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.