Ente Certificazione Macchine, as Notified Body no. 1282 for the Regulation (EU) 2017/745 will take part in the institutional meeting organised by the Ministry of Health involving the major players of the Italian regulatory panorama.

On 18 July 2023, ECM Medical Devices Division will attend the meeting day involving Notified Bodies and Accredia, organised by the Ministry of Health.

The aim of the meeting is to discuss the activity of notified bodies and the aspects related to the entry into force of Regulation (EU) 2017/745 (MDR). The agenda will in fact address aspects related to the transitional period, as well as the latest updates on ongoing European activities.

By encouraging debate between authoritative interlocutors, these meetings represent an important opportunity for alignment between notified bodies and institutional organisations, in order to find a shared approach to the application of the regulations.

Ente Certificazione Macchine – Notified Body No. 1282 for Regulation (EU) 2017/745 – is accepting new certification applications to assess the conformity of medical devices according to MDR requirements. In light of the extension of the transitional provisions, introduced by Regulation (EU) 2023/607, we invite manufacturers to contact us to clarify the conditions for extending the validity of MDD certificates and to start the MDR certification process as soon as possible.

For more information, please contact ECM Sales Manager Ing. Diego Stevanella at diego.s@entecerma.it | (+39) 393 2471040