In order to CE mark Class III devices the following requirements should be met to this end:

• The Manufacturer must implement a Medical Quality Management System that will comply with the requirement of the MDD 93/42/EEC directive. The best is to adopt a harmonized standard such as ISO 13485:2003 which s now the gold QMS standard in this Industry. In addition, we recommend, for commercial reasons, that this system should meet ISO 9001:2000, but ISO 9001:2000 alone does not comply with the requirements of the medical equipment directives. For more information, see CE QMS Requirements.
  
  
• A Design Dossier should be prepared for each class III device family; it should contain, among other elements, a general product description (including planned variations), design specifications and control and verification techniques used, standards applied to the design and outcome of the product Risk Analysis (according to EN/ISO 14971), operation manual and approved instructions included in the product, material safety data sheets, labeling, and any other relevant information in line with the product class, as requested in Annex I “Essential Requirements” of MDD 93/42/EEC, including clinical and medical support information (according to Annex X) and biocompatibility reports.
  
  
• • The Company will be asked to contract an Authorized Regulatory Representative based in one of the countries members of the European Union.

The Company's QMS and Class III Design Dossier are required to be audited by a Notified Body in order to obtain the CE mark approval. In this way, the Company will be authorized to sell the product in the European Union and many other countries outside Europe that have accepted the CE marking as an acceptable certification of efficiency and safety of medical devices.