“ CE” The logo is derived from the foreign language prefix of the European Community. In English, EurpeanCommunities begins with “ EC” , translated as “ Comply with European regulatory requirements ” . Because it is expressed in the French as: CommeunanteEuropenne, the prefix is: CE” The abbreviation of the European Commission is also “ EC” . Therefore, the symbol is represented as “ CE” .

 

There are two types of CE marks affixed to medical devices. That is, the CE certification mark without the identification number of the notified body and the CE certification mark with the identification number of the notified body.

 

If a notified body participates in the conformity evaluation process conducted by 3, it is usually marked with its identification number CE mark. The notified body is required to participate in all conformity evaluation procedures except those in accordance with Appendix VII. Therefore, the CE mark without identification number is only used for Class I medical devices that do not need sterilization and do not have measurement functions.

 

b.1. Advantages of the CE mark

 

According to the MDD, if devices bear the CE mark, they may be marketed in any member State of the European Union. In the European Union, the old accreditation system, which is still in force, can be used until the transition period (13 June 1998), but it is only necessary if the device placed on the market does not comply with the MDD requirements (i.e., no CE marking) &127.

 

b.2, the role of the CE mark

 

CE is a mandatory requirement that all medical device products sold to the EU market must be labeled “ CE” . In Europe, in addition to competent authorities such as industry and commerce inspectors who will check whether medical devices on the market bear the CE mark, customs will also only allow products with the CE mark to pass through the border. In addition, users of medical devices (doctors, hospitals) will also check whether they carry the CE mark when purchasing new devices. Obviously, the CE mark can be used as a device in the EU “ Pass ” .

 

b.3, the meaning of the CE mark on medical devices

 

The significance of the CE mark mainly has the following points:

 

— The device meets the basic requirements of 3MDD

 

— The device may be legally placed on the market within the European Union.

 

— The device has passed a corresponding conformance evaluation procedure.

 

The European Commission has published a list of 19 Member States that have transposed the Medical Device Directive (MDD) and Active Implantable Medical Device Directive (MIMD) into national legislation:

 

1. Austria; 2. Belgium; 3. Denmark; 4. Finland; 5. France; 6. Germany; Seven. Greece; 8. Iceland; 9. Ireland; 10. Italy; 11. Luxembourg; 12 Netherlands; 13. Norway &127; 14. Portugal; Fifteen. Spain; 16. Switzerland; 17. Sweden; 18. United Kingdom; 19. Liechtenstein.