The European Parliament has adopted a text addressing challenges in implementing medical device regulations. This document responds to problems identified in applying the 2017 legislative framework, affecting patients' access to essential medical technologies. The proposed measures aim to ensure supply continuity and improve certification procedures.
Regulations (EU) 2017/745 and 2017/746 were adopted to strengthen safety and transparency standards for medical devices and in vitro diagnostic devices. Initial objectives included enhancing patient safety following several scandals involving faulty medical equipment and promoting innovation in the sector. The current framework seeks to ensure rigorous clinical assessments and post-market monitoring.
Transition periods for implementing the regulations have been extended multiple times, most recently by Regulation (EU) 2024/1860. The European Commission must present concrete proposals by the end of the first quarter of 2025. Implementation will be coordinated by the Commission in collaboration with member states and the European Medicines Agency.
Patients will benefit from better access to safe and innovative medical devices. Manufacturers, especially SMEs, will experience more efficient certification procedures. Healthcare professionals will have access to quality medical technologies. The Eudamed system will ensure greater transparency for all stakeholders. Online health applications will require certification to protect user data.