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Regulatory affairs executive of a medical device company

Shape field (scope)

The scheme Regulatory Affairs Executive of a medical device company TÜV HELLAS concerns a specialized professional who handles issues regarding the specific European and National regulatory framework for Medical Devices (EU regulations & Greek legislation) in companies that trade, distribute or produce medical devices.

Cognitive framework (syllabus)

  • Definitions of Medical Devices
  • Certification procedure
  • Obligations and roles of economic operators
  • European Directives, Regulations, MEDDEVs, Borderline Manual
  • Procurement legislation
  • Ministerial Decision on the Circulation of Medical Devices
  • Decisions and Circulars of the Ministry of Health and EOF, ISO 13485 & ISO 9001 & ISO 14971 requirements related to the regulatory framework of Medical Devices
  • Medical Device Codifications
  • Code of Conduct for Collective Bodies
  • Information referred to in a CE Mark certificate, a Product Declaration of Conformity and an Attestation for the YA DY8/1348/2004
  • Procedure for registration of products in the Registers, Knowledge of the requirements for making product information available
  • Knowledge of labelling requirements
  • Knowledge of medical device performance monitoring requirements
  • Definition of adverse event
  • Specific requirements of the Competent Authority regarding the handling of adverse events

Test methodology

Theoretical examination

Certification requirements

At least secondary education and relevant professional experience

Contact Information