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CE Marking Presentation

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Dr Madhu Aman Sharma
Dr Madhu Aman Sharma

Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health, and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU. When is CE marking mandatory? CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking. Some products are subject to several EU requirements at the same time. You must make sure that your product complies with all the relevant requirements before affixing the CE marking to it. It is forbidden to affix the CE marking to products for which EU specifications do not exist or do not require the affixing of CE marking.

Presentations & Public Speaking
1 of 21
01 CE Marking Awareness Training www.k2amanagement.com
CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA) 02 www.k2amanagement.com
03 Why CE marking is required? www.k2amanagement.com
04 Growth really does matter CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.
05 When is CE marking mandatory? CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking.. www.k2amanagement.com
06 What Products Need CE Marking? • Toys • Machinery • Electrical /electronic equipment • Personal protective equipment • Radio equipment • Medical devices • Active implantable medical devices • In vitro diagnostics • Simple pressure vessels • Gas appliances • Lifts www.k2amanagement.com • Recreational craft • Equipment and protective systems for use in explosive atmospheres • Non-automatic weighing instruments • Cableways • Construction products • Explosives for civil use • New hot water boilers • Measuring Equipment • Pressure equipment
07 CE Directive 2006/42/EC on Machinery Scope of the Machinery Directive This Directive applies to the following products: a. machinery; b. interchangeable equipment; c. safety components; d. lifting accessories; e. chains, ropes and webbing; f. removable mechanical transmission devices; g. partly completed machinery. www.k2amanagement.com
08 Regulation (EU) No 305/2011 on Construction Products Scope of the (EU) 305/2011 Regulation This Regulation applies to Construction Products. www.k2amanagement.com
09 Regulation (EU) 2017/745 on Medical Devices Scope of the (EU) 2017/745 Regulation This Regulation Scope of the Medical Devices Regulation www.k2amanagement.com
10 Regulation (EU) 2016/425 on Personal Protective Equipment Scope of the Regulation on Personal Protective Equipment This Directive applies to personal protective equipment (PPE). www.k2amanagement.com
11 CE Directive 2009/48/EC on Toy Safety Scope of the Toy Safety Directive This Directive applies to products designed or intended, whether or not exclusively, for use in play by children under 14 years of age. www.k2amanagement.com
12 CE Directive 98/79/EC on in vitro diagnostic medical devices Scope of the In Vitro MD Directive This Directive applies to in vitro diagnostic medical devices and their accessories. www.k2amanagement.com
07 How to obtain CE marking? As the product's manufacturer, you bear sole responsibility for declaring conformity with all requirements. You don't need a license to affix the CE marking to your product, however, before doing so, you must: www.k2amanagement.com
1 Identify Applicable EU Derivative(S) 3 Identify Appropriate Route of Conformity 5 Write Product Technical Documents 2 4 Identify Applicable EU Derivative Requirements for Your Product Assessment of the Product Confirmity 07 www.k2amanagement.com
08 Technical dossier documenting conformity Your technical dossier should include all the documents that prove that your product complies with the technical requirements. www.k2amanagement.com
09 Efficient systems are put in place The technical documentation provides information on the design, manufacture, and operation of a product and must contain all the details necessary to demonstrate the product conforms to the applicable requirements. www.k2amanagement.com
10 How to demonstrate compliance with EU rules? Harmonised standards are developed by recognised European Standards Organisations: CEN, CENELEC, or ETSI. Following harmonised standards in the design and manufacture of your products will ensure your products are in line with corresponding EU rules; this is known as ‘presumption of conformity'. www.k2amanagement.com
11 Sign off EU declaration of conformity As a manufacturer, it is your responsibility to draw up the EU declaration of conformity www.k2amanagement.com
12 USE CE MARK www.k2amanagement.com
13 Tech know-how Comply with CE Marking is a critical issue when you place your product in EU market. We at K2A Management understand the Process and provide ypu full guidance and support in complying with EU regulation requirements. www.k2amanagement.com
14 CONTACT US K2A Management # 94 SPRING PARKLAND, DUDLEY, BIRMINGHAM, UK #346 STREET 21 BT, KHAN MEANCHEY, PHNOM PENH, CAMBODIA www.iso- certifications.com www.k2amanagement.co m Find Us on Social

