have been carried out and that the apparatus complies with the essential requirements and must affix the notified body's identification number during the manufacturing process.
(1) Annex based on Module A with additional requirements appropriate to the sector.
ANNEX IV
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 10(5)
(Technical construction file)
This Annex consists of Annex III plus the following supplementary requirements:
The technical documentation described in point 4 of Annex II and the declaration of conformity to specific radio test suites described in Annex III must form a technical construction file.
The manufacturer, his authorised representative established within the Community or the person responsible for placing the apparatus on the market, must present the file to one or more notified bodies, each of the notified bodies must be informed of others who have received the file.
The notified body must review the file and if it is considered that it has not been properly demonstrated that the requirements of the Directive have been met, the notified body may issue an opinion to the manufacturer, his representative or the person responsible for placing the apparatus on the market and must inform the other notified bodies who have received the file accordingly. Such an opinion must be given within four weeks of receipt of the file by the notified body. On receipt of this opinion, or after the end of the four-week period, the apparatus may be placed on the market, without prejudice to Articles 6(4) and 9(5).
The manufacturer or his authorised representative established within the Community or the person responsible for placing the apparatus on the market must keep the file for a period ending at least 10 years after the last apparatus has been manufactured at the disposal of the relevant national authorities of any Member States for inspection.
ANNEX V
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 10
Full quality assurance
1. Full quality assurance is the procedure whereby the manufacturer who satisfies the obligations of point 2 ensures and declares that the products concerned satisfy the requirements of the Directive that apply to them. The manufacturer must affix the marks referred to in Article 12(1) to each product and draw up a written declaration of conformity.
2. The manufacturer must operate an approved quality system for design, manufacture and final product inspection and testing as specified in point 3 and must be subject to surveillance as specified in point 4.
3. Quality system
3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body.
The application must include:
- all relevant information for the products envisaged,
- the quality system's documentation.
3.2. The quality system must ensure compliance of the products with the requirements of the Directive that apply to them. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.
It must contain in particular an adequate description of:
- the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality,
- the technical specifications, including the harmonised standards and technical regulations as well as relevant test specifications that will be applied and, where the standards referred to in Article 5(1) will not be applied in full, the means that will be used to ensure that the essential requirements of the Directive that apply to the products will be met,
- the design control and design verification techniques, processes and systematic actions that will be used when designing the products pertaining to the product category covered,
- the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,
- the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out, as well as the results of the tests carried out before manufacture where appropriate,
- the means by which it is ensured that the test and examination facilities respect the appropriate requirements for the performance of the necessary test,
- the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,
- the means to monitor the achievement of the required design and product quality and the effective operation of the quality system.
3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It must presume compliance with these requirements in respect of quality systems that implement the relevant harmonised standard.
The notified body must assess in particular whether the quality control system ensures conformity of the products with the requirements of the Directive in the light of the relevant documentation supplied in respect of points 3.1 and 3.2 including, where relevant, test results supplied by the manufacturer.
The auditing team must have at least one member experienced as an assessor in the product technology concerned. The evaluation procedure must include an assessment visit to the manufacturer's premises.
The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.
3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to uphold it so that it remains adequate and efficient.
The manufacturer or his authorised representative must keep the notified body that has approved the quality system informed of any intended updating of the quality system.
The notified body must evaluate the modifications proposed and decide whether the amended quality system will still satisfy the requirements referred to in point 3.2 or whether a reassessment is required.
It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.
4. EC 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 must allow the notified body access for inspection purposes to the locations of design, manufacture, inspection and testing, and storage and must provide it with all necessary information, in particular:
- the quality system documentation,
- the quality records as foreseen by the design part of the quality system, such as results of analyses, calculations, tests, etc.,
- the quality records as foreseen by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
4.3. The notified body must carry out audits at reasonable intervals to make sure that the manufacturer maintains and applies the quality system and must provide an audit report to the manufacturer.
