CE Marking for MDD – 93/42/EEC

CE Marking for Medical Devices (MDD) – 93/42/EEC

CE Marking acts as a notified body for Medical Device Directives, intended to distribute medical devices within the European Economic Area. Covers all the medical products that are used in human body right from heart valves to scalps.

Following are the Directives of CE Marking that applies to all the manufacturers of medical devices:

  • MDD (Medical Devices Directive) includes all the general medical devices that are not covered by the Active Implantable Medical Devices Directives or In Vitro Diagnostics Directive.
  • AIMDD (Active Implantable Medical Devices Directive) covers all the active devices and related accessories destined to implant in humans permanently.
  • IVDD (In Vitro Diagnostics Directive) is applied to all the devices and various kits that are used away from the patient. This is done to diagnose the exact medical condition of a patient.

Our expert trainers will provide various training classes for understanding all the products under MDD, AIMD and IVVD. We will draft technical documentation and design as per the requirements of directives. You will get proper guidance by our experts in selection of perfect Conformity Assessment Procedure. We will make you learn the complete implementation of QMS as per ISO 13485 requirements and product evaluation as per the required standards. We will conduct Internal audit and prepare your business for final audit with the help of Notified Body and Certification of CE Marking.