Register/Notify your MDD-Medical Devices and
IVDD-In Vitro Diagnostic Medical Devices in Europe by CE Marking
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What is CE Marking ?
Why is it called
How does CEM affect export to Europe?
In which countries is CEM required?
How many directives are there ?
What products need CEM ?
Which directive applys ?
How to obtain CE Marking ?
Who is going to enforce CEM ?
How can Wellkang help you ?
Why do I need a Representative in Europe ?
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CE Marking

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How many countries
are currently requiring CE Marking?

Are you ready for Brexit impacts? Do you have a Brexit contingency plan?

You may need either an EU/EC European authorized representative based in EU-27 countries or a UK Authorised Representative based in UK, or may need both EU & UK representatives, depending on different brexit scenarios.

Register/Notify your MD-Medical Devices & IVD-In Vitro Diagnostic Medical
Devices with MHRA in UK & other EEA (EU/EFTA) authorities by world-leading
consultancy- Wellkang team based in both UK (England) & EU-27 (Ireland).

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How many countries
are currently requiring products to bear CE Marking?

Total 30 (15+10+2+3) EEA* countries.

Before May 1, 2004 these were the 15 European Union (EU) member countries: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxemburg, the Netherlands, Portugal, Spain, Sweden and United Kingdom (Great Britain) plus the European Free Trade Association - EFTA's 3 member states: Iceland, Liechtenstein and Norway.

Since May 1, 2004, the following 10 new member states joined the EU, which also adopted the CE-Marking requirements:
Estonia, Latvia, Lithuania, Poland, Czech Republic, Slovakia, Hungary, Slovenia, Malta, and Cyprus.

Since January 1, 2007, Bulgaria and Romania joined the EU and adopted the CE-Marking requirements:

* 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.

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. What is UKCA marking (UK Conformity Assessed marking or UKCA mark)?
  3. The CE marking logo (Free download CE mark logo)
  4. Download of the EC Rep symbol/logo
  5. CE Marking (CE mark) EU/EC Declaration of Conformity: definition and required content
  6. What is a manufacturer? What are the responsibilities of a manufacturer?
  7. Is the Own Brand Labeller or Private Labeller considered as the legal Manufacturer?
  8. Why is CE marking called "European passport"?
  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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