Thanks to the efforts and resources put in place in recent years to expand its expertise, the Medical Devices ECM Division is gaining even more international relevance.

In collaboration with Meditrial – a world-leading organisation in clinical research – ECM took part in one of the projects promoted by CRISPEL (Centro di Ricerca Interdipartimentale per gli Studi Politico-costituzionali e di Legislazione comparata dell’Università di Roma) and the Ministry of Health, in the field of medical devices.

THE PROJECT

Specifically, Ente Certificazione Macchine was involved in providing the notified body’s point of view on some aspects of the MDR process in relation to the ESF – the Early Feasibility Study Programme developed by the FDA. The aim of the project was to assess the compatibility between the new EU Regulation 2017/745 (MDR) and the US ESF Early Feasibility Study Programme. The MDR analysis – conducted by our Clinical Expert Dr. Marianna Mastroroberto – has provided some clarifications and considerations regarding some aspects of the clinical investigation and certification process.

THE CONTEXT

The new Regulation (EU) 2017/745 is bringing many changes to the medical device world. Medtech companies, Notified Bodies and all stakeholders will have to comply with the new requirements. In this phase, the analysis and study of the new regulation is essential in order to better understand it, clarify unclear points and compare it with existing legislation.

We are very proud to have participated in such a prestigious and internationally relevant research project, together with experienced and authoritative partners. At the same time, being invited to contribute to a highly specialised topic is an important recognition of our work and expertise.

ECM is pursuing its path towards MDR accreditation with perseverance and dedication, never interrupting its certification activities and guaranteeing its services, even in the most difficult moments of the pandemic. We have now reached the final stage involving the European Commission, which will conclude the accreditation process. We hope to reach our goal as soon as possible.

For more information on our services, please contact our Sales Manager Antonio Balassone at antonio@entecerma.it | mob. (+39) 393 2471040.