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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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How does CEM affect export to Europe?
In which countries is CE Marking required?
How many directives are there ?
What products need CEM ?
Which directive applys ?
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CE Marking

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How
affect export to Europe ?

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How does CE Marking
affect the export to Europe?


If the new product directives apply to your products and you want to continue to export to the European market (or introduce new products), then CE Marking will be crucial to your success.

It is NOT unusual nowadays that non-EU manufacturers and exporters have had their product(s) seized by customs officials in the European Union at the worst or returned to them because they do not have the CE marking affixed to the product(s).

The CE Marking can be, at the same time, of both benefits and disadvantages.
Benefits:
  • With this "passport" your products can easily gain access to the entire European Union (EU) plus European Free Trade Association (EFTA) market.
  • There will be only one set of laws and regulations for the entire marketplace which guide the designing, manufacturing and labeling of products. The multiple and conflicting national restrictions on regulated products will be eliminated. Thus the CE Marking on your product will make your trade with EU countries cheaper and easier.
  • Your product will be made safer for consumers and thus the damage claims and liability premiums will be reduced.

Disadvantages:
  • New product directives may exceed the current national laws and regulations. It may cost a manufacturer extra to modify the currently existed design and/or production line in order to continue exporting to or gain access to this huge European market.
  • Extra costs in obtaining the product Certificate of Registration for CE Marking and any, if applicable, required testing certification.
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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:-

  1. What is CE marking (CE mark)?
  2. The CE marking logo (Free download CE mark logo)
  3. Download of the EC Rep symbol/logo
  4. CE Marking (CE mark) EU/EC Declaration of Conformity: definition and required content
  5. What is a manufacturer? What are the responsibilities of a manufacturer?
  6. Is the Own Brand Labeller or Private Labeller considered as the legal Manufacturer?
  7. Why is CE marking called "European passport"?
  8. Does my product need CE Marking in order to be sold/exported on/to the European Market?
  9. How to obtain CE Marking for my product?
  10. How can Wellkang Tech Consulting help me to obtain CE Marking for my product?
  11. Wellkang can be your Authorized Representative in Europe for CE Marking purpose !
  12. Complete list of all CE Marking Directives and Guidelines to Directives
  13. Complete list of all (more than 1000) Notified Bodies for CE marking
  14. Complete list of all European and/or international standards related to CE marking
  15. 85/374/eec: Directive of Liability for Defective Products (for all products)
  16. 1999/34/ec: Directive of Liability for Defective Products (amending) (for all products)
  17. 2000: (Proposal for a new) General Products Safety Directive (for all products)
  18. 92/59/eec: Directive of General Products Safety (for all products)
  19. 93/68/eec: "CE Marking" Directive (for all products)
  20. 93/465/eec: Conformity Assessment Procedures & CE Marking Rules, & Annex (for all products)
  21. Guide to Implementation of directives based on new approach & global approach (for all products)
  22. 73/23/eec: Directive of Low Voltage Electrical Equipment
  23. Guideline to Low Voltage Directive (LVD) 73/23/eec & Annex I, II
  24. 2000&2001 Framework of implementation of (LVD) Directive 73/23/eec
  25. 87/404/eec: Directive of Simple Pressure Vessels
  26. 88/378/eec: Directive of Toys & Annex I, II, ... IV
  27. 89/106/eec: Directive of Construction Products
  28. 89/336/eec: Directive of Electromagnetic Compatibility (EMC)
  29. Guideline to Directive of Electromagnetic Compatibility (EMC) 89/336/eec
  30. Communication 2000 in framework of implementation of EMC Directive 89/336/EEC
  31. 89/686/eec: Directive of Personal Protective Equipment (PPE)
  32. 90/384/eec: Directive of Non-automatic Weighing Instruments
  33. 90/396/eec: Directive of Appliances Burning Gaseous Fuels (AppliGas)
  34. 2001 Commission Communication in Framework of Impl (AppliGas) Directive 90/396/eec
  35. 92/42/eec: Directive of Efficiency of (Liquid or Gaseous fueled) Hot Water Boilers
  36. 93/15/eec: Directive of Explosives for Civil Uses
  37. 93/42/eec: Directive of Medical Devices
  38. 2001 Guidelines for Classification of Medical Devices
  39. Guidelines relating to the demarcation between Directives 90/385/eec, 93/42/eec and 65/65/eec.
  40. 90/385/eec: Directive of Active Implantable Medical Devices
  41. 98/79/ec: Directive of In Vitro Diagnostic Medical Devices
  42. Guidelines to Medical Devices Vigilance System
  43. List of Harmonised (European) Standards for Medical Devices
  44. List of Notified Bodies for Medical Devices Directive
  45. 93/65/eec: Directive of Air Traffic Management Equipment & Systems
  46. 94/9/ec: Directive of Equipment used in Potentially Explosive Atmospheres (Atex)
  47. Guidelines to directive 94/9/ec (Atex)
  48. 94/25/ec: Directive of Recreational Craft
  49. 95/16/ec: Directive of Lifts
  50. 96/48/ec: Directive of Trans-European High-speed Rail System
  51. 96/57/ec: Directive of Energy Efficiency: Household Refrigerators & Freezers
  52. 96/98/ec: Directive of Marine Equipment
  53. 98/37/ec: Directive of Machinery
  54. 2000: Comments on Directive of Machinery 98/37/ec
  55. 99/5/ec: Directive of Radio Equipment & Telecommunications Terminal Equipment (R&TTE)
  56. 2000/9/ec: Directive of Cableway Installations to Carry Persons
  57. 2000/14/ec: Directive of Noise Emission in the environment by equipment for use outdoors


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