Decision 93/465/EEC |
modules for conformity assessment
& rules for CE marking
Official Journal L 220 , 30/08/1993 p. 0023 - 0039
COUNCIL DECISION 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization directives.
1. The procedures for conformity assessment which are to be used in the technical harmonization directives relating to the marketing of industrial products will be chosen from among the modules listed in the Annex and in accordance with the criteria set out in this Decision and in the general guidelines in the Annex.
These procedures may only depart from the modules when the specific circumstances of a particular sector or directive so warrant. Such departures from the modules must be limited in extent and must be explicitly justified in the relevant directive.
2. This Decision lays down rules for affixing the CE conformity marking provided for in Community legislation concerning the design, manufacture, placing on the market, entry into service or use of industrial products.
3. The Commission shall report periodically on the functioning of this Decision, and on whether conformity assessment and CE marking procedures are working satisfactorily or need to be modified.
1. Decision 90/683/EEC is hereby repealed.
2. References to the Decision repealed shall be construed as references to this Decision.
CONFORMITY ASSESSMENT PROCEDURES AND CE MARKING IN THE TECHNICAL HARMONIZATION DIRECTIVES
I. GENERAL GUIDELINES
A. The principal guidelines for the use of conformity assessment procedures in technical harmonization directives are the following:
(a) the essential objective of a conformity assessment procedure is to enable the public authorities to ensure that products placed on the market conform to the requirements as expressed in the provisions of the directives, in particular with regard to the health and safety of users and consumers;
(b) conformity assessment can be subdivided into modules which relate to the design phase of products and to their production phase;
(c) as a general rule a product should be subject to both phases before being able to be placed on the market if the results are positive (1) ;
(d) there are a variety of modules which cover the two phases in a variety of ways. The directives must set the range of possible choices which can be considered by the Council to give the public authorities the high level of safety they seek, for a given product or product sector;
(e) in setting the range of possible choices open to the manufacturer, the directives, will take into consideration, in particular, such issues as the appropriateness of the modules to the type of products, the nature of the risks involved, the economic infrastructures of the given sector (e.g. existence or non-existence of third parties), the types and importance of production, etc. The factors that have been taken into account must be explicitly spelled out by the Commission in these directives;
(f) the directives will, in setting the range of possible modules for a given product or product sector, attempt to leave as wide a choice to the manufacturer as is consistent with ensuring compliance with the requirements.
The directives will set out the criteria governing the conditions in which the manufacturer chooses the most appropriate modules for his production from the modules laid down by the directives;
(g) the directives should avoid imposing unnecessarily modules which would be too onerous relative to the objectives of the directive concerned;
(h) notified bodies should be encouraged to apply the modules without unnecessary burden for the economic operators. The Commission, in cooperation with the Member States, must ensure that close cooperation is organized between the notified bodies in order to ensure consistent technical application of the modules;
(i) in order to protect the manufacturers, the technical documentation provided to notified bodies has to be limited to that which is required solely for the purpose of assessment of conformity. Legal protection of confidential information is required;
(j) whenever directives provide the manufacturer with the possibility of using modules based on quality assurance techniques, the manufacturer must also be able to have recourse to a combination of modules not using quality assurance, and vice versa, except where compliance with the requirements laid down by the directives requires the exclusive application of a certain procedure;
(k) for the purposes of operating the modules, Member States must notify on their own responsibility bodies under their jurisdiction which they have chosen from the technically competent bodies complying with the requirements of the directives. This responsibility involves the obligation for the Member States to ensure that the notified bodies permanently have the technical qualifications required by the directives and that the latter keep their competent national authorities informed of the performance of their tasks. Where a Member State withdraws its notification of a body, it must take appropriate steps to ensure that the dossiers are processed by another notified body to ensure continuity;
(l) in addition, with regard to conformity assessment, the sub-contracting of work shall be subject to certain conditions guaranteeing:
- the competence of the establishment operating as sub-contractor, on the basis of conformity with series EN 45 000 standards, and the capability of the Member State that has notified the sub-contracting body to ensure effective monitoring of such compliance,
- the ability of the body notified to exercise effective responsibility for the work carried out under sub-contract;
(m) notified bodies which can prove their conformity with harmonized standards (EN 45 000 series), by submitting an accreditation certificate or other documentary evidence, are presumed to conform to the requirements of the directives. Member States having notified bodies unable to prove their conformity with the harmonized standards (EN 45 000 series) may be requested to provide the Commission with the appropriate supporting documents on the basis of which notification was carried out;
(n) a list of notified bodies must be published by the Commission in the Official Journal of the European Communities and constantly updated.
B. The principal guidelines for the affixing and use of the CE marking are the following:
(a) The CE marking symbolizes conformity to all the obligations incumbent on manufacturers for the product by virtue of the Community directives providing for its affixing.
