The course aims to make the student able to know the regulatory framework for the certification, production and marketing of medical devices in compliance with the regulations in force at national, European and international level. In this context, the objective is also to make the student learn what the regulations are related to medical devices also in the topics concerning clinical investigations.
The necessary prerequisites for this course are the knowledge acquired by the student in the field of medical devices of different types (invasive, active, implantable, diagnostic, therapeutic, ...).
The course is based on a series of lectures, held by the teacher and by experts in the field. Practical exercises will also be proposed to be carried out in groups that will involve the return of the results of the group work to the class.
The learning assessment will consist of a written test on the course topics, with 30 multiple choice theoretical questions and 3 exercises. The duration is 3 hours.
The course contents consist of the following topics:
The regulatory and normative context of the European Union for medical devices. Definition of medical device: qualification and classification of medical devices according to Regulation 2017/745 (MDR). The contents of the technical documentation required by Regulation 2017/745 (MDR). The risk management and clinical evaluation process. Clinical investigations and Good Clinical Practice. Quality Management System according to MDR and ISO 13485. Regulation in non-EU countries (in particular MDSAP and FDA in the USA).
Other information can be requested from the teacher or the CdS coordinator.
