ECM increases its involvement with the main European regulatory bodies and organisations for medical devices.

As Notified Body no. 1282 for the European Directive 93/42/EEC (MDD), ECM is an important player in the periodic meetings organised at international level by the institutions. In particular, in the next few days our Technical Manager Eng. Vanessa Biavati will be involved in two relevant events.

64th NBCG-Med meeting (Notified Bodies Coordination Group – Medical Devices)

The meeting, which will take place online on 14 and 15 April, will engage Notified Bodies in a discussion with stakeholders and representatives of the European Commission. The main regulatory issues of the moment will be discussed and explored, based on the direct experience of the participants and in consideration of the upcoming application of the new MDR 2017/745 Regulation.

Team-NB Ordinary General Assembly

The General Assembly of Team-NB, the European association that brings together the major European Notified Bodies for medical devices, will take place on 14 April, with ECM participating as an active member of the association. The meeting is an important opportunity of dialogue and updating among certification bodies, in order to promote a better alignment at regulatory level.

The aim of these meetings is to encourage the exchange of opinions and experiences among attendees, helping the parties involved to face the problems encountered through shared solutions.

Ente Certificazione Macchine is pleased to participate and contribute to the discussion. At the same time, our experience is enhanced by the interaction with prestigious and competent interlocutors. Only through careful and continuous participation in these events is it possible to get an in-depth understanding of the regulatory framework and the directions of the future scenario.

For information on our services in the medical device field, please contact the ECM Sales Manager Antonio Balassone at antonio@entecerma.it | (+39) 393 2471040.