Brief Introduction of
CE Marking Directive: 93/68/EEC
COUNCIL DIRECTIVE 93/68/EEC of 22 July 1993
THE COUNCIL OF THE EUROPEAN COMMUNITIES, has adopted this directive:
The following Council Directives are hereby amended:
1. 87/404/EEC of 25 June 1987 (simple pressure vessels) (7);
2. 88/378/EEC of 3 May 1988 (safety of toys) (8);
3. 89/106/EEC of 21 December 1988 (construction products) (9);
4. 89/336/EEC of 3 May 1989 (electromagnetic compatibility) (10);
5. 89/392/EEC of 14 June 1989 (machinery) (11);
6. 89/686/EEC of 21 December 1989 (personal protective equipment) (12);
7. 90/384/EEC of 20 June 1990 (non-automatic weighing instruments) (13);
8. 90/385/EEC of 20 June 1990 (active implantable medical devices) (14);
9. 90/396/EEC of 29 June 1990 (appliances burning gaseous fuels) (15);
10. 91/263/EEC of 29 April 1991 (telecommunications terminal equipment, including the mutual recognition of their conformity) (16);
92/42/EEC of 21 May 1992 (efficiency requirements for new
hot-water boilers fired with liquid or gaseous fuels) (17);
12. 73/23/EEC of 19 February 1973 (electrical equipment designed for use within certain voltage limits) (18).
From Article 2 to Article 13
Detailed amendments were given, throughout from Article 2 to Article 13, to the 12 Council Directives listed in Article 1. Amendments varied from Directive to Directive. But, in general, the following basic points were included in the amendments to almost every Directive:
- Throughout the text, the term EC mark was replaced by CE marking;
- Member States shall presume that products bearing the CE marking comply with all the provisions of this Directive, including the conformity assessment procedures;
- (a) Where the products are subject to other Directives covering other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that the products in question are also presumed to conform to the provisions of those other Directives.
(b) However, where one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate conformity only to the 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 required by the Directives and accompanying such products;
- EC verification
4.1 EC verification is the procedure whereby a manufacturer or his authorized representative established within the Community ensures and declares that the products are in conformity to the type described in the EC type-examination certificate or with the design and manufacturing schedule referred to in Annex II section 3 having received a certificate of adequacy;
4.2 The manufacturer shall take all the necessary measures for the manufacturing process to ensure that the products conform to the type described in the EC type-examination certificate or to the design and manufacturing schedule referred to in Annex II section 3. The manufacturer or his authorized representative established within the Community shall affix the CE marking to each product and draw up a declaration of conformity;
4.3 The approved body shall carry out the appropriate examinations and tests in order to check the conformity of the products with the requirements of this Directive by examination and testing of products;
4.4 The manufacturer or his authorized representative must be able to supply on request the approved body's certificates of conformity;
- (a) where a Member State establishes that the CE marking has been affixed unduly, the manufacturer or his authorized representative established within the Community shall be obliged to make the product conform as regards the provisions concerning the CE marking and to end the infringement under the conditions imposed by the Member State;
(b) where non-conformity 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 ;
- The CE conformity marking shall consist of the initials "CE " in the form shown below;
- If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.
- The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm;
- The affixing of markings on the products which are likely to deceive third parties as to the meaning and form of the CE marking shall be prohibited. Any other marking may be affixed to the products or the data plate provided that the visibility and legibility of the CE marking is not thereby reduced;
- EC declaration of conformity
The EC declaration of conformity must contain certain elements;
- The manufacturer must establish the technical documentation and he or his authorized representative established within the Community must keep it on Community territory at the disposal of the relevant national authorities for inspection purposes for a certain period after the last product has been manufactured;
Where neither the manufacturer nor his authorized representative is established within the Community, this obligation is the responsibility of the person who places the products on the Community market, e.g. the importer;
- Technical documentation must enable the conformity of the product to the requirements of this Directive to be assessed. It must, as far as relevant for such assessment, cover the design, manufacture and operation of the product. It must include certain information;
1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 1994.
They shall apply these provisions from 1 January 1995.
2. Until 1 January 1997 Member States shall allow the placing
on the market and the bringing into service of products which
comply with the marking arrangements in force before 1 January
(1) OJ No C 160, 20. 6. 1991, p. 14; and OJ No C 28, 2. 2. 1993, p. 16.
(2) OJ No C 125, 18. 5. 1992, p. 178; OJ No C 115, 26. 4. 1993, p. 117; and Decision of 14 July 1993 (not yet published in the Official Journal).
