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