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IVDD-In Vitro Diagnostic Medical Devices in Europe by CE Marking
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 CE Marking 
 The "Trade Passport to Europe" for non-EU Products 
Your One-Stop Information Source -
 Here you can find everything you need to know about CE marking: 
CE mark approval, CE testing, CE mark requirements, etc.

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      This website is the property of Wellkang® Tech Consulting, an international B2B regulatory consulting group. Wellkang is proud to present at this website with world's most comprehensive multi-lingual information guide on CE Marking.

CE Marking (CE-Marking), also known unofficially as "CE mark" or "EC Mark", as shown on the top of this page, is a mandatory mark for many (estimatively around 70%) of the products sold on the EFTA plus European Union (EU) single market (including totally 30 EEA* countries) and it is often referred as the "Trade Passport to Europe" for non-EU products.

EU legislation, e.g. EU directive concerning Liability for Defective Products, make EU importers liable for the products they import, including the machinery they provide to their employees for work. Many non-EU exporters are finding that no matter how interested a prospective EU importer may be in the product, the importer will NOT risk importing non-conforming products (i.e. the products without CE Marking) which, in case of accident, may generate legal action against them. The liability claims in a law suit can be as high as 70 millions EUROs.

CE Marking may be achieved through several modules. One of the most practical ways, which is preferred by many EU importers who are neither specialized in the complicated CE Marking process nor willing to take risk, is that the manufacturer designates an Authorized Representative in the EU member states who will handle the CE Mark approval, CE testing issues and ensure to meet the CE mark requirements, meanwhile the importers and/or distributors focus on the marketing and sales of the products.

The manufacturer may need only ONE Authorized Representative in EU whereas may have many importers and/or distributors. The Authorized Representative may in some cases register the product(s) in the EU member states and thus obtain a Certificate of Registration. The Product Certificate of Registration for CE Marking obtained from one EU member state is valid for the entire EFTA plus EU market, i.e. 30 countries.

In general, CE Marking is most probably required if you want to sell, to the 27 European Union (EU) and 3 European Free Trade Association (EFTA) member states, the following 22 groups of products:

    appliances burning gaseous fuels, cableway installations to carry persons, construction products, electrical equipment, equipment and protective systems for explosive atmospheres, explosives for civil uses, hot water boilers, household refrigerators & freezers, lift, machinery, marine equipment, measuring instruments, medical devices, active implantable medical devices, in vitro diagnostic medical devices, non-automatic weighing equipment, personal protective equipment, pressure equipment, simple pressure vessels, recreational craft, radio equipment & telecommunications terminal equipment, toys and trans-European conventional rail system.

* The European Economic Area (EEA):

The EEA includes EU countries and also Iceland, Liechtenstein and Norway. It allows them to be part of the EEA single market.

Switzerland is a member of EFTA, but neither an EU nor EEA member. It however is still part of the single market.

Click here >> you can find the definition of every group of products.

We are trying our best efforts to maintain this site as a one-stop FREE CE Marking (CE Mark) information source. Hope you may find everything you need to know about CE marking. Let world leading Wellkang Tech Consulting group help you in (CE Marking) CE mark approval, ce testing for Medical Devices (MDD), Personal Protective Equipment (PPE), Low Voltage Electrical Equipment (LVD), Electromagnetic Compatibility (EMC), Machinery, Toys, etc. Please click the following links to learn more about many 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. Examples of EEA/EU/UK CFS/FSC: Certificate of Free Sale (Free Sales Certificate) for Medical Device
  9. Does my product need CE Marking in order to be sold/exported on/to the European Market?
  10. How to obtain CE Marking for my product?
  11. How can Wellkang Tech Consulting help me to obtain CE Marking for my product?
  12. Wellkang can be your Authorized Representative in Europe for CE Marking purpose !
  13. Complete list of all CE Marking Directives and Guidelines to Directives
  14. Complete list of all (more than 1000) Notified Bodies for CE marking
  15. Complete list of all European and/or international standards related to CE marking
  16. 85/374/eec: Directive of Liability for Defective Products (for all products)
  17. 1999/34/ec: Directive of Liability for Defective Products (amending) (for all products)
  18. 2000: (Proposal for a new) General Products Safety Directive (for all products)
  19. 92/59/eec: Directive of General Products Safety (for all products)
  20. 93/68/eec: "CE Marking" Directive (for all products)
  21. 93/465/eec: Conformity Assessment Procedures & CE Marking Rules, & Annex (for all products)
  22. Guide to Implementation of directives based on new approach & global approach (for all products)
  23. 73/23/eec: Directive of Low Voltage Electrical Equipment
  24. Guideline to Low Voltage Directive (LVD) 73/23/eec & Annex I, II
  25. 2000&2001 Framework of implementation of (LVD) Directive 73/23/eec
  26. 87/404/eec: Directive of Simple Pressure Vessels
  27. 88/378/eec: Directive of Toys & Annex I, II, ... IV
  28. 89/106/eec: Directive of Construction Products
  29. 89/336/eec: Directive of Electromagnetic Compatibility (EMC)
  30. Guideline to Directive of Electromagnetic Compatibility (EMC) 89/336/eec
  31. Communication 2000 in framework of implementation of EMC Directive 89/336/EEC
  32. 89/686/eec: Directive of Personal Protective Equipment (PPE)
  33. 90/384/eec: Directive of Non-automatic Weighing Instruments
  34. 90/396/eec: Directive of Appliances Burning Gaseous Fuels (AppliGas)
  35. 2001 Commission Communication in Framework of Impl (AppliGas) Directive 90/396/eec
  36. 92/42/eec: Directive of Efficiency of (Liquid or Gaseous fueled) Hot Water Boilers
  37. 93/15/eec: Directive of Explosives for Civil Uses
  38. 93/42/eec: Directive of Medical Devices
  39. 2001 Guidelines for Classification of Medical Devices
  40. Guidelines relating to the demarcation between Directives 90/385/eec, 93/42/eec and 65/65/eec.
  41. 90/385/eec: Directive of Active Implantable Medical Devices
  42. 98/79/ec: Directive of In Vitro Diagnostic Medical Devices
  43. Guidelines to Medical Devices Vigilance System
  44. List of Harmonised (European) Standards for Medical Devices
  45. List of Notified Bodies for Medical Devices Directive
  46. 93/65/eec: Directive of Air Traffic Management Equipment & Systems
  47. 94/9/ec: Directive of Equipment used in Potentially Explosive Atmospheres (Atex)
  48. Guidelines to directive 94/9/ec (Atex)
  49. 94/25/ec: Directive of Recreational Craft
  50. 95/16/ec: Directive of Lifts
  51. 96/48/ec: Directive of Trans-European High-speed Rail System
  52. 96/57/ec: Directive of Energy Efficiency: Household Refrigerators & Freezers
  53. 96/98/ec: Directive of Marine Equipment
  54. 98/37/ec: Directive of Machinery
  55. 2000: Comments on Directive of Machinery 98/37/ec
  56. 99/5/ec: Directive of Radio Equipment & Telecommunications Terminal Equipment (R&TTE)
  57. 2000/9/ec: Directive of Cableway Installations to Carry Persons
  58. 2000/14/ec: Directive of Noise Emission in the environment by equipment for use outdoors
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