(3) OJ No C 14, 20. 1. 1992, p. 15; and OJ No C 129, 10. 5. 1993, p. 3.
(4) OJ No C 136, 4. 6. 1985, p. 1.
(5) OJ No C 231, 8. 9. 1989, p. 3; and OJ No C 267, 19. 10. 1989, p. 3.
(6) OJ No C 10, 16. 1. 1990, p. 1.
(7) OJ No L 220, 8. 8. 1987, p. 48; Directive amended by Directive 90/488/EEC (OJ No L 270, 2. 10. 1990, p. 25).
(8) OJ No L 187, 16. 7. 1988, p. 1.
(9) OJ No L 40, 11. 2. 1989, p. 12.
(10) OJ No L 139, 23. 5. 1989, p. 19; Directive last amended by Directive 92/31/EEC (OJ No L 126, 12. 5. 1992, p. 11).
(11) OJ No L 183, 29. 6. 1989, p. 9; Directive amended by Directive 91/368/EEC (OJ No L 198, 22. 7. 1991, p. 16).
(12) OJ No L 399, 30. 12. 1989, p. 18.
(13) OJ No L 189, 20. 7. 1990, p. 1.
(14) OJ No L 189, 20. 7. 1990, p. 17.
(15) OJ No L 196, 26. 7. 1990, p. 15.
(16) OJ No L 128, 23. 5. 1991, p. 1.
(17) OJ No L 167, 22. 6. 1992, p. 17.
(18) OJ No L 77, 26. 3. 1972, p. 29.
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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:-
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- 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
- 2001 Framework of implementation of 88/378/eec: Directive of Toys
- 89/106/eec: Directive of Construction Products
- 2001 Guidance to 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
- Technical-Aspects relating 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)
- Useful Facts relating to Directive (PPE) 89/686/eec
- 2001 Framework of implementation of (PPE) Directive 89/686/eec
- 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
- Guidelines for Conformity Assessment of Breast Implants According to Directive 93/42/eec
- Guidelines on Assessment of Medical Devices Incorporating Materials of Animal Origin
- Guidelines on Medical Devices With Measuring Function
- Guidelines on Medical Devices: Subcontracting – Quality System Related
- Guidelines on Medical Devices: Treatment of Computers Used to Program Implantable Pulse Generators
- Guidelines on Medical Devices: Demarcation with other Directives- Directive 89/336/EEC EMC & Directive 89/686/EEC PPE
- Guidelines on Medical Devices: EMC Requirements
- Guidelines on Medical Devices Labelling: USE-BY DATE
- Guidelines on Medical Devices Labelling: Translation procedures
- Guidelines on Homogeneous Production Batches
- 93/65/eec: Directive of Air Traffic Management Equipment & Systems
- 97/15/eec: amending 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)
- 2001 Framework of implementation of (Atex)Directive 94/9/ec
- 94/25/ec: Directive of Recreational Craft
- 2001 Proposed New Version for: directive 94/25/ec (RecCraft) 55p
- 2001 Guidelines&Framework: directive 94/25/ec (RecCraft)
- 95/16/ec: Directive of Lifts
- 96/48/ec: Directive of Trans-European High-speed Rail System
- 2001/16/ec: Directive of Interoperability of Trans-European Conventional Rail System
- 96/57/ec: Directive of Energy Efficiency: Household Refrigerators & Freezers
- 96/98/ec: Directive of Marine Equipment
- 97/23/ec: Directive of Pressure Equipment
- 2000&2001 Framework: directive 97/23/ec Pressure Equipment
- 98/37/ec: Directive of Machinery
- 2000: Comments on Directive of Machinery 98/37/ec
- Useful Facts relating to Machinery 98/37/ec
- 2001 Proposal to amend Directive of Machinery 98/37/ec
- 99/5/ec: Directive of Radio Equipment & Telecommunications Terminal Equipment (R&TTE)
- 2001 Framework of implementation of Directive 99/5/EC R&TTE
- 2001 Guidance on Directive 99/5/EC 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
- 1999 Agreement on Mutual Recognition of conformity assessment between European Union and United States of America
- 2000 amendation to Agreement on Mutual Recognition of conformity assessment between European Union and United States of America
- 1998 Agreement on Mutual Recognition of conformity assessment between European Union and Canada
- 1998 Agreement on Mutual Recognition of conformity assessment between European Union and Australia
- 1998 Agreement on Mutual Recognition of conformity assessment between European Union and New Zealand
- 1999 Agreement on Mutual Recognition of conformity assessment between European Union and Israel
- 2001 proposal Agreement on Mutual Recognition of conformity assessment between European Union and Japan
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