Confindustria Emilia has organized a meeting entitled “Medical Devices Regulation: state of the art in the Medical Devices and Healthcare sector” in Modena, focusing on the crucial issue of Medical Devices Regulation (MDR), EU Regulation 745/2017. The event, which will be held tomorrow, aims to provide a comprehensive update on the status of implementation of the Regulation, analyzing in particular the critical issues and developments that have emerged eight years after its entry into force.

THE IMPACT OF THE MDR REGULATION ON THE SECTOR

The MDR Regulation has introduced changes that have had a profound impact on the entire biomedical sector, generating significant changes not only for manufacturers and distributors of medical devices, but also for hospitals and healthcare professionals.

Although regulatory compliance requires manufacturers to meet more stringent EU safety standards (MDR), this challenge can be successfully overcome by choosing the right partner.

THE PARTICIPATION OF ENTE CERTIFICAZIONE MACCHINE

The initiative offers a high-profile discussion forum, bringing together leading experts in the field, including representatives from major certification bodies. The participation of these specialists will allow us to address topics of practical interest that are fundamental for companies, such as the general aspects of the Regulation, the timelines to be followed, and the documentation to be submitted for MDR by manufacturers.

We are particularly pleased to announce the participation of Dr. Tatiana Vignudelli, Head of the QMS (ISO13485) scheme and Deputy Technical Manager MDD/MDR at Ente Certificazione Macchine. Her contribution will significantly help to address the new requirements and promote alignment between notified bodies and companies in the sector, bringing her experience in the field of technical documentation assessment for medical devices.