Scope of Work of SAMD

The SAMD shall be responsible for:

·         Managing the National Medical Device Information Sys­tem

·         Managing the database of persons placing medical devices  on market and database of adverse events.

·         Ensuring accessibility of information and communication with the European database of medical devices

·         Provision the clinical evaluation of medical devices.

·         Medical devices classification according to MDD

·       Information and investigation of adverse incidents includ­ing the communication/collaboration with European Com­mission and member states of European Economic Zone related to them.

·      State Supervision over compliance with the requirements  set by the medical devices law and legislation established on the basis of it: market supervision, notified bodies, manufacturers, supervision over the notification and in­vestigation of adverse events, the organization of clinical investigations; deciding on application of the rule for clas­sification of medical devices in the event of a dispute be­tween the manufacturer and notified body.

·         Inspection of conformity of medical devices to requirements.

      ·       Contestation of preceptor act.

      ·       Set up national standards for the most frequently used  medical devices.