TQMC Network: CE Marking

CE Marking | ISO 9000 | SA 8000 | ISO 14000 | QS 9000 & ISO / TS 16949 | HACCP | eSCM

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CE Mark is required for certain exports to the European Market. These are made mandatory by Directives released by the European Union. The products requiring CE mark are: (this is not an exhaustive list)

DIRECTIVE No.	DIRECTIVE NAME
73/23/EEC	Low Voltage Equipment (LVD)
87/404/EEC	Simple Pressure Vessels
88/378/EEC	Toys
89/106/EEC	Construction Products (CPD)
89/336/EEC 92/31/EEC	Electromagnetic Compatibility (EMC)
89/392/EEC REPEALED BY 98/37/EC	Machinery
89/686/EEC 93/95/EEC 96/58/EC	Personal Protective Equipment (PPE)
90/384/EEC	Non-automatic Weighing Instruments
90/385/EEC	Active Implantable Medical Devices (AIMD)
90/396/EEC	Gas Appliances
92/42/EEC	Efficiency of Liquid or Gaseous Fuelled Hot Water Boilers
93/15/EEC	Explosives for Civil uses
93/42/EEC	Medical Devices (MDD)
93/97/EEC REPEALED BY 98/13/EC	Satellite Earth Station Equipment
94/9/EC	Equipment in Potentially Explosive Atmospheres -"ATEX"
94/25/EC	Recreational Craft
94/62/EC	Packaging and Packaging Waste
95/16/EC	Lifts
96/57/EC	Energy Efficiency: Household Refrigerators & Freezers
98/79/EC	In Vitro Diagnostic Medical Devices
97/23/EC	Pressure Equipment (PED)
98/37/EC	Machinery
1999/5/EC	Radio & Telecom Terminal Equipment
2000/9/EC	Cableway Installations for Passengers
2000/14/EC	Noise Emission in the environment by equipment for use outdoors

Recently added New Directives:

RoHS Directive

General Product Safety

Recent updated list of Directives

Process of CE Marking ( self-certification mode )

1. Study which directive/s is applicable

2. Determine which standard/s are applicable

3. Test your product to ascertain if it complies

4. Make a test report

5. Make Technical Construction File:

Technical documentation - The manufacturer must draw up a technical Construction file (TCF). The technical documentation is intended to provide information on the design, manufacture and operation of the product.

6. Prepare a technical file documenting compliance with the applicable

requirements.

7. Prepare and sign a manufacturer’s self-declaration of conformity.

8. Apply the CE Mark to the product.

9. Ship the product to the European Union with a copy of the signed

declaration of conformity.

NOTE:

High risk products cannot be self certified

Higher risk products will also call for implementation and certification of the designated Quality Management System.

Process of CE Marking ( third party-certification mode )

The steps essentially remain the same.

In this case, the test must be witnessed by a Notified Body.

The test report will be made by the Testing Laboratory, and declaration will be made by the Notified Body.

The CE Mark will carry a number linking to the Notified Body.

DISCLAIMER: This matter is reproduced here as a guide only. For authentic and up-to-date information,
please contact the Notified Body.

How to reproduce the CE Mark ?

The CE mark is covered by Council Decision 93/465/EC. Annex B(d) gives these guidelines:

1. The CE conformity marking must consist of the initials 'CE' taking the following form:

ce mark

If the CE conformity 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.

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