where we are

News center
Stay up-to-date with the latest industry news and announcements. Subscribe to our free ECM e-newsletters and publications.

News archive

  • 03.05.17 Medical Devices Directive: news and updates from European Notified Body round table
    In the last weeks, it’s been held in Brussels the 56° coordination meeting of European Notified Bodies for Medical Devices Directive 1993/42/CE. For ECM, already involved as Notified Body in many European meeting for the other directives of our expertise, it has been the first time as Notified  Body for Medical Devices Directive, participating with our Technical Manager Eng. Vanessa Biavati.
    Amongst the faced topics, the most relevant has been the discussion in matter of the new Regulation for Medical Devices (MDR – Medical Device Regulation), whose emission is expected in the next months. When the new Directive will be effective, it will replace the actual 93/42/CE, therefore both manufacturers and Notified Bodies have to face a series of very important changes.

    What is going to happen to certificates issued in accordance with the actual directive? What will change and how long will the transition time be, to let manufacturers adapt to new requirements? How the Medical Devices classification will change?

    As Notified body for this directive, Ente Certificazione Macchine is constantly updated about the development and news of the new MDR, and it’s preparing to face the imminent changes and giving manufacturers an answer for those needs dictated by the regulation transition expected in the near future.

Ente Certificazione Macchine© 2015 ECM

Via Cà Bella 243, 40053 Valsamoggia
Location Castello di Serravalle (Bo) Italy
Privacy Policy Cookie

P. +39 051 6705141 - F. +39 051 6705156info@entecerma.it P.IVA 02604150363

lock_outlineRestricted
Area
made by Krescendo

Login

Or

Sign Up