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MEDICAL DEVICES

CODE 108670
ACADEMIC YEAR 2022/2023
CREDITS
  • 5 cfu during the 4th year of 8451 CHIMICA E TECNOLOGIA FARMACEUTICHE (LM-13) - GENOVA
  • 3 cfu during the 3nd year of 8451 CHIMICA E TECNOLOGIA FARMACEUTICHE (LM-13) - GENOVA
  • 4 cfu during the 4th year of 8452 FARMACIA (LM-13) - GENOVA
  • 6 cfu during the 5th year of 8452 FARMACIA (LM-13) - GENOVA
  • SCIENTIFIC DISCIPLINARY SECTOR CHIM/09
    LANGUAGE Italian
    TEACHING LOCATION
  • GENOVA
  • SEMESTER 2° Semester
    MODULES This unit is a module of:
    TEACHING MATERIALS AULAWEB

    AIMS AND CONTENT

    AIMS AND LEARNING OUTCOMES

    Medical devices are, together with medicines, a fundamental tool to ensure the current efficacy of the medical treatments. Their use in the diagnostic, therapy and rehabilitation fields is essential, and this justifies the development of this world market and its distinctive and strong technological innovativeness. The knowledge of the medical device definition and classification, together with the knowledge of the rules regulating their production, control, marketing and surveillance, represents an important basis for Pharmacy and CTF graduates, who can look towards this area as an interesting occupational field.

    The aim of these lessons is: to present the regulatory classification of medical devices; to provide a basic knowledge of the rules regulating the production, control, marketing and surveillance of medical devices, differentiated on the basis of the risk class; to mention some aspects related to the national regulation (CND classification). At the end of the course, the student should possess the fundamental knowledge of the definition and classification of medical devices and of IVD medical devices, and of the related rules regulating their production and marketing.

    TEACHING METHODS

    The course includes 8 hours of frontal lesson, with the support of the didactic material provided to the students through Aulaweb.The course includes 8 hours of frontal lesson, with the support of the didactic material provided to the students through Aulaweb.The course includes 8 hours of frontal lesson, with the support of the didactic material provided to the students through Aulaweb.

    SYLLABUS/CONTENT

    • Definition of medical device
    • Regulatory classification of medical devices
    • Technical and regulatory aspects regulating the production and marketing of medical devices and IVD medical devices

    RECOMMENDED READING/BIBLIOGRAPHY

    The attendance to the lessons and the material provided on Aulaweb are sufficient to prepare the final exam. For further detailed-study, the recommended texts are the following:

    • Regulation (EU) 2017/745
    • Regulation (EU) 2017/746

     

    TEACHERS AND EXAM BOARD

    Exam Board

    BRUNO TASSO (President)

    ELEONORA RUSSO

    LESSONS

    Class schedule

    All class schedules are posted on the EasyAcademy portal.

    EXAMS

    EXAM DESCRIPTION

    The exam involves passing a written test composed of multiple-choice questions.

    ASSESSMENT METHODS

    The exam evaluates the knowledge of the regulatory classification of medical devices and of the main rules regulating their production and marketing.