The “CE” logo is derived from the foreign language prefix of the European Community. In English, EuropeanCommunities has the prefix "EC" and is translated as "in compliance with European regulatory requirements." In French it's Commeunante Europenne and the first letter is “CE”. The abbreviation of European Commission is “EC”, too. So express the mark as “CE”.

 

　　CE markings placed on medical instruments are divided into two categories, one are CE marking with Identification number of notified body, the other one without it.

 

　　If a notified body Notified Body need to participate in conformity assessment procedures (except for the procedures in Appendix Ⅶ), So those CE-sign without identification number are only suitable for category I medical device dispense with sterilization and measuring function.
 

　　b.1、Advantages of CE-sign

 

　　According to MDD, A machine with CE certificate could be sold in any market of all member states of European Union. In the EU countries, the old accreditation system still in force can be used in the transition period (June 13, 1998),However, its application is limited to the equipment placed in the market which is not in accordance with the MDD requirement (ie no CE mark) & 127.

 

　　b.2、The role of the CE mark

 

　　CE is a mandatory requirement, all medical devices for EU market must have CE-sign. In Europe, medical devices on sale will be checked by officers in Companies Registration Office and only those with CE-sign are allowed to be brought across European borders. Furthermore, users like hospitals and doctors will check the sign when purchasing new devices. Obviously, CE certification mark is a kind of pass in European Union.
 

　　b.3、The meaning of the CE mark on medical devices

 

　　Following are the main points of CE-sign:

 

　　—The medical device meets basic requirements in 3MDD.

 

　　—The devices could be launched into market legally.

 

　　—The device has passes a corresponding conformity assessment procedure.
 

　　b.4、Now, The European Commission have announced the list of 19 member states which have converted MDD and MIMD into native laws and regulations:

 

　　1. Austria 2. Belgium 3. Denmark 4. Finland 5. France 6. Germany 7. Greece 8. Iceland 9. Ireland 10. Italy 11. Luxembourg 12. Netherlands 13. Norway 14. Portugal 15. Spain 16. Switzerland 17. Sweden 18. Sweden 19. Liechtenstein.