New MDR 2017/745: ECM increases its competences

16 September 2020

Next 29-30 September 2020, our Technical Expert Tatiana Vignudelli will attend as speaker at the Technical Documentation Training organized in Bruxelles by Team-NB, the association that brings together the major European Notified Bodies for medical devices. The meeting is an opportunity for the training and alignment among the notified bodies on the subject of the technical documentation assessment of medical devices, according to the Regulation (MDR) 2017/745.

As well as helping notified bodies to address the new requirements of technical documentation in their assessments, the meeting encourages discussion and feedback among participants, in order to promote a better harmonization on shared issues.

As Notified Body for the MDD 93/42/EEC DirectiveEnte Certificazione Macchine is an active member of Team-NB – the European Association of Notified Bodies for Medical Devices founded in 2001, which currently includes 24 members from 14 different countries. The aim of the association is to promote transparency and communication between Notified Bodies, in order to guarantee a continuous updating and dialogue on regulatory matter.

Being part of such an international association and being called as speakers to bring its contribution and experience is a great prestige for Ente Certificazione Macchine, as well as a unique opportunity of interaction with highly competent interlocutors.

ECM keeps on its road to achieve at the soonest the accreditation as Notified Body for MDR Regulation 2017/745, while continuing to carry out the certification activities in accordance with MDD 93/42/EEC. For information about our services: Sales Manager ECM Antonio Balassone – | mob. +39 393 2471040