4.4. Additionally, the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may carry out tests or have them carried out in order to check the proper functioning of the quality system where necessary; it must provide the manufacturer with a visit report and, if a test has been carried out, with a test report.
5. The manufacturer must, for a period ending at least 10 years after the last product has been manufactured, keep at the disposal of the national authorities:
- the documentation referred to in the second indent of point 3.1,
- the updating referred to in the second paragraph of point 3.4,
- the decisions and reports from the notified body which are referred to in the final paragraph of point 3.4 and in points 4.3 and 4.4.
6. Each notified body must make available to the other notified bodies the relevant information concerning quality system approvals including references to the product(s) concerned, issued and withdrawn.
ANNEX VI
MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER STATES WHEN DESIGNATING NOTIFIED BODIES IN ACCORDANCE WITH ARTICLE 11(1)
1. The notified body, its director and the staff responsible for carrying out the tasks for which the notified body has been designated must not be a designer, manufacturer, supplier or installer of radio equipment or telecommunications terminal equipment, or a network operator or a service provider, nor the authorised representative of any of such parties. They must be independent and not become directly involved in the design, construction, marketing or maintenance of radio equipment or telecommunications terminal equipment, nor represent the parties engaged in these activities. This does not preclude the possibility of exchanges of technical information between the manufacturer and the notified body.
2. The notified body and its staff must carry out the tasks for which the notified body has been designated with the highest degree of professional integrity and technical competence and must be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of any inspection, especially from persons or groups of persons with an interest in such results.
3. The notified body must have at its disposal the necessary staff and facilities to enable it to perform properly the administrative and technical work associated with the tasks for which it has been designated.
4. The staff responsible for inspections must have:
- sound technical and professional training,
- satisfactory knowledge of the requirements of the tests or inspections that are carried out and adequate experience of such tests or inspections,
- the ability to draw up the certificates, records and reports required to authenticate the performance of the inspections.
5. The impartiality of inspection staff must be guaranteed. Their remuneration must not depend on the number of tests or inspections carried out nor on the results of such inspections.
6. The notified body must take out liability insurance unless its liability is assumed by the Member State in accordance with national law, or the Member State itself is directly responsible.
7. The staff of the notified body is bound to observe professional secrecy with regard to all information gained in carrying out its tasks (except vis-à-vis the competent administrative authorities of the Member State in which its activities are carried out) under this Directive or any provision of national law giving effect thereto.
ANNEX VII
MARKING OF EQUIPMENT REFERRED TO IN ARTICLE 12(1)
1. The CE conformity marking must consist of the initials "CE" taking the following form:
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If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.
2. The CE marking must have a height of at least 5 mm except where this is not possible on account of the nature of the apparatus.
3. The CE marking must be affixed to the product or to its data plate. Additionally it must be affixed to the packaging, if any, and to the accompanying documents.
4. The CE marking must be affixed visibly, legibly and indelibly.
5. The equipment class identifier must take a form to be decided by the Commission in accordance with the procedure laid down in Article 14.
Where appropriate it must include an element intended to provide information to the user that the apparatus makes use of radio frequency bands where their use is not harmonised throughout the Community.
It must have the same height as the initials "CE".
Joint Declaration of the European Parliament, the Council and the Commission
The European Parliament, the Council and the Commission recognise the importance of the requirement relating to the prevention of harm to the network or its functioning which causes an unacceptable degradation of service taking into account in particular the need to safeguard the interests of the consumer.
Therefore, they note that the Commission will carry out a continuous assessment of the situation in order to evaluate whether that risk occurs frequently and, in such a case, to find an appropriate solution in the framework of the Committee acting in accordance with the procedure laid down in Article 15.
Such a solution will, where appropriate, consist of the systematic application of the essential requirement provided for in Article 3(3)(b).
Furthermore, the European Parliament, the Council and the Commission state that the procedure described above applies without prejudice to the possibilities foreseen in Article 7(5) and to the development of voluntary certification and marking schemes to prevent either the degradation of service or any harm to the network.