ECM will take part in the roundtable discussion with Notified Bodies at the AFI Symposium in Rimini on June 12, focused on innovation and the use of new technologies for substance-based medical devices under the MDR.

On Thursday, June 12, 2025, our Technical Manager Tatiana Vignudelli will speak at the afternoon session of the 64th AFI Symposium – the Italian Association of Pharmaceutical Industry Professionals (Scientific Society), a key event for the pharmaceutical and medical device sectors, taking place in Rimini from June 11 to 13. ECM will participate in Session X – Medical Devices, focusing on innovation and new technologies for substance-based medical devices within the MDR framework, in a roundtable discussion featuring several Italian Notified Bodies.

A ROUNDTABLE ON REGULATORY CHALLENGES

The Notified Bodies’ roundtable in Session X will address some of the most pressing challenges posed by Regulation (EU) 2017/745 (MDR), including:

• management of legacy devices and strategies for clinical data collection and presentation;
• critical issues and synergies between companies and authorities regarding combination products;
• the certification pathway for innovative medical devices;
• the impact of artificial intelligence on risk/benefit analysis for substance-based medical.

This roundtable aims to foster a technical and constructive exchange among authorities, companies, and certification bodies, contributing to the development of a more consistent and effective approach within the MDR regulatory framework.

ECM’S EXPERTISE IN MDR CERTIFICATION

ECM – Ente Certificazione Macchine is Notified Body No. 1282 for the certification of medical devices in accordance with Regulation (EU) 2017/745. With a multidisciplinary team and extensive experience in medical device certification, ECM supports manufacturers throughout all stages of the certification process, ensuring rigorous assessment and reliable timelines. Participation in the AFI Symposium provides a valuable opportunity to share expertise, understand industry needs, and actively contribute to the harmonized application of the MDR in an increasingly complex and dynamic regulatory landscape.

Would you like to learn more about our certification services for medical devices under the MDR? Contact our Sales Team: Diego Stevanella diego.s@entecerma.it | Marzia Pellegrini marzia.p@entecerma.it

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