Thus, such conformity is not limited to the essential requirements relating to safety, public health, consumer protection, etc., as certain directives may impose specific obligations not necessarily forming part of the essential requirements.
(b) The CE marking affixed to industrial products symbolizes the fact that the natural or legal person having affixed or been responsible for the affixing of the said marking has verified that the product conforms to all the Community total harmonization provisions which apply to it and has been the subject of the appropriate conformity evaluation procedures.
(c) Where the industrial products are subject to other directives concerning other aspects and which also provide for the affixing of the CE marking, the latter must indicate that the products are also presumed to conform to the provisions of those other directives.
However, where one or more of these directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking indicates conformity to the provisions only of those directives applied by the manufacturer. In this case, particulars of the directives applied, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions accompanying the products or, where appropriate, on the data plate.
(d) 1. The CE conformity marking must consist of the initials 'CE' taking the following form:
If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.
2. Where the directive concerned does not impose specific dimensions, the CE marking must have a height of at least 5 mm.
3. The CE marking must be affixed to the product or to its data plate. However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and to the accompanying documents, where the directive concerned provides for such documents.
4. The CE marking must be affixed visibly, legibly and indelibly.
(e) Any industrial product covered by the technical harmonization directives based on the principles of the global approach must bear the CE marking, save where the specific directives provide otherwise; such exceptions constitute derogations not from the marking requirement but from the administrative procedures for conformity evaluation, which may in certain cases be considered too cumbersome. Appropriate grounds must accordingly be given for any exception to or derogation from the marking requirement.
The CE marking is the only marking which certifies that the industrial products conform to the directives based on the principles of the global approach.
Member States must refrain from introducing into their national regulations any reference to a conformity marking other than the CE marking in connection with conformity to all the provisions contained in the directives on CE marking.
(f) The CE marking must be affixed at the end of the production control phase.
(g) The CE conformity marking must be followed by the identification number of the notified body within the meaning of paragraph I.A where the said body is involved in the production control phase within the meaning of this Decision.
Such identification numbers must be assigned by the Commission as part of the body notification procedure. The Commission must publish lists of the notified bodies in the Official Journal of the European Communities; such lists must be updated regularly.
A notified body must be assigned the same number when it is notified under several directives. The Commission must ensure that each notified body receives a single identification number, however many directives it is notified under.
(h) It is necessary to lay down provisions concerning the use of certain products. In this case, the CE marking and the identification number of the notified body may be followed by a pictogram or any other mark indicating, for example, the category of use.
(i) The affixing for any other marking liable to deceive third parties as to the meaning and form of the CE marking must be prohibited.
(j) A product may bear different marks, for example marks indicating conformity to national or European standards or with traditional optional directives, provided such marks are not liable to cause confusion with the CE marking.
Such marks may therefore only be affixed to the product, its packaging or the documentation accompanying the product on condition that the legibility and visibility of the CE marking are not thereby reduced.
(k) The CE marking must be affixed by the manufacturer or his agent established within the Community. In exceptional, duly warranted cases, the specific directives may provide that the CE marking can be affixed by the person responsible for placing the product on the Community market.
The identification number of the notified body must be affixed under its responsibility either by the body itself or by the manufacturer or his agent established within the Community.
(l) Member States must take all provisions of national law necessary to exclude any possibility of confusion and to prevent abuse of the CE marking.
Without prejudice to the provisions in the directive concerned relating to the application of the safeguard clause, where a Member State establishes that the CE marking has been affixed unduly, the manufacturer, his agent or, exceptionally, where the specific directives so provide, the person responsible for placing the product in question on the Community market is obliged to make the product comply and to end the infringement under conditions imposed by the Member State. Where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in the safeguard clauses.
II. MODULES FOR CONFORMITY ASSESSMENT
Specific directives may allow the CE marking to be affixed to the packaging or the accompanying documentation, instead of to the product itself.
The declaration of conformity or the certificate of conformity (whichever of the two applies in the directive concerned) must cover either individual or several products and shall either accompany the product(s) covered or be kept by the manufacturer. The appropriate solution for the directive concerned will be specified.
References to Articles refer to the standard paragraphs of Annex II.B to the Council resolution of 7 May 1985 (OJ No C 136, 4. 6. 1985, p. 1), which have become standard Articles in the 'new approach' directives.
The development of computerized communication of certificates and other documents issued by notified bodies is envisaged within INSIS.
Specific directives may use modules A, C and H with additional provisions containing supplementary requirements which figure in the boxes in the modules.
Module C is designed to be used in combination with module B (EC type-examination). Modules D, E and F will also normally be used in combination with module B; however, in special cases (for example, when dealing with certain products of very simple design and construction) they may be used on their own.
Module A (internal production control)
1. This module describes the procedure whereby the manufacturer or his authorized 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 the directive that apply to them. The manufacturer or his authorized manufacturer 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 paragraph 3 and he or his authorized representative established with the Community must keep it for a period ending at least 10 years (2) after the last product has been manufactured at the disposal of the relevant national authorities for inspection purposes.
