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Arazy Group Home » CE Mark » CE Medical Devices » Class IIa/IIb Devices
 
 
Class IIa / IIb Devices
 
In order to CE mark Classes IIa and IIb devices. the following requirements should be met to this end:
  • The Manufacturer must implement a Medical Quality Management System that will comply with the requirements of the MDD 93/42/EEC directive. The best, it 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 Technical File should be prepared for each family of devices; it should contain product and manufacturing information as to the product Risk Analysis (according to EN/ISO 14971), operation manual or approved instructions included in the product, material safety data sheets, labeling and any other relevant documentation depending on the product type, as required 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 to be based in one of the countries member of the European Community.

  • The Company's QMS and Class IIa and IIb Technical Files 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 products 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.
These requirements shall be limited to the aspects of manufacture concerned with securing and maintaining sterile conditions
 
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