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CE Marking Presentation

  • 2. CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA) 02 www.k2amanagement.com
  • 4. 04 Growth really does matter CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.
  • 5. 05 When is CE marking mandatory? CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking.. www.k2amanagement.com
  • 6. 06 What Products Need CE Marking? • Toys • Machinery • Electrical /electronic equipment • Personal protective equipment • Radio equipment • Medical devices • Active implantable medical devices • In vitro diagnostics • Simple pressure vessels • Gas appliances • Lifts www.k2amanagement.com • Recreational craft • Equipment and protective systems for use in explosive atmospheres • Non-automatic weighing instruments • Cableways • Construction products • Explosives for civil use • New hot water boilers • Measuring Equipment • Pressure equipment
  • 7. 07 CE Directive 2006/42/EC on Machinery Scope of the Machinery Directive This Directive applies to the following products: a. machinery; b. interchangeable equipment; c. safety components; d. lifting accessories; e. chains, ropes and webbing; f. removable mechanical transmission devices; g. partly completed machinery. www.k2amanagement.com
  • 8. 08 Regulation (EU) No 305/2011 on Construction Products Scope of the (EU) 305/2011 Regulation This Regulation applies to Construction Products. www.k2amanagement.com
  • 9. 09 Regulation (EU) 2017/745 on Medical Devices Scope of the (EU) 2017/745 Regulation This Regulation Scope of the Medical Devices Regulation www.k2amanagement.com
  • 10. 10 Regulation (EU) 2016/425 on Personal Protective Equipment Scope of the Regulation on Personal Protective Equipment This Directive applies to personal protective equipment (PPE). www.k2amanagement.com
  • 11. 11 CE Directive 2009/48/EC on Toy Safety Scope of the Toy Safety Directive This Directive applies to products designed or intended, whether or not exclusively, for use in play by children under 14 years of age. www.k2amanagement.com
  • 12. 12 CE Directive 98/79/EC on in vitro diagnostic medical devices Scope of the In Vitro MD Directive This Directive applies to in vitro diagnostic medical devices and their accessories. www.k2amanagement.com
  • 13. 07 How to obtain CE marking? As the product's manufacturer, you bear sole responsibility for declaring conformity with all requirements. You don't need a license to affix the CE marking to your product, however, before doing so, you must: www.k2amanagement.com
  • 14. 1 Identify Applicable EU Derivative(S) 3 Identify Appropriate Route of Conformity 5 Write Product Technical Documents 2 4 Identify Applicable EU Derivative Requirements for Your Product Assessment of the Product Confirmity 07 www.k2amanagement.com
  • 15. 08 Technical dossier documenting conformity Your technical dossier should include all the documents that prove that your product complies with the technical requirements. www.k2amanagement.com
  • 16. 09 Efficient systems are put in place The technical documentation provides information on the design, manufacture, and operation of a product and must contain all the details necessary to demonstrate the product conforms to the applicable requirements. www.k2amanagement.com
  • 17. 10 How to demonstrate compliance with EU rules? Harmonised standards are developed by recognised European Standards Organisations: CEN, CENELEC, or ETSI. Following harmonised standards in the design and manufacture of your products will ensure your products are in line with corresponding EU rules; this is known as ‘presumption of conformity'. www.k2amanagement.com
  • 18. 11 Sign off EU declaration of conformity As a manufacturer, it is your responsibility to draw up the EU declaration of conformity www.k2amanagement.com
  • 20. 13 Tech know-how Comply with CE Marking is a critical issue when you place your product in EU market. We at K2A Management understand the Process and provide ypu full guidance and support in complying with EU regulation requirements. www.k2amanagement.com
  • 21. 14 CONTACT US K2A Management # 94 SPRING PARKLAND, DUDLEY, BIRMINGHAM, UK #346 STREET 21 BT, KHAN MEANCHEY, PHNOM PENH, CAMBODIA www.iso- certifications.com www.k2amanagement.co m Find Us on Social