Last October, our Technical Manager Eng. Vanessa Biavati, and our Clinical Expert Dr. Marianna Mastroroberto, took part in the MDR Clinical Data Training organized by Team NB – the association that brings together the major European Notified Bodies for medical devices.

The meeting, focused on the new requirements of Regulation (EU) 2017/745 for clinical evaluation, was a key moment of dialogue and discussion in order to achieve a better harmonization between the notified bodies involved in sharing the application of the new regulation.

ECM is a member of the NB Team, a prestigious recognition that means to become part of an internationally recognized organization, where members work together to clarify and bring their opinion on the main regulatory issues.

Team NB – the European Association of Notified Bodies for Medical Devices – was founded in 2001 and currently has 26 members from 14 different countries, who cooperate with the purpose of promoting trasparency and communication between Notified Bodies, to provide constant update and discussion at the regulatory level. The association aims to support the innovation and continuous development of the medical devices sector, through the guarantees of quality, safety and effectiveness ensured by certification.

Being part of Team NB means participating in moments of exchange fundamental for a better understanding of the regulatory landscape, dealing with interlocutors of high competence and experience. The regulatory changes that will be introduced by the new MDR 2017/745 require constant updating, supported by open dialogue with institutions and other stakeholders.

The certification of medical devices is an essential element for manufacturers to maintain high confidence in their products. Therefore, it is essential to choose a Notified Body that – in addition to the proven skills resulting from accreditation – is aware of the regulatory evolution, in order to ensure high standards of reliability and safety.

ECM is working with commitment and dedication on the necessary activities to obtain as soon as possible the accreditation as Notified Body for the MDR. Given the increasing knowledge it is acquiring, ECM invites manufacturers and medical devices professionals to prepare for the incoming changes by contacting us: ECM Sales Manager Antonio Balassone – antonio@entecerma.it | mob. +39 393 2471040