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IVDD-In Vitro Diagnostic Medical Devices in Europe by CE Marking
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What is CE Marking ?
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CE Marking

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Why is CE Marking
 called the "Passport to Europe" ? 

CCC-mark.com

Why is CE Marking called-
the "Passport to Europe" for non-EU products?

The European Union's 'New Approach directives' are mandatory on all member countries to enact through national legislation.

This legislation requires manufacturers to display CE Marking on their product, packaging and accompanying literature. Where a new approach directive is in force, it is (with few exceptions) an offence to place a product on the market without CE Marking. The manufacturer is legally responsible for ensuring that the product confirms to the requirements of the directive and for applying CE Marking.

CE Marking is one important measure that the EU has adopted to establish the single market and foster economic development for the member states. The objective of the directives is to simplify the movement of goods into and within the EU. This may eventually lead to the free movement of goods throughout Europe as more and more european countries are expected to join the EU. The European Commission thus refers to the CE Marking as a "Passport" which allows products to be freely circulated within the EU single market.
Often, consumers will consider CE Marking on a product as an indication of conformance to laid down minimum standards, and therefore a minimum level of quality which other products may lack. CE Marking is thus for many consumers a "Symbol of Quality." Being a manufacturer exporting to EU, if you have not got your products fixed with CE Marking, it is now time to invest in it. A CE Marking on your product will be more valuable than millions of dollars spent on TV advertising. Nowadays, it is not unusual to see some high-quality, even known brand, products have to appear in Second-hand Stores (which sells used products) or on street-vendor's Stands. Why? lack CE Marking!

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Please click the following links to learn more about every CE-Marking-related European Union Directive, Guidelines to Directives, Frameworks of implementation of Directives, and Agreements on Mutual Recognition of conformity assessment between European Union and other countries such as USA, Japan, Canada, Australia, New Zealand and Israel:-

