OVERVIEW

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 devices 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.

AIMS AND CONTENT

LEARNING OUTCOMES

This course aims to introduce the definitions of medical device and of in vitro diagnostic (IVD) medical device, and to illustrate the regulatory classification and the description of the different types of medical devices, analyzing the European regulations establishing the quality, efficacy and safety requirements that these products must fulfill to be placed on the market.

The objectives of the course are: to classify and compare from a regulatory point of view the different types of medical devices and IVD medical devices, discerning them from other kinds of products like medicines, medical-surgical devices and cosmetic products; to provide a basic knowledge of the rules regulating the production, control, marketing and surveillance of these products; to define the role of the national and international institutions ruling and monitoring the production and the marketing of these products.

AIMS AND LEARNING OUTCOMES

The aim of these lessons is: to present the regulatory classification of medical devices; to provide 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); to describe from a technological point of view some medical devices considered relevant for their widespread diffusion in clinical practice and routine use, or for their marked innovative nature.

At the end of the course, students will be able to describe the key aspects of the regulations governing medical devices and in vitro diagnostic medical devices, and will be able to distinguish these two types of products and differentiate them from other products, such as medicinal products. Furthermore, students will be able to technologically describe some of the medical devices and in vitro diagnostic medical devices discussed in class.

PREREQUISITES

Not necessary.

TEACHING METHODS

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

Any student with documented Specific Learning Disorders (SLD), or with any special needs, shall reach out to the Lecturer and to the dedicated SLD Representative in the Department (Prof. Luca Raiteri, Luca.Raiteri@unige.it) before class begins, in order to liaise and arrange the specific learning methods and ensure proper achievement of the learning aims and outcomes. VERY IMPORTANT: any request for compensatory tools and adaptations in the exam MUST be done within 10 working days before the date of the exam according to the instructions that can be found at https://unige.it/disabilita-dsa/comunicazioni.

SYLLABUS/CONTENT

• Definition of medical device
• Regulatory classification of medical devices
• Technical and regulatory aspects regulating the production and marketing of medical devices and in vitro diagnostic medical devices
• Description of some medical devices and in vitro diagnostic medical devices, selected on the basis of their widespread use in clinical practice and routine use (e.g. rapid tests for Covid-19, pregnancy tests) or their technological innovation

RECOMMENDED READING/BIBLIOGRAPHY

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

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

TEACHERS AND EXAM BOARD

LESSONS

LESSONS START

Visit the following webpage: https://corsi.unige.it/corsi/8451/studenti-orario

The timetable for this course can be found at: Portale EasyAcademy.

Class schedule

The timetable for this course is available here: Portale EasyAcademy

EXAMS

EXAM DESCRIPTION

The exam involves passing a written test composed of multiple-choice questions and one open-ended question.

ASSESSMENT METHODS

The exam will assess knowledge of the classification of medical devices and in vitro diagnostic medical devices, as well as the main regulations governing their production and marketing. The ability to describe the functioning of selected devices discussed in class will also be assessed.

Furthermore, assessment parameters include:

• mastery of the subject matter;

• the ability to comprehensively address the required topics;

• the quality of the presentation and the correct use of specialized vocabulary.

FURTHER INFORMATION

Contact the teacher for further information not included in the teaching sheet.