CE marking of General Class devices (except for Self-testing Devices and Annex II Devices) meets IVDD 98/79 EEC In-Vitro Diagnostic Medical Devices Directive, Annex III. 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 general product description and variations, documents of the quality system, information on the design, description and explanation needed to understand the product characteristics and operation, outcome of the risk analysis, applicable standards, description of sterilization or cleaning procedures, outcome of design and inspections calculations, test reports, operation assessment data that evidence safe operation, labels and operational instructions, stability analysis results. According to the type of device, some of these requirements may not apply.
  
  
• According to such Directives, the Company is legally required to appoint an Authorized Representative based in one of the countries members of the European Union. Therefore, Medes Ltd. UK will provide representation services before the European Community Competent Authorities, and will act as Authorized Representative in all transactions involving these Authorities.
  
  
• Once the product Technical File has been completed, a copy is kept by the Authorized Representative. He registers the Company and lists the product before Competent Authorities and the process is completed. Competent Authorities analyze the registration forms and once they have been accepted, they issue an Official Record 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 devices.
  
  
• The product may be introduced in the European Common Market ONLY after the registration documents are placed with the Competent Authority by the Authorized Representative.
  
  
• It is recommended though NOT mandatory that the Company should adjust to a quality Management System including the organizational structure and responsibilities, manufacturing processes and systematic control of the production quality. In addition, procedures for surveillance and corrective actions should be in place.