CE marking is a declaration by the manufacturer that meets all the appropriate provisions of the relevant legislations implementing certain European Directives. CE marking gives companies easier access into the European market to sell their products without adaptation or rechecking. The initials “CE” do not stand for any specific words but are a declaration by the manufacturer that his product meets the requirements of the applicable European Directives.
We offer a full range of Self Certification and through notified body for CE Mark compliance and CE management services for any industry across the globe. CE marking services are quality certification services used to indicate conformity with the essential health and safety requirements set out in European Directives.
The first step to compliance is determining which directives apply to the product. A product may be regulated by more than one directive. The CE mark does not disclose which directive(s) or standards apply to the product, nor will it indicate the method of conformity assessment used to bring the product into compliance. This information is provided by other accompanying documents, such as the Declaration of Conformity. The Manufacturer or the Authorized Representative affixes the CE marking to the product. It is not affixed by a Notified Body.
List of New Approach directives for CE Marking:
90/396/EEC Appliances burning gaseous fuels
2000/9/EC Cableway installations designed to carry persons
89/106/EEC Construction Products
2004/108/EC Electromagnetic compatibility
94/9/EC Equipment and protective systems in potentially explosive atmospheres
93/15/EEC Explosives for civil uses
95/16/EC Lifts
2006/95/EC Low voltage equipment
2006/42/EC Machinery safety
2004/22/EC Measuring instruments
90/385/EEC Medical devices: Active implantable
93/42/EEC Medical devices: General
98/79/EC Medical devices: In vitro diagnostic
92/42/EEC New hot-water boilers fired with liquid or gaseous fluids (efficiency requirements
90/384/EEC Non-automatic weighing instruments
94/62/EC Packaging and packaging waste
89/686/EEC Personal protective equipment
97/23/EC Pressure equipment
1999/5/EC Radio and telecommunications terminal equipment
94/25/EC Recreational craft
87/404/EEC Simple pressure vessels
88/378/EEC Toys safety
The steps of CE marking and CE certification procedure
Step 1: Identify the Directive(s) that are applicable to your product. You can download these directives free of charge from the www.newapproach.org website.
Step 2: Identify the conformity assessment procedure that must be taken. This could be self-declaration, involve testing, inspection or quality system assessment from a Notified Body or a combination of these. The conformity assessment procedure will differ depending on your product and the Directive in respect of which you will be CE marking. If you are unsure about which procedure to take, please Contact Us for clarification at info@swisoindia.com
Step 3: Determine the dates by which you must take action. This will be the date that the Directive comes into force. The majority of directives are already in force. In these cases, it is an offence to place a product on the market without CE marking because it indicates a presumption of conformity with all relevant Legislation.
Step 4: Identify if there are any Harmonised European Standards applicable to your product. These are not always mandatory for manufacturers although there is a presumption that conformity to these standards will give conformity with the relevant part of the Directive. Whenever possible or appropriate, manufacturers should follow harmonised standards.
Step 5: Ensure the product complies with all the essential requirements of the Directive(s). Take appropriate measures to comply or identify existing data and test reports.
Step 6: Maintain Technical Documentation required by the Directive(s). Your technical documentation should support your compliance with the requirements of the Directive. It is essential to retain this documentation and get it assessed from SWISSCERT.
Step 7: Prepare the Declaration of Conformity and the required supporting evidence. The Declaration of Conformity along with the Technical Documentation should be available to Competent Authorities (EU Members) upon request.
Step 8: Check that no other purely national requirements exist in the countries where the product will be sold. These may include national standards, labeling or packaging requirements.
Step 9: Affix CE marking on your product and/or its packaging and accompanying literature as stated in the directive.