Where neither the manufacturer nor his authorized 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.
3. Technical documentation must enable the conformity of the product with the requirements of the directive to be assessed. It must, as far as relevant for such assessment, cover the design, manufacture and operation of the product (3) .
4. The manufacturer or his authorized representative must keep a copy of the declaration of conformity with the technical documentation.
5. 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 the directive that apply to them.
Module B (EC type-examination)
Module C (conformity to type)
Module D (production quality assurance)
Module E (product quality assurance)
Module F (product verification)
Module G (unit verification)
Module H (full quality assurance)
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Please click the following links to learn more about every CE-Marking-related European Union Directive, Guidelines to Directives, Frameworks of implementation of Directives, and Agreements on Mutual Recognition of conformity assessment between European Union and other countries such as USA, Japan, Canada, Australia, New Zealand and Israel:-
- What is CE marking (CE mark)?
- The CE marking logo (Free download CE mark logo)
- Download of the EC Rep symbol/logo
- CE Marking (CE mark) EU/EC Declaration of Conformity: definition and required content
- What is a manufacturer? What are the responsibilities of a manufacturer?
- Is the Own Brand Labeller or Private Labeller considered as the legal Manufacturer?
- Why is CE marking called "European passport"?
- Does my product need CE Marking in order to be sold/exported on/to the European Market?
- How to obtain CE Marking for my product?
- How can Wellkang Tech Consulting help me to obtain CE Marking for my product?
- Wellkang can be your Authorized Representative in Europe for CE Marking purpose !
- Complete list of all CE Marking Directives and Guidelines to Directives
- Complete list of all (more than 1000) Notified Bodies for CE marking
- Complete list of all European and/or international standards related to CE marking
- 85/374/eec: Directive of Liability for Defective Products (for all products)
- 1999/34/ec: Directive of Liability for Defective Products (amending) (for all products)
- 2000: (Proposal for a new) General Products Safety Directive (for all products)
- 92/59/eec: Directive of General Products Safety (for all products)
- 93/68/eec: "CE Marking" Directive (for all products)
- 93/465/eec: Conformity Assessment Procedures & CE Marking Rules, & Annex (for all products)
- Guide to Implementation of directives based on new approach & global approach (for all products)
- 73/23/eec: Directive of Low Voltage Electrical Equipment
- Guideline to Low Voltage Directive (LVD) 73/23/eec & Annex I, II
- 2000&2001 Framework of implementation of (LVD) Directive 73/23/eec
- 87/404/eec: Directive of Simple Pressure Vessels
- 88/378/eec: Directive of Toys & Annex I, II, ... IV
- 89/106/eec: Directive of Construction Products
- 89/336/eec: Directive of Electromagnetic Compatibility (EMC)
- Guideline to Directive of Electromagnetic Compatibility (EMC) 89/336/eec
- Communication 2000 in framework of implementation of EMC Directive 89/336/EEC
- 89/686/eec: Directive of Personal Protective Equipment (PPE)
- 90/384/eec: Directive of Non-automatic Weighing Instruments
- 90/396/eec: Directive of Appliances Burning Gaseous Fuels (AppliGas)
- 2001 Commission Communication in Framework of Impl (AppliGas) Directive 90/396/eec
- 92/42/eec: Directive of Efficiency of (Liquid or Gaseous fueled) Hot Water Boilers
- 93/15/eec: Directive of Explosives for Civil Uses
- 93/42/eec: Directive of Medical Devices
- 2001 Guidelines for Classification of Medical Devices
- Guidelines relating to the demarcation between Directives 90/385/eec, 93/42/eec and 65/65/eec.
- 90/385/eec: Directive of Active Implantable Medical Devices
- 98/79/ec: Directive of In Vitro Diagnostic Medical Devices
- Guidelines to Medical Devices Vigilance System
- List of Harmonised (European) Standards for Medical Devices
- List of Notified Bodies for Medical Devices Directive
- 93/65/eec: Directive of Air Traffic Management Equipment & Systems
- 94/9/ec: Directive of Equipment used in Potentially Explosive Atmospheres (Atex)
- Guidelines to directive 94/9/ec (Atex)
- 94/25/ec: Directive of Recreational Craft
- 95/16/ec: Directive of Lifts
- 96/48/ec: Directive of Trans-European High-speed Rail System
- 96/57/ec: Directive of Energy Efficiency: Household Refrigerators & Freezers
- 96/98/ec: Directive of Marine Equipment
- 98/37/ec: Directive of Machinery
- 2000: Comments on Directive of Machinery 98/37/ec
- 99/5/ec: Directive of Radio Equipment & Telecommunications Terminal Equipment (R&TTE)
- 2000/9/ec: Directive of Cableway Installations to Carry Persons
- 2000/14/ec: Directive of Noise Emission in the environment by equipment for use outdoors
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