 a 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)
RADIO and TELECOM EQUIPMENTS (R & TTE) go here - 87/404/EEC - Simple pressure vessels - 88/378/EEC - Safety of toys - 89/336/EEC - Electromagnetic compatibility - 89/686/EEC - Personal protective equipment - 90/385/EEC - Active implantable medical devices - 90/396/EEC - Appliances burning gaseous fuels - 94/9/EC - Equipment and protective systems intended for use in potentially explosive atmospheres - 94/25/EC - Recreational craft - 95/16/EC - Lifts - 96/98/EC - Marine equipment - 97/23/EC - Pressure equipment - 98/37/EC - Machinery - 99/5/EC - Radio and telecommunications terminal equipment - 99/36/EC - Transportable pressure equipment - 2004/22/EC - Measuring Instruments - 2006/95/EC - Low voltage - Energy efficiency requirements for household electric refirgerators, freezers and combinations thereof
- Energy efficiency requirements for ballasts for fluorescent lighting
- Energy labelling of household appliances
Recently added New Directives:
REACH - the new legislation for Chemicals go here
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, Instruction booklet for safe use and maintenance. NOTE: High risk products cannot be self certified
Higher risk products will also call for implementation and certification of the designated Quality Management System.
You cannot CE Mark your product, if there are no applicable Directives for your product. General Product Safety Directive is not to be counted
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. 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:  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. NOTE: CE and UL Marking is not concerned about the functionality of your product. The requirement is only that if your product fails, it must fail safely without causing injury/ damage to persons/ environment. CAUTION: 1. The liability of the manufacturer/ seller is huge. Even if your product is sold for 300 INR, you can be sued as much as 75 million Euros - in case of injury/ damage to persons/ environment 2. When you ship your product to the EU, if your CE Marking is not done properly, the Port Authority in the country can quarantine your products and you will have to pay demmurage. The case arises when you have not identified all the Directives in your DoC, or you have not tested as per the required IEC/EN Standards, or you have put the CE Mark when there is no applicable Directive 3. Even if you have used the servives of a Notified Body, the manufacturer will be sued, and not the Notified Body.
for contacting the right Notified Body in India, send us a brief right up about your product, and we will direct you to the right people
We are based in Mumbai, but we have reps all over India. for CE Marking Consultancy, Certification and Training CONTACT US NOW!
Services offered:
1. Identifying applicable directives and testing standards and testing labs for your products
2. determining if Self Certification is permissible
3. Risk Assssment
4. Making TCF
5. Identifying the right Notified Body
We can also assist you in UL/CSA Marking for exports to USA/Canada
For UL Mark, all the safety Critical itens in the BOM of your product have to be tested if it is not an UL registered component. Testing has to be done for these items as per UL Standards.
Self certification is not permitted.
DISCLAIMER: This matter here is a guide only. For authentic and up-to-date information, The DIRECTIVES and STANDARDS listed here have been subsequently REVISED . You must refer to the CURRENT REVISION and AMENDMENTS if any. |
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