Shape field (scope)
The scheme Regulatory Affairs Executive of a medical device company TÜV NORD Ελλάδας 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