EU Medical Device Regulation 745/2017 and Post-Market Surveillance: Regulatory Analysis, Clinical Cases and Personal Experience

This thesis analyses the European regulatory framework for medical devices, focusing on Regulation (EU) 2017/745 (MDR) and the Post-Market Surveillance (PMS) system. The first chapter outlines the transition from Directive 93/42/EEC to the MDR, which introduced a lifecycle-based approach emphasizing safety, transparency, and clinical evidence. It examines key innovations such as stricter requirements for notified bodies, the EUDAMED database, the Unique Device Identification (UDI) system, the Person Responsible for Regulatory Compliance (PRRC), and the mandatory implementation of PMS and Post-Market Clinical Follow-up (PMCF) activities. The second chapter explores PMS as a proactive system designed to ensure device safety and performance after market placement. It analyses methodologies, regulatory obligations, and implementation challenges, with a focus on implantable devices. Case studies from the literature—such as hip prostheses, breast implants, and embolization coils—highlight the importance of real-world data, artificial intelligence, and clinical registries in detecting risks and improving patient safety. The third chapter presents the internship experience at EME Srl, a manufacturer of Class IIb electromedical devices, and describes the implementation of PMS activities for the Shock Med device. The analysis included the development of PMS, PMCF, vigilance, and complaint reports, confirming the device’s favorable benefit-risk profile and full compliance with MDR requirements. Overall, the thesis demonstrates how the MDR and PMS framework enhance regulatory robustness, promoting a transparent, evidence-based, and patient-centered approach to medical device governance in the European Union.