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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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In which countries is CEM required?
How many directives are there ?
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Which directive applys ?
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CE Marking

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How to obtain
CE Marking for my product ?

How to achieve CE mark approval, CE testing and meet all CE mark requirements, for my product?

There are a series of steps outlined below for CE mark approval. Depending upon your product and the nature of the risks it presents:
  1. Determine if any directives apply to your product. If more than one applies you will have to comply with all of them.

  2. Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).

  3. Choose the conformity assessment procedure from the options (modules) called out by the directive for your product. There are several modules available for the Conformity Assessment Procedures as listed below:

    Module A: internal production control
    Module Aa: intervention of a Notified Body
    Module B: EC type-examination
    Module C: conformity to type
    Module D: production quality assurance
    Module E: product quality assurance
    Module F: product verification
    Module G: unit verification
    Module H: full quality assurance

The directives often use a series of questions about the nature of your product to classify the level of risk and refer to a chart called "Conformity Assessment Procedures". The chart includes all of the acceptable options available to a manufacturer to certify their product and affix the CE Marking.

Minimal Risk

Options for products with minimal risk include self certification where the manufacturer prepares a Declaration of Conformity and affixes the CE Marking to their own product.

Greater Risks

Many directives require products/systems with greater risks to be independently certified; this must be done by a "Notified Body". This is an organization that has been nominated by a Member Government and has been notified by the European Commission. Notified bodies serve as independent test labs and perform the steps called out by directives. They must have the necessary qualifications to meet the testing requirements set forth in the directives. Notified bodies may be a private sector organization or a government agency. Manufacturers may choose a notified body in any member state of the European Union. Lists of notified bodies are published by the European Commission in the Official Journal of the European Communities.

A Notified Body is usually able to offer some of the services required:

  • product testing
  • type examination certificate issue
  • Technical File and design dossier evaluation
  • surveillance of product and quality system
  • identification of standards

    If your products need to be certified by a Notified Body, then you will need to do as the follows:

  1. Select the applicable product standards and test methods for your product and select a Notified Body.

    Let Leading European Consultants help you to achieve CE Marking ! Click NOW !

  2. Establish an Authorized Representative in the European Union for your product.

    Some directives require that a manufacturer designate in the European Union an authorized representative to produce Technical Documentation (or sometimes called Technical File) in a timely fashion when called upon to do so. The CE Marking itself is not meant to provide details about the product to Surveillance Authorities.
    Technical Documentation (Technical File): The directives require for many products that a Technical Documentation (Technical File) be prepared by the manufacturer. The Technical Documentation (Technical File) holds information that verifies that the testing was conducted properly and that the product complies with applicable standards.

  3. Prepare a Declaration of Conformity.
    The Declaration of Conformity must contain information adequate for tracing the product back to the manufacturer or the authorized representative in the European Union. It may include a list the directives and standards that your product conforms to, product identification, the manufacturer's name, address and signature.
  4. Register your product in EU
    Many products, for instance, Class I Medical Devices, are required to be registered in the EU and, if proved, get a Certificate of Registration. Without this Certificate of Registration, the products are NOT allowed to be affixed with the CE Marking and be placed on the market.

  5. Affix the CE Marking to your product.
    There are specific rules to adhere to for the CE Marking. These rules address the size and location of the Marking; affixing the CE Marking to products, packaging and material or documents shipped with the product; and specific limitations on when and who is permitted to affix the 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:-

US FDA Agent service

  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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