The ECM’s competences in the field of medical devices recognised at European level

12 January 2022

ECM Medical Devices Division invited as speaker to the MDR training of the European Notified Bodies for medical devices.

The next 13 and 25 January 2022, our Technical Expert Tatiana Vignudelli will participate as a speaker at the MDR Technical Documentation Training organized by Team-NB, the association that brings together the major European Notified Bodies for medical devices.

These training events have a twofold objective:

  • to help Notified Bodies deal with the new technical documentation requirements in their assessment activities;
  • to achieve a better harmonisation between Notified Bodies, thanks also to the exchanges facilitated by case studies.

Facing the complexity of the new MDR 2017/745 Regulation, the Team-NB trainings are an opportunity for study and alignment among Notified Bodies to deepen the most current and complex regulatory issues. In particular, this session will focus on the topic of technical documentation assessment of medical devices. Dr. Vignudelli from ECM, together with experts from other notified bodies, will discuss the requirements to be met and the information that the technical documentation must contain to demonstrate the conformity of the device.

Ente Certificazione Macchine is an active member of Team-NB – the European Association for Medical Devices of Notified Bodies founded in 2001, which today counts 28 members from 17 different countries. Thanks to this direct and continuous participation, it is possible to get an in-depth understanding of the regulatory landscape and future directions of the regulatory scenario.

Would you like to receive information about our services for the medical device market? Contact our Sales Manager Eng. Diego Stevanella at | mob. (+39) 393 2471040