The recent meeting entitled “Medical Devices Regulation: state of the art in the Medical Devices and Healthcare sector”, in which Dr. Tatiana Vignudelli, Head of SGQ (ISO13485) and Deputy Technical Manager MDD/MDR at Ente Certificazione Macchine, participated in the round table, proved to be a crucial and highly attended opportunity for discussion for the medical device industry. The event, organized by Confindustria Emilia Area Centro, highlighted not only the ongoing commitment to compliance, but also the persistent critical issues that manufacturers and Notified Bodies are facing eight years after the entry into force of Regulation (EU) 2017/745.

THE CHALLANGES OF CERTIFICATION AND OPEN DISCUSSION

The session saw a responsive and attentive audience, eager to share experiences and find clarity. The central theme remained that of the difficulties and uncertainties in MDR certification. Despite the extensions provided for in Regulation (EU) 2023/607, the certification process for new devices and those in transition continues to present procedural complexities and more stringent requirements for technical documentation and clinical evaluation.

Another hot topic that was widely discussed was the management and evaluation of changes to certified medical devices. Determining when a change requires a new substantive evaluation or a simple notification, and how to properly document this process in accordance with the MDR, represents a significant point of friction and operational uncertainty for companies.

THE MDR REVIEW: A FINAL ROAD MAP

The event also provided a crucial update on the forecasts for the revision of the MDR regulation. The regulatory community eagerly awaits developments that should lighten and streamline some of the most burdensome aspects of the Regulation, while maintaining high safety standards.

Current estimates indicate that the official proposal for the revision of the MDR Regulation should be published by December 2025.

This proposal will be followed by the actual legislative adoption process, the timing of which is notoriously difficult to define precisely, but which is nevertheless estimated to take 18-24 months.

The meeting therefore reaffirmed the centrality of the MDR to patient safety and the competitiveness of the sector, while emphasizing the need to address current operational challenges with an eye to imminent regulatory changes.