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Class I Devices
 
CE marking of Class I devices meets the 93/42 EEC Medical Device Directives, Annexes VII and I. To this end, the following requirements should be met:
  • A Technical File for each family of devices should be prepared. This file should contain legal information, documentation, manufacturing process and performance of the product to show its effectiveness and safety. It includes the product Risk Analysis according to the EN 14971 harmonized European Standard, material safety data sheets, biocompatibility of materials, hygiene and sterility tests, manufacturing processes control procedures, operation manual/instructions, and any relevant documentation, as required by Exhibit I “Essential Requirements” of MDD, including clinical and medical support information. According to the type of device, some of these requirements may not apply.

  • Once the product Technical File has been completed, a copy is kept by the Authorized Representative (see next paragraph). He registers the Company and lists the product before the Competent Authorities and the process is completed. Competent Authorities analyze the registration forms and once they have been accepted, they issue an Official Register Letter in 1-2 months. After this, the CE marking can be applied on the product to be sold in Europe and other countries where CE certification is accepted as effective evidence of safety for medical instruments.

  • The product may be introduced in the European Common Market ONLY after the registration document had been placed with the Competent Authorities through the Authorized Representative.
 
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