www.CE-marking.com

  1. Does my product need CE Marking in order to be sold/exported on/to the European Market?
  2. How to obtain CE Marking for my product?
  3. How can Wellkang Consultant Firm help me to obtain CE Marking for my product?
  4. Wellkang can be your Authorized Representative in Europe for CE Marking purpose !
  5. Buy a Directive or Guideline on Directive in Chinese, English, French, Portuguese and/or Spanish.
  6. Complete list of all CE Marking Directives and Guidelines to Directives
  7. new Complete list of all (more than 1000) Notified Bodies for CE marking
  8. new Complete list of all European and/or international standards related to CE marking
  9. 85/374/eec: Directive of Liability for Defective Products (for all products)
  10. 1999/34/ec: Directive of Liability for Defective Products (amending) (for all products)
  11. 2000: (Proposal for a new) General Products Safety Directive (for all products)
  12. 92/59/eec: Directive of General Products Safety (for all products)
  13. 93/68/eec: "CE Marking" Directive (for all products)
  14. 93/465/eec: Conformity Assessment Procedures & CE Marking Rules, & Annex (for all products)
  15. Guide to Implementation of directives based on new approach & global approach (for all products)
  16. 73/23/eec: Directive of Low Voltage Electrical Equipment
  17. Guideline to Low Voltage Directive (LVD) 73/23/eec & Annex I, II
  18. 2000&2001 Framework of implementation of (LVD) Directive 73/23/eec
  19. 87/404/eec: Directive of Simple Pressure Vessels
  20. 88/378/eec: Directive of Toys & Annex I, II, ... IV
  21. 2001 Framework of implementation of 88/378/eec: Directive of Toys
  22. 89/106/eec: Directive of Construction Products
  23. 2001 Guidance to 89/106/eec Directive of Construction Products
  24. 89/336/eec: Directive of Electromagnetic Compatibility (EMC)
  25. Guideline to Directive of Electromagnetic Compatibility (EMC) 89/336/eec
  26. Technical-Aspects relating Directive of Electromagnetic Compatibility (EMC) 89/336/eec
  27. Communication 2000 in framework of implementation of EMC Directive 89/336/EEC
  28. 89/686/eec: Directive of Personal Protective Equipment (PPE)
  29. Useful Facts relating to Directive (PPE) 89/686/eec
  30. 2001 Framework of implementation of (PPE) Directive 89/686/eec
  31. 90/384/eec: Directive of Non-automatic Weighing Instruments
  32. 90/396/eec: Directive of Appliances Burning Gaseous Fuels (AppliGas)
  33. 2001 Commission Communication in Framework of Impl (AppliGas) Directive 90/396/eec
  34. 92/42/eec: Directive of Efficiency of (Liquid or Gaseous fueled) Hot Water Boilers
  35. 93/15/eec: Directive of Explosives for Civil Uses
  36. 93/42/eec: Directive of Medical Devices
  37. 2001 Guidelines for Classification of Medical Devices
  38. Guidelines relating to the demarcation between Directives 90/385/eec, 93/42/eec and 65/65/eec.
  39. 90/385/eec: Directive of Active Implantable Medical Devices
  40. 98/79/ec: Directive of In Vitro Diagnostic Medical Devices
  41. Guidelines to Medical Devices Vigilance System
  42. new List of Harmonised (European) Standards for Medical Devices
  43. new List of Notified Bodies for Medical Devices Directive
  44. new Guidelines for Conformity Assessment of Breast Implants According to Directive 93/42/eec
  45. new Guidelines on Assessment of Medical Devices Incorporating Materials of Animal Origin
  46. new Guidelines on Medical Devices With Measuring Function
  47. new Guidelines on Medical Devices: Subcontracting – Quality System Related
  48. new Guidelines on Medical Devices: Treatment of Computers Used to Program Implantable Pulse Generators
  49. new Guidelines on Medical Devices: Demarcation with other Directives- Directive 89/336/EEC EMC & Directive 89/686/EEC PPE
  50. new Guidelines on Medical Devices: EMC Requirements
  51. new Guidelines on Medical Devices Labelling: USE-BY DATE
  52. new Guidelines on Medical Devices Labelling: Translation procedures
  53. new Guidelines on Homogeneous Production Batches
  54. 93/65/eec: Directive of Air Traffic Management Equipment & Systems
  55. 97/15/eec: amending Directive of Air Traffic Management Equipment & Systems
  56. 94/9/ec: Directive of Equipment used in Potentially Explosive Atmospheres (Atex)
  57. Guidelines to directive 94/9/ec (Atex)
  58. 2001 Framework of implementation of (Atex)Directive 94/9/ec
  59. 94/25/ec: Directive of Recreational Craft
  60. 2001 Proposed New Version for: directive 94/25/ec (RecCraft) 55p
  61. 2001 Guidelines&Framework: directive 94/25/ec (RecCraft)
  62. 95/16/ec: Directive of Lifts
  63. 96/48/ec: Directive of Trans-European High-speed Rail System
  64. 2001/16/ec: Directive of Interoperability of Trans-European Conventional Rail System
  65. 96/57/ec: Directive of Energy Efficiency: Household Refrigerators & Freezers
  66. 96/98/ec: Directive of Marine Equipment
  67. 97/23/ec: Directive of Pressure Equipment
  68. 2000&2001 Framework: directive 97/23/ec Pressure Equipment
  69. 98/37/ec: Directive of Machinery
  70. 2000: Comments on Directive of Machinery 98/37/ec
  71. Useful Facts relating to Machinery 98/37/ec
  72. 2001 Proposal to amend Directive of Machinery 98/37/ec
  73. 99/5/ec: Directive of Radio Equipment & Telecommunications Terminal Equipment (R&TTE)
  74. 2001 Framework of implementation of Directive 99/5/EC R&TTE
  75. 2001 Guidance on Directive 99/5/EC R&TTE
  76. 2000/9/ec: Directive of Cableway Installations to Carry Persons
  77. 2000/14/ec: Directive of Noise Emission in the environment by equipment for use outdoors
  78. 1999 Agreement on Mutual Recognition of conformity assessment between European Union and United States of America
  79. 2000 amendation to Agreement on Mutual Recognition of conformity assessment between European Union and United States of America
  80. 1998 Agreement on Mutual Recognition of conformity assessment between European Union and Canada
  81. 1998 Agreement on Mutual Recognition of conformity assessment between European Union and Australia
  82. 1998 Agreement on Mutual Recognition of conformity assessment between European Union and New Zealand
  83. 1999 Agreement on Mutual Recognition of conformity assessment between European Union and Israel
  84. 2001 proposal Agreement on Mutual Recognition of conformity assessment between European Union and Japan


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