Thursday, February 26, 2015

Ce marking requirements

What is CE compliant mean? Identify the directive (s) and harmonised standards applicable to the product. Check the product-specific requirements.


Identify whether an independent conformity assessment is required from a Notified Body. Test the product and check its.

The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements. There are specific rules to adhere to for the CE Marking. It is required for products manufactured anywhere in the world that are then marketed in the EU.


The Directives outline the saftey and performance requirements for medical devices in the European Union (EU). Create technical documentation, and 6. Verify the product’s specific requirements, 3.

This is probably the most widely used and recognized marking required by the EU. Select and appoint a European Authorized Representative to act on your behalf within the EU if you have no physical location in Europe. This process determines the existence of any hazards, the extent of any risks to people, animals, goods or the environment. The Regulation encompasses product safety requirements to protect the health and safety of users. The various RoHS markings seen on different pieces of equipment, are illegal and have no legal meaning or standing.


CE marking on a product is mandatory. This makes the CE marking recognizable worldwide even to those unfamiliar with the EEA. How does the CE Mark Work? CE Marking : Are there any size requirements on the CE logo itself?


A CE Mark is a symbol that must be affixed to many products before they can be sold on the European market. The CE marking has been put in place to ensure products on the market comply with the directives of the EU. The requirements range from knowing and complying with the directives to affixing the CE marking the right way. The CE marking (an acronym for the French Conformite Europeenne) certifies that a product has met EU health, safety, and environmental requirements , which ensure consumer safety.


Manufacturers in the European Union (EU) and abroad must meet CE marking requirements where applicable in order to market their products in Europe. The CE marking is applied by the manufacturer (or Authorized Representative, if mandated) on the product. The mark must be at least mm high, but this requirement is waived for small products under those Directives which require the logo to actually be marked on the product itself (as opposed to provided on the instructions or packaging).

All CE marking Directives either indicate the parameters for the marking or direct the reader to Annex II of Regulation no. CE marking is not mandatory in Switzerland but products bearing the CE mark are allowed on the Swiss market. CE marking is only required for goods exported from Switzerland to the EU (or EEA) which fall within the scope of EU directives.

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