All products entering the EU market must have a CE mark that represents a self-conformity declaration to indicate that the product complies with the relevant directives formulated by the EU. The directives that medical devices need to meet are the Active Implantable Medical Devices Directive (AIMDD, 90/385/EEC), the Medical Device Directive (MDD, 93/42/EEC) and the In Vitro Diagnostic Devices Directive (IVDD, 98 /79/EC).

   Medical Device Directive (MDD), the MDD Directive applies to most medical devices sold into the EU. It is divided into 6 levels according to different requirements for evaluation by certification bodies.

The harmonized assessment of the certification body includes the review of technical documents according to the essential requirements specified in the directive, and the review of the quality system according to standard EN 46001 or EN/ISO 13485. Contents required for medical equipment CE certification technical file:

   the name and address of the manufacturer/or European representative;

   product and model description;

  EC Declaration of Conformity;

  risk assessment;

  Basic safety checklist;

   applicable blending standards/or other standards;

  Market feedback and complaint analysis;

   Instructions for use and labels;

   authorized representative;

   lines, diagrams (if applicable);

  Calculations, test reports or other supporting materials;

   Inspection process and process description;

   Sterilization or other special process (if applicable);

  Packaging materials and methods for sterilization products;

  Quality system, quality manual;