What is CE Marking

• The letters "CE" are the abbreviation of French phrase "Conformité Européene" which
literally means "European Conformity". The term initially used was "EC Mark" and it was
officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993.
• CE marking indicates that a product has been assessed by the manufacturer and deemed to
meet EU safety, health and environmental protection requirements.
• By applying CE Marking on the product & issuing an “EU Declaration of Conformity” one
assures his product to be sold freely in any part of the European Economic Area (EEA)
irrespective of its country of origin.
 Countries that fall under EEA
Belgium Italy
Bulgaria Croatia
Cyprus Latvia
Denmark Liechtenstein
Germany Lithunia
Estonia Luxembourg
Finland Malta
France The Netherlands
Greece Norway
Hungary Austria
Ireland Poland
Romania Slovenia
Spain Czech Republic
Iceland Sweden
Benefits of CE Marking
 What is EU Directive
• Directive is a legislative act that sets out a goal that all EU
countries must acheive.

• Directives explain how manufacturers are able to

demonstrate conformity with the essesntial requirements.
 Categories of CE Marking
Medical Non-Medical Devices
Medical devices are categorised into into All devices or products that don't fall under

one of three classes – medical device category are considered

Class I, II, or III – based on their risks and as non medical devices.
the regulatory controls necessary to
provide a reasonable assurance
of safety and effectiveness.
 Types of Certification in CE
Marking
• Self Certification

• Certificate of Compliance

• Notified body
 Importance of CE
• Environment Friendly

• Safe for users

• Best Quality

• Product Expiration
 Steps to get CE Marking
• Identify the EU requirements of your product.
• Check whether your product meets the specific
requirements.
• Check whether your product needs to be tested by a
Notified body.
• Test your product
• Compile the technical file
• Drafting of Declaration of Conformity
Products not Certified under CE
• Food items

• Cosmetics

• Pharmaceuticals