The sixth edition of Regulatory Affairs Day was held yesterday, confirming its status as one of the most important event in Europe for the analysis and in-depth examination of the regulatory framework governing medical devices (MD) and in vitro diagnostics (IVD). The event brought together the main stakeholders in the sector in Rome, from institutions to companies, notified bodies and professionals, for a day entirely dedicated to the future of the MedTech sector.

THE EVENT

The event’s agenda focused the debate on the progress made and the critical issues still open in the complex process of transition to the MDR and IVDR Regulations. The discussion centred not only on the technical aspects of compliance, but also on broader strategic issues, such as the prospects for the sustainability of the regulatory system and the identification of concrete strategies to ensure competitiveness and innovation in European industry.

THE CONTRIBUTION OF ENTE CERTIFICAZIONE MACCHINE

A significant contribution to the debate was made by ENTE CERTIFICAZIONE MACCHINE (ECM), a Notified Body (NB) active in the sector. Its participation demonstrates the organisation’s ongoing commitment to supporting informed and shared growth in the supply chain. ECM played an active role in one of the most crucial sessions of the day.

In particular, Vanessa Biavati, ECM’s Technical Manager for Medical Devices, spoke as a representative of the Notified Bodies in the round table entitled: “Feedback from experience gained in the certification of products and quality systems”. Her speech offered a direct and operational perspective on the challenges and best practices that have emerged so far in the conformity assessment process, providing essential insights for companies and for the future development of guidelines.

The session provided an opportunity to analyse in detail the difficulties encountered by manufacturers and Notified Bodies themselves during the certification process according to the new standards, highlighting the importance of constant and transparent dialogue between all stakeholders. This opportunity for dialogue and in-depth discussion proved essential in guiding the sector throughon a path that requires technical expertise and strategic vision to maintain the excellence and accessibility of medical devices on the European market.