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CE MARKING
Prepared By-
Ranjitha Nagara
WHAT CE MARKING
• CE marking is an administrative marking with which the manufacturer
or importer affirms its conformity with European health, safety, and
environmental protection standards for products sold within the
European Economic Area. It is not a quality indicator.
• The letters "CE" are the abbreviation of French phrase "Conformité
Européene" which literally means "European Conformity.
Requirements of CE MARKING
• Product is health to consumers
• Environmental friendly
• Safe for users
European Economic Area Countries under
EEA
Benefits of CE Marking
CE MARKING
• CE marking is divided into two categories
Medical products Non-medical products
Class 1 Stationary
Battery
Class 2A 2B Switches
Electrical wire/equipments
Class 3A 3B 3C Electronics
Toys
Machinery
Sunglasses
Watches
CE Marking Directives
TYPES OF CERTIFICATION
• Self certification – here the product is being conformed by the
manufacturer itself keeping the directives in mind. This doesn’t hold much
value as it is not certified by any certification body.
• Certificate of Compliance – Independent certification body or 3rd party
body conducts test and see whether the product is up to the requirements
of EU directives before certifying them officially.
It is a non-notified body and is usually given for non-medical and low risk
product.
• Notified body are Certification body registered under EEA whose approval
is required to get a CE marking done on the product which holds greater
value than the rest.
DOCUMENTS REQUIRED FOR CE MARK
MEDICAL DEVICES
• ISO 13485:2016 FROM MANUFACTURER
DOCUMENTS REQUIRED FOR CE MARK NON-
MEDICAL DEVICES
• ISO 9001, ISO 14001, ISO 45001
CE MARKING.pptx
CE MARKING.pptx
CE MARKING.pptx

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CE MARKING.pptx

  • 2. WHAT CE MARKING • CE marking is an administrative marking with which the manufacturer or importer affirms its conformity with European health, safety, and environmental protection standards for products sold within the European Economic Area. It is not a quality indicator. • The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity.
  • 3. Requirements of CE MARKING • Product is health to consumers • Environmental friendly • Safe for users
  • 4. European Economic Area Countries under EEA
  • 5. Benefits of CE Marking
  • 6. CE MARKING • CE marking is divided into two categories Medical products Non-medical products Class 1 Stationary Battery Class 2A 2B Switches Electrical wire/equipments Class 3A 3B 3C Electronics Toys Machinery Sunglasses Watches
  • 8. TYPES OF CERTIFICATION • Self certification – here the product is being conformed by the manufacturer itself keeping the directives in mind. This doesn’t hold much value as it is not certified by any certification body. • Certificate of Compliance – Independent certification body or 3rd party body conducts test and see whether the product is up to the requirements of EU directives before certifying them officially. It is a non-notified body and is usually given for non-medical and low risk product. • Notified body are Certification body registered under EEA whose approval is required to get a CE marking done on the product which holds greater value than the rest.
  • 9. DOCUMENTS REQUIRED FOR CE MARK MEDICAL DEVICES • ISO 13485:2016 FROM MANUFACTURER
  • 10. DOCUMENTS REQUIRED FOR CE MARK NON- MEDICAL DEVICES • ISO 9001, ISO 14001, ISO 45001