Find out more about MIMT, the educational objectives of the new postgraduate course of Sapienza University of Rome, Confindustria Dispositivi Medici and Rome Technopole, as well as the educational results you will achieve.



The postgraduate course in Integrated Management of Medical Technologies Regulatory Affairs is the Level II University Master’s degree of 12 months which will allow young graduates and healthcare professionals and beyond to analyze and delve into the developments taking place in the medical devices sector, in particular concerning the regulatory and healthcare management world. The postgraduate course will train specialized figures who will be able to guide researchers and companies in the process of placing medical devices on the market in full compliance with regulations.

The Director explains

The continuous evolution of the medical devices sector leads to countless new  challenges and opportunities that require highly qualified and trained professionals. For these purposes, we are committed to providing academic excellence to train tomorrow’s leaders in the sector
with this postgraduate course. The aim of this Level II Master’s degree is to analyze and examine the developments taking place in the world of regulation and management, as well as to train specialized figures in the sector in order to teach them how to guide researchers and companies in the process of placing medical devices on the market in full compliance with regulations. We are certain that the participants will be ready to contribute to managerial and technological advancement within the medical devices sector at the end of the didactic program. Together with the entire scientific teaching committee, we are looking forward to seeing the success that our students will achieve through this stimulating educational path.

Prof. Iole Vozza

Objectives of the Level II Master’s degree

Understand the regulatory framework and examine the classification rules of the medical devices sector

The first aim of this postgraduate course is to provide participants with a solid understanding of the regulatory framework of medical devices in the European Union, focusing on Regulations (EU) 2017/745 and (EU) 2017/746 and the subsequent amendments (EU Regulation 2023/607 of 15.03.2023). They will acquire knowledge on the medical devices sector, on contextual data, on healthcare spending on medical devices and on the related recent problems regarding the so-called “health payback’’ (Decree Law of the Italian Ministry of Health in agreement with the Ministry of Economy and Finance of 07.06.2022, Decree Law of the Italian Ministry of Health 06.10.2022), on market access (HTA, VBP, Coding, reimbursement), on registration requirements, conformity assessment, CE marking and market surveillance.They will be able to correctly interpret and apply regulatory provisions, understanding their impacts on the development, production and marketing of medical devices.

Learn about the classification of medical devices

Another important objective of the postgraduate course is to examine the lassification of medical devices according to current legislation. Participants will examine the different types of medical devices and their implications in terms of compliance requirements and assessment procedures. They will develop skills to identify the appropriate type for a specific medical device depending on its purpose of use, associated risks and other relevant factors.

Understand conformity assessment procedures

Participants will learn the requirements to obtain the CE marking and the various modules of conformity assessment, such as risk analysis, clinical evaluation, biological evaluation and laboratory tests. They will be able to manage the conformity assessment process in order to ensure compliance with regulatory requirements and the safety of medical devices.

Learn about lifecycle management of medical devices

Participants will explore the development, manufacturing, commercialization, and post-market surveillance phases of medical devices. They will examine contextual data, healthcare spending, issues related to technology assessment (HTA), performance coding, reimbursement mechanisms and Value Based Procurement (VBP), as well as healthcare statistics for the assessment of healthcare services and their outcomes. Moreover, they will acquire essential skills to manage tasks related to each phase, including documenting, monitoring and reporting adverse events, updating clinical data and managing any changes concerning medical devices.

Acquire knowledge regarding market surveillance mechanisms and responsibility of the actors involved

Participants will explore the roles and responsibilities of manufacturers, notified bodies, competent authorities and end users in ensuring the safety and the effectiveness of medical devices. They will be able to assess and manage the risks associated with medical devices and actively contribute to market surveillance, as well as understand the importance of “real world” data in post-market activities.