CE Marking
Conformite Europene Why do I need CE ?
The CE marking is a product certification. CE is a French acronym for "Conformite Europene", which in English means European Conformity. CE mark on product signifies that a product has met EU health, safety, and environmental requirements, which also ensures consumer safety. CEmarking isMandatory for the Products, which are to be placed in EU countries. If product is not CE marked it may be rejected at the port of entry.
At present, 31 countries in EU ask for CE Mark and other countries are likely to ask for the same in the future.
Product must comply with the Directive(s) and the Standards set by the European Union. One ormoreDirectivesmay be applicable for the same product. Contact ICSto find out,which directives and standards are applicable to your products.
Which products need it?The products requiring CE marking include below directives
- Toy & safety Directives,
- Medical devices Directive
- Machinery Directive,
- LVD Directive,
- EMC Directive
- Radio and Telecom equipment Directive
- Construction Products Regulation,
- In vitro diagnostic devices Directive,
- Lifts Directive
- Personal protective equipments Directive
- There are about 35 Directives requiring CE marking.
Before a manufacturer or importer is allowed to affix CE-marking on his product, there are a few steps to be undertaken by the Manufacturer or his authorized representative.
Benefits of CE marking- Indicates to governments that the product can be legally sold within the European Union (EU) and the European Free Trade Area (EFTA)
- Ensures the product can move freely throughout the European Single Market
- Promotes public health and safety
- Enhances product credibility
- Leads to improved sales and greater customer satisfaction
- Ensures product compliance with the essential requirements of the relevant European health, safety and environmental protection legislation.
- Permits the withdrawal of the non conforming products by enforcement authorities
- Reduce liability claims, timescale and costs.
What should be the content of technical file?
Generally the technical file requires the following things
- Description of the product with model / variants
- Product's Drawing & Component Drawings etc
- Result of Risk Analysis
- Test Reports against applied Harmonized EN Standards
- Product Labels
- Instruction for Use
- Signed Declaration of Conformity
- Affix CE mark
Road Map to get CE Marking Certification
- From 1 July 2013, under the Construction Products Regulation (CPR), it became mandatory for manufacturers to apply CE marking to any of their products covered by a harmonised European standard (hEN) or a European Technical Assessment (ETA). This was a major change in the United Kingdom as affixing of CE marking under the old Construction Products Directive (CPD) had been voluntary. This, coupled with other changes introduced by the CPR, left the construction industry facing its most significant change for a decade in the way in which construction products were to be sold in Europe. - See more at: Click Here .
- ISO 9001 is being updated! ISO 9001 Quality Management Systems is under review, with the draft version now available for purchase. The final updated version is expected by the end of 2015. Learn more about the changes and how you can contribute to or purchase the draft version of ISO 9001:2015
- On 13 November, leaders from the European and Japanese standardization organizations have signed a joint Cooperation Agreement in Tokyo. The Cooperation Agreement between CEN, CENELEC and JISC provides a new framework for closer collaboration on various aspects of standardization, which will facilitate trade in goods and services between Europe and Japan.
- On July 11, 2014 the European Commission has published an updated list of European harmonized standards that pertain to the Machinery Directive (2006/42/EC) in the Official Journal of the European Union. Besides updates to existing standards, this list (2014/C 220/01) also contains 16